A EUROPEAN CODE OF GOOD PRACTICE
FOR HYPERBARIC OXYGEN THERAPYCENTRE FOR HYPERBARIC MEDICINE
Hospital
Critical care unit
Emergency room
Medical services

HYPERBARIC FACILITY
HYPERBARIC SYSTEM

HYPERBARIC CHAMBER
Pressure vessel
Mono or multiplace

Air compressors
Air andOxygen storage

Chamber operators
TechniciansSupervisors

Physicians
Attendants
Nurses

Prepared by the Working Group «SAFETY»
of the COST Action B14 «HYPERBARIC OXYGEN THERAPY»May 2004

A EUROPEAN CODE OF GOOD PRACTICE FOR HBO THERAPYA EUROPEAN CODE OF GOOD PRACTICE
FOR HYPERBARIC OXYGEN THERAPY

List of content

Page

List of authors.............................................................................................................. 1
Acknowledgements ..................................................................................................... 1
1. Introduction ............................................................................................................. 1
2. Definitions ............................................................................................................... 2
3. Staffing ....................................................................................................................4
3.1. Responsibilities................................................................................................. 4
3.2. Competencies and education ........................................................................... 4
3.3. Minimum team during a hyperbaric session for multiplace chambers .............. 5
3.4. Minimum team during a hyperbaric session for monoplace chambers ............. 5
3.5. Fitness and health surveillance ........................................................................ 5
4. Equipment ............................................................................................................... 6
5. Gas supply .............................................................................................................. 6
5.1. Quality .............................................................................................................. 6
5.2. Quantity ............................................................................................................ 7
6. Risk management ................................................................................................... 7
6.1. Process............................................................................................................. 7
6.2. Generic hazards ............................................................................................... 8
6.3. Specific hazards ............................................................................................... 9
7. Procedures............................................................................................................ 11
7.1. Standard Operating Procedures ..................................................................... 127.2. Emergency Operating Procedures ................................................................. 127.3. Maintenance ................................................................................................... 127.4. Record keeping .............................................................................................. 127.5. Patient safety.................................................................................................. 13
8. Annexes ................................................................................................................ 16
Annex 1 – ECHM Educational and Training Standards for the Staff of Hyperbaric
Medical Centres 1997 (informative)....................................................................... 16
Annex 2 – ECHM Recommendation for Safety in Multiplace Medical Hyperbaric
Chambers 1998 (informative) ................................................................................ 35
Annex 3 – COST B14 Working Group «Technical Aspects» Final Report 2001
(informative)........................................................................................................... 48
Annex 4 – Framework for Operating Manual ......................................................... 68
Annex 5 – Record Keeping.................................................................................... 70
Annex 6 – Patient Management ............................................................................ 72
Annex 7 – Prohibited Materials.............................................................................. 73

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A EUROPEAN CODE OF GOOD PRACTICE FOR HBO THERAPY

List of authors
Jacek Kot (Secretary, PL), Jordi Desola (E), Antonio Gata Simao (P), Roly GoughAllen (UK), Robert Houman (B), Jean-Louis Meliet / Francois Galland (F), Christian
Mortensen (DK), Peter Mueller (D), Seppo Sipinen (FIN)
Acknowledgements
The COST Working Group «Safety» (WGS) would like to thank the British Hyperbaric
Association (BHA) for allowing the WGS to draw heavily on their document "Healthand Safety for Therapeutic Hyperbaric Facilities: A Code of Practice”, which was
published in late 2000. This COST WGS document also draws on other European
documents, directives and publications as listed in References.
A special mention must also be made to the two documents of the European
Committee for Hyperbaric Medicine (ECHM) listed below which were also
instrumental in the production of this European Code of Good Practice for HBO
Therapy.
• ECHM Educational and Training Standards for the Staff of Hyperbaric
Medical Centres (Annex 1)• ECHM Recommendations for Safety in Multiplace Medical Hyperbaric
Chambers (Annex 2)
Also the contribution made by the COST Working Group «Technical Aspects» (WGT)
is greatly appreciated for their previous work and report (Annex 3) and for identifying
the need for this publication which is intended to compliment the forthcoming
prEN14931 document once it is published.
The Draft prEN14931 document, the French diving regulations and Italian guidelines
from ISPESL were also reviewed when producing this Code of Good Practice.
COST B14 WGS would like to thank all parties for their assistance in the productionof this document and refer you to the References for the complete list of documentsthat were considered when drawing up this publication.
1. Introduction
The main goal of this document is to present a European Code of Good Practice for
HBO Therapy based on existing experience from experts of hyperbaric centres,
committees, professional and scientific associations.
This document is intended to be a reference document for European countries for
Guidelines, Regulations, and Standards in hyperbaric medicine.
It relates to hyperbaric treatment as a procedure affecting patients, staff and any third
parties involved in the therapeutic process and not to the medical protocols unlessthese protocols modify the level of safety.
This document was written by members of Working Group «Safety» of the COST
Action B14 «Hyperbaric Oxygen Therapy» and approved by the Management
Committee.
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A EUROPEAN CODE OF GOOD PRACTICE FOR HBO THERAPYThis document applies to all facilities for Hyperbaric Medicine that provide hyperbaric
treatments to patients. Codes for ensuring the safety of patients and staff should also
apply to medical research exposing human subjects to a hyperbaric environment.
The scope of this document covers the safety of patients, staff, third parties and theinfrastructure which includes the organisation of the facility, staff education, standard
and emergency procedures.
It does not relate to manufacturing aspects and technical requirements for hyperbaric
system and other medical devices used in hyperbaric treatments as they are or will
be covered by dedicated European Norms of their own.

2. Definitions
In this Code the following terms and definitions are used:
Hyperbaric therapies are methods used to treat diseases or injuries using pressure
higher than local atmospheric pressure inside a hyperbaric chamber.
Within hyperbaric therapies, Hyperbaric Oxygen Therapy (HBO) consists ofbreathing oxygen at a pressure higher than local atmospheric pressure. Pressure ofsession, oxygen partial pressure and duration of session should be according to thestate-of-art.
Thus, HBO is defined by all three essential elements:
 breathing oxygen
 increased ambient pressure a hyperbaric chamber.
Therefore, this document applies to all hyperbaric therapies, and the term HBO isused to describe them all.
A hyperbaric therapeutic chamber is a pressure vessel capable of accommodating
one or more persons with the purpose of providing medical treatment. Two kinds oftherapeutic chambers exist:••

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Multiplace chambers have two or more compartments and allow access ofstaff/patients and equipment while maintaining pressure in the main
compartment. They are intended to hold two or more persons including theattendant.
Monoplace chambers are single compartment vessels designed for a single
patient. They do not allow direct access to the patient during the treatment.

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A hyperbaric chamber system consists of the hyperbaric chamber(s) including the
support equipment (gas and energy supplies, etc).
A hyperbaric facility consists of the therapeutic hyperbaric system(s) together withassociated plant, buildings, staff (both technical and medical), and a specificadministrative organisation. Two kinds of hyperbaric facilities exist: hospital based
and standalone. However, in each and every hyperbaric facility there should be anarea adequately equipped to receive and care for medical emergencies.
A centre for hyperbaric medicine is a medical facility that provides HBO for
patients and additional treatments, surveillance and attention to the medical
conditions of the patient. The centre for hyperbaric medicine must be physicallylocated in or functionally linked to a hospital. Centres should be categorised
according to their capability to treat patients that require critical care.
A hyperbaric session is a period of increased pressure above ambient atmosphericpressure, within a therapeutic hyperbaric chamber, for the purposes of treatment of apatient. It includes treatment when breathing oxygen, air, or breathable mixtures.
A hyperbaric treatment consists of the total (one or more) hyperbaric sessions asprescribed.
A patient is any person suffering from a medical condition, who may occupy a
hyperbaric chamber during a hyperbaric treatment with the purpose of altering thenatural course of their illness. This definition of a patient includes persons who
receive prophylactic hyperbaric oxygen, and those who are control subjects intherapeutic trials of hyperbaric therapy.
A third party means every other person in the vicinity of the facility not necessarily
involved in the hyperbaric treatment (eg. patient’s family, transport staff, etc.).
A breathable gas means any gas or mixture of gas administered to the occupants of
the hyperbaric chamber at a specific pressure.
A standard operating procedure describes the detailed working practice for all
anticipated normal activities within the facility.
An emergency operating procedure describes the behaviour of the staff inabnormal operational conditions or during any foreseeable unplanned or adverse
situations.
A medical device is defined as any item of equipment required for the treatment of
the patient and not for the operation of the chamber (which is itself a medical device).
Internal equipment is a part of the hyperbaric chamber system.

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3. Staffing
Each staff member should be familiar with their functions and responsibilities.
3.1. Responsibilities
All hyperbaric facilities need various staff with different skills and these staff arereferred to by the skill they bring to the team. These skills are defined below.
The Medical Director is the appointed physician responsible for all functions
developed in the hyperbaric centre.
The Hyperbaric Physician is responsible for the clinical activity related to hyperbaric
treatments.
The Hyperbaric Nurse is responsible for the practical implementation of patient careduring hyperbaric treatment.
The Supervisor is responsible for all safety during the hyperbaric session.
The Attendant is responsible for direct care of the patient inside the multiplacechamber, within the limitation of their qualification.
The Chamber Operator is responsible for the safe operation of the chamber system
according to the operating procedures.
The Technician is responsible for maintenance and repair of equipment inaccordance with laid down procedures.
OthersMany other professionals with different qualifications may be engaged within a
hyperbaric centre, depending on the special characteristics of each and the hospitalor institution where it is located.
3.2. Competencies and education
Competencies and education of hyperbaric personnel should follow the standards
presented in the ECHM/EDTC document (see Annex 1). This document needs to be
regularly updated so the aspects not currently covered may require the use ofnational standards in the meantime.
All staff should maintain their skills by training and continuous education whichshould be documented.
According to European Directive N° 89/391/EEC the employer must ensure that all
staff are also adequately trained in the occupational hazards.

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3.3. Minimum team during a hyperbaric session for multiplace chambers
During any session the functions involved are:Supervision of the treatment (medical aspect and safety of operations),
Operation of the chambers,
Attendance of patients under pressure,
Emergency assistance under pressure if needed.
Thus, the minimum recommended team size is three people:
One hyperbaric physician.
One attendant
One operator.
Actual team sizes will depend on risk assessments and shall consider the multi-roleabilities of the available staff. Special consideration should be made for the possibilityof the need to give immediate assistance.
A supervisor must be appointed.
The location of the individual members of the minimum team is the responsibility ofeither the duty physician or duty supervisor, however the whole nominated teamshould remain in the facility and immediately available.
3.4. Minimum team during a hyperbaric session for monoplace chambers
During any treatment the functions involved are:Supervision of the treatment (medical aspect and safety of operations),
Operation of the chambers,
Emergency assistance if needed.
Thus, the minimum recommended team size is two people:
One hyperbaric physician
One operator.
The location of the individual members of the minimum team is the responsibility ofeither the duty physician or duty supervisor, however the whole nominated teamshould remain in the facility and immediately available.
3.5. Fitness and health surveillance
Exposure to the pressurised environment may result in occupational hazards. To
prevent the risks:
3.5.1. People working even occasionally under pressure must undergo an
appropriate initial and periodical medical examination to be recognised fit for
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hyperbaric exposures according to national regulations for work under pressure.
Consideration should also be given to daily fitness, and the possibility of pregnancy
or illness.
3.5.2. Any illness related to working under pressure must be reported according tonational regulations. The employee must be declared fit for hyperbaric exposures
before returning to work under pressure.
3.5.3. Facilities must adopt a set of published decompression procedures in order toreduce to a minimum the risks associated with single and repeated exposures. They
may include additional safety considerations to the standard procedures. Proceduresshould consider the limits of repeated exposures (pressure, duration and surface
interval) per person within a 24 hour period and the number of daily exposures
without a break (see section 6.3.5.). Obligation for decompression stops should be
kept to the minimum, enabling decompression to atmospheric pressure within areasonable time. In any event, procedures for immediate recompression of
attendants should be in place.
4. Equipment
4.1. Hyperbaric chambers and internal equipment must comply with the prEN14931.
4.2. Medical devices should comply with the recommendations of the Annex B of theprEN14931.
4.3. Other equipment
Equipment that does not belong to the internal equipment of the chamber and which
is not a medical device, should be of an appropriate design and fit for use in thehyperbaric environment up to the maximum working pressure of the chamber it isused within. General safety recommendations given in the Annex B of theprEN14931 may be applicable.
4.4. MaintenanceAll the facility’s equipment should be maintained according to the manufacturer’s
instructions.

5. Gas supply

5.1. Quality
Breathable gases administered to the patients must comply with the European
Pharmacopoeia, with consideration given for impurities and their additional toxic
effects due to the increased ambient pressure. Gases not listed in the European
Pharmacopoeia (i.e. helium) should comply at least with appropriate standards
covering breathing gases for divers at work.

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Air to pressurise the chamber(s) must comply with EN 12021. In the absence ofavailable standards, any other gas must be breathable at least with the same level ofsafety as for divers at work.
5.2. Quantity
The volume of all gases must comply with the prEN14931.
6. Risk management

6.1. Process
Risk management is a systematic application of management policies, proceduresand practices to the tasks of analysing, evaluating and controlling risks.
According to EN ISO 14971 it is the responsibility of the manufacturer to perform therisk management of the medical device.
Any activity within the hyperbaric facility needs to be covered by the risk
management process performed by each individual facility.
The risk management process shall be documented and shall include the following
elements:
 Risk analysis
o intended use / intended purpose identificationo hazard identificationo risk estimation
 Risk evaluationo risk acceptability decisions
 Risk control
o option analysis
o implementationo residual risk evaluationo overall risk acceptance
The first step in risk management is a risk assessment which is a careful
examination of what, in the work place, could cause harm to people, so that one canweigh up whether enough precautions have been taken or more should be done toprevent harm. The aim is to take all reasonable steps to make sure that no one getshurt or becomes ill. The important things to be decided are whether a hazard issignificant, and whether it is covered by satisfactory precautions so that the risk issmall.
Taking into account the intended use of the hyperbaric chambers (types of sessions,breathing mixtures, numbers of persons inside, treatment protocol) it is necessary tolook for the hazards (hazard identification), where a hazard is something with the

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potential to cause harm (this may include, by its very nature, the hyperbaric
environment, plant, equipment, and human factors).
For each identified hazard there is a risk estimation, where a risk is the possibility
that harm will occur and its nature and severity.
All risk assessments should be documented and all the staff should be informed
about outcomes of the assessment. Records from risk assessment should be kept for
future reference.
After the evaluation of risk, the decision is taken whether the existing precautions andpractices are adequate or whether more could be done (risk acceptability
decisions). If there is a possibility to take some precautions to avoid a hazard or tominimise the risk (risk control), the analysis of possible solutions is performed(option analysis) and modifications to the system are implemented.
After each modification the whole process of risk assessment is repeated. Even after
all precautions have been taken, some risk usually remains (residual risk). For eachsignificant hazard the decision should be made if it is acceptable (overall risk
acceptance).
Parts of the risk management process are generic and/ or specific for each facility.
Other facilities may have some similar process but it is a facility’s duty to analyse andreduce the risks to an acceptable level. It is not acceptable to copy or use other risk
assessments without first applying them to each individual hyperbaric facility.
In a centre for hyperbaric medicine, risks may arise from medical, technical,
mechanical, administrative, environmental or human factors related to the functioningof the facility. Where the risk cannot be eliminated completely, substitution of theexisting arrangement by an alternative, safer, procedure or method should beconsidered. Where elimination of a hazard is not possible, the control measures andprocedures to minimise the risk should be defined and documented in the Standard
Operating Procedures.
This process is annually reviewed or whenever introducing new equipment,machinery or when other local events may effect the working environment.
6.2. Generic hazards
Hazards may be divided into subcategories as suggested in Annex D of the ISO EN
14971:a) energy hazards and contributory factorsb) biological hazards and contributory factorsc) environmental hazards and contributory factorsd) hazards resulting from incorrect output of energy and substancese) hazards related to the use of the medical device and contributory factorsf) inappropriate, inadequate or over-complicated user interfaceg) hazards arising from function failure, maintenance, ageing and contributory
factors.

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6.3. Specific hazards
A list of specific hazards is included in the COST B14 Working Group «TechnicalAspects» Final Report – see Annex 3.
A hyperbaric treatment requires a number of phases, which must be in the correct
sequence. Some of these phases may be complex and involve technical as well as
medical procedures, which on there own do not present a hazard but in combination
may. It is essential to take account of this potential problem when conducting the risk
assessments. Before the facility can accept any patient it is vital to check if it has thecompetence (including technical, medical and staffing) to treat a patient with their
specific condition. All system checks and evaluation of the patient should becompleted before any session starts. Many factors need to be considered and it is
not possible to provide an exhaustive list of hazards and risks in this code, but someexamples of hazards found in therapeutic hyperbaric facilities are listed below:
A.
B.
C.
D.
E.
F.
G.
H.
I.
J.
K.
L.
M.
N.
O.
P.

pressures (risk of explosion, loss of pressure vessel integrity);adequacy and integrity of pressurised gas supplies;
pressure differentials (catheter / cannula cuffs, seals, vascular lines, drainage);
oxygen (risk of ignition, cerebral and pulmonary toxicity);
quality and quantity of breathing gas supplies;
electricity (electrical safety within the pressure vessel);prohibited materials within the chamber (see Annex 7);
fire (procedures for prevention, suppression, and evacuation);suitability of medical devices used inside the chamber;staff health and safety, including medical surveillance and precautions against
dysbaric injuries in staff’;hygiene and infection control (disinfection of masks, hoods, ventilators andassociated equipment, alert pathogens policy, chamber disinfection);management of body fluids, waste, sharps and infected materials;
manual handling of patients on entry, exit from chamber and during treatment(use of slides, hoists and other patient handling aids);
noise hazards and control measures (both for internal occupants of chambers
and external staff);thermal stressany other hazards (display screen equipment, slip, trip, bump and fall hazards
etc).

6.3.1. Oxygen toxicity
Cerebral oxygen toxicity is an inherent risk to both patients and attendants whobreathe greatly increased partial pressures of oxygen during, or while decompressing
from hyperbaric treatments. The risk of convulsions due to cerebral oxygen toxicity
may be considerably greater in cases such as pyrexia, hypoglycaemia, elevatedinspired carbon dioxide levels, increased cardiorespiratory workloads or intracerebral
pathology.
The possibility of unpredictable oxygen convulsions, both in patients and attendants,
should be anticipated and individual therapeutic facilities should develop anddocument procedures for responding to such events and their foreseeable sequelae.

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Pulmonary oxygen toxicity in staff is unlikely outside the context of saturation
recompression of a diving casualty. It may become a problem in patients given
extended or frequent repeated treatments, or acutely ill patients receiving high levels
of inspired oxygen between treatments. This possibility should be kept in mind by
medical staff when deciding the risks and benefits of alternative treatment regimens
for individual patients. Calculation of Units of Pulmonary Toxicity Dose (UPTD) may
help in some cases, but each case must be judged on its merits.
6.3.2. Electrical safety
Electrical safety and the risk of fire in the hyperbaric environment are closely linked.
Guidance on electrical safety issues is detailed in the Annex B of the prEN14931.
The installation of additional electrical equipment (eg. for research) should be limited
only for devices which comply with hyperbaric conditions.
6.3.3. Prohibited materials
The single greatest risk to accidents comes from introducing prohibited materials
inside the pressure vessels. Therefore it is essential that all patients and staff ensurethat checks are in place to avoid this risk. For the list of prohibited materials refer toAnnex 7.
6.3.4. Fire safety
The risk of fire is a major and very real concern in the hyperbaric environment. The
potential for accidental ignition of flammable materials is increased in the hyperbaric
environment and their burning rate is markedly enhanced by a raised percentage orraised partial pressure of oxygen. Care must be taken to exclude various flammable
substances and equipment that could be sources of ignition as many different typesof equipment may not be appropriate for the hyperbaric environment. For multiplacechambers, fire prevention and fire fighting systems are detailed in the prEN14931;
however an individual risk assessment should be made in all cases. Chambers
should have a written emergency policy detailing procedures for in-chamber fire
prevention, and general actions in the event of fire in the chamber and/or the facility
buildings. Fire in the facility buildings and evacuation procedures including removing
patients from the chamber should be specifically considered and documented.
6.3.5. Dysbaric injuries during / after hyperbaric treatment
Patients who have breathed oxygen during the majority of their hyperbaric treatment
may develop a barotrauma but are unlikely to develop decompression
illness/sickness.
Attendant staff may breathe compressed air during much of a hyperbaric treatment,
and they are potentially at risk of any kind of dysbaric injuries. Therapeutic hyperbaric
facility staff should receive training in the recognition and prevention of
decompression illness/sickness in themselves and attendants, and proceduresshould be in place to ensure the timely assessment and recompression treatment of
any staff members if required. Restrictions on travel and physical exercise may need
to be considered.
Hyperbaric facility staff should be aware of the limitations on diving, flying or travel inmountainous regions for a specified time after attending a hyperbaric treatment,
depending on the pressure and length of exposure.
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6.3.6. Manual handling
Hyperbaric chambers treating unconscious, ventilated patients, and patients who areless than fully ambulant, particularly in multiplace chambers with no walk-in door,
may recognise an appreciable risk of musculoskeletal injury to staff involved in thetransfer of patients in and out of the chamber. Mechanical hoists, slide systems, andother patient handling aids should be used to control and reduce the risks to all thestaff. The specific methods employed should be dictated by risk assessments in theparticular context of each individual therapeutic facility. Written procedures forreasonably predictable scenarios should be developed.
6.3.7. Thermal stress
For the comfort and safety of attendants and patients, the Standard Operating
Procedures for the therapeutic hyperbaric facility should specify ways in which thechamber environment can be maintained in thermal balance to avoid detrimental
effects of excessive heat or cold to the chamber occupants. Upper and lower limits
should be set and adhered to. Guidance on thermal parameters is detailed in theprEN14931.
7. ProceduresCouncil Directive 93/42 states that it is the responsibility of the manufacturer tosupply the information needed to use all the medical devices, taking into account thetraining and knowledge of the users.
Council Directive 89/391 states that the employer must identify safety measures inorder to prevent hazards linked to their activity becoming a problem.
In consequence, each therapeutic hyperbaric facility should develop its own
operating manual which details the working practices for all anticipated activities
within the facility.
The operating manual should contain all such information and instructions, including
standard and emergency procedures and contingency plans to give advice, to guide,or to regulate the behaviour of those taking part in the function of the facility, either ina medical or technical capacity. Emergency procedures must be developed to coverunplanned events. The manufacturer’s operating manual must become an integral
part of the facilities operating manual.
A proposed framework for operating manual for hyperbaric facility is given in Annex
4.
The operating manual should be reviewed periodically and updated as appropriate.
All staff should be familiar with the guidance contained therein, relevant to theirposition. A copy must be immediately available for any operating staff.

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7.1. Standard Operating Procedures
The Standard Operating Procedures shall cover the general procedures fortherapeutic hyperbaric chamber operation as well as hyperbaric treatment protocols.
They shall also provide contingency procedures for any reasonably foreseeable
emergency (see below).
A clinical assessment of the risks and benefits of hyperbaric exposure specific toindividual patients in the context of the disease processes or injuries from which they
are suffering are the responsibility of the Medical Director. Areas that may warrant
attention are listed in Annex 4.
7.2. Emergency Operating Procedures
All hyperbaric facilities will either, adopt their hospital general emergency proceduresor develop their own.
During hyperbaric treatments, medical and system events that require technicalaction as well as medical input for their prompt and appropriate management are
inherent and predictable occurrences. The technical constraints of the hyperbaric
environment complicate the management of medical emergencies. Hyperbaric
facilities may approach such emergencies in different ways, depending on their
specific circumstances (type of hyperbaric facilities and chambers, availability of
specialised personnel, condition of patients, medical devices used in treatment).
Each hyperbaric facility should develop and document procedures to guide theactions of its staff in the event of specific emergencies and these must be integrated
with the general emergency procedures.
Emergency Procedures must be clearly defined, understood and exercised on aregular basis to ensure that the whole team is adequately trained. Areas that may
warrant attention are listed in Annex 4.

7.3. Maintenance
Each hyperbaric facility shall ensure that the hyperbaric system is serviceable andmaintained in a safe working condition.
Based on the manufacturer's instructions, a register of maintenance should:
 describe all maintenance procedures and the frequency that each task needs to be
carried out;
 record all actions (i.e. particular formal inspections, re-certifications, spare partschanges) and technical incidents or breakdowns.
7.4. Record keeping
Therapeutic hyperbaric facilities should record and maintain data relating to the
Health and Safety, technical and clinical aspects of their operation. All staff
potentially affected by such hazards should be made aware of this information which
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should be an intrinsic part of the facility’s Standard Operating Procedures
documentation. Record keeping should be kept on three levels: facility, system andpatient. The minimum set of information recorded in the logs is presented in the
Annex 5.
7.5. Patient safety
Standard Operating Procedures for therapeutic hyperbaric facilities should document
guidelines or facility policy for the reception, treatment and discharge of patients inthe facility.
Reception of a patient should involve medical staff taking a clinical history or handover of the patient’s clinical details as his/her clinical condition indicates or allows.
This should be accompanied by an appropriate pre-treatment assessment by thehyperbaric physician.
A guide of matters that can be developed for the phases of patient management andassociated issues is summarised in Annex 6 and 7.

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A EUROPEAN CODE OF GOOD PRACTICE FOR HBO THERAPYREFERENCES, RELEVANT LEGISLATION, STANDARD, GUIDELINES AND
LITERATURE

References:
1. Health and Safety for Therapeutic Hyperbaric Facilities: A Code of Practice,
British Hyperbaric Association, 2000
2. Council Directive 93/42 of June 1993 concerning medical devices (12.7.93
N°L 169/1 – 169/43, 1993
3. Council Directive 89/391/EEC of 12 June 1989 - Introduction of measures toencourage improvements in the safety and health of workers at work, 1989.
4. French Diving Regulations (decree 90-277 of 28 March 1990 and applying
orders – Brochure N° 1636 "Works in Hyperbaric Environment", French
Republic Official Journal), 1990.
5. ISPESL – Guidelines – Safety Supervision of multiplace hyperbaric chambers
in a clinic environment – Rev Oct 1999.
6. prEN14931. Pressure vessels for human occupancy (PVHO) – Multiplacepressure chamber systems for hyperbaric therapy – Performance, safety
requirements and testing, 2004
7. European Norm 12021, Respiratory protective devices – Compressed air forbreathing apparatus, 1999
8. European Norm ISO 14971, Medical devices – Application of risk
management to medical devices – Amendment 1: Rationale for requirements(ISO 14971:2000/AM1:2003).
9. European Pharmacopoeia
10. 6th ECHM Consensus Conference on Prevention of dysbaric injuries in diving
and hyperbaric work, Geneva, 2003

Relevant legislation, standards, guidelines:
1. DIN 13256 , Part 2: Pressure vessels for human occupancy: accessiblepressure vessels for hyperbaric therapy; safety requirements and testing.
Beuth Verlag GmbH, Berlin, 2000
2. DIN 13256. Part-3: Pressure vessels for human occupancy: fire extinguishingsystems in pressure vessels: safety requirements and testing, Beuth Verlag
GmbH, Berlin, 2001
3. Guide to Fire Safety Standards for Hyperbaric Treatment Centres, British
Hyperbaric Association, 1996
4. Guide to Electrical Safety Standards for Hyperbaric Treatment Centres, British
Hyperbaric Association, 1996
5. National Fire Protection Association (NFPA 99) Chapter 20 Hyperbaric
Facilities, 2002

Relevant literature:
1. First European Consensus Conference on Hyperbaric Medicine – Theapplications of Hyperbaric Oxygen; standards for education and training,
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future directions of research; technical requirements. Lille University Medical
Center, Lille, France. Wattel F, ed., 1994
2. Handbook of hyperbaric medicine. Oriani-G; Marroni-A; Wattel-F (Ed.), Berlin,
Springer: 737-740, 1996
3. Multiplace chamber safety guidelines, UHMS,1994, UNITED-STATES
4. Hyperbaric Facility Safety: A Practical Guide. Workman-T (Ed.), Best
Publishing USA, 1999
5. Hyperbaric Medicine Practice - Second Edition, Edited by Eric P. Kindwall,
Harry T. Whelan, 2000
6. Textbook of Hyperbaric Medicine. Jain-KK (Ed.), Hogrefe & Hubner
Publishers, USA, 1999
7. The Training and Education of Hyperbaric Unit Personnel, British Hyperbaric
Association, 1999

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Annex 1

8. Annexes

Annex 1 – ECHM Educational and Training Standards for the Staff of Hyperbaric
Medical Centres 1997 (informative)

EDUCATIONAL AND TRAINING STANDARDS FOR
THE STAFF OF HYPERBARIC MEDICAL CENTRES
Written by
Jordi Desola* and Jurg Wendling**
for theJoint Educational Subcommittee(*) European Committee for Hyperbaric Medicine (ECHM)(**) European Diving Technical Committee (EDTC)FOREWORD
These educational and training standards are the result of some years ofinternational discussion which began prior the 1st European Consensus Conference
on Hyperbaric Medicine, Lille, in September 1994 where one session was devoted to"Personnel education and training policies". A comprehensive paper and thesubsequent debate defined the 5 different personnel categories ideally involved in
the staff of a Centre of Hyperbaric Medicine.
A working group being formed to define the requirements for medical doctors in thefields of diving and hyperbaric medicine. An important feature of this project was thecollaboration between the European Committee for Hyperbaric Medicine (ECHM),
which is primarily a medical committee, and the European Diving Technology
Committee (EDTC) which is a 15-nation committee with not only government,
industry and trades union representatives but also with a doctor nominated from eachmember country. This joint subcommission was formed by J. Desola (Spain), D.Elliott(United Kingdom), P. Longobardi/ P. Pelaia (Italy), F. Wattel (France), and J.
Wendling (Switzerland). It was chaired by J.Desola on behalf of the ECHM and
J.Wendling by the EDTC.
The Goal-setting Principles for Harmonised diving Standards in Europe waspublished by the EDTC in 1997 and includes a section on the "Qualifications,education and training of medical doctors"(appendix 2).
The work presented here has been done by the Joint Medical Subcommittee of these
two main committees and, from time to time, reports by this Subcommittee havebeen submitted to and approved by each of the two parent bodies.
It is the purpose of this paper to summarise what has been accomplished and to lookat the future tasks of a Joint Medical Subcommittee of the ECHM & EDTC.
INTRODUCTION
A Hyperbaric Centre must guarantee the best use of its equipment, and services.

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Depending on the kind of facility and of the final aim of its services, the Hyperbaric
Centre can function on a continuous (24 hours a day) basis or intermittently, during
periods of time scheduled in advance.
Depending on its technical availability’s, the location, and the available medical
services, the Hyperbaric Centre can be a hospital facility, or an open self standing
Centre.
A hospital Hyperbaric Centre must guarantee its assistance 24 hours a day, andmust be able to offer adequate treatment for all kinds of diseases, including thoserequiring critical care inside the Chamber.
A self standing Hyperbaric Centre might have a certain work schedule, and must limit
its services to those patients not in emergency situation. It must be in functional
relation or contact with a general hospital.
In cases that a transportable hyperbaric chamber is used, the schedules, profiles,
staff and regulations will be the same of a self standing centre.
Staff requirements affecting these types of facilities should agree with theaforementioned conditions of availability and system of work.
This work aims to review the kind of staff needed by the Hyperbaric Centre, to define
their behaviour and giving some general rules to be applied in each situation,
depending on the conditions of each Centre. In the final items, the minimal personalrequirements of a Hyperbaric Centre will be mentioned.
In order to develop its functions correctly, a hyperbaric Centre needs different
professional qualifications. These could be summarised as follows:
1) The Medical Director and Physicians/Medical Doctors
2) Nurses
3) Attendants
4) Chamber Operators
5) Technicians6) Others
Characteristics, functions and background which should be followed by the whole
staff will be reviewed. In each category the following items will be detailed:A) Definition of functionsB) BackgroundC) Specific educational profile
D) Academic requirements and degrees
E) Continuous Education
F) Dedication

1 – THE MEDICAL DIRECTOR
THE PHYSICIANS / MEDICAL DOCTORSA) Functions.
The Medical Director is responsible for all functions developed in the Hyperbaric
Centre. This includes the following aspects.
1. Supervision of the correct operation of the hyperbaric facilities.
2. Medical care to the patients inside the Chamber, if a multiplace facility isused and whenever it might be necessary, due to reasons of critical care

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depending on the severity of the case, or special controls during
therapeutical procedures.
3. Quality assurance.
4. Follow up of patients.
5. Definition of protocol procedures for treatment.
6. Organisation and participation in multicentric over all protocols andtreatments.
The functions of the main Medical Director are complemented by a variable numberof collaborators of the same or similar background and education, in which theMedical Director can delegate some responsibilities, but always under his control.
One or two people will not be enough to guarantee a 24 hours a day service, as thelong stays inside the Chamber (when a multiplace facility is used) that they must
often endure, renders them incapable of further decompressions in the following
hours. A whole hyperbaric medical staff working in shifts would therefore benecessary.
B) Background.
The Medical Director is a Medical Doctor with a wide multidisciplinary education.
Internal Medicine, Critical Care and/or Intensive Medicine, Reanimation andAnaesthesiology, can provide the best background.
Other specialisation might also be adequate, if the candidate has documented
experience and he has received the necessary education and training in Hyperbaric
Medicine.
Sport or commercial diving can give to the Medical Director a great deal of additional
knowledge. This also provides awareness of the whole problem concerning thisspecialisation and it can add some complementary knowledge on diving andhyperbaric technology and practice. However this actual diving experience will not be
required for the recognition of the Medical Director.
C) Educational profile.
The Medical Director should have followed a full Medical Educational
Multidisciplinary Programme, in different fields of Medicine. A Medical Doctorate in
Medicine is the basis. The medical education must be completed with Postgraduate
courses in both Diving and Hyperbaric Medicine, preferably followed in University
Departments.
D) Academic requirements and degrees.
The Medical Director, like all the medical staff in a Hyperbaric Centre, will be
subjected to all regulations of WORK UNDER PRESSURE established by theEuropean Community.
Even if Medical Directors have received a good self-trained education, they need a
specific titulation degree, in order to avoid legal problems concerning the possible
responsibilities deriving from the practice.
Definition of jobs
The training objectives of each job need to be defined in relation to the competencies
that are expected from the incumbent. A number of the jobs in diving and hyperbaric
medicine have tasks and objectives in common and so it is possible to optimise theefficiency of the educational program and avoid too much overlap by adopting a
modular structure.
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I. The Medical examiner of divers
 Competent physician to perform the periodic "Fitness to dive assessments" ofworking and recreational divers and compressed air workers, except the initialassessment of novice professional divers.
IIa. The Diving medicine physician
 Competent to perform the initial and all other assessments of working andrecreational divers or compressed air workers.
 Can manage diving accidents and advise diving contractors and others on diving
medicine and physiology* (with the back-up of a hyperbaric expert or consultant).
 Should have knowledge in relevant aspects of occupational health. (He or she does
not need to be certified specialist in occupational medicine to be in accordance withthe standards).
IIb. The Hyperbaric oxygen physician
 Responsible for HBO sessions at the treatment site (with backup of a hyperbaric
expert or consultant) Should have appropriate experience in anaesthesia and intensive care in order tomanage the HBO patients (he or she does not need to be certified specialist inanaesthesia to be in accordance with the standards)
 Competent to assess and manage clinical patients for HBO treatment
III. The Hyperbaric expert or consultant (hyperbaric and diving medicine) Competent as chief of a hyperbaric facility (HBO centre) and/or to manage themedical and physiological aspects of complex diving activities1.
 Competent to manage research programs.
 Competent to supervise his team (HBO doctors and personnel, health professionals
and others).
 Competent to teach relevant aspects of hyperbaric medicine and physiology to allmembers of staff.
IV. The Associated specialists
This title is not a job qualification, but rather a function. It covers experts, consultants
and specialists of other clinical specialities who can be nominated as competent toadvise within their own speciality upon specific problems in the diving and hyperbaric
field.
Contents of the Modules
Levels of competence:a - basicb - need to knowc - must be expert

Modules of formation and subjects

Jobs:

1

I

IIa

IIb

III

optional additional qualification for bell diving (saturation, mostly off-shore)

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1

Annex 1

Physiology & pathology of diving and hyperbaric exposure:1

Hyperbaric physics

b

c

c

c

2

Diving related physiology I (functional anatomy, respiration, hearing and

b

c

b

c

b

c

a

c

equilibrium control, thermoregulation)
3

Hyperbaric pathophysiology (Immersion effect, blackout mechanism incl
apnoea, psychology, working performance/endurance under water)

4

Hyperbaric pathophysiology (decompression theories, bubbles)

b

c

b

c

5

acute Dysbaric disorders, DCI (Barotrauma, DCS)

b

c

b

c

6

chronical Dysbaric disorders (Long term effects)

b

c

a

b/c

7

HBO-Basics (effects of hyperbaric oxygen)

-

b

c

c

8

O2 Intoxication

a

c

c

c

9

Inert gas-effects (Narcosis/HPNS)

a

c

a

c

10

medicaments under pressure

b

c

c

c

11

non-dysbaric diving pathologies (Hypothermia, near drowning, fauna&flora

a

c

-

c

a

a

-

b/c

-

a /c

effects, injuries and accidents in water, the sick diver)122

diving fatalities
Diving technology and safety:

1

b

1

1

diving procedures (Bell diving)b

2

Diving procedures (SCUBA, surface supplied, bell, TUP, SURD, 02-Deco,

b

c

a

a/ c

b

b

a

a/c

b

b

a

a/c

3
4

mixed gas diving
Divers (Recreational SCUBA diving, technical and deep diving, Apnoeadiving, professional diving: offshore, inshore, scientific, media, recreational
diving instructor, Caissonwork, astronauts)
Diving gear (SCUBA, SSUBA, mixed gas, rebreathers, monitoring
equipment, working tools, suits)

5

Diving tables and computers (incl altitude and interval)

b

b

b

a/c

6

Regulations and standards for diving

b

b

-

a/c

7

Safety planning / management (monitoring)

b

b

-

a/c

c

c

c

c

3

Fitness to dive1

Fitness to dive criteria and contraindications (for divers, tunnel workers andHBOT patients and chamber personnel)

2

Fitness to dive assessment (diagnostics)

c

c

c

c

3

Fitness to dive standards and regulations (prof and recreational d.)

c

c

b

c

a

c

a

c

-

c

c

c

4

Diving accidents:
1

Diving accidents / incidents (assessment and preclinical treatment incl.
ORL, barotraumas, CPR)

2
1

Diving accident management clinical (Diagnostics, patient care, follow-up)

as required

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3

Diving accident management: Differential diagnosis

a

c

c

c

4

HBO-T for diving accidents (Tables and strategies)

a

c

c

c

5

Rehabilitation of disabled divers

-

a

a

b/c

b

c

c

5
1

Clinical HBO:
Chamber technique (multiplace, monoplace, transport chambers, wet
recompression)

2

HBO: Mandatory Indications

-

a

c

c

3

HBO: Recommended Indications

-

-

c

c

4

HBO: experimental and anecdotal Indications

-

-

b

c

5

Data collection / statistics / evaluation

-

b

b

c

6

general basic treatment (nursing)

-

b

c

c

7

Diagnostic, monitoring and therapeutical devices in Chambers

-

c

c

c

8

Risk assessment, incidents monitoring and safety plan in HBO-Chambers

-

b

c

c

9

Safety regulations

-

c

c

c

6

Diverse:1

Research standards

-

a

a

c

2

Paramedics teaching program

-

b

a

c

3

Management /Organisation of HBO facility

-

a

a

c

7

Practical training:
1

Fitness for chamber-dive test (of the course participants)

-

+

+

+

2

CPR

-

+

+

+

3

Practice in field first aid (diving accidents)

-

+

-

+

4

Practical training FTD exam (skills)

+

+

+

+

5

Demo : professional diving

+

+

-

+

6

Demo : HBO-T

-

+

+

-

+

+

+

-

+

7

Introduction to (wet)-Diving(+)

8

Practice in HBO-T (including pressure test)-

9

Practice in attendants teaching

-

+
2

+

4

+
+

3

Standards for course organisation and certification
Teaching courses
In order to comply with this EDTC/ECHM standard the person responsible for the
professional contents of the course must be a hyperbaric medical expert orconsultant (job type III)2

recommended
exceptions possible, if important reasons of unfitness to dive3
as required4

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1. The course curriculum should be declared as being ”in conformity with the
ECHM/EDTC standards” and the educational objective (jobs I and IIa, IIb) stated.
2. The course organisers are invited to send a copy of the curriculum to the joint
medical subcommittee of ECHM/EDTC (through the national co-ordinator).
3. The final tests for individual evaluation are mandatory, and should cover all thetaught subjects (see list) at the level of competence required for each subject.
The standards do not prescribe the status of the teaching institution but it is strongly
recommended that courses are university based, are approved for such training
courses by national health authorities, speciality training boards or are under the
auspices of the national scientific society for diving medicine and/or hyperbaric
medicine.
How a course is to be organised is not prescribed in these standards. Evenings,
week-ends or full weeks are possible. For clinical teaching, an internship or residency
may be appropriate. The acknowledgement of a high teaching standard is based ona credible final test of the candidates.
Modules and course organisation
The actual organisation and conduct of the modules will be influenced by local
factors and so it is proposed that these details can be decided on a national basis
and probably left to the individual course directors. The following proposal indicates
the total teaching hours considered necessary to achieve appropriate competencies
in the following jobs.

I
IIa
IIb

III

Medical examiner of divers

25 lecture hours + 3 hours
practical
Diving medicine physician
The above + 30 additional lectures+ 10 hours practical
Hyperbaric medicine physician
60 hours + a practical phase (5different types of clinical caseswith different indications fortreatment)
Diving and hyperbaric medicine expert This needs further review (seeor consultant
below)The proposal serves as a guideline and is not mandatory. When one of theseteaching programmes includes topics covered elsewhere a reduction in the numberof lecture hours may be justifiable.
Recognition of an expert
The experience needed to become an expert cannot be learned from a course. The
essentials have already been described in general terms. The candidate should
already be an accredited specialist or equivalent.

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Except in those countries where some equivalent or higher standards already exist,
those who wish to be acknowledged as experts or consultants in the fields of diving
and hyperbaric medicine should send their curriculum to their national co-ordinator(representing the Joint Medical Subcommittee or to that subcommittee itself if thatnation has no co-ordinator) who may decide on the basis of the agreed standards.
The Joint Medical Subcommittee will be informed by the national co-ordinator and
can issue a list of experts if required. In the future the verification of achieved
qualifications will be done by a national health authority or a scientific body (EUlegislation). The aim is to achieve a recognition of the standards by those so that they
automatically could take over the role of the national co-ordinator.
E) Continuous Medical Education (Quality Control and Competency).
The Medical Director should undertake a periodic Continuous Education programme,
about the main aspects of Underwater and Hyperbaric Medicine. Participation in
Courses, Workshops and Conferences organised by International Societies well-known
in this field, such as the European and Baromedical Society (EUBS), the Foundation for
the International Congress on Hyperbaric Medicine, the Undersea & Hyperbaric
Medical Society (UHMS), or other courses approved or reviewed by the ECHM, could
also be adequate.
Professional ethics and medical deontology oblige all Medical Directors to communicate theirobservations and improvements in the different fields of Diving and Hyperbaric Medicine totheir colleagues of the international scientific community. In addition, the Medical Director musttake advantage of the experiences of his international colleagues, and must take part in the
wide-spread studies that might be performed.
The highest qualified Hyperbaric Centres should organise Courses, Workshops andperiodical activities aiming to improve the education of specialised staff at all levels.
In most countries, the conditions for maintaining the active status of an individual aredefined by some system of continuous medical education credit points (CME, asintroduced in the USA some time ago). The ECHM & EDTC need to define theminimum requirement for this in a flexible way that provides enough freedom for thenational bodies to establish a more detailed system. It is expected that these national
requirements will be compatible with this guidance.
The following procedure is proposed:
Job I:A minimal activity of 10 medical assessments of divers fitness per year is neededplus attendance at one refresher course (usually 2-days) in two years. Reactivation
after a lapse needs participation in two 2-day refresher courses or a repeat of the fullbasic course.
Job IIa:
Continuing experience in the field of professional diving (e.g. advising a professional
diving contractor or some equivalent activity) and participation in a course orcongress previously approved by the national co-ordinator. Reactivation after a lapse
should be on the basis of a specifically approved course. Where this cannot be
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Annex 1

achieved, the candidate should submit an alternative training programme to thenational co-ordinator for approval.
Job IIb:
Active employment in an HBO facility (or equivalent activity) and attendance at one
national and/or international congress on hyperbaric medicine per year. Reactivation
after a lapse needs a 10 working days in a HBO facility and attendance at two
congresses in two years.
Job III:
Will rely on the decision of the national co-ordinator
The refresher seminars can serve to update the participants in order to confirm theiractive status and to reactivate those who temporarily have not maintained theirrequired activity. They can also serve as an introduction to doctors of otherspecialities who may also gain CME credits in their own specialities. This not only
can help the financing of a course but can be a chance for promoting HBO to those
who would not attend the HBO scientific congresses.
F) Dedication.
All Hyperbaric Centres should have a permanent Medical Director, with partial or
full-time dedication depending on the characteristics of each Centre, complemented bya variable number of collaborators of the same or similar background and education.
Hospital centre treating patients in situation of emergency will probably need more than
three medical doctors.

2 – NURSESA) Functions.
As in all fields of Medicine, nurses complete medical treatment and they are responsible
for the practical implementation of patient treatment.
The Hyperbaric Nurses perform the usual functions of their profession with somevariations due to the characteristics of the hyperbaric activity :1. Nursing measures belonging to the common pathologies of the Hyperbaric
Therapeutics to be applied to the patients in a self standing chamber.
2. Nursing assistance of patients inside the hyperbaric chamber, taking special
care of the specific conditions of the hyperbaric environment.
3. Adaptation of conventional medical techniques and specific treatments of each
illness to the hyperbaric environment, so the other treatments that the patient ishabitually receiving have not to be interrupted while in the chamber.
4. In some cases, operating the external controls of a Monoplace Hyperbaric
chamber according to the compression and decompression schedules
established.
B) Background.
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Annex 1The Hyperbaric Nurse must have the corresponding degree of her profession. Specificeducation in Critical Care Nursing will be very useful. Knowledge of other specialisation
like angiology, traumatology, and wound care will also be appropriate.
Special courses on Diving and Hyperbaric Medicine are essential.
The nurse may receive the necessary training in the same institution from the Medical
Director.
C) Specific educational profile.
Hyperbaric Nurses should also receive a complementary education, according to theirprofessional level, in the following matters:
1. General principles
Pneumatics.

ofDecompression

Theory,DivingTechnique,and

2. Hyperbaric Technique.
3. Safety and preventive measures.
4. Operation of monoplace hyperbaric chambers.
5. Intensive critical care of patients.
6. Other aspects inherent in both Diving and Hyperbaric Medicine, concerning her
profession.
D) Academic requirements and degrees.
A basic education and a nursing degree will be required.
Special courses for hyperbaric nurses are highly recommended but they will not bestrictly required.
The hyperbaric nurse will be subjected to the regulations on WORK UNDERPRESSURE established by the European Community.
E) Continuous Education.
As in all fields of Health and Medicine, Hyperbaric Nurses must complete and continue
their education by reading specialised texts, and attending Courses and Congresses.
Their affiliation to specialised professional societies, such as the Nurses Baromedical
Association or to other entities that might be created, would be of the greatest interest.
F) Dedication.
All hospital based Hyperbaric Centres should have a permanent team of Nurses, withpartial or full-time dedication depending on the needs of each Centre.
One or two people will not be enough to guarantee a 24 hours a day service, as thelong stays inside the Chamber that they must often endure (when a multiplace facility isused) renders them incapable of decompressions in the following hours. A whole teamof hyperbaric nurses working in shifts would therefore be necessary.

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3 – ATTENDANTS
A) Functions.
Patients inside a multiplace chamber need always to be under the control andsupervision of trained personnel. Critical patients will always be joined by a doctor, anurse, or both.
Other patients however do not need such kind of direct and special medical and nursing
assistance, and in those cases the participation of a type of staff, specially trained,
although not necessarily highly qualified may be adequate.
These are some of the activities attributed to attendants:
1. Patient care in non invasive, non-specialised medical activities inside andoutside the chamber.
2. Accompanying patients who are receiving treatment inside the Multiplace
Chamber, but who do not need special assistance by doctors and nurses, but
only by way of support, control, and to give them confidence.
3. Other activities to develop inside or outside the Chamber, indicated by the
Medical Director or the Nurse.
If monoplace chambers are used, the majority of these activities may be adopted bydoctors and/or hyperbaric specialists and nurses.
B) Background.
Attendants can come from different professions regarding Underwater and Hyperbaric
Medicine, such as:
1. Sport or commercial divers.
2. Health auxiliaries, medical students, paramedics, or assistants.
3. Other professions preferably although not necessarily health/related.
Items 1 and 2 are the most adequate conditions or origins for working as an attendant.
However, these degrees should not be necessarily requested.
Their education and training may be accomplished in the same hyperbaric institution.
C) Specific educational profile.
At a level according to their capacity, previous experience and kind of work, Attendantsshould be instructed in the following aspects:
1. General principles of Medicine and Therapeutics.
2. Medical First Aid.
3. General principles of Diving and Hyperbaric Medicine.
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Their basic education may be received in the same institution
specialist and/or doctors and nurses.

Annex 1from a hyperbaric

As a result of this non-specific education programme, the Attendants should meet thefollowing requisites.
a) To feel comfortable in the hyperbaric environment.
b) Excellent practice with hyperbaric techniques and necessary manoeuvres foradapting patients to the pressure.
c) Sufficient knowledge of the main non invasive medical instruments generally
used under pressure.
d) Capacity to interpret, but not to operate, the meaning of the control instruments
placed inside the Hyperbaric Chamber. They must also be familiar with thepressure and control devices.
e) To give First Aid care in the case of an emergency.
D) Academic requirements and degrees.
There is no specific degree providing the requirements of an Attendant. Some entities
organise educational courses adapted to this activity. However only a course on
Medical First Aid should be strictly required.
The Attendants will be subjected to the regulations of WORK UNDER PRESSURE
established by the European Community.
E) Continuous Education.
The Attendants will be informed in the same Institution, about any news on Underwaterand Hyperbaric Medicine and Technique which could affect their activity. Theirattendance at activities in the field of Diving and Hyperbaric Medicine should be
encouraged.
F) Dedication.
All hospital and self standing Hyperbaric Centres using multiplace hyperbaric chambers
should have a permanent team of Attendants, with partial or full-time dedication
depending on the needs of each Centre. One or two people will not be enough toguarantee a 24 hours/day service, as the long stays inside the Chamber that they must
often endure (if a multiplace facility is used) renders them incapable of further
decompressions in the following hours.
If monoplace chambers are used, the attendants may not be necessary since all theirfunctions are done externally by nurses and doctors and/or hyperbaric specialists.

4 - CHAMBER OPERATORSA) Functions.

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A Hyperbaric Facility may achieve a high level of sophistication that will require
specialised attention and care.
The Hyperbaric Chamber itself, the air-compressors, other pressurised gas sources, or
the gas reserves, have some special devices whose manipulation might be very
complex.
Monoplace chambers are handled sometimes by nurses and doctors and/or Hyperbaric
specialists.
When multiplace chambers are used, the Hyperbaric Centre must have qualified
personnel to manage the hyperbaric facilities. These functions must be preferably
carried out by specialised chamber Operators.
The functions of the Chamber Operator of a Multiplace facility will be:
1. Operation of the internal and external devices of the Chamber.
2. Control and operation of the mechanisms for compression and decompression,and for delivering gas mixtures and oxygen.
3. Control and application of the safety regulations concerning prevention of fire,and oxygen toxicity.
4. Calculation, application and control of compression and decompression
schedules for patients, Specialists and/or Doctors, Nurses and Attendants,
applying decompression stops, when necessary.
5. Sometimes, interventions inside the Chamber under pressure, in order to control
or check the correct operation of determined parts of the pneumatic circuits ordevices.
6. Adaptation and checking of the medical instruments carried by the patients
before being introduced into the Chamber, in order to assure their correct
operation, and to avoid dangerous or undesirable effects.
7. Control and checking of the operation of auxiliary facilities of the Chamber: aircompressors, sources of compressed air or medical gases, air reserves,pneumatic circuits, control systems.
8. Maintenance of the facility. Small repair jobs or technical interventions due toproblems which occasionally might occur, and which do not require theintervention of highly specialised technical staff.
B) Background.
Hyperbaric Operators usually come from a commercial diving environment, where often
received specialised training. This is not indispensable and Operators can come fromother areas.
Despite the fact that they come from a non-health-related profession, they will need tolearn elemental principles of health since they will be in contact with patients.

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Some paramedical professions and health-related activities common in hospitals, may
provide a good basis from which the candidate may be trained by the same institution to
become a chamber Operator.
C) Specific educational profile.
Whatever their previous experience might be, the Hyperbaric Operator need goodknowledge in the following subjects:
1. General Pneumatics.
2. General Mechanics and Electromechanics.
3. Decompression Theory. Decompression schedules.
4. Diving and Hyperbaric Technology.
5. Medical First Aid
6. General principles of Medicine, and Medical Therapeutics.
Courses on Diving and Hyperbaric Medicine for auxiliary staff, will provide good training
in all these matters.
D) Academic requirements and degrees.
Some diving centres, off-shore facilities, and other specialised entities, result in somecountries in specific degrees adapted to the activity of a chamber Operator. However,this condition should not be regarded as indispensable until the European Community
establishes a specific degree for chamber Operators.
A Degree in professional diving with a specialisation in hyperbaric systems and facilities
will be adequate.
A technical speciality degree in pneumatic systems, or similar titulation, would be ofgreat benefit although it is not absolutely indispensable.
The Chamber Operators will be subjected to the regulations of WORK UNDERPRESSURE established by the European Community.
E) Continuous Education.
Hyperbaric Operators will need to receive Continuous Education according to theadvances in the field of hyperbaric technology and also in decompression theory. They
must be regularly updated on the main aspects of the diseases that will be treated in
the chamber.
For this reason, his periodical contact with other specialised Centres is highly
recommended.
F) Dedication.
Since Chamber Operators are in charge of the operation of the Multiplace Hyperbaric
Chamber, their presence is absolutely essential in all hospital or self standing Multiplace
Hyperbaric Centres.
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Annex 1

A permanent Chamber Operator, with partial or full-time dedication depending on theneeds of each Centre, will therefore be needed.
In monoplace facilities, their services are also appreciated, but their functions can bealso attributed to other types of trained personnel.

5 – TECHNICIANS

A) Functions.
The Hyperbaric Centre needs employ to specialised technical staff, whose functions willbe the checking and control of the chamber, pneumatic circuits, gas or compressed air
reserves, air-compressors and the rest of the technical parts of the facility.
B) Background.
The Hyperbaric Technician must have a high level of knowledge in high, middle and low
pressure pneumatics. They should also possess a deep knowledge of diving andhyperbaric technology. Some experience in the field of medical technology would bevery suitable.
Some Chamber operators can also be technicians.
C) Specific educational profile.
In some areas, real specialists in diving systems or hyperbaric facilities will probably bevery difficult to find. In many cases, a high pressure Technician and some of thetechnical staff of a Hospital will quite easily be able to adapt his knowledge receiving
some additional instruction on pneumatics and high pressure.
D) Academic requirements and degrees.
The Hyperbaric Technician must have either an official degree with speciality inPneumatic Systems, or an official specific degree in Hyperbaric technology, in the
countries where these degrees exist.
This activity should not be entrusted topersons or firms which, although experienced, might not be in a legal condition to give
warranties, and cover responsibilities in case of a possible disfunction, emergency, oreven catastrophe.
E) Continuous Education.
The Hyperbaric Technician, being a high level Specialist, must always be aware of thelatest technological advances and new changes which might occur in his sector, inorder to use the most adequate systems.
F) Dedication.

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Annex 1

Depending on the amount of work and of the technical characteristics of eachHyperbaric Centre, maintenance of the facilities might be performed by full-timeHyperbaric Technicians or by subcontracted specialised firms or enterprises. Bothconditions are equally acceptable.

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Annex 1

6 - OTHER STAFF

Many other professionals with different qualifications may and should be engaged witha Hyperbaric Medical Centre, depending on the special characteristics of each and thehospital or institution where it is situated. Some of them are listed below.
1. Administrative
2. Statisticians
3. Rehabilitation
4. Fire specialists
5. Engineers
6. Others
Since the activities of these professionals do not adopt special characteristics ormodifications by being carried out in a hyperbaric centre, and as their duties will besimilar to their usual jobs, their functions, background, requirements, and dedication will
not be detailed in this document. All these conditions will be developed as in otherplaces or jobs.

7 - ACREDITATIONS AND CREDENTIALSThe ECHM will create a Subcommittee for specialist assessment or accreditation, thatwill establish a credential document as explained in the aforementioned criteria in
section 1 of this document.
The selection and guarantee process will be established by the Subcommittee in a
separate document, in which the following items will be specified:
1. Educational criteria.
2. Procedure for obtaining the credential.
3. Usefulness and validity of the credential.
In the meantime, lacking specific degrees in Underwater and Hyperbaric Medicine, theaforementioned credential will be the guarantee for a Hyperbaric Specialist.

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Annex 1

8 - MINIMAL REQUIREMENTS

The aforementioned staff may be adapted to each facility according their particularconditions. The number of persons integrating the full staff will be enough to provide in
any case at least the following persons and professions for every session of hyperbaric
treatment.
A) Multiplace chambers facility.
1 Medical Director
1-3 Physicians / Medical Doctors
1 Nurse
1 Chamber OperatorB) Monoplace chambers facility.
1 Medical Director
1 Nurse or attendant
The dedication and functions of each one will be developed as explained above. Other
types of staff will be included optionally according to the special characteristics of eachcentre and their needs.

9.- THE JOINT MEDICAL SUBCOMMITTEE OF
ECHM AND EDTC
This committee will operate on the basis of the tasks outlined above. The members
are the two chairmen of the education and training subcommittee of the ECHM andof the medical subcommittee of the EDTC respectively. Further two to threemembers are nominated by the chairmen on the basis of their special competence
and experience in one of the relevant topics. As the chairmen each represent a
specific subcommittee, any major changes or decisions must be discussed withinthese subcommittees before going to the meetings of the EDTC or ECHM
respectively.
Each country interested in educational courses recognised by EDTC/ECHM should
be represented by a member who has been acknowledged by the national hyperbaric
medicine authority (or of all such authorities if there are more than one such authority
in a country). Normally this would be either the national member of ECHM or thenational medical representative on the EDTC. If not the same individual, both could
attend if appropriate.
The EDTC and ECHM representatives of each country should nominate a national
co-ordinator of teaching programmes, who could be the joint subcommittee member
himself or who could delegate for that purpose (for instance to the national healthand safety authority or any representative scientific body covering all aspects of
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Annex 1

hyperbaric medicine). The national co-ordinator will have the duty to supervise thenational programs, the certification procedures and the status of the course directors.
In order to enhance credibility of certification and to help those who do not yet have theexperience necessary to establish a good validation system, the Joint Medical Subcommittee
will create a pool of multiple choice questions with an evaluation grid, in the main European
languages. This will be available for all members. Evaluation of the answers should be doneby an international group nominated by the Joint Medical Subcommittee. This Subcommittee
may also certify a national teaching syllabus or educational course if desired by its organisers,
thus helping the national societies or other authorities in getting accepted by theirgovernmental health and safety department or by their speciality boards.

Correspondence:
Jordi Desola, MD,PhD
Chairman
Educational Subcommission of the E.C.H.M.
FAX: +34-934-503-736
E-Mail: cris@comb.es
Jurg Wendling, MD
Chairman
Medical Subcommission of the E.D.T.C.
FAX: +41-323-223-839
E-Mail: mail@wendling.ch

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Annex 2Annex 2 – ECHM Recommendation for Safety in Multiplace Medical Hyperbaric
Chambers 1998 (informative)

ECHM Recommendations for Safety inmultiplace medical hyperbaric
chambers

Coordination and Correspondence :D. MATHIEU,
Service d'Urgence Respiratoire,de Réanimation Médicale et de Médecine hyperbare Hôpital Calmette- CHRU - 59037 LILLE - FRANCE
Tél : 03.20.44.54.91
Fax : 03.20.44.50.94
E-mail : dmathieu@chru-lille.fr

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1 - PRINCIPLES

Annex 21

1.1 - Scope of work
1.2 - Risk assessment
1.3 - List of reference documents
1.4 - Major points to be considered

1
1
1
2

2 - MANAGEMENT AND ORGANIZATION

2

2.1 - Responsible persons
2.2 - Supporting documentation* Safety manual* Hyperbaric Equipment Construction Data Book
* Maintenance register* Compression and decompression procedure manual* Day to day logging of personnel pressure exposures
2.3 - Personnel training / medical fitness
2.4 - Relationship with external emergency services
2.5 - Safety posters on site

3 - EQUIPMENT
3.1 - Construction of Hyperbaric Chamber* Pressure vessel* Architecture* Electric devices* Plumbing* Measurements, analysis, recorders* Fire fighting systems* Breathing masks* Lock attendant station
3.2 - Construction of buildings* Patients access* Connection with hospital* Fire precautions* Gas storage, compressors room, distribution plumbing* Equipment authorized for use under pressure
3.3 - Maintenance program* Schedule for maintenance operations* Air quality controls* Maintenance logging* Emergency drills

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2
3
3
3
3
3
3
3
4
4

4
4
4
4
5
5
6
6
6
6
7
7
7
7
7
7
8
8
8
8
8

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4 - OPERATIONS
4.1 - Staffing* Number and role of persons* Under pressure patients attending policy
4.2. Patient preparation / control* Information to the patients* Medical preparation* Practical preparation

5 - CONCLUSION

May 2004

Annex 2

9
9
9
9
9
9
9
10

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Annex 2E C H M RECOMMENDATIONS FOR SAFETY IN
MULTIPLACE MEDICAL HYPERBARIC CHAMBERS

1-PRINCIPLES
1.1-Scope of work
The purpose of this document is NOT to produce a new set of rules, standard or regulations
for the safety of H B O. These rules, standards and regulations exist and are available invarious forms and countries. A list of the major international ones is given below forreference.
This document is intended to be guidelines for the manager or any responsible person in an H
B O operation to help him making sure that all necessary safety precautions are taken care ofproperly.

1.2 Risk assessment
To make sure safety precautions are adapted to the situation, a risk assessment is necessary.
This is depending on the type of hyperbaric installation, the patients and the indications, aswell as the number of exposures carried out on a regular basis in the hyperbaric facility.
This document will not provide answers to all questions, it is only guidelines. An adapted
response to eliminate the risks and to reduce the unavoidable ones to an acceptable level mustbe established under the manager control for each particular Hyperbaric Centre.

1.3 List of reference documents
European Directives :CEN Medical devices:
CEN Pressure vessels:
CEN Noise at work :CEN Chemical agents:
CEN Electric devices / explosive atmospheres
1994
CEN Electric devices / electrocution
February 1993

93/42/CE
97/23/CE
86/188/CE
98/24/CE
94/9/CE
73/23/CE

dated 14 June 1993
dated 29 May 1997
dated 12 May 1986
dated 07 April 1998
dated 23 March
dated

19

1

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A EUROPEAN CODE OF GOOD PRACTICE FOR HBO THERAPYStandards :Annex 2

Air quality standard (medical air, breathable air...)
ASME PVHO
1998
NFPA
1998
UHMS (Monoplace 1991 and Multiplace 1994 - HBO Chamber Safety)
ECHM (Training standard) 1997

Other documents : Many independent control organisms have produced rules orcertification
policies for hyperbaric and diving systems which may be used forconformity
assessment of pressure vessels for human occupancy of HBO chambers(Bureau Véritas, Germanishe Lloyd, Lloyds, DNV,...)

1.4 Major points to be considered
Establishing and controlling a safety policy, at work for the attendants as well as in medical
practice for the patients, is one of the duties of the manager of the Hyperbaric Facility. Subdelegation of responsibilities should be clearly set and made known to the personnel.
The equipment used for HBO treatment is susceptible to generate risks both to the personnel
and to the patients, therefore some construction and maintenance standards should be referred
to for the equipment control and for the monitoring of the maintenance and in case of any
modification carried out on that equipment. This topic includes fire protection and fire
extinguishing systems.
Operational procedures need to be specified, posted and logged.

2 - MANAGEMENT AND ORGANIZATION
2.1 Responsible persons
It is the duty of manager of the Hyperbaric Centre to organize safety in the facility and heshould designate in writing who is in charge of:- Equipment, its maintenance and control (from compressed gases supplies to thechambers,
the controls panel, and the exhaust of gases and fire fighting equipment outside andinsidethe chambers),- Running the sessions and monitoring the operation,- Informing the patients, controlling their personal items and objects eventually carried
inside the chamber.

2
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Annex 2

2.2 - Supporting documentation* Safety manual
The safety manual is prepared and signed by the manager of the facility; it should include all
information necessary to carry out the hyperbaric sessions safely, including the description ofduties of the personnel involved. The content of this Safety Manual should be known by all
and specific information should be given to new comers to make sure they are perfectly awareof its content.
* Hyperbaric Equipment Construction Data Book (As built)
A technical document should contain all information concerning the plant, as built drawings,
all certificates with a list and dates of validity for easy check, basic operational procedures,
maintenance program recommended by the manufacturer, and logging of all modifications
carried out on the equipment.
* Maintenance register
Based on the manufacturer recommendations, a register of maintenance should be opened tolog all actions of the maintenance team, in particular formal inspections, re-certifications, andspare parts changes. Near missed or break down should also be entered for further actions.
* Compression and decompression procedure manualAll pressure profiles used in the treatment should be categorized and identified with proper
description. This includes decompression procedures applicable to the exposed personnel on
the occasion of the attendance of the patients.
Any emergency compression (access), decompression (evacuation) or recompression (in caseof DCI symptoms) procedures to be used for the attendants should also be in that document.
* Day to day logging of personnel pressure exposures
A register of exposure should receive information about individual staff exposures, and thesame data should be logged in a personal log-book supplied by the employer to each person
qualified to be exposed to pressure.

2.3 - Personnel training / medical fitness
Any person exposed to pressure should be fit to do so. This is based on occupation medical
fitness to undergo pressurization. A specific assessment is needed on a yearly basis. A
certificate of fitness should be issued, and eventually entered in the personal log-books.
The content of medical examination may be under national rules. If not, it should be definedand agreed with the concerned occupational doctor.
3
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Annex 2

2.4 - Relationship with external emergency services
A joint visit of the plant with the Fire Brigade in charge of the place is highly recommended
and the conclusion should be a jointly defined contingency plan for fire outside the chamberand help in case of fire inside.

2.5 - Safety posters on site
Through out the plant, where specific safety information is needed, proper posters should
remember to the patients and to the personnel the applicable safety rules (Non smoking area,
items not to be taken in the chamber, maximum value for oxygen monitoring and action incase of high alarm signal...)At the lock attendant position, information on panel operation should be clearly displayed(valve function, positions, piping diagrams, emergency items...)3 - EQUIPMENT
3.1 - Construction of Hyperbaric Chamber* Pressure vessel
Specific construction and inspection rules apply to pressure vessels according tovarious national rules. After 2002, European pressure vessels regulation will havebeen harmonized under the Directive : CEN Pressure vessels, 97/23CE, dated 29 May
1997.
* Architecture
Basically the number of chambers in an installation should be such that, in case of
emergency it should be possible to enter the treatment chamber and provide assistanceinside. The minimum is a 2-compartment installation, one chamber being kept at
atmospheric pressure to give access. It is generally considered acceptable to carry out
decompression of personnel in that access chamber provided a procedure is preparedto free that chamber quickly to face the need to enter the main chamber.
Patient access to the treatment chamber is of primary importance for the personnel andall effort should be made to provide mechanical help for handling beds and stretchers
when the entrance doors are not with easy and wide access. Many chambers derived
from diving chambers engineering are very poorly designed in this respect. In addition
this is a serious hazard in case of emergency evacuation.

4
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Annex 2* Electric devices
Electricity may cause two types of hazards : Electrocution and Fire.
Electrocution prevention
Any electrical medical device in contact with the patients should be protected against
the hazards of electrocution for the patients in accordance with medical rules
applicable to such medical devices.
Any electrical device used in the chamber as tools or equipment should be protectedagainst electrocution as a tool or equipment used in a conductive environment (CENElectric devices, electrocution, 73/23/CE, dated 19 February 1993).
Fire precautions
Fire may be triggered in the chamber either by conductors overheating (short circuit)or by sparks. Due to the high partial pressure of oxygen always present in compressed
air, fire will develop extremely fast if material burning in compressed air is present at
the place of fire trigger
Therefore :All power wires should be selected in the category : M2
All equipment should be built in such a way that no spark may start a fire.
Any equipment not specifically designed for use in compressed air should bevalidated by a competent person who will assess the risk of bursting a fire during
normal use and in case of breakdown (fail safe).
A simple means to prevent dangerous, sparks is to select electrical equipment withCE marks showing it is acceptable for use in flammable or explosive atmosphere(CEN Electric devices, explosive atmospheres, 94/9/CE, dated 23 March 1994,* Plumbing
Regular piping should be in agreement with pressure vessels systems rules.
Oxygen and gases with high oxygen concentration (FO2 > 0.25) circuits, require
special precautions (reduce pressure as much as practicable in all distribution lines, allequipment must be oxygen compatible and internally cleaned by a competent person
on installation). No ball valve should be used to operate oxygen circuits. All gas
storage area should be properly ventilated or equipped with a leakage alarm (highoxygen content).
Connecting oxygen cylinders to the circuit should be made only by qualified
personnel.

5
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Annex 2

* Measurements, analysis, recorders ...
Calibration of meters is part of the maintenance program. It should be done at regularintervals and logged into the maintenance register.
Pressure profiles and oxygen content of the atmosphere should be recorded* Fire fighting systems
Internal fire fighting system includes : A manual extinguishing system operable by theattendant, a sprinkler type water deluge triggered independently from inside oroutside. Override valves (inside and outside) should be available to prevent flooding
when fire is eventually under control.
It is part of fire prevention to be able to decompress quickly the chamber forevacuation and at the same to cool efficiently the burning material and reduce
immediately the partial pressure of oxygen closer to 0.2 bar. A fast decompression
valve operable from outside at the attendant position, eventually sealed with a safety
breakable thread, is a strong recommendation.
* Breathing masks
In case of fire it is extremely important that any extra oxygen input in the atmosphereshould be stopped, and that breathing masks be available for all. Shifting HBO masks
to air will cover the need for the patients; extra masks should be available, one foreach attendant eventually present in the chamber.
Very little can be done to protect hoses delivering gases to the masks, they should bebuilt in heat and fire resistant material, the deluge system is intended to protect them
until evacuation can be carried out.
* Lock attendant station
A special care should be given by the manufacturer of the system to make the controlof the chambers easy and fool proof. Proper markings are needed showing gas circuits
and functions of valves as well as their position. When video screen are used, theirlocation and brightness should be controlled. Communication system should have aback-up arrangement, and the quality of microphones and speakers in the chambers
should be of good quality, a permanent listening capability for the lock attendant isneeded. A telephone line in connection with the telephone control panel of thebuilding should be available at the position of the lock attendant
Noise level due to decompression of gases should be removed from the place byproper piping and silencers.

6

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Annex 2

3.2 - Construction of buildings* Patients accessIn addition to the access to the chamber some care should be given in the room
available for patient preparation, inspection and handling around the installation inparticular when intensive care patients are concerned.
* Connection with hospital
Many of the indications of HBO are for intensive care patients, who require special
equipment and transport from the hospital, a close connection with the hospital is amust for Hyperbaric Centres accepting intensive care indications. This includes
laboratories and medical analysis capabilities.
* Fire precautions
The hazard of fire in the Ilyperbaric, facility are related to gas storage, oxygen circuits,pressure vessels and the fact that for some indications decompression of patients forevacuation may be fatal to the patient (arterial embolism, DCI, some CO poisoning
cases ...). And it also may be dangerous for the attendant involved in such cases.
A contingency plan should be prepared with the fire brigade to take into account thosespecific hazards and organize fire fighting procedure accordingly.
All markings in relation with fire fighting and evacuation must be displayed* Gas storage, compressors room, distribution plumbing...
It is of primary importance that, in all situations, pressure could be maintained in thechamber and that ventilation should not be interrupted for more than a few minutes.
The gas supply system should be so arranged that in case of failure (compressor,
electricity, cooling water, piping breaks ...) a back up system become operational atonce to match the gas requirements for the treatment and the possible required
decompression of personnel. This can be achieved via gas storage, emergency
compressors, emergency electric supply... A document should demonstrate the risk
assessment, which leads to the choice of an adapted solution. The corresponding
emergency procedure should be in writing and should be part of the training of thepersonnel in charge.
* Equipment authorized for use under pressure
The equipment permanently used in the chamber and designated for use underpressure should be devoted to that activity and be clearly identified. It should havebeen evaluated for suitability of the purpose either by the initial manufacturer of thechamber or jointly by the user and the manufacturer of the equipment.

7

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Annex 2A list of those equipments should be part of the safety manual. Example: hospitalwheel chairs should be greased with non burning grease, private wheel chairs have tobe left outside, ...
Any new item to be entered into the chamber should be controlled by a competentperson who will sign an authorization to use under pressure, eventually in association
with special recommendations or safety rules when applicable and after questioning
the manufacturer.

3.3 - Maintenance Program* Schedule for maintenance operations
In the instruction manual provided by the manufacturer of the installation, there should
be proper guidelines for the maintenance schedule. The manager of the installation
will formalize the maintenance program in the safety manual.
In particular only products and spare parts recommended by the manufacturer should
be used (oxygen compatible lubricants for example).
* Air quality controls.
The frequency of air quality controls is depending of the type of compressors used, thetype of filtering units and the activity of the centre. This should be defined inagreement with the guidelines given by the manufacturer(s) of the gas production plantand incorporated into in the safety manual.
* Maintenance logging
All maintenance operations carried out by technicians should be logged in themaintenance register and signed by the technician in charge.
Entries should be left open for the personnel to report on day-to-day breakdowns andremedial actions taken.
* Emergency drills
The manager of the installation should recommend safety drills, mostly oriented
towards fire prevention and fire fighting, all personnel should participate to thosesafety drills, which should also be logged in the operation log-book.

8

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Annex 24 -OPERATIONS
4.1 - Staffing* Number and role of persons
During any treatment the functions involved are :Supervision of the treatment (medical aspect and safety of operations),
Operation of the chambers,
Attendance of patients under pressure,
Emergency assistance under pressure if needed
Depending on the type of centre, the number of simultaneous use of pressure chamber
the minimum team stalling is variable. There should be a minimum of 3 qualified
persons outside (Supervision, lock attendant and emergency help).
Any staff member accepted for compression should be medically fit to undergopressurization.
* Under pressure patients attending policy
It is presently a common practice in several hyperbaric units not to attend walk-in
patients for the whole session, the attendant being locked out after compression oreven not being compressed at all when patients have experience of the exposure
The policy on patient attending under pressure should also be clearly defined in thesafety manual. Instructions to un-attended patients should be sufficient for them toface minor problems under pressure and to control properly oxygen mask leakage(both ways).

4.2 - Patient preparation / control* Information to the patients
The content and the procedure of information to the patients should be clearly
established, eventually with a specific leaflet or document to be given to the patients,on the occasion of exposures. Who is in charge of this information and copies of the
documents are to be included in the safety manual.
* Medical preparation
Before entering the chamber, all patients should be controlled to assess their medical
situation, in particular when they are connected to medical devices or when they were
dressings on wounds ...
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Annex 2

* Practical preparation
Policy concerning patients clothing, bedding equipment, inspection of personal items
is needed, A recommendation should be that patients keep a minimum of personal
clothes and receive at least a blouse covering the remaining clothes. That blouse being
made out of low flammability material (cotton). Consequently a personal items storage
look should be made available for each patient.

5-CONCLUSION
Basically there are few construction problems left when the manufacturer of the HBO facility
is safety conscious and the buyer ready to invest in a safe system. Most of the safety
problems in HBO are related to the procedures used and the precautions enforced during the
day-to-day work.
These precautions are directly under the control of the personnel. The personnel should bewell aware of the centre safety policy; he (she) should have received the initial training, acopy of the safety manual and be given a clear definition of his (her) responsibilities during
the sessions.
The management, after establishing that policy in a safety manual, should also make sure it isproperly applied. This needs personal involvement and frequent controls.

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Annex 3Annex 3 – COST B14 Working Group «Technical Aspects» Final Report 2001
(informative)

WG Technical Aspects: Presentation of
the results
In order to push forward the development of a European norm for therapeutic hyperbaric
facilities, the COST B14 Working Group «Technical Aspects» conducted a risk analysis,
following the format of the European Norm “Medical Devices – Risk Analysis” (EN 1441).
The main aim was to demonstrate the need for a norm, by identifying all the risks linked
to the use of any hyperbaric installation. For this Annex C of the EN 1441 was used.
Five different types of risk have been summarised:
•
•
•
•
•

Energy Hazards (Electricity, heat, mechanical force, pressure)
Biological hazards (bio contamination, toxicity, pyrogenicity)
Environmental hazards (inadequate supply of power or coolant, incompatibility
with other devices)
Hazards related to the use of the device (inadequate operating instructions,
inadequate specification of accessories, use by unskilled/ untrained personnel)
Hazards arising from functional failure, maintenance and ageing(inadequacy of performance characteristics for the intended use, inadequate
maintenance)

As a complement to this identification of the risks and with a view to make a morecomprehensive document, method statement EN 1441 outlining the functional analysis
was also documented.
The results, which you can find in the annex, are a list of all risks linked to the use of the
HBO Facility. Each type of risk is identified with its consequences for the patient (P), theaccompanying personnel (A) and the operators (O).
Each identified risk may have additional implications or introduce another type of risk andtherefore these are listed in the cross reference column.
The work presented is intended to be a non-exhaustive list of risks. It is the first step,which should bring us closer to a normalisation process. These results may therefore be
integrated into the ongoing normalisation process, as well as highlighting the need forthe future work of the Working Group «Safety Aspects».
This study was the first step of a process needed to be carried out and was theachievement of the Working Group «Technical Aspects».
On behalf of the members of WGT.

Robert HOUMAN
Secretary

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Annex 3

C2: Assesment form for hazards occurring during hyperbaric oxygen

Items

Hazard/ type of error

Consequences

P A

O Cross
Ref.

ENVIRONMENT Earthquake zone

PREMISESMECHANICALELECTRICALSERVICEFIRE
PROTECTION

May 2004

Walls crash-collaps

X X

XHigh risk of flooding

Flooding of the chamber X X
localsX

High risk of pollution

Bad quality of compressed X X
airRoom do not fit to Patient's way
receive the chamberdifficulties

isof X XX

4, 6

Not enough space for Bad organization
ancillary rooms

X X

X

4

Not good foundation

X X

X

Bad construction as Collapse of the frame - crash X X
cracks on:- explosion when in pressure- steel plates;- forged pieces;- diaphragms;- elliptic ends;- portholes;- medical lock.
Short circuit of:Fire - explosion
X X- lighting system;- electric devices;- comunication system.

X

4, 6

X

2, 4

Electric spark

Fire - explosion

X X

X

4

Electrostatic spark

Fire - explosion

X X

X

4

Spark from mechanical Fire - explosion
friction

X X

X

4

Bad working of fire No fire extinguishingfighting system

X X

X

4, 5,
6

Collapse of the frame

full

3, 4

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Annex 3COMPRESSED Bad working
AIR SYSTEM

Uncorrected compression or X X
decompression protocole

OXYGENSYSTEM

Dirt inside circuit

Explosion

X X

XHigh pressure

Explosion

X X

XRust inside piping

Explosion

X X

X

inside Explosion

X X

X

High
temperature Explosion
inside circuit

X X

X

Bad lubrication

Explosion

X X

XWrong gasket

Explosion

X X

X

Build
up
chamber

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6

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Annex 3C3 : BIOLOGICAL HAZARDSP A O Cross
Hazard / type ofConsequences
Ref.
error
1 – Risks linked to hardware : chambers and pressure part design andmanufacturing
X X X 2, 5,Overpressurisation Damage to structures
6
above
the
rated
working pressure
X X
Pressurisation
over Decompression illness
5, 6
the stop pressure
Pressurisation rate too Rise in ambient temperature X X
2, 5,
fast
6
X
X
Depressurisation rate Decompression illness
2, 5,
too fast
Pulmonary barotrauma
6
X
X
Chamber paint Incorrect typeContamination of chamber
4
atmosphere
Adequate
Contaminationof Inability to complete therapy X X
4, 6
Chamberchamber atmosphereventilation
Reducers
Failure open / free- Damage
topressure X X X
4flow
vessels / explosion / rupture
Exhausts
Inadequate size / not Noise/
unnecessary
4, 6protected / not well ventilation / suction injury /placedto
avoid blockage
pocketing of 02
X X X
Noise
Health hazard
Hearing loss
2 – Risks linked to hardware : Respiratory gases
X X
Poisoning/Hypoxia
4, 5, 6
Medical Gases Correctlabel/type/purity
Purity of gases Contamination
Poisoningofinside X X
4personnel/ hypoxia. Fire
Purity of Air
Contamination
Poisoningofinside X X
4personnel/ hypoxia. Fire
Compressor air Incorrect
position Contaminationof X X2
intakesheight etc.
atmosphere
Compressor
Faulty contaminated Poisoningofchamber X X
2high pressure
air
personnel
Compressor
Faulty contaminated Poisoningofchamber X X
2
Low pressure
air
personnel
Purity of oxygen Contamination
Poisoningofinside X X
4personnel/ hypoxia. FireX
Liquid Oxygen
Position/
safe Injury / off-gassing / Firedistances
Cleanliness
Purity of helium Contamination
Poisoningofinside X X
personnel/ hypoxia. Fire

Items

May 2004

51

A EUROPEAN CODE OF GOOD PRACTICE FOR HBO THERAPY

Qualitycalibration
gases
Mixing of gases

Incorrect specification Inaccurate analysers

Annex 3

X X

Cerebral/pulmonary oxygen X
toxicity
X X
Mixing of gases High Nitrogen partial Nitrogen narcosispressure
3 - Risks linked to hardware : gas breathing devices and associated pipes
Reducers
Failure open / free- Damage
toBIBSs/ X X Xflow
explosion / rupture of pipes /damage to the patient
X X X
BIBS
Contaminated/poor
Raised ppO2 in chamber
fitting/leaking.
Fire risk
Breathing resistancePatient not receiving 100%
O2
BIBS
tracking Malfunction
Vacuum injury/pressure loss X
regulator
X
Allergenic substances Allergic reaction
Transmissionof Infectious
cutaneous, X
infectious diseases
broncho-pulmonarorgeneral diseases
4 - Risks linked to hardware : accessories / others
X X
Plastic
Nonchamber Burning/off gassing
compatible
ContaminationX X X
Inappropriate
Staticelectrical Fire
Materials/
discharge.
furnishings
Off gasing if burning
X X X
Chamber Lights Too Hot / Not bright Fire/ heat source
enoughMedical procedures difficult
X X X
Speakers
Electrical short
Sparks / FireX X XHeat Source
Over heating
Fire / Burn risk
Fire
Incorrect typeNotfunctionat X X X
extinguishers
depth/contaminatedatmosphere
X X X
Equipment
Fumes/off gassing
Electrical shock/ Firecharging areas Electrical faults
Heat
X X X
Loose
Trapped/Electrical Shock
Cables/Wires
Chaffing/Arching/Fire
5 - Risks linked to chamber operations
X X X
Control
panel Lackoffunction/ Contamination/ Fire risk
alarmssettings to highHypoxia / Poisoning
Humidity control Incorrect safe level
Sparks /Fire/ Uncomfortable X X X
X X
Compression
Injury to personnel Barotrauma / Heat
rates
inside chamber
X X
Decompression Injury to personnel DCI
rates
inside chamber
X X XIncorrect / Dirty Contamination
Fire
Clothing

4, 5, 6

May 2004

52

High oxygen level

4, 5, 6

4, 5

4, 5

2, 4, 6

4, 5

4, 6
4, 6

2, 4, 52, 4, 6
4
5

4

4

5, 6
6
5, 6
5, 6
4

A EUROPEAN CODE OF GOOD PRACTICE FOR HBO THERAPY

Dirt/
Dust
/ Poor house keeping
Contamination / Fire /Contamination
Explosion /BannedContamination
Fire / Off gassing
Substances
BannedBiggest single causes Injury / Fireequipment/ of accidents / Fire
Substances
inside Chamber
Inappropriate
Contamination
Contaminationofcleaning
atmosphere. Scratching ofchemicals
view ports
Water supply
Insufficient
Volume/ Unable to fight O2 rich fireclean/
Contamination / diseases
6 - Risks linked to medical devices
Equipment
All come on together Patient
vital
equipment
touch key pads with compression / inoperable
faultyLaryngoscopes Incorrect batteries / Fire risk
/Batterysparking switch
equipment
Patient
Affected by pressure / Patient
inadequately
Ventilator
density of ambient ventilatedpressure
Artificial
Resistance of patient Pulmonary barotrauma
ventilation
Infusion Pumps Affected by pressure / Patient
inadequately
density of ambient supplied with drug doses
pressureprescribed
Intravenous
Lack of sealing
Gaseous embolisations
infusionsIngress of bubbles
Bed/trolley type Rams/Oil/ pneumatic Contamination,
lossofheight of bed
Diabetic
Affected by pressure Inaccuratemonitors
Patient
Affected by pressure / Inaccurate / can not change
Monitoring
density of ambient settings / failurepressure
7 - Risks linked to managing the patient
Patient
Lack off
Contamination of chamber
Changing areas
environment/ Fire risk
Infection Control Poor
standards/ Cross infection of patients /inadequate
Staff
Shoes/Oversho Lack off / dirt / Oil in Contamination / Firees
Chamber
Patient Lockers Lack off/ not lockable Will mean patient will takebanned substances into
chamber/Fire/
Contamination

May 2004

Annex 3

X X

X

4, 6

X X

4, 6

X X X

4

X X

4

X X

6

X

X X X

4

X

4, 5

X

5

X

4, 5

X

5

X X

4, 6

X

4, 6

X

4, 6

X X X

4, 6

X X

4, 6

X X X

4

X X X

4, 6

53

A EUROPEAN CODE OF GOOD PRACTICE FOR HBO THERAPY

Annex 3C4 Environmental Hazards
Items

Hazards/type oferror

Consequences

ENTRANCETOCHAMBER
Entrance into the Inadequate
Personnel
injury,chamber
construction, improper damage of material
use,
Incorrect/
Dirty Contamination,
Cross infection, Fire
Clothing
electrostatic spark
Shoes/Overshoes
Lack off / dirt / Oil in Infection, Fire
Chamber
Prohibited items
Contamination,
Cross infection, injury,
Spark, malfunction
fire
BUILDING&
CHAMBER
Building/ housing
Combustible/
Inability to escape.
insufficient
fire Burns,
lackof
protection
protection
Building
DesignInjury / lack of safety /Architecture
Lifting / Fire protection
ChamberInadaptable device
Personnel
Injury,ergonomics
damage of material
Medical lock size
Unable to quickly lock Poor quality care toin/outessential patients/
dangerous
equipment
due to delays withessential drugs
More items inside thanstrictly necessary
Chamber paintNon compatible
Poisoning
Plastic

Burning/off
gassing,
Contamination
Inappropriate
Contamination
Poisoning, damage ofcleaning chemicals
equipment
Environmental
Failure/ lack of regular Infection, intoxication,
control
unit/ maintenance
Hypo
andRegenerator of air
hyperthermia, sparks,
fire
Communication
Inadequate,
Early termination ofsystems/External
malfunctions, Can not treatment, Poor quality
assistancecall for assistancecare to patients Inability
to call for urgent or any
assistance
BIBS exhaust
Free flow/
Vacuum injury, leak into
Malfunction
chamber atmosphere
Mainselectrical Break down/ power Inability to complete
systems
cuts.
exposition safely
May 2004

Non compatible

PA

O Cross

X

X

X

4, 6

X

X

X

3, 4

X

X

X

X

X

X

3, 4,
5
3, 4

X

X

X

2, 4

X

X

X

X

X

X

2, 4,
6
4

Ref.

X

4

X

X

3, 4

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

2, 3,
4
3, 4,
6
4, 6

2, 4,
6

2, 4,
6
2, 4,
6

54

A EUROPEAN CODE OF GOOD PRACTICE FOR HBO THERAPY

Annex 3

Batterysystems

electrical Hydrogengas/ Explosion, Fire, Inability
insufficient power / to complete exposition
timesafelyUPSelectrical Not working when Inability to complete
systems
required,Sufficient exposition safely
time/powerforemergency
requirements
Emergency
Not working when Inability to complete
generator electrical required,
Sufficient exposition safely
systemstime/powerforemergency
requirements
Chamber
Inadequate
Intoxication,
ventilation
ventilation, failure
Infection Control
Poor
standards/ Cross infection
inadequate
Door seals/ "O" Damage
No Compression / loss
rings
of pressure
Door
Lack of door stops / Physical Injury
weight/handles
doors
not
hung
correctly
Silencers
Dirty/
Blocked/ Explosion,
physicalcorroded
InjuryPipework
Inadequate
Injury/damage/explosion
Pressure
relief Not large enough / Explosion, Damage tovalvesincorrectly set / Faulty pressure hull, Injury
Reducers
Failure open / free- Unintentional Increaseflow
of pressure

X

X

X

X

2, 4,
6

X

X

2, 4,
6

X

X

X

X

X

X

X

X

X

3, 4,
5, 6
3, 4,
5, 6
2, 4,
5, 6
2, 4,
6

X

X

X

X

X

X

X

X

X

X

X

Fumes/off gassing
Intoxication, electrical X
Electrical faults
shock, fire
Heat
Inadequate
Noise, O2 pockets, X
construction,
suction injury, DCS
malfunction
Malfunction,short- Poor quality care to X
circuitpatients, fire

X

X

X

Heat Source

Over, lack of heat

Fire / Burn
Hypothermia

risk

/ X

X

X

Loose
Cables/Wires

Trapped/Chaffing/Sparks

Electrical Shock, fire

X

X

X

contaminated Infection, intoxication

X

X

Equipment
charging areas
Exhausts

Chamber Lights

Compressor
pressure

May 2004

high Faulty,
air

X

X

X

X

2, 4,
6

2, 4,
6
2, 4,
6
2, 4,
6
2, 3,
4,
5,6
2, 3,
4, 6
2, 3,
4, 6
2, 3,
4, 5,
6
2, 3,
4, 5,
6
2, 3,
4, 5,
6
2, 3,
4, 5,
6

55

A EUROPEAN CODE OF GOOD PRACTICE FOR HBO THERAPY

Compressor
pressure

Low Faulty,
air

Oxygen supply
Computers outside
Manifolds

contaminated Infection, intoxication

X

X

X

X

Inability to complete X
treatment safely
Wrongposition/ Asphyxia,
hypoxia, X
inappropriate material intoxication, DCI/ rating / erroneouslabeling

X

Malfunction,amountFailurepurity, Hypoxia, DCI, fire

INTERNAL
EQUIPMENTInternal
fixed Not ergonomic
Personnel injury
equipmentInternal equipment Un-allowed
air Damage, health hazard
pockets, malfunction
Internal
battery Malfunction, sparks
Fire, health hazard
equipment
Patient Ventilator
Malfunction, affected Hypo- hyperventilation,by pressure & density lung overpressureof gasInfusion Pumps
Malfunction, affected Patient
inadequately
by pressure / density supplied
with
drug
of ambient pressure
doses prescribed
Patient Monitoring Malfunction, affected Poor quality care toby pressure / density patientsof ambient pressure
Diabetic monitors
Affected by pressure Inaccurate

May 2004

Annex 3

X

X

X

X

X

X

X

X

X

2, 3,
4, 5,
6
2, 3,
4, 6
2, 4,
5, 6
2, 4,
5, 6

X

X

4
4, 5,
6
2, 3,
4, 6
3, 4,
5, 6

X

3, 4,
5, 6

X

3, 4,
5, 6

X

3, 4,
5, 6

56

A EUROPEAN CODE OF GOOD PRACTICE FOR HBO THERAPY

C5Annex 3

Hazards related to the use of a medical device
Chambers for Hyperbaric Oxygen Therapya) Inadequate labelling
Items

Hazard/Type of error

Harm/Consequences

P

A

O

Cross
Ref.
Chamber

Main chamber with No compression
patient lockConfusion inlet valve No compression
with outlet valve
Fire
Confusion
main Inability to stop a fire,
suppression chamber
and accidental deluge
personnel lockElectrical
Main chamber light
Darkness, panic, inability
power
to observe patients
Alarms, warnings
Inabilitytodetecttechnical
problem:
Overpressure,high
PPO2 of the chamber
atmosphere etc
Lossof
different Inability to perform thefunctions i.e. TcPO2, corresponding functions
communication
devices, TV, panel
illumination etc.
Breathing
If different gases are Treatment
failure,place
simultaneously used
incorrect patient statistic,
numbertreatment evaluation etc
Gases
Confusion O2 with air DCI for personnel
Confusion air with O2 Fire risk, Oxygen toxicity
Confusion Helium with Asphyxia for personnel
O2
O2 with Mix
Therapeutic failure inpatients, risk of DCI for
personnel
Mix with O2
Oxygen toxicity

X

6

X
X

X

6

X

X

6

X

X

X

X

6

X

X

3

X
X
X

X
X
X

3, 6
3, 6
3, 6

X

X

3, 6

X

X

3, 6

X

X

6

b) Inadequate operating instructions
Items
Chamber

May 2004

Hazard/Type of error

Harm/Consequences

P

A

Fast compression
Fast decompression
Overpressurization

Barotrauma
Oxygen toxicity

X

X

O

Cross
Ref.
3, 6

57

A EUROPEAN CODE OF GOOD PRACTICE FOR HBO THERAPY

Gas: AirStarting a treatment Aborted treatment
without enough supply
Gas:
Starting a treatment Fire if use of lubricants,
Oxygenwithout enough supply Aborted treatment
Gas: Helium Starting a treatment Inability to perform a
without enough supply saturationordeep
treatment
Gas:
Starting a treatment Inability to perform a
Gasmix
without enough supply saturationordeep
treatment
Electricity
Unplugged device
No function, malfunctionof device before or
during treatment
Patients
Patient instructions
Barotrauma
Oxygen toxicity
Risk of fire if patients
carry banned substances

Annex 3

X

X

X

X

3, 6
X

3, 6

X

3, 6

X

3, 6

X

X

X

6

X

X

X

6

P

A

O

c) Inadequate specification of accessories
Items

Hazard/Type of error

Harm/Consequences

Cross
Ref.
Fire
Malfunction
suppression
Electrical
Main chamber light
power
Alarms, warnings

BIBS

Hoods

Vacuumbottles
Respirator
Infusionpumps
May 2004

Inability to stop a fire,
accidental deluge
Darkness, panic, inability
to observe patients
Inability to detect technicalproblem:
Overpressure,high PPO2 of the chamber
atmosphere etc
Lossof
different Inability to perform thefunctions i.e. TcPO2, corresponding functions
communication
devices, TV, panel
illumination etc.
If different gas are Treatment failure, incorrect
simultaneously used patient statistic, treatment
evaluation etc
Reuse of old hoods
Rupture of the hood, riskof fire, interruption oftreatment
Not suitable for high Lack of suction
pressure, Rupture of
Glass/plastic
Not suitable for high Inefficientpatient
pressureventilation
Not suitable for high False volume deliverypressure

X

X

X

2, 6

X

X

X

6

X

X

X

6

X

X

X

6

X

X

X

X

3

X

6

X

6

X

3, 6

X

3, 4, 658

A EUROPEAN CODE OF GOOD PRACTICE FOR HBO THERAPY

Infusions
TcPO2
EKG
Blood
pressure

Unsuitablefor Rupture, air insufflations in
overpressure
the patient’s vein
No or false readings False wound evaluation ofunder hyperoxia
TcPO2
No or false readings Misinterpretation of results
under pressure
No or false readings Misinterpretation of results
under pressure

Annex 3X

3, 4, 6

X

4, 6

X

4, 6

X

4, 6

g) Use by unskilled/untrained personnel
Items

Hazard/Type of error

Harm/Consequences

Chamber

Overpressure,
Oxygen toxicity
prolonged exposure
DCI
Compression Fast compression or Barotrauma
rate
decompression
IV lines
Introduction of air Air embolism
bubbles in the iv line

P

A

O

X

X

Cross
Ref.
3, 6

X

X

3, 6

X

3, 4, 6h) Reasonably foreseeable misuse
Hazard/Type of error

Harm/Consequences

P

A

O

OxygenSparks in chamber

X

X

X

Pressure

Overpressurization

Fire, explosion, oxygen
toxicity
Damage to chamber

Cross
Ref.
2, 6

X

X

X

2, 3, 6

Harm/Consequences

P

A

O

Missing selection of Increase of side effecthigh risk patients(Oxygentoxicity,
Claustrophobia,
Barotrauma)

X

X

Cross
Ref.
6

A

O

Cross
Ref.
3, 4, 6

A

O

Cross
Ref.

Items

i) Insufficient warning of side effects
Items
Patients

Hazard/Type of errorj) Inadequate warning of hazards likely with the reuse of a single use device
Hazard/Type of error

Harm/Consequences

P

Reuse of mask filters

Contamination

X

Items
Filtersk) Incorrect measurement and other methodological aspects
Items

May 2004

Hazard/Type of error

Harm/ConsequencesP

59

A EUROPEAN CODE OF GOOD PRACTICE FOR HBO THERAPY

Chamberpressuregauge

Pressure lower than Insufficient treatment
real
Pressure higher than Risk of DCI in tenders
real
Oxygentoxicityinpatients
Air
supply Pressure lower than Premature interruption of
gauge
real
treatment
Pressure higher than None
real
O2
supply Pressure higher than None
gauge
real
Pressure lower than Premature interruption ofrealtreatment

Annex 3

X
X

6
X

6

X

6
6
6

X

6

l) Incorrect diagnosis
Items
Patients

Hazard/Type of error

Harm/Consequences

P

A

O

Insufficient response Oxygen
toxicity,
to complications
Barotrauma
Choice of treatment Ineffective
treatment,
protocolrisk of complication

X

X

Cross
Ref.
6

X

X

6

Harm/Consequences

P

A

O

False
reporting Unjustified
Treatment(under/over)
failure, false billing
False
reporting Medico
legal(under/over)
implications in case ofpermanent disability inpatient
False
reporting Medico
legal(under/over)
implications in case ofpermanent disability inpatient

X

Cross
Ref.
6

X

X

X

6

X

X

X

6

P

A

O

m) Erroneous data transfer
Items
Treatment
numberPressure

Treatment
duration

Hazard/Type of erroro) Incompatibility with consumables/accessories/other devices
Items
Ventilator
Infusionpumps
InfusionsVacuumbottles
May 2004

Hazard/Type of error

Harm/Consequences

Insufficient ventilation Insufficient treatment
False volume delivery Insufficient treatment

X
X

Cross
Ref.
3, 4, 63, 5, 6

Unsuitable
overpressure
Unsuitable
overpressureX

3, 5, 6for Rupture, gas embolism / X
gas emphysemas

3, 6

for Rupture, gas embolism

60

A EUROPEAN CODE OF GOOD PRACTICE FOR HBO THERAPY

IV lines
Air entrapment
Gas embolism
Pomades,
Flammable
topical Risk of firecreams, oil creams
pads
Various
Flammability
Fire

May 2004

Annex 3

X
X

X

X

3, 6
4, 6

X

X

X

4, 6

61

A EUROPEAN CODE OF GOOD PRACTICE FOR HBO THERAPY

Annex 3

C6 Hazards arising from functional failure, maintenance and ageing
1. Inadequacy of performance characteristics for the intended use

ITEMS

Hazards/ type of error

Harm/ Consequences

P A O CROSSREF.

Air compression

Failure on compression Overpressure,
X X
system:Unable to complete
too fast,
therapies,
injury,too slow,
Barotrauma / Heat
not enough,no compression

Cylinderstorage HP

gas Lack of volume / size

Unable to complete X X
therapies if power cut

Cylinderstorage LP

gas Lack of volume / size

Unable to complete X X
therapies if power cut

Pipework
gases

2, 3, 5forall Inadequate / size / Unable to carry on X X X 4pressure rating / material treatment/
injurydamage/ explosion
Failure open / free-flow
Damage to pressure X X X 4vessels / explosion /ruptureAir
decompression

Failureon DCI,
X X
5decompression,
Too slow,
too fast,no decompression
Not adequate, failure, FO2
increase,
Fire X X X 5
Inadequate size / not danger,
Hyperoxia,
protected / not well Noise / unnecessary
placedto
avoid ventilation / suction
pocketing of 02
injury / blockage
Insufficient / poor
Inability to complete X X
4treatments safely

Reducers

Air ventilation

Heating /Cooling
Humidification

Incorrect levels

Static/Sparks//Shocks/Comfort

Fire X X X

Distributionof Not adequate, failure, Fire danger, Hyperoxia
therapeutic gas
leak O2 inside chamber

X X X 3

Self
contained Not
Operators unable to X X X
Breathingavailable/malfunction/
stay to assist in the
Apparatus (SCBA) Staff not trained in its emergency evacuationuse.
of chamber personnel
BIBS
tracking Malfunction
Vacuum injury/pressure X X
4regulatorloss
May 2004

62

A EUROPEAN CODE OF GOOD PRACTICE FOR HBO THERAPY

Annex 3Gas
distribution Poor
designPanels
Maintenance/ failure

Control panel
Control
alarms/ Lack of gas inability to X X
3treat
Incorrect gas/ hypoxia/
poisoningNotadequate Positioning, accident
X X X 3, 5(ergonomic), failure,panel Lack of function/ settings Contamination/ Fire risk X X X 3, 5
to highHypoxia / Poisoning

Watch
systems Not adequate,
andalarms Lack of function(passive),
Analyzers, …
Protective
Not adequate,
systems (active), Lack of function
Sprinkler
Fire extinguishers Incorrect typeFire suppression
Outside chamber

Lackof
Maintenance

failure, Contamination/ Fire risk X X X 3, 5
Hypoxia / Poisoning

failure, Contamination/ Fire risk X X X 2, 3, 5
Hypoxia / Poisoning
Not
function
depth/contaminatedatmospherefunction/ Inability to fight fire
Injury to personnel

at X X X 2, 3, 5

X X X 2, 3, 5

Fire
explosive Lack of care in following Fire / Hazards/ Injury
X X X 2hazards
standard
operatingprocedures
Temperature
Hyper-/ HypothermiaMayrequireearly X X
3, 4, 5
controltermination of treatment
SoftwareEquipment
key pads

Malfunction

Therapyearlyterminated X X

touch All come on together with Patient vital equipment X
compression / faulty
inoperable

3, 4, 5
X 3, 5

Communications/Primary

Poor quality

Confusion / Errors / X X
PanicCommunications/
SecondaryNot functioning

Speakers

Electrical short

3, 5
Panic / incorrect actions X X/ injury / lack ofcommunications
Sparks / FireX X X 2, 3, 5Lighting primary

Inadequate

Mistakes at work

X X

5Lighting
secondaryLack of maintenanceInability to complete X X
treatments safely

5

May 2004

3, 5

63

A EUROPEAN CODE OF GOOD PRACTICE FOR HBO THERAPY

Ergonomics
in Not adequate
and outside thechamber
Patient Access
Steps / Door widths /Wheel chair accessAnnex 3

Injuries to personnel

X X X 2, 3

Delays / Lifting / Injury

X X

2, 3, 4

Doorweight/handles

Lack of door stops / Injury to personnel
doors not hung correctly

Silencers

Dirty/ Blocked / corroded Explode
InjuryPressure Gauges

Inaccurate

Decompression Illness

X X

5Equipment
tagging
numbering
Equipment
charging areas

Inadequate/ incorrect

Break down / failure
X X
Unable to treat patients

5

Fumes/off gassing
Electrical faults
Heat
Not adequate, failure

Electrical shock/ FireX X X 4

Explosion, Fire, Injury

X X X 3, 5

Accessories&/

fracture

X X X 2, 3, 4
/ X X X 4

Medical records

Incorrect for patient / Poor quality of care
X X
5Inadequate/
notcomplete / up to date/available
Mainselectrical Break down/ power cuts/ Inability to complete X
X 2, 5systems
Not adequate
treatments safely
Battery electrical Hydrogengas/ Inability to complete X
X 4systems
insufficient power / time treatments safely
UPSelectrical Sufficient time/power for Inability to complete X
X 4systems
emergency requirements treatments safely
Generator
Not
working
when Inability to complete X
X 4, 5electrical systems required
treatments safely
Personal
No adequate education Accident, safety not
X X 5
assured2. Lack of, or inadequate specification for maintenance, including inadequate
specification of post maintenance functional checks,

ITEMS

Hazards/ type of error Harm/ Consequences

Safety inspection

Notadequate/ Potentiallyregularly
conditions
Not adequate, (no Damage, Injury, failure
identification of eachelement
Not adequate
Damage, Injury, failure

User manual

Technical
Documentation
May 2004

P A O Crossrefharmful X X X 5
X X X 5

X X X 564

A EUROPEAN CODE OF GOOD PRACTICE FOR HBO THERAPY

Compressor
filtration system
Environmental
control unit/ Rain
View Ports

Failure/ lack of regular Contamination/ Injury
X
maintenanceFailure/ lack of regular Contamination/ Injury
X
maintenance
Damage /Scratched/ Severe pressure lossX
Out of date
Decompression Illness
Back up machinery Inadequate/ lack off
Break down / failureX
Not
serviced. Unable to treat patients
maintained
Patient monitoring Failure/ lack of regular Inaccurate / injury
X
maintenance
O2
Analyzers/ Failure cell expired
Too high PP02X
Primary
Inaccurate/ Fire risk
maintenance
O2
Analyzers/ As above & Needs to Too high PP02
X
Secondaryagree with primaryFire risk
CO2 analyzers
Failure/ inaccurate
Contamination/X
inadequate
flushing/
ventilation/ poisoning
CO2 Scrubbers
Noise/chemical burns/ Contamination/X
corrosion. Electrical inadequate
flushing/
faults.
ventilation/ poisoning
Door seals/ "O" Damage
No Compression / loss ofrings
pressure
Valves needle
Lack of maintenance Lack of compression/ Supply
Fire suppression
Tested/function
for Inadequate
fire X
Inside chamber
hyperbaric
suppression & electricalenvironment
shock
And
gas
density.
Electrical connection
trip
Power fuses
Badposition/ Lack of power for life
Switchboards
incorrect rating / faulty support
trips / resets
Liquid Oxygen
Position/
safe Injury / off-gassing / Fire X
distances
Cleanliness
Computers& Failureinsideor Lack of compression
VDU's
outsidechamber. Inability to treat patients
Affected by pressure. Inability
tofinishHeat
treatment
Heat/ Fire
Unauthorized
Malfunction / Fire. Malfunction/
Fire. X
chamberContamination/ Contamination / Electric
equipment
Electric Shock
Shock
Humidity control
Incorrect safe level
Sparks/Fire/ X
Uncomfortable

May 2004

Annex 3

X X 3
X X 4
X X
X 4

X X 3, 4, 5
X X 3, 4, 5

X X 3, 4, 5
X X 3, 4, 5

X X 4

X X 2, 4, 5
X X
X X 2, 3, 5

X 2, 3, 5

X X 4

X 2, 3, 5

X X 4, 5

X X 3, 565

A EUROPEAN CODE OF GOOD PRACTICE FOR HBO THERAPY

Annex 3Banned equipment Biggest single causes Injury / FireX
/ Substances inside of accidents / Fire
Chamber
Patient Lockers
Lack off/ not lockable Will mean patient will take X
banned substances into
chamber/Fire/
Contamination
Patient Ventilator
Affected by pressure / Patient
inadequately X
density of ambient ventilatedpressure
Infusion Pumps
Affected by pressure / Patient
inadequately X
density of ambient supplied with drug doses
pressureprescribed
Patient Monitoring Affected by pressure / Inaccurate / can not X
density of ambient change settings / failurepressure
Bed/trolley type
Rams/Oil/ pneumatic Contamination, loss of X
height of bed
Diabetic monitors
Affected by pressure Inaccurate
X
Loose
Trapped/Electrical ShockX
Cables/Wires
Chaffing/Arching/Fire

X X 3, 4, 5

X X

X

3, 4, 5X

3, 4, 5X

3, 4, 5

X X 3, 4X
3, 4, 5X X 2

3. Inadequate maintenance,

ITEMS
User manual

Duties of staff
Equipment
maintenance
Equipment
documentation

Hazards/ type of Harm/ Consequences P
error
No determination of Lackofplannedeach responsibility, maintenance/
breakdown
Personnel unclear of Injury/ damage
their duties
Break down
Unabletotreat X
patients
Lack of adequate Lackofplannedrecords
maintenance/
breakdown

A

O
X

cross
ref
5

X

X

5

X

X

5

X

5

4. Lack of adequate determination of end of device life,

ITEMS

Hazards/ type of error

UsermanualWork safety
facilityofHarm/Consequences
the Damage, injury

P

A

O

CROSS REF

X

5

A

O

5. Loss of mechanical integrity,

ITEMS

May 2004

Hazards/
error

type

of Harm/ Consequences P

CROSS
REF
66

A EUROPEAN CODE OF GOOD PRACTICE FOR HBO THERAPY

Annex 3Mechanicalelements
Valves 1/4 turnWork safety of the Damage, injury
Xfacility
Lack of maintenance Lack of compression/ Supply/ Exhaust
Non
Return Lack of maintenance Reduced gas flow too
Valvesslow compression
Pressure relief Insufficient
size/ Damage to pressure
valvesfaultyhull
Manifolds
Position / material / Incorrectgases X
rating / labelingsupplied /Injury

X

X

2

X
X

X

X

4

X

4, 5

6. Inadequate packaging (contamination and/ or deterioration of the device),

ITEM
S
BIBS

Hazards/ type of error

Harm/ Consequences

P

A

O

Contaminated/poor
fitting/leaking.
Breathing resistanceRaisedPPO2
in X
chamber
Fire risk, Patient notreceiving 100% O2

X

X

CROSS
REF

7. Improper re-use

ITEMS

Hazards/ type of error

Harm/ Consequences P A O

Accessories

Contamination

Cross infections

May 2004

X X

CROSS
REF
3, 4

67

A EUROPEAN CODE OF GOOD PRACTICE FOR HBO THERAPY

Annex 4

Annex 4 – Framework for Operating Manual
FRAMEWORK FOR OPERATING MANUAL FOR HYPERBARIC FACILITY
1. DESCRIPTION AND FUNCTION OF THE HYPERBARIC SYSTEM
1.1.
Pressure chamber(s)1.2.
Control panel (including computer system if fitted)
1.3.
General supply panel
1.4.
Gas supply :1.4.1. Compressors
1.4.2. Gas storage
1.4.3. Oxygen supply
1.5.
Power supply and backup supplies
1.6.
Breathing systems
1.7.
Monitoring of patients
1.8.
Communication (primary and secondary)
1.9.
Environmental control
1.10.
Fire protection and fire fighting
1.11.
Maintenance
2. STANDARD OPERATING PROCEDURES
2.1. System
2.1.1. Preparation
2.1.1.1. Daily and session checks
2.1.1.2. Preparation dependent on patient condition
2.1.2. Operation
2.1.2.1. Conducting single and successive sessions (including themonitoring of critical parameters. i.e. pressure, time, oxygen
breathing, chamber oxygen percentage, gas supplies, attendanttimes etc.)
2.1.2.2. Use of locks
2.1.2.3. Recording the session (Treatment Log)
2.1.2.4. Shut down procedure after each session
2.1.2.5. End of day shut down procedure
2.1.3. Management of supplies (gas, drugs, etc.)
2.1.4. Cleaning and disinfecting procedures
2.1.5. Use of all medical devices
2.2. Treatment protocols (standard and extended) with detailed instructions
2.3. Patient
2.3.1. Admission (including informed consent)
2.3.2. Preparation
2.3.3. Handling, management and monitoring
2.3.4. Assessment and management of adverse effects(see Emergency Procedures)
2.3.5. Discharge
2.4. Team2.4.1. Contact details and call out procedures
2.4.2. Qualification requirements
2.4.3. Team roles and sizes
2.5. Record keeping
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Annex 42.5.1. Facility
2.5.2. System
2.5.3. Patient
3. EMERGENCY OPERATING PROCEDURES
3.1. Medical
3.1.1. cardio-respiratory complains including procedures for safe defibrillation
3.1.2. loss of consciousness
3.1.3. convulsions
3.1.4. neuropsychologic acute reactions (including panic, claustrophobia,
aggression)
3.1.5. vomiting
3.1.6. dysbaric injuries to patients and staff:
3.1.6.1. any barotrauma
3.1.6.2. decompression illness / sickness
3.2. System
3.2.1. uncontrolled change of pressure
3.2.2. loss of gas supplies
3.2.3. contamination of gas supplies
3.2.4. contaminated atmosphere inside chamber
3.2.5. high oxygen levels in the chamber atmosphere3.2.6. inability to maintain adequate temperature
3.2.7. fire in the chamber
3.2.8. fire in the facility
3.2.9. loss of communications (visual, verbal)
3.2.10. power failure
3.2.11. internal equipment malfunction
3.2.12. medical device malfunction
3.2.13. BIBS malfunction
3.2.14. any external threats to the facility

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Annex 5Annex 5 – Record Keeping
RECORD KEEPING
Levels of record keeping:
1. Facility
a. Personnel:
 Recording of initial and continuing education programs,
 Staff duty rotas Staff hyperbaric exposure recording
b. Protocols for the assessment and treatment of all conditions for which
the facility offers hyperbaric therapy
2. Systema. Session record should include: Identification of chamber (for multi chambers facility), Name of the duty hyperbaric physician, Name of the duty supervisor, Name of operator(s) and attendant(s), Patients name and location in the chamber, Number of treatments (treatment number for each patient) Use of specific medical devices (TcPO2, ventilator, monitor, etc.)
 Patients incidents Safety checks (prevention fire, shoes, clothing, etc.),
 Protocol used
 Start date/time and compression time, Breathing mixtures for patients and attendants,
 Time of delivery of therapeutic breathing mixtures,
 Time and pressure of attendant’s exposures,
 Session end date/time Technical actions (eg. ventilation of chamber), Technical incidents
 Any other factors likely to affect the safety or health of any
person engaged in the operationb. Before / after use
 General checks and tests of facility’s systems:
1. Recording of all available supplies (air, oxygen, electricity,etc.)
2. Recording the status of the alarms systems,
3. Recording the status of the emergency systems,
4. Recording of daily functional tests (pre use) following theoperating instructions,
5. Recording of functional test (pre use) of specific medical
devices (TcPO2, ventilator, monitor, etc.)
c. Disinfection records:
 Records of changing masks, equipment and consumables, Records of cleaning and disinfection of chamber, masks, hoods,
tubes, etc.)
d. Register of maintenance, Records of all maintenance and repairs
May 2004

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Annex 5

 Records of quality control of gases
 Records of incidents and accidents
3. Patienta. Patient identification and administrative informationb. Informed consent to treatmentc. Introduction to hyperbaric procedures (including preparation, protocols,
environmental factors, possible adverse effects)
d. Medical diagnosis with indication for hyperbaric treatmente. Alert Data (allergies, contraindications, infections, etc.)
f. Medical and nursing records (consultations, clinical results, drugs,
surgery, TcPO2 results, etc.)
g. Protocol of treatment
h. Record of each hyperbaric session (see 2a above)

May 2004

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A EUROPEAN CODE OF GOOD PRACTICE FOR HBO THERAPY

Annex 6

Annex 6 – Patient Management
PATIENT MANAGEMENT
1. Reception
1.1. Method(s) of patient referral
1.2. Assessment of patient suitability for type of facility.
1.3. Transport of patients to the therapeutic hyperbaric facility.
1.4. Pre-treatment clinical assessment of patient for suitability of medical condition
for hyperbaric oxygen treatment.
1.5. Pre-treatment clinical assessment for other medical conditions which might beaffected by hyperbaric treatment including possible relative and absolutecontraindications for hyperbaric therapy.
1.6. Introduction of patient to the hyperbaric procedure, including
1.6.1. Preparation (prohibited items, patient clothing policy)
1.6.2. Protocols (methods of oxygen delivery)
1.6.3. Chamber environmental factors (pressure, temperature, humidity,
noise)
1.7. Patient briefed as to possible adverse effects of HBO.
1.8. Informed consent to treatment.
2. Treatment
2.1. Procedures during compression for different patient conditions.
2.2. In-chamber patient management including physiological and clinicalmonitoring.
2.3. Procedures during decompression for different patient conditions.
2.4. Patient clinical record keeping, including monitoring of side and adverse
effects
2.5. Re-assessment of patient.
3. Follow-up/discharge
3.1. Admission/transfer/referral for in-patient hospital care.
3.2. Referral to other hyperbaric facilities.
3.3. Patient discharge and review arrangements.
3.4. Written instructions for the patient on discharge;
3.5. Arrangements for transfer of clinical responsibility to alternative speciality
when hyperbaric phase of treatment is complete;
3.6. Written discharge summary;
3.7. Follow-up including possible long term effects

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Annex 7

Annex 7 – Prohibited Materials
Each and every item added to the hyperbaric environment posses a potential risk
which should be assessed prior to its approval. All approved items taken inside thehyperbaric chamber should be assessed for their necessity.
The following items comprise a reasonably comprehensive listing of items andmaterials that should be either prohibited or severely limited inside the chamber. The
letter(s) following each item indicates the general reason for prohibiting it, the coding
is shown below.
• C - possibility of damaging the fabric of the chamber• D - contamination of the environment• E - explosion risk
• F - fire source (including static charges) or a combustible substance• L - could be broken or damaged by pressure• M - will possibly cause a mess
• P - affects ability of diver
LISTING (in alphabetical order):• Adhesives (F)• Aerosols (D, E, F)• Aftershave (D, F)• Alcohol (D, F, P)• Batteries with unprotected leads (F)• Chemical cleaners, eg; trichlorethylene, 'Freon', etc (D)• Cigarettes, cigars, tobacco of all kinds (F, M)• Cleansing powder (C, F, P)• Clothing, bedding included blankets, sheets, pillows, mattresses, etc. (F)• Drugs, non prescribed (P)• Electrical equipment including tape recorders, radios, etc (F)• Explosives (F)• Glass thermometers, including batteries containing mercury (C, D, P)• Ink pens (M)• Lighters, matches (F)• Newspaper (F)• Non-diving watches (L, M)• Petroleum based lubricants, grease, fluids (F)• Sugar and fine powders and other flammable food stuffs (E, F)• Thermos flasks (L, P)
IMPORTANT NOTE
It is important to be aware that the clothing of occupants entering the chamber and bedding
constitute an additional hazard as it may be either synthetic, wool, contaminated orcontaining prohibited items. 100% cotton or other hyperbaric compatible materials should be
used.

May 200473