REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Report on the issue of the reprocessing of medical devices in the European Union, in accordance with Article 12a of Directive 93/42/EEC
Date: 2010-08-27
Institutions: European Commission
Subjects: harmonisation of standards, medical device, occupational safety, public health, radiation protection, radiobiology

EN 

EN 

   EN 

 
EUROPEAN COMMISSION 

Brussels, 27.8.2010 
COM(2010) 443 final 

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL  

Report on the issue of the reprocessing of medical devices in the European Union, in 
accordance with Article 12a of Directive 93/42/EEC 

(Text with EEA relevance) 

EN 

   EN 

 
 
  
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL  

Report on the issue of the reprocessing of medical devices in the European Union, in 
accordance with Article 12a of Directive 93/42/EEC 

(Text with EEA relevance) 

1. 

INTRODUCTION 

1.1. 

Scope and structure of the report 

This report addresses the issue of the reprocessing of medical devices in the European Union, 
in accordance with Article 12a of Council Directive 93/42/EEC of 14 June 19931 concerning 
medical devices. 

The  first  section  of  this  document  includes  some  background  information  while  the  second 
and third parts of the report distinguish between the reprocessing of reusable medical devices 
and the reprocessing of single use medical devices. This report assesses in further detail the 
public  health,  ethical,  liability,  economic  and  environmental  aspects  of  the  reprocessing  of 
single use medical devices. 

The  reprocessing  of  a  medical  device,  for  the  purpose  of  this  report,  includes  steps  needed 
such as routine maintenance, disassembly, cleaning, disinfection and/or sterilisation to allow 
safe reuse. 

1.2. 

Background of the report 

1.2.1. 

1980s, the shift to the use of single use medical devices 

Historically, medical devices were usually developed as reusable medical devices. Their reuse 
was facilitated by their shape, their design, their size and the fact that they were usually made 
of  resistant  materials  like  glass,  metal  or  rubber,  and  reprocessed  by  steam  sterilisation 
process. 

However, the emergence of blood transmitted diseases, like hepatitis in the early 1980s, and 
the  risk  of  nosocomial  transmission  by  reuse  of  contaminated  syringes  have  heightened 
interest  in  the  development  of  single  use  injection  medical  devices.  The  discovery  of  the 
Human Immunodeficiency Virus and its transmission by, among others, contaminated blood 
has put more pressure on the development of single use medical devices.  

In addition to these major public health concerns, the advancements in technology led to the 
development  of  more  sophisticated  and  complex  medical  devices.  These  devices  were 
generally made in plastics not resistant to aggressive physical / chemical treatments, to high 
temperatures and therefore to steam sterilisation processes, but allowing mass production and 
giving them specific qualities and properties. New instruments were also developed for mini-
invasive  procedures,  with  smaller  lumens  and  with  more  intricate,  delicate  working 

1 

OJ L 169, 12.7.1993, p. 1 

EN 

2 

   EN 

                                                 
mechanisms. These devices were not as easy, or even impossible, to clean or sterilise properly 
and  it  was  therefore  impossible  for  the  manufacturer  to  demonstrate  that  they  were  safely 
reusable. Because of this, some devices were labelled as "single use".  

1.2.2.  Medical devices European regulatory framework 

Rules  relating  to  the  safety  and  performance  of  medical  devices  were  harmonised  in  the 
European  Union  in  the  nineties,  beginning  with  Council  Directive  90/385/EEC  of  20  June 
1990  on  the  approximation  of  the  laws  of  the  Member  States  relating  to  active  implantable 
medical  devices2  and  later  followed  by  Council  Directive  93/42/EEC  concerning  medical 
devices  and  by  Directive  98/79/EC  of  the  European  Parliament  and  of  the  Council  of  27 
October 1998 on in vitro diagnostic medical devices3. 

These three legal texts form the core legal framework for medical devices. Their aim is both 
to  ensure  a  high  level  of  protection  of  human  health  and  safety  and  the  functioning  of  the 
internal market.  

Directive 93/42/EEC concerning medical devices distinguishes between reusable devices and 
those intended for single use.  

In particular: 

•  The medical devices intended for single use must bear on their label an indication 

that the device is for single use4.  

•  For the reusable medical devices, the manufacturer must provide information on 
the  appropriate  process  to  allow  reuse,  including  cleaning,  disinfection,  and 
packaging and, where appropriate, the method of sterilisation to be used, and any 
restriction on the number of reuses5.  

Directive  93/42/EEC  was  lastly  amended  by  Directive  2007/47/EC  of  the  European 
Parliament and of the Council of 5 September 20076 which, in order to address some concerns 
about  patient  safety,  provides  further  clarification  on  the  definition  of  the  term  "single  use" 
and introduces new requirements for single use medical devices.  

In particular, Directive 2007/47/EC provides that: 

•  “single  use  device”  means  a  device  intended  to  be  used  once  only  for  a  single 

patient7; 

•  The  manufacturer's  indication  of  single  use  must  be  consistent  across  the 

Community8; 

2 
3 
4 
5 
6 
7 
8 

OJ L 189, 20.7.1990, p. 17 
OJ L 331, 7.12.1998, p. 1 
Annex I section 13(3)(f) of Directive 93/42/EEC 
Annex I section 13(6)(h) of Directive 93/42/EEC 
OJ L 247, 21.9.2007, p. 21 
Article 1(2)(n) of Directive 93/42/EEC 
Annex I section 13(3)(f) of Directive 93/42/EEC 

EN 

3 

   EN 

                                                 
•  If  a  device  bears  an  indication  that  it  is  for  single  use,  information  on  known 
characteristics and technical factors known to the manufacturer that could pose a 
risk if the device were to be reused must be provided in the instruction for use9.  

In  addition  to  the  above,  in  order  to  ensure  that  the  reprocessing,  and  in  particular  the 
reprocessing  of  single  use  medical  devices,  does  not  endanger  patients'  safety  and  health, 
Article 12a of Directive 93/42/EEC requests the Commission to engage in further analysis in 
order  to  see  if  additional  measures  are  appropriate  to  ensure  a  high  level  of  protection  for 
patients, and to submit this report on the issue of the reprocessing of medical devices in the 
European Union to the European Parliament and to the Council. 

1.3.  Methodology  

1.3.1.  Medical Devices Expert Group consultation 

In order to start its analysis of the issue, the Commission services consulted the members of 
the Medical Devices Expert Group10 from 23rd May 2007 to 31st July 2007. 

This  group  includes  representatives  from  national  competent  authorities,  medical  device 
industry and other stakeholders in the area of medical devices. 

National competent authorities' representatives were invited to describe the situation in their 
country  with  regards  to  the  reprocessing  of  medical  devices,  while  industry  and  other 
stakeholder representatives were asked to give information in their fields of activity.  

1.3.2.  Public consultation 

With the aim to broaden the consultation, a questionnaire was published on the Commission’s 
website from 6th July 2007 to 15th August 2007.  

Contributions were received from a wide range of stakeholders, including national competent 
authorities,  medical  device  companies,  public  and  private  associations  (e.g.  medical  device 
manufacturers and reprocessing service providers), hospitals, national health services as well 
as individuals. 

Following these two consultations, a synthesis document was published on the Commission's 
website on 29th May 200811. 

1.3.3.  Workshop 

Based on the findings of the above mentioned consultations, and in addition to meetings with 
various stakeholders and fact finding missions both in single use medical device manufacturer 
premises and reprocessing facilities, the Commission services organised a workshop12 on 5th 
December  2008  with  the  aim  to  collect  further  data  and  get  a  clearer  picture  of  the 
reprocessing practice, in particular on public health, economic and environmental aspects of 
the reprocessing of single use medical devices. 

9 
10 
11 
12 

Annex I section 13(6)(h) of Directive 93/42/EEC 
http://ec.europa.eu/transparency/regexpert/detail.cfm?ref=1574&l=M 
http://ec.europa.eu/consumers/sectors/medical-devices/files/guide-stds-directives/synthesis_en.pdf 
http://ec.europa.eu/enterprise/newsroom/cf/itemshortdetail.cfm?item_id=3280 

EN 

4 

   EN 

                                                 
Representatives from the national competent authorities, the medical device industry and the 
reprocessing  services  providers,  as  well  as  various  experts  of  the  medical  devices  sector, 
attended the workshop. 

The  outcome  of  this  workshop  was  published  on  the  Commission's  website  on  18th  May 
200913. 

1.3.4.  The SCENIHR opinion 

With the aim to ensure the highest level of health protection and in order to be provided with 
a sound and independent scientific analysis on the issue, the Commission asked the Scientific 
Committee  on  Emerging  and  Newly  Identified  Health  Risks14  (SCENIHR)  for  its  scientific 
opinion on the safety of reprocessed medical devices marketed for single use.  

In  particular,  the  Committee  was  asked  to  assess  whether  the  use  of  reprocessed  single  use 
medical devices constitutes a hazard for human health, and if applicable, to characterise the 
risk  for  human  health  and  to  establish  under  which  conditions  or  uses  the  reprocessing  of 
single use medical devices poses a risk. 

2. 

THE REPROCESSING OF REUSABLE MEDICAL DEVICES 

Some  medical  devices,  such  as  many  of  the  surgical  instruments,  are  intended  by  their 
manufacturers  to  be  reused.  Therefore  their  reuse  is  taken  into  account  in  the  development 
process  of  the  medical  devices  and  has  particular  implications  on  the  choice  of  the  raw 
materials and the design of the device.  

Directive 93/42/EEC requires that, where a manufacturer intends its device to be reused, this 
manufacturer must  provide information on the appropriate process to allow reuse, including 
cleaning, disinfection, and packaging and, where appropriate, the method of sterilisation to be 
used, and any restriction on the number of reuses15. This implies that the manufacturer, on the 
basis  of  the  materials  used  and  the  design  of  the  product,  must  validate  the  reprocessing 
process  to  be  applied  in  order  to  ensure  that  the  medical  device  will  not  be  altered  by  such 
reprocessing process, will perform as intended and will be safe for a number of reuses.  

3. 

THE REPROCESSING OF SINGLE USE MEDICAL DEVICES 

During  the  years  following  the  implementation  of  Directive  93/42/EEC,  the  shift  of  some 
categories  of  medical  devices  from  reusable  devices  to  single  use  devices  was  progressive. 
Therefore,  reusable  and  single  use  medical  devices  intended  for  the  same  use  have  been 
coexisting on the market. This was misleading for hospitals, and sometimes, in order to face 
increasing financial pressures, some medical devices have continued to be reprocessed, either 
in hospitals or via third party reprocessing providers, despite the fact that they were intended 
for single use.  
Single use medical devices, such as needles or angioplasty catheters, are not developed and 
designed to withstand a reprocessing procedure and the manufacturer does not need to provide 
any  instruction  or  validated  process  to  allow  a  safe  reprocessing  of  the  device  but  only 

13 

14 
15 

http://ec.europa.eu/consumers/sectors/medical-
devices/files/pdfdocs/summary_5_12_2008_workshop_en.pdf 
http://ec.europa.eu/health/ph_risk/committees/04_scenihr/04_scenihr_en.htm 
Annex I section 13(6)(h) of Directive 93/42/EEC 

EN 

5 

   EN 

                                                 
information on the characteristics or technical factors  known to  the manufacturer that could 
pose a risk if the device were to be reused. The reprocessing is therefore carried out on the 
basis of procedures developed by the user or by the reprocessing service provider, but without 
complete  information  on  the  design  and  composition  of  the  product.  According  to  a  report 
from  the  Netherlands16,  the  validation  of  a  reprocessing  process  for  single  use  medical 
devices, especially the cleaning, is a task that usually cannot be performed in a hospital since 
the required equipment, knowledge, experience and resources are unlikely to be available.  

Contrary  to  reusable  medical  devices,  for  which  requirements  are  set  out  in  Directive 
93/42/EEC  to  ensure  their  safe  reuse,  the  reuse  of  single  use  medical  devices  may  not  be 
without  risk  from  a  public  health  point  of  view.  In  addition  ethical,  liability,  economic  and 
environmental aspects of reprocessing single use medical devices should also be looked at and 
are therefore further developed in this report.  

3.1. 

Situation at the European Union's level 

The  reprocessing  practice  of  single  use  medical  devices  is  not  currently  regulated  in  the 
European Union and different national legislations regulate this practice throughout Europe. 
Few  countries  allow  the  reprocessing  of  single  use  medical  devices  and  have  developed 
guidelines (e.g. Germany), while some countries prohibit it (e.g. France) and some Member 
States do not have any specific regulations on this aspect. 

3.2. 

Situation at International level 

At international level different situations may occur, in particular the following: 
In the United States17, before medical devices can be reprocessed and reused, a third-party or 
hospital  reprocessor  must  comply  with  the  same  requirements  that  apply  to  original 
equipment  manufacturers,  including  submitting  documents  for  pre-market  notification  or 
approval,  registering  reprocessing  firms  and  listing  all  products,  submitting  adverse  event 
reports, tracking devices whose failure could have serious outcomes, correcting or removing 
from the market unsafe devices and meeting manufacturing and labelling requirements. 

In Canada, Health Canada does not regulate the reuse of single use medical devices, as under 
the  current  Act  and  Regulations  Health  Canada  does  not  have  provisions  for  that  authority. 
Certain provinces have banned reuse of single critical use devices and other provinces have 
stated that hospitals should use a licensed reprocessor. 

In Australia18, a reprocessor who reprocesses a medical device originally intended for single 
use only becomes the manufacturer of the reprocessed device, and as such is required to apply 
the relevant conformity assessment procedure for the product. 

In  Japan19,  the  requirements  for  single  use  devices  are  that  the  label  must  contain  “single 
use” and the instruction for use must contain “reuse is prohibited”. 

16 

17 

18 
19 

National Institute for public Health and environment – "Reprocessing of medical devices, Possibilities 
and limiting factors" 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-
UseDevices/default.htm 
http://www.tga.gov.au 
Article 222(5), Ministerial Ordinance on Pharmaceutical Affairs Law 
Notification  by  Director-General,  Pharmaceutical  and  Food  Safety  Affairs  Bureau,  Yakusyokuhatsu 
#0310003, March 10, 2005 

EN 

6 

   EN 

                                                 
 
3.3. 

Public health considerations on the reprocessing of single use medical devices 

To  identify  and  characterize  the  potential  hazards  and  risks  associated  with  the  use  of 
reprocessed  single  use  medical  devices,  the  Scientific  Committee  on  Emerging  and  Newly 
Identified  Health  Risks  (SCENIHR)  was  asked  for  its  scientific  opinion  on  the  safety  of 
reprocessed medical devices marketed for single use.  

This opinion20 was adopted on 15th April 2010. SCENIHR's answers to the terms of reference 
are detailed in the annex to this report.  

3.3.1.  Risks and hazards identified by the SCENIHR 

For both categories of devices, single-use and reusable medical devices, cleaning, disinfection 
and/or sterilisation are needed before the device can be reused. For reusable medical devices, 
the procedures, conditions and number of reuses are already considered at the design stage of 
the device. The choice of the material and geometry (shape) of the device are also considered 
at this stage.  

Information  on  the  reprocessing  procedures  to  be  followed  must  be  provided  by  the 
manufacturer  of  reusable  medical  devices,  and  this  is  not  the  case  for  single  use  medical 
devices.  

The  SCENIHR  in  its  opinion  identified  the  main  following  hazards  and  risks  linked  to  the 
reprocessing of single use medical devices.  

After  use,  all  medical  devices  that  have  been  in  contact  with  patients  may  contain 
contaminants  including  pathogenic  micro  organisms,  the  elimination  of  which  during  the 
cleaning, disinfection and sterilisation steps may be difficult. If the efficacy of these steps is 
not  properly  validated  the  resulting  persistence  of  the  contamination  poses  a  hazard  of 
infection for the next  patient  on  whom the medical device is used.  Some simulation studies 
and  a  few  clinical  studies  have  shown  that  reprocessing  of  single  use  medical  devices  may 
result  in  improper  cleaning,  disinfection  and/or  sterilisation  leaving  a  bioburden  on  the 
reprocessed  single  use  medical  device,  which  introduces  a  risk  of  infection  when  using  the 
reprocessed single use medical device. 

A  specific  problem  pointed  out  by  the  SCENIHR  is  the  elimination  of  prion  contamination 
since  only  aggressive  cleaning  methods,  not  compatible  with  the  commonly  used  materials, 
can  ensure  complete  prion  inactivation.  This  issue  was  further  developed  in  a  previous 
SCENIHR  opinion  on  the  safety  of  human  derived  products  with  regard  to  Variant 
Creutzfeldt-Jacob Disease21. 

Chemical residues as a result of reprocessing may pose a toxic risk when a device is reused. 
In  addition,  changes  of  the  physical  and  chemical  characteristics  of  the  devices  may  occur 
which  may  eventually  have  an  impact  on  the  performance  of  the  reprocessed  single  use 
medical device.  

It has been shown that a reprocessed single use medical device can be modified in its structure 
or functionality and may potentially cause some damage to the patient or health-care workers, 
e.g. mechanical failure of the device. 

20 
21 

http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_027.pdf 
http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_004.pdf  

EN 

7 

   EN 

                                                 
The risks are related primarily to the use of the device. 

Three  categories  of  devices  could  be  identified  based  on  the  Spaulding  classification, 
reviewed by Alvarado22. This classification is based on the risk linked to the use of the device, 
depending on the degree of invasiveness, independently from the fact that these devices are 
intended for single or multiple uses.  

(1) 

(2) 

(3) 

Non-critical  use  (in  general,  for  intact  skin  contact  only  or  no  contact  with 
the patient) e.g. basins, thermometers, blood pressure cuffs; 

Semi-critical  use 
intact  mucous  membranes  without 
penetration  of  tissues)  e.g.  flexible  endoscopes,  laryngoscopes,  endotracheal 
tubes; 

(contact  with 

Critical use (surgically invasive medical procedures) e.g. catheters, implants, 
needles, surgical instruments.  

In case of reprocessing, the highest risk occurs when a reprocessed single use medical device 
is used for invasive medical procedures, while the lowest risk is associated with external (skin 
contact only) use. 

The  number  of  documented  incidents  is  very  small,  although  it  can  be  speculated  that  the 
reporting  of  incidents  is  incomplete.  However,  regarding  adverse  events,  there  may  be  a 
“grey”  area  for  which  the  recognition  and  reporting  of  incidents  is  difficult,  such  as  a 
prolonged  surgical  procedure  due  to  stiffness  of  a  reprocessed  single  use  catheter,  and  a 
prolongation  of  hospital  stays.  Furthermore,  long-term  effects  may  not  be  identified  and 
attributed to the use of reprocessed medical devices. 

3.3.2.  Conclusion on public health considerations on the reprocessing of single use medical 

devices 

Three  major  hazards  were  identified  by  the  SCENIHR  i.e.  a  remaining  contamination,  the 
persistence of chemical substances used during the reprocessing process and the alterations in 
the performance of the single use medical devices due to the reprocessing. 

A specific problem is the elimination of prion contamination, since only relatively aggressive 
cleaning  methods,  not  compatible  with  the  commonly  used  materials,  can  ensure  prion 
inactivation. 

In  order  to  identify  and  reduce  potential  hazards  associated  with  reprocessing  of  a  specific 
single use medical device, the whole reprocessing cycle starting with the collection of these 
single  use  medical  devices  after  (first)  use  until  the  final  sterilisation  and  delivery  step, 
including its functional performance, needs to be evaluated and validated. 

Not all single use medical devices are suited for reprocessing in view of their characteristics 
or the complexity of certain single use medical devices. 

22 

Alvarado  CJ.  Revisiting  the  Spaulding  classification  scheme.  In:  Rutala  WA,  editor.  Chemical 
germicides in healthcare. Washington DC: APIC; 1994. p. 203-8 

EN 

8 

   EN 

                                                 
The  risk  is  highest  when  the  reprocessed  single  use  medical  device  is  used  in  a  critical 
procedure,  i.e.  when  used  for  an  invasive  medical  procedure.  In  contrast,  the  risk  is  much 
lower for non-critical medical procedures in which reprocessed single use medical devices are 
used. 

It  must  be  noted  that  the  World  Health  Organization  identified  similar  hazards,  risks  and 
limitations of reusing single use medical devices in a report titled "Medical device regulations 
– Global overview and guiding principles"23. 

3.4. 

Ethical  and  liability  considerations  on  the  reprocessing  of  single  use  medical 
devices in the current situation 

In addition to public health considerations, the reprocessing of single use medical device may 
raise ethical and liability concerns.  

3.4.1.  Ethical considerations  

As highlighted in the SCENIHR opinion, the use of a reprocessed single use medical device 
may pose an additional risk to the patient in comparison with using a new single use device. 
Therefore,  the  issue  of  patient  information  and  prior  informed  consent  before  she/he 
undergoes the medical procedure needs to be considered. 

Furthermore,  the  reprocessing  of  single  use  medical  devices  may  create  different  levels  of 
healthcare provisions and, as a consequence, may create inequalities between patients. 

The  above  mentioned  ethical  considerations  should  be  however  balanced  with  the  potential 
cost savings generated by the reprocessing practice which, in a context of costs containment 
for healthcare services, could be seen as a way to facilitate and increase access to innovative 
technology for the patients. 

However,  cost  savings  are  very  much  dependent  on  the  type  and  level  of  quality  of  the 
reprocessing  practice  and,  to  date,  there  is  no  clear  evidence  and  data  to  quantify  the  cost 
savings  that  could  create  the  reprocessing  of  single  use  medical  devices  and  to  establish  to 
what extent the patient would benefit from these potential cost savings.  

The  economic  aspects  of  reprocessing  single  use  medical  devices  are  further  developed  in 
section 3.5. 

3.4.2.  Liability considerations 

3.4.2.1.  Liability of healthcare professionals  

Healthcare professionals may be liable in case of mishandling of a medical device with regard 
to  patients’  health.  Since  their  liability  may  be  engaged,  healthcare  professionals  should  be 
informed in case they are using reprocessed single use devices, in view of the fact that it may 
have  consequences  on  the  handling  of  the  device,  for  instance  in  terms  of  stiffness  of  a 
reprocessed catheter, and may constitute an additional risk of medical complications. 

23 

http://www.who.int/medical_devices/publications/en/MD_Regulations.pdf  

EN 

9 

   EN 

                                                 
3.4.2.2.  Liability of the original manufacturer 

The original manufacturer is responsible for the safety and performances of his product when 
it is used in accordance with its intended purpose.  

For  reusable  devices,  the  manufacturer  shall  remain  responsible  for  product  related  aspects 
when the device is reused if the hospital or the third party reprocessing service provider has 
followed  the  information  the  manufacturer  has  provided  on  the  appropriate  process  to 
reprocess the device.  

Directive  93/42/EC  requires  for  single  use  medical  devices  that  the  instruction  for  use 
contains  information  on  known  characteristics  and  technical  factors  known  to  the 
manufacturer  that  could  pose  a  risk  if  the  device  were  to  be  reused24.  However,  the 
responsibility of the original manufacturer shall be clarified in case of reprocessed single use 
medical device failure and medical complication due to and only to the reprocessing practice.  

Currently, such reprocessed single use medical devices are usually labelled under the name of 
the original manufacturer. The requirements regarding the labelling of reprocessed single use 
medical devices products might therefore need to be clarified in order to reflect the liability in 
case of product failure and ensure the traceability of reprocessed single use medical devices.  

3.4.2.3.  Liability of the reprocessing service provider 

Where a user or a third party reprocessing service provider develops and validates a procedure 
for reprocessing single use medical devices, this user or this third party reprocessing service 
provider  shall  be  responsible  for  the  implications  of  the  reprocessing  along  the  guidelines 
developed and validated.  

Where the reprocessing of single use medical devices is done via a third party reprocessing 
service  provider,  the  sharing  of  liability  between  the  user  and  the  reprocessing  service 
provider currently appears unclear. 

3.4.2.4.  Conclusion on ethical and liability considerations on the reprocessing of single use 

medical devices in the current situation 

In the current situation, the reprocessing of single use medical devices raises ethical concerns 
in terms of potential inequalities between patients. In addition, the issue of prior information 
and consent of patients needs to be considered. 
Regarding  the  liability,  it  would  be  necessary  to  clarify  the  responsibilities  of  each 
stakeholder and to inform healthcare professionals in case they are using reprocessed single 
use  medical  devices,  as  their  responsibility  may  be  engaged  in  case  of  adverse  events. 
The requirements regarding the labelling of reprocessed single use medical devices shall be 
clarified, in particular for the purpose of traceability of these devices. 

3.5. 

Economic considerations on the reprocessing of single use medical devices 

The  economic  considerations  are  the  main  driver  in  the  reprocessing  of  single  use  medical 
devices. 

24 

Annex I, section 13(6)(h) of Directive 93/42/EEC 

EN 

10 

   EN 

                                                 
In the current context of increasing resources constraints and the needs for cost-containment 
in healthcares, the reprocessing of single use medical devices has been used by some hospitals 
to reduce their expenses. Indeed, new single use medical devices might be expensive and their 
reuse offers the possibility of dividing their purchasing costs over multiple patients. 

However,  the  reduction  of  the  purchasing  cost  of  a  device,  even  if  very  visible  and  not 
disputable,  is  only  one  of  the  elements  needed  to  assess  any  potential  cost  reduction  when 
using reprocessed single use medical devices. Various other costs and considerations need to 
be  taken  into  account  (e.g.  number  of  reuses,  costs  for  developing  and  validating  a 
reprocessing  process,  costs  for  performing  the  reprocessing  process,  costs  for  logistics  and 
transport,  insurance  costs,  liability  costs  in  case  of  failure  of  the  reprocessed  single  use 
medical device). 

In  the  light  of  the  above,  to  date,  there  are  few  and  poor  quality  scientific  evidence  and 
economic  evaluation  to  demonstrate  that  the  reprocessing  of  single  use  medical  devices  is 
globally a cost-saving practice. 

According to  a systematic  literature  review on the  economic analysis of reprocessing single 
use medical devices25 published in 2008, although this practice is used routinely, there is little 
available evidence of sufficient quality in the published literature. The published evidence on 
the  cost-effectiveness  of  reprocessing  single  use  medical  devices  is  inconclusive  and  the 
authors concluded that their review indicates that the cost-effectiveness of reusing single use 
medical devices is not established. 

3.5.1.  Methodology for costs calculation 

The methods used for the calculation of the costs are often vague and not well described.  

The costs generally do not include several elements like the costs linked to potential adverse 
events  and  clinical  consequences  for  patients.  In  addition,  the  costs  are  generally  calculated 
but not really based on a direct observation. Therefore, several elements of the costs could be 
missing, like the cost of the facilities, the real cost of the consumption of water, energy, etc. 
The costs can vary a lot between healthcare facilities depending on the existence of a central 
sterilisation  unit  in  the  hospital,  the  number  of  medical  devices  reprocessed  per  year  (scale 
effect) and the existence of a quality management system for the sterilisation process. 

In addition, these studies do not include a validation to ensure that, after the reprocessing, the 
reprocessed single use medical device presents an acceptable level of safety, in particular, on 
functionality  and  on  biocontamination  aspects.  This  validation  process  should  include  the 
determination  of  the  number  of  safe  reuses  for  a  type  of  single  use  medical  device,  the 
verification  of  the  functionality  of  the  reprocessed  single  use  medical  device  and  a  quality 
management  system  for  the  reprocessing  process  ensuring  that  the  complete  process  was 
performed with a sufficient level of quality and safety. The cost of this validation process is 
never included in the published studies. 

25 

Jacobs.P and al. Economic analysis of reprocessing single use medical devices: a systematic literature 
review. Infect Control Hosp Epidemiol 2008;29:297-301 

EN 

11 

   EN 

                                                 
3.5.2.  Economic studies perspective 

The studies published on the reprocessing of single use medical devices are always conducted 
from  the  hospitals'  perspective  and  do  not  take  into  account  other  costs  of  the  reprocessing 
practice,  like  the  cost  for  the  insurance  systems  or  the  patients  in  case  of  clinical 
consequences or liability. 

3.5.3.  Level of quality and safety of the reprocessing 

A  recent  study  performed  in  Belgium26  demonstrates  that,  in  the  case  where  an  equivalent 
level of safety and  quality  is  achieved for reprocessed single use angiography catheters, the 
cost  of  these  reprocessed  devices  is  higher  than  the  cost  of  new  single  use  angiography 
catheters.  Such  equivalent  level  of  safety  and  quality  would  be  ensured  by  following  the 
standards  harmonised  under  Directive  93/42/EEC.  In  addition,  this  study  demonstrates  that 
without scale benefits (taking into effect the decrease of the costs brought by a scale effect), 
and taking into account the cost of an estimate rate of adverse event, the reprocessing costs 
are generally higher than buying single use medical devices. 

3.5.4.  Prices of single use medical devices 

A major parameter in these economic studies is also the prices of single use medical devices. 
These prices are highly variable between hospitals, countries and medical devices and could 
evolve a lot during the marketing life of a medical device. Therefore, even if the high price of 
a  new  single  use  medical  device  could  lead  to  the  assumption  that  the  reprocessing  is  cost-
effective, a variation in the price of this device due to an increase in the market competition 
could reverse completely this assumption.  

3.5.5.  Conclusion  on  economic  considerations  on  the  reprocessing  of  single  use  medical 

devices 

To  date,  the  published  economical  data  do  not  allow  drawing  any  conclusion  on  the  cost-
effectiveness of the reprocessing practice for single use medical devices when performed with 
a  sufficient  level  of  quality  and  safety.  This  cost-effectiveness  needs  to  be  demonstrated  by 
long-term studies including a large number of patients and clear calculation of the direct and 
indirect costs. 

3.6. 

Environmental considerations on the reprocessing of single use medical devices  

Environmental  considerations  are  usually  advocated  as  another  argument  in  favour  of 
reprocessing single use medical devices. 

On the one hand, the increasing use of single use medical devices has a negative impact on 
the environment, due in particular to the resources needed for the raw material production, the 
manufacturing, the transport of the devices from the manufacturer or the retailer to the user 
and the management of the waste generated after their use. 

26 

The  impact  of  reprocessing  single  use  devices  in  Belgium  -  An  economic  study  -  Larmuseau  David, 
Siok  Swan  Tan  -  Erasmus  MC  University  Medical  Center,  Institute  for  Medical  Technology 
Assessment, Rotterdam, Netherlands – April 2008 

EN 

12 

   EN 

                                                 
It is not disputable that the reprocessing of single use medical devices has the environmental 
benefit  of  reducing  products'  end  of  life  waste  management  to  some  extent.  However,  this 
environmental  impact  has  some  limitations  since,  according  to  some  data  provided  by  a 
reprocessing company, only 38% of the highly complex medical devices can be reprocessed27. 

On  the  other  hand,  the  reprocessing  practice  presents  also  some  negative  environmental 
impacts that must be taken into consideration. 

The  reprocessing  of  single  use  medical  devices  requires  adequate  equipment,  specific 
knowledge,  skills  and  resources,  which  are  likely  to  be  present  only  in  specialised 
reprocessing  companies  and  therefore  would  require  the  collection  and  the  transport  of  the 
devices  from  and  to  the  user,  which  have  an  impact  on  the  environment.  In  addition,  the 
cleaning,  disinfection  and  sterilisation  process  implies  important  resources  and  energy 
consumption (e.g. water and electricity), the use of chemical substances and the re-packaging 
of  the  reprocessed  devices.  All  those  steps  have  a  direct  and  negative  impact  on  the 
environment.  The  environmental  impact  is  also  very  dependent  on  the  level  of  quality  of 
reprocessing required and on the scale effect. 

3.6.1.  Conclusion  on  environmental  considerations  on  the  reprocessing  of  single  use 

medical devices 

To date, no comprehensive study balances quantitatively all the environmental implications of 
reprocessing single use medical devices versus discarding those devices. 

Available  data  very  much  focus  only  on  the  waste  reduction  that  the  reprocessing  of  single 
use  medical  devices  creates  to  some  extent.  Various  elements,  such  as  the  environmental 
impact  of  transport,  resources  and  energy  consumption,  as  well  as  the  use  of  chemical 
disinfectants, must be taken into consideration. 

4. 

CONCLUSION 

In the absence of quantitative data, it is not possible to quantify the risk associated with the 
use  of  reprocessed  single  use  medical  device.  The  number  of  documented  incidents  is  very 
small, although it can be speculated that the reporting of incidents is incomplete. Regarding 
adverse events there may be a “grey” area for which the recognition and reporting of incidents 
is  difficult.  In  addition,  long-term  effects  may  not  be  identified  and  attributed  to  the  use  of 
reprocessed medical devices. 

Three  major  hazards  were  however  identified  by  the  SCENIHR  i.e.  a  remaining 
contamination,  the  persistence  of  chemical  substances  used  during  the  reprocessing  process 
and  the  alterations  in  the  performance  of  the  single  use  medical  devices  due  to  the 
reprocessing. 

In  addition,  not  all  single  use  medical  devices  are  suited  for  reprocessing  in  view  of  the 
characteristics  (e.g.  material  used,  geometry),  their  complexity  and  their  intended  use  (non 
critical,  semi-critical,  critical).  In  order  to  identify  and  reduce  potential  hazards  associated 
with  the  reprocessing  of  a  specific  single  use  medical  device,  the  whole  reprocessing  cycle 

27 

Dr. Matthias Tschoerner, Reprocessing of highly complex medical devices, accessed on 22/04/2010 at 
http://www.eamdr.com/mm/Matthias_Tschoerner.pdf 

EN 

13 

   EN 

                                                 
starting with the collection of these single use medical devices after (first) use until the final 
sterilisation and delivery step, including its functional performance, needs to be evaluated and 
validated. 

It  must  be  noted  that  the  SCENIHR  expressed  specific  concern  about  the  potential 
contamination  with  transmissible  agents  such  as  prions,  for  which  elimination  and 
inactivation  is  not  possible,  or  the  procedure  is  not  compatible  with  the  materials  generally 
used for a single use medical device. 

It is not disputable that reprocessing single use medical devices leads to a waste reduction to 
some extent and offers the possibility of dividing the purchasing costs of these devices over 
multiple  patients.  However,  to  date,  no  comprehensive  study  clearly  demonstrates  that 
reprocessing  single  use  medical  devices  is  globally  a  cost  effectiveness  and  environmental 
friendly practice when done under high quality standards. 

In the light of the above, taking into account the potential hazards and risks identified by the 
SCENIHR  in  terms  of  the  remaining  contamination,  persistence  of  chemical  residues  and 
alteration of the functionality, the Commission will assess which are the appropriate measures 
to be put forward in the context of the Recast of the Medical Devices Directives with regards 
to the reprocessing of single use medical devices in order to ensure a high level of protection 
for  patients.  This  assessment  will  also  take  into  account  potential  economic,  social  and 
environmental consequences that any envisaged measure may have. 

EN 

14 

   EN 

ANNEX 

SCENIHR answers to the terms of reference 

Does  the  use  of  reprocessed  single  use  medical  devices  constitute  a  hazard  for  human 
health  (patients,  users  and,  where  applicable,  other  persons)  causing,  for  example, 
infection/cross contamination and/or injury? 

Inadequate  cleaning,  disinfection,  and/or  sterilisation  during  the  reprocessing  of  single  use 
medical  devices  introduces  the  hazard  of  persistence  of  a  bioburden  resulting  in  a  risk  of 
infection during subsequent use of the reprocessed single use medical device for patients and 
users, as a single use medical device is not designed to be reprocessed. This hazard which also 
occurs with devices designed for reprocessing and reuse, is characterised by the presence of 
contaminants  of  biological  origin  on  the  used  single  use  medical  device  including  proteins 
and micro-organisms such as bacteria and viruses. In addition, residues of chemicals used for 
cleaning, disinfection or sterilisation pose a hazard of toxic reactions. Furthermore, alterations 
in the performance of the device due to reprocessing may pose a hazard such as device failure 
during subsequent medical procedures. Of special concern is the potential contamination with 
transmissible agents such as prions, for which elimination and inactivation is not possible, or 
the  procedure  is  not  compatible  with  the  materials  generally  used  for  a  single  use  medical 
device. 

If yes, please characterise the risk for human health. 

In  the  absence  of  quantitative  data  related  to  the  eventual  residual  biological  and  chemical 
contamination after reprocessing, it is not possible to quantify the risk associated with the use 
of reprocessed single use medical devices. 

Some  experimental  laboratory  simulation  studies  have  demonstrated  the  risk  of  both 
microbiological  and  chemical  residues  occurring  after  reprocessing.  The  number  of 
documented  incidents  is  very  small,  although  it  may  be  speculated  that  the  reporting  of 
incidents  is  incomplete.  In  the  existing  inventory  in  the  United  States28,  no  evidence  of  an 
increased  risk  was  noted  for  patients  from  reprocessed  devices.  This  apparent  lack  of  an 
increased risk may be associated in part with the limitations that the United States impose on 
the reuse of reprocessed medical devices.  

If yes, under which conditions or uses does the reprocessing of single use medical devices 
pose a risk? Please consider in particular, the following: 

–  Intended use of the device; 

–  Reprocessing  method  used:  cleaning,  sterilisation  and/or  disinfection 
(depending generally on the material of the device) and lack of instruction on 
the reprocessing method to be used; and 

–  Other characteristics such as functionality, handling, raw material or design 

of the device.  

28 

http://www.gao.gov/new.items/d08147.pdf  

EN 

15 

   EN 

                                                 
The  risk  is  highest  when  the  reprocessed  single  use  medical  device  is  used  in  a  critical 
procedure,  i.e.  when  used  for  an  invasive  medical  procedure.  In  contrast,  the  risk  is  much 
lower for non-critical medical procedures in which reprocessed single use medical devices are 
used. 

The design and choice of material of the single use medical devices is very important for the 
outcome  of  cleaning,  disinfection,  and/or  sterilisation  and  the  risk  of  persistence  of  a 
bioburden. 

The  choice  of  the  method  of  cleaning,  disinfection,  and/or  sterilisation  must  depend  on  the 
chemical composition and nature of the single use medical device. Inappropriate methods may 
lead to the introduction of chemical contaminants with adverse biological effects. 

Possible  changes  in  the  physico-chemical  characteristics  (e.g.  stiffness,  brittleness,  and 
surface characteristics) of the material of a reprocessed single use medical device may pose a 
risk in terms of performance of the device. Material deterioration resulting in device failure 
may occur with repeated reprocessing cycles. 

Additional  critical  issues  in  using  reprocessed  single  use  medical  devices  may  be  the 
identification  and traceability of  the reprocessed medical  device, and for more  sophisticated 
and complex medical devices, the continued availability of documentation needed for proper 
use of the medical device. 

SCENIHR recommendation 

Not all single use medical devices are suited for reprocessing in view of their characteristics 
or  the  complexity  of  certain  single  use  medical  devices.  The  possibility  for  reprocessing  is 
dependent on the material used and the geometry of the medical device. In order to identify 
and  reduce  potential  hazards  associated  with  reprocessing  of  a  specific  single  use  medical 
device, the whole reprocessing cycle starting with the collection of these single use medical 
devices after (first) use until the final sterilisation and delivery step, including its functional 
performance, needs to be evaluated and validated. 

EN 

16 

   EN