JOINT PRINCIPLES ON MEDICAL DEVICE REPRESENTATIVE
RE-ENTRY INTO HEALTH CARE FACILITIES DURING THE COVID-19 PANDEMIC
Background
The Global Medical Technology Alliance (“GMTA”) member associations represent
companies that develop, distribute, and manufacture medical devices, diagnostics, anddigital health technologies that are vital to diagnosing and treating COVID-19 patients aroundthe world.
In response to the COVID-19 pandemic, many national and local health authorities
recommended interim cancelation or delay of “elective” surgical procedures, which includes
non-urgent but medically necessary procedures. Physicians and health care organizations
have responded appropriately and generally delayed “elective” cases around the world.
Health Care Industry Representatives (“HCIRs”) that represent medical technology
companies, both manufacturers and distributors, are often called upon by clinicians toprovide this support in patient-care or restricted areas of a Health Care Facility (“Facility”).
Although some HCIRs have been called upon during the pandemic to support procedures
essential for COVID-19, many HCIRs primarily support “elective” procedures and have notbeen requested to enter facilities until recently. As facilities resume elective procedures
based on their local circumstances, GMTA members are committed to supporting the needsof patients who have had their procedures delayed.
GMTA member associations support the principles offered below concerning the re-entry ofHCIRs into health care facilities to facilitate patient access to the medically necessary carethat they have delayed with evidence-based criteria for protecting patients, clinicians, andHCIRs from COVID-19 transmission. Alignment around these principles will furtherconsistency in safety and testing protocols and lead to improved compliance. It will also
ensure that HCIRs, who provide technical support to improve patient outcomes, are adhering
to relevant national and local safety standards. Greater consistency will also improve theability of HCIRs to provide support for technology used in procedures when and where
needed with minimal impediment or delay.
GMTA member associations are closely collaborating with medical societies, hospital
associations, and other groups representing the interests of patients, facilities, and clinicians,
both domestically and abroad, to promote adoption of these principles.
Prevailing Assumptions and Objectives
As the aim is to provide current, evidence-based recommendations, we anticipate that theprinciples may be updated to integrate improvements in the understanding of COVID-19 andthe capabilities and availability of other resources such as diagnostic testing. These
Principles are intended to account for: (1) the need for patient care; (2) the limited availabilityof Personal Protective Equipment (“PPE”); (3) the capabilities and availability of diagnostic
testing; (4) the current understanding about COVID-19 disease and immunity; (5) the lack ofan approved vaccine; and (6) the application of local laws, regulations, and official/healthauthority guidelines, which shall prevail in the event of any conflict or inconsistency withthese Principles.
The Principles seek to minimize the transmission of COVID-19 to patients, clinicians, andHCIRs, in a manner that protects patients first, while also protecting clinicians and HCIRs in
a way that (1) conserves the use of limited PPE for the priorities where such PPE would be
most needed, (2) avoids unnecessarily duplicative, inefficient, or otherwise wasteful activities
or expenditures, and (3) meets the obligations of both providers and suppliers. Consensus
in the health care community toward best practices decreases confusion, improvescompliance, and prioritizes provider access to limited PPE.

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GMTA Joint Principles
1. Roles and Limitations of the HCIR in Health Care Facilities (“Facilities”)
An HCIR may represent a medical device manufacturer or a distributor of one or more
device manufacturers. By virtue of their training, knowledge, and expertise, HCIRs, inconnection with the surgical device used in a procedure may:

provide technical assistance to the surgical team;

expedite the procedure and facilitate the safe and effective application of surgicalproducts and technologies;1provide on-site product/technology expertise to the perioperative team and help
clinicians make critical, real-time choices.2

support the clinical/operating room team to ensure that the appropriate range ofnecessary devices and accessories are available during a procedure, especiallywhen dealing with medical technology that involves multiple devices, different
sizing specifications and/or accessories; and

serve other roles that include: training Facility staff on the safe and effective useof medical devices; delivering, installing, maintaining, servicing/repairing medicaldevices; updating device-related information and guidance; and programmingand calibrating implant devices among others.

At all times, the role of the HCIR is subject to the following controls and limitations:
HCIRs should enter and be present in the clinical setting only at the request ofand under the supervision of the presiding Health Care Professional (“HCP");HCIRs should be transparent that they are acting on behalf of the Company in atechnical support capacity for the relevant device used in the and only in respectof approved indications; andHCIRs should not interfere with a HCP’s independent clinical decision-making.

2. Social Distancing and Safety Precautions
HCIRs entering all areas of the Facility should take safety precautions in accordancewith prevailing national and local public health recommendations (e.g., regardinghandwashing and face coverings) both to protect the individual HCIR and others inthe Facility.

Facility social distancing and safety policies applicable to staff should apply equally toHCIRs accessing the same areas of the Facility.

3. COVID-19 Testing and Screening
Facility screening procedures applicable to staff should be equally applicable toHCIRs entering the facility, including but not limited to screening for symptoms, close
contact with COVID-19 cases, etc.



Facility testing policies for HCIRs entering both restricted and non-restricted areas
should follow current national and local priority recommendations for COVID-19
diagnostic testing for Facility staff.

Any required COVID-19 diagnostic testing of asymptomatic individuals should only be

1 American College of Surgeons, Revised Statement on Health Care Industry Representatives in theOperating Room, October 1, 2016, https://www.facs.org/about-acs/statements/91-industry-repsin-or
2 Association of periOperative Registered Nurses, AORN Position Statement on the Role of the HealthCare Industry Representatives in Perioperative Settings, https://www.aorn.org//media/aorn/guidelines/position-statements/posstat-personnel-health-care-reps.pdf (For example,some implant systems include hundreds of component options with certain nuanced variations
that can be most efficiently and effectively communicated by an on-site, interactive resource andadvisor)2implemented in accordance with applicable national and local health authority
requirements or guidance.
4. Elective Procedures and Crisis-Level Emergency Surgical Procedures and PersonalProtective Equipment (“PPE”)
Consistent with national and local regulations and health authority guidance, HCIRs
can work with HCPs and facilities with videoconferencing capabilities in theiroperating rooms/procedure suites to provide virtual support in surgical cases whereremote attendance does not compromise patient safety, medical outcomes, orprivacy.

Since Facilities establish the case-specific administrative and engineering infection
prevention controls, Facilities are best positioned to determine the proper PPE for
individuals that are present in the room for a particular procedure according torelevant health authority requirements or guidance (“Proper PPE”).3

Surgical case scheduling and prioritization policies should account for the sufficiency
of PPE inventory, including Proper PPE for any HCIRs essential to an “elective”
procedure.

Facilities operating within a crisis-level capacity4 may require HCIRs essential toemergency surgical and other invasive procedures to provide their own PPE if thefacility is in short supply to the extent this practice is consistent with applicablenational and local regulations and guidance.

HCIRs and Facilities should follow national and local health authority guidance forconserving PPE and infection control regarding the use, reuse, and decontaminationof any PPE, whether supplied by the Facility or by an HCIR.

5. Training and Education regarding COVID-19 Safety and Precautions


HCIRs are trained on general infection prevention and control within procedural
settings.

HCIRs should have an understanding of national and local health authority guidancefor COVID-19 infection prevention and PPE use (including donning and doffing).

HCIRs should have an understanding of Facility policy related to COVID-19 safetyprinciples.

Training and education are a shared responsibility. The HCIR’s employer has adirect interest in ensuring that their representatives are trained to conduct theiractivities safely, and the Facility is best positioned to educate and train on the site’s
specific policies and procedures.

Virtual training and education should be encouraged where possible to minimize
contact with other individuals.

3 Proper PPE may include some combination of respiratory protection, masks, face shields, eyeprotection, gowns, head covers, gloves, shoe coverings, or coveralls.
4 Crisis Capacity operations (made necessary by a catastrophic disaster) involve adapting spaces,

personnel, or supplies in ways which are not consistent with usual local standards of care toprovide the best possible care to patients given the circumstances and resources available.

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