Scientific Advisory Panel On
Reprocessing Of Medical Devices

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Contact: Policy Bureau Enquiries

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Terms Of Reference

The Scientific Advisory Panel (SAP) on Reprocessing of Medical Devices (RMD) acts as a forum of advice and a sounding board for management and scientists of Health Canada (HC). Health Canada will consider all proposals made by the Advisory Panel, but will not be bound by them. Health Canada will retain the authority to determine actions and make policy decisions.

1. Mandate

To provide scientific and technical advice on current and emerging issues related to the reprocessing of medical devices.

The Panel fulfils its mandate by advising HC on two issues:

1. The feasability of reprocessing single-use devices.
   
   
2. The current problems encountered by users in reprocessing reusable medical devices and potential solutions to these problems.

2. Reporting Structure

The Panel reports to the Director General (DG), Therapeutic Product Directorate (TPD), who acts as the Executive Secretary to the Panel. The Therapeutic Products Directorate will provide technical and administrative support to the Panel as appropriate.

3. Membership, Participation And Qualifications

1. Members - The Panel will consist of a chair and core members. Ad hoc members may be added to address specific topics.
   
   
2. Size of the Panel - The number of core members on the Panel will be not more than 15.
   
   
3. Selection of Members - The DG will select and appoint the members and a Chair from a list of nominees. Potential members are identified by HC through surveying health professionals and associations.

The membership of the Panel will be chosen to reflect an appropriate regional representation, covering various areas of expertise and knowledge such as:

• microbiology
• infection control
• biomedical engineering
• hospital reprocessing of devices (cleaning, disinfection, and sterilization)

Since members are appointed as individuals on the basis of their individual expertise, they will not represent their firms, organizations or affiliations directly. They serve on the Panel as knowledgeable individuals in their own right and in the best interests of all Canadians.

Health Canada staff may not serve as members of the Panel. The TPD staff will provide secretariat support and regulatory and technical information at the call of the Chair.

4. Tenure Of Members And Duration Of The Panel

Core members are appointed for the full time the Panel meets. Ad hoc members serve for shorter terms as needed to address specific topics. The Panel is expected to complete its mandate within two years.

5. Security Clearance, Conduct And Conflict Of Interest

Panel members will be subject to a security clearance to the level of "enhanced reliability". Sometimes, but not often, this may entail the taking of members' finger prints should the RCMP require them. Security clearance is valid for ten years.

Panel members are expected to conduct themselves in an appropriate manner; i.e., the use of their positions cannot be reasonably construed to be for their private gain, or that of any other persons or organization. They must refrain from any conflict of interest and, indeed, its very appearance. In situations where conflict of interest, or the appearance thereof arises in the course of the work of the Panel, the individual involved must declare its existence. A decision to disqualify the individual from participation in the discussion will be made by the Chair in consultation with the Secretariat, according to the circumstances or specific situation.

Guidance on conflict of interest will be provided to potential members when discussing their appointment. Before appointment, all potential Panel members will be required to submit conflict of interest declarations to disclose to the Directorate any circumstance that may place, or be seen to place, the member in a real, apparent or potential conflict of interest. It will be incumbent upon the member to update his / her disclosure should his / her personal situation change.

All members must protect and maintain as confidential any trade secret or privileged information divulged during the work of the Panel. Members may only discuss this information with persons on the Panel or Therapeutic Products Directorate staff; they must not divulge information obtained from the work of the Panel, including presentations made to it, until such time as this information has been officially released for public distribution. Documents leaving HC, including electronic and word processing records must be securely stored at all times and must be returned to HC or permanently deleted on request.

Discussion of Panel work with the media or at conferences should only be done when authorization is given by the DG-TPD in consultation with the Chair.

6. Indemnification And Legal Assistance

Members will be volunteers and will therefore be covered under Treasury Board's "Volunteer Policy" which makes them eligible for indemnification and legal assistance. Members are only protected by this policy when the advice given lies within the mandate of the Panel.

7. Compensation

Members will be compensated for their travel and accommodation expenses according to federal government policy.

8. Management And Administration

Members will receive briefing materials and other documentation well in advance of the meetings. Specific questions on the issues to facilitate Panel discussion will be determined by the Therapeutic Products Directorate staff.

Panel members will be expected to demonstrate fairness and a commitment to in-depth examination of the matter under review. Discussion during meetings shall be open, frank and free-flowing. All members of the Panel will have equal status during discussions.

The Record of Proceedings (RoP) of meetings will be circulated to members of the Panel and then approved by the Chair. The RoP will be made available to stakeholders at the discretion of the DG. The RoP will be written to capture the advice of the Panel. There will be no attribution. There will be no other official record of the meeting.

Advice of the Panel will be reached by consensus. Lack of consensus may indicate uncertainty of information. In such cases, the Panel shall make a recommendation with respect to further study of the issue and a proposal for resolution. In cases where there is a real divergence of opinion, the different opinions will be documented, and the number of members supporting each opinion recorded.