Scientific Advisory Panel on Reprocessing of Medical Devices (SAP-RMD) January 16-17, 2006

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Record of Proceedings

Panel Members Present: Dianne Trudeau (Chair), Michelle Alfa, Janina Berenyi, Susan Hadfield, Linda Jakeman, Sue Lafferty, Colleen Landers, Diane Pinsonneault, Jean Richmond, Cheryl Swan, Mary Vearncombe, Alice Wong, Timothy Zakutney.

Regrets: Michael Gardam, Sudha Kutty

Health Canada (HC) Representatives: Jean-Bernard Bitchoka, Theresa Burke, Maureen Burton, Monique Chaîné, Rolande D'Amour, Lois Duthie, Gina Coleman, Philip Neufeld, Eric Ormsby, Roland Rotter, Hripsime Shahbazian, Dongjiang Song

Day 1 Proceedings

Opening Remarks & Welcome

Members of the Panel were welcomed and thanked for their time and effort for agreeing to serve on this Panel. Roundtable introductions of members of the Panel, presenters and HC representatives were done.

Review of the Agenda and Conflict of Interest (COI) declaration

The agenda was reviewed and it was noted that some items would likely need to be postponed as well as others shifted to other times during the meeting. A declaration of conflict of interest was done. Members had no conflict to declare.

Review of previous minutes and final approval

Minutes were accepted with minor revision to Item 4 - Reprocessing of Reusable Devices (page 3). Members asked to capture a concern that the current classification system used by Medical Devices Bureau does not seem to agree with health care providers view of classification and therefore perhaps the classification system needs to be reviewed.

Members were advised that the classification system is part of the Medical Devices Regulations, and has been developed to harmonize with international partners, therefore any changes to these rules would be very difficult to introduce due to the harmonization agreements with other countries.

Members agreed that regardless of classification of a device the information on adequate and appropriate cleaning and sterilization of reusable devices has to be available from the manufacturers.

Travel and accommodation

This item was postponed to Day 2.

Review and update of the contact list for information dissemination purposes

Members provided a list of parties that should be notified of all advisories pertaining to reprocessing of medical devices. The list includes the following:

Within the hospitals - CEO/COO, Chief Nursing Officer, VP Clinical Services, Biomedical/Clinical Engineering, Risk Management (Research and Applied Learning), Patient Safety, Legal, Infection Prevention and Control, Sterile Processing Department (SPD), Operating Room, Chief of Staff, Materials Management/Logistics

CHICA Canada (Community and Hospital Infection Control Association of Canada)
College of Physicians and Surgeons
College of Dentistry
Regional Health Authorities
Ministries of Health

Progress report on the reprocessing of Single Use Devices Issue

HC presented a brief update on the Single Use Device Issue. The issue has not yet gone to the management committee. The Issue Analysis Statement (IAS) has been revised to account for all the recommendations made by the Panel. Other upcoming steps are to develop a regulatory impact analysis statement, to meet with the US FDA to discuss their processes with respect to the SUDs issue. Time line currently estimated for Canada Gazette (CG) part I prepublication is for spring of 2006, followed by 75 day comment period. It is estimated that by summer 2006 will be going to CG part II. Guidelines are being considered as a reference within the new regulations. It was noted that all affected parties will be informed of any new regulatory requirements. It was suggested that the draft proposal could be circulated to SAP-RMD members for review and comments prior sending it out for consultation. It was agreed that the draft could be circulated via e-mail for feedback.

The chair reviewed the remaining items on the agenda for the day:

Of the devices identified by the Panel, identify the reusable devices that in the opinion of the Panel, cannot be safely cleaned and resterilized because of their design, method of assembly, or materials. As well, identify reusable devices that are considered possible to clean but that may present difficulties when cleaning.

Discussion on information to be provided by manufacturers to purchasers of reusable devices.

Discuss creation of a document based on the document produced by National Coordinating Committee of Therapeutic Goods Administration of Australia entitled "Reducing Public Health Risks Associated with Reusable Medical Devices"

Review sample instructions provided by manufacturers for the cleaning and sterilization of various types of reusable medical devices that have been identified as having insufficient cleaning details.

Make recommendations to HC for improvements in the cleaning instructions of these devices.

To continue with the remaining agenda items in a timely manner, the members agreed to consider working on different items as sub-groups. Two sub-groups were created.

First sub-group members: Dianne Trudeau (Chair), Michelle Alfa, Janina Berenyi, Susan Hadfield, Linda Jakeman, Sue Lafferty, Jean Richmond, were tasked to continue work on the Table.

Second sub-group members: Mary Vearncombe (Chair), Colleen Landers, Diane Pinsonneault, Cheryl Swan, Alice Wong, Timothy Zakutney, were tasked to review the ISO Standard 17664 and the TGA document.

The work on the Table continued with the first sub-group and reached the Minimally Invasive Surgery section. The work will continue tomorrow morning.

The work by the second group on the ISO Standard and the TGA document was initiated; review of the first document was completed. The group will reconvene tomorrow to continue their work.

Regarding the next item to review sample instructions provided by manufacturers for the cleaning and sterilization and make recommendations to HC for improvements in the cleaning instructions of these devices, members agreed that it would not be possible to review all of them within the time constraints of the meeting. It was decided that rather than reviewing all the instructions, these would instead be referenced in the Table under appropriate sections. General recommendations encompassing the sample instructions will be included as an appendix to the table.

Closing remarks and Adjournment of Day 1

Members will reconvene tomorrow morning to continue their work on the table, the TGA document and the remaining agenda items.

Day 2 Proceedings

Review of the Agenda

The chair reviewed the items on the agenda. Significant changes were made to the agenda to continue work on the table and to include a new item requested by MDB.

Accordingly the following items of the agenda were deferred to the next meeting:

Sterilization parameters

Sterilization of rigid containers and packaging

Overview of the orientation program at the St-Joseph's Healthcare Centre

Make recommendations to health care facilities for improvements in staff training, process validation, record keeping and obtaining/verification of proper tools to ensure the quality of reprocessing procedures.

A new item was introduced for discussion:

Safety of Linvatec Surgical Handpieces Manufactured by ConMed Linvatec, Largo, Florida: The PowerPro handpieces are permeable to fluid ingress under the side panels of the handle, and residual debris under the side panels may not be easily removed during cleaning.

The morning session started by each sub-group continuing their work on remaining tasks. Groups were asked to finalise their tasks and report back after the first break.

First sub-group reported that the work on the table was not complete. Members were informed that Linda Jakeman has agreed to complete the work on orthopaedics section of the table and send it to the Panel for their input. It was estimated that two more hours were needed to go through the remaining sections of the table. The members agreed to continue to work on the rest of the table at the end of the meeting to complete the table.

The chair informed the members that the presentation on travel and accommodation will take place before lunch.

The possible dates for the next meeting have been discussed. Members suggested to target mid-May. It was agreed that the length of the meeting will depend on number of agenda items that the Panel will need to address. At the end of the day based on progress made the members will be able to decide how many days would be required. There is also the proposal of the possible meeting with the manufacturers. Some members felt that most of the documents need to be finalized before the Panel could submit their recommendations to HC for consideration. The members felt that the Panel may not be ready to meet with the manufacturers. HC may need some time to address some of these issues with the manufacturers. There was a suggestion that since MDB has regular meetings with MEDEC, they could present issues to MEDEC at one of their meetings. It was explained that the members present at that meeting may not be the right representatives to address these issues. There was a comment that members would like to meet with some manufacturers that are not necessarily a MEDEC member. It was agreed that this needs to be discussed further before planning a meeting with manufacturers.

Second sub-group reported on their progress. Two documents were considered: ISO Standard 17664 and the document produced by National Coordinating Committee of Therapeutic Goods Administration of Australia entitled "Reducing Public Health Risks Associated with Reusable Medical Devices".

Discussion on information to be provided by manufacturers to purchasers of reusable devices.

The sub-group chair provided a detailed report of the suggested addendum. Members have recommended endorsing the ISO Standard 17664 with the addendum to specific sections. Members asked if they could take these recommendations to the up-coming CSA meeting, and ask CSA to consider the SAP-RMD recommended addendum. A copy was provided to the chair for CSA consideration.

Panel recommended that manufacturers meet ISO 17664 with the proposed addendum.

Discuss creation of a document based on the document produced by National Coordinating Committee of Therapeutic Goods Administration of Australia entitled "Reducing Public Health Risks Associated with Reusable Medical Devices"¹

The chair reported that the sub-group has reviewed the document and had a discussion regarding possible options: writing a Canadian document similar to this document or endorsing the document by taking the recommendations in the Executive summary and amending them for Canadian application. The members noted that writing a new document would require extensive resources that they do not feel the panel is able to accommodate. The group agreed that it is more feasible to endorse this document by adding recommendations and using Canadian references where applicable and providing a reference to the TGA document.

The group proposed amendments to the Recommendations listed in the Executive summary of the TGA document. It was suggested that the sub-group will prepare a covering document with the recommended amendments to the TGA document and the TGA document will be referenced as a source. However, due to copyright issues the chair will contact TGA to ensure their agreement to reproduce the document or provide a link to the document prior referencing it in any form.

Based on TGA response the Panel will consider providing a set of recommendations and providing a link to the source document as a reference.

¹ Reducing the public health risks associated with reusable medical devices http://www.tga.gov.au/devices/reusdev_phr.htm

Travel and accommodation

Presentation available upon request

A brief presentation on the HC policy on travel and accommodation was provided. It was noted that there is a Treasury Board policy that sets strict guidelines for administration of travel and accommodation and other expenses for government. It can be viewed on TB website. Steps involved in processing of travel and accommodation requests were described. Members' questions were addressed. Some members requested if Office of Science could verify with the Travel office to see if seat selection could be accommodated when requested.

It was noted that if the members decide to have a dinner as a group, they need to inform HC so that hospitality authority could be prepared for approval.

The members were asked to inform the coordinator if there is a cancellation or change of travel plans so that HC could make appropriate arrangements.

Safety of Linvatec Surgical Handpieces Manufactured by ConMed Linvatec, Largo, Florida

MDB presented the issue to the Panel asking for their advice on criteria regarding the level of sterile residual soil and possible hazard involved.

On September 19, 2005, Health Canada advised hospitals of concerns that Linvatec PowerPro battery-powered surgical handpieces may be permeable to body fluids during surgery, and that these fluids cannot be easily removed during cleaning. Models affected included the PRO5200 and the PRO5300. These handpieces are designed to be autoclaved after use, but are not intended to be opened for cleaning.²

On December 28, 2005 Health Canada Issued further Information on the Safety of Linvatec Surgical Handpieces Manufactured by ConMed Linvatec, Largo, Florida.³

In that letter HC provided an update regarding the safety of this product. The letter indicated that:

Health Canada has reviewed the manufacturer's evidence and the results of the OHA-sponsored study and concluded that the risk of patient infection from residual debris on Linvatec handpieces to be negligible, and that hospitals may continue to use these devices provided they reprocess them according to the manufacturer's instructions.

HC indicated that, the issue of residual debris, common to a large number of reusable surgical instruments, continues to be a risk management concern to health care facilities and HC will consult with its Scientific Advisory Panel on Reprocessing of Medical Devices (SAP-RMD) and device manufacturers to address this concern.

Panel members noted that the issue of residual debris or ingressed sterilized soil needed to be reviewed as much more of an issue than simply proving that the soil is indeed sterile. Manufacturers may be able to prove that the soil is sterile, however, what needs to be addressed is whether this sterile soil poses a hazard to the patients, therefore the manufacturer has to prove that this sterile debris is safe.

Members stated that there are too many unknowns and lack of sufficient knowledge in order to be able to state that any soil is in fact sterile. A device containing soil can still cause adverse reactions in patients, and due to patients returning home sooner it becomes impossible to trace possible infections caused by residual soil on devices with post-op infections.

Some medical devices are extremely hard to clean; therefore visible inspection of clean should be performed. Members agreed that it would be very helpful for the users if a guideline could be set with respect to the amount of residual soil that is acceptable.

It was noted that current approach in health care facilities is that "if you can't clean it you can't sterilise it", therefore "visually clean" should be a minimum requirement. To even consider that you can sterilise something that is not clean goes against all existing national and international standards on sterilization.

If there is a problem with a design of the device, then manufacturers should be informed in order to address these design flaws. Members suggested that since the Canadian market is relatively small, perhaps an international market discussion with the FDA, TGA and European regulators could be considered in order to pressure the manufacturers to correct design flaws.

A subgroup of members was tasked to develop a recommendation to HC regarding this issue. The group members were: Michelle Alfa (Chair), Susan Hadfield, Sue Lafferty, Diane Pinsonneault, Mary Vearncombe and Alice Wong.

The rest of the members agreed to continue working on the table in order to complete it by the end of the meeting. There was a discussion if the recommendations from the TGA document could be included into this table. It was suggested that there is a need to ensure that these recommendations do not contradict each other and decide on appropriate format.

The subgroup returned to the panel and presented the following recommendation with respect to ingress of blood and other materials:

"Ingress of blood or other materials into areas of medical devices that are inaccessible to cleaning precludes the currently accepted cleaning expectation of visibly clean for surface areas that are accessible to tissue, blood, body fluids, or other organic material as outlined in AAMI TIR 30 or 12. Even though steam sterilization may kill all micro organisms present in this material there are other concerns related to the residual material.

Medical devices are exposed to blood, tissue, secretions, bone, etc, during the surgical procedures. As such, the expectation is that when these fluids mix with the sterile debris in sequestered sites, it would be possible for some of the debris to seep out and gain access to the surgical site either by directly falling into it or by indirect transfer. Such sterile debris getting into the surgical site could increase the risk of patient complications, eg. adverse reaction to the organic material derived from another patient or the material could function like a foreign body thereby increasing the risk of endogenous infections. There is also a possibility that cleaning agents e.g. enzymatic detergents or other chemical detergents or environmental microorganisms such as those that thrive in water/moist environments may also ingress. Even though the microorganisms will likely be killed by the steam sterilization the endotoxins from gram-negative organisms could remain and also contribute to adverse patient reactions.

This problem is heightened for all other sterilization modalities which do not have the same margin of safety that has been established for steam sterilization. As such a medical device that allows ingress of patient secretions, cleaning agents and/or endotoxins is not acceptable when reasonable alternatives exist that do not have the same potential for sequestration of this material."

Panel accepted the recommendation and submitted for consideration to HC.

There was a recommendation of a possible 3^rd letter issued from HC with respect to residual material based on SAP-RMD recommendations.

The table was completed with the exception of the Orthopaedics section. Linda Jakeman has volunteered to work on Orthopaedics section and send it to the members for review. The revised table will be circulated for review and comments by all members.

Regarding the table members agreed that all additional comments from meeting pertaining to the reprocessing of reusable devices could be listed as recommendations.

Members noted that some instructions are not device specific and though instructions have improved in general, manufacturers will need to continue to improve their instructions for specific devices.

It was noted that there should be standardized formats for sterilizing times. Not all sterilizers in health care facilities can comply with the instructions that manufacturers include with their devices. It should be recommended that these facilities not purchase these devices if they cannot comply with the instructions, or that they send their devices out to a reprocessor.

² http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/2005/linvatec_nth-aah-eng.php

³ http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/2005/linvatec_2_nth-aah-eng.php

Next steps

The members were canvassed for dates for the next meeting. It was tentatively scheduled for May 15, 16, 2006 with possibility of a third day for a one day meeting with industry. It was noted that since the Panel has not finalised the work on the table and the two documents (ISO and TGA) it would be premature to schedule a meeting with the manufacturers at this time. It was agreed that the chair will assess the status of these documents before planning such a meeting. Further communication in this regard with the chair will be required.

All the items not covered at this meeting will be discussed at the next meeting. Action items:

• Linda Jakeman to complete the Orthopaedics section of the table and circulate for comments.
• Tim Zakutney to provide a paragraph for the TGA document (life cycle management).
• Colleen Landers to provide references for CSA documents.
• Members to provide examples with reference on sterilization times and temperatures to the coordinator prior the next meeting for circulation to the members.

Meeting adjourned.