Scientific Advisory Panel on the Reprocessing of Medical Devices (SAP-RMD) October 17-18, 2005

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Contact: Policy Bureau Enquiries

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Record of Proceedings

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

Invited Presenters: Mike Dodd (CSA), Stephen Dibert (MEDEC), Shawn Kenny (UHN).

Health Canada (HC) Representatives: Jean-Bernard Bitchoka, Theresa Burke, Maureen Burton, Monique Chaîné (Logistics Coordinator), Rolande D'Amour, Lois Duthie, Andrew Gaffen, Philip Neufeld (MDB Lead), Nancy Shadeed, Hripsime Shahbazian (OoS Scientific Advisor), Dongjiang Song.

Day 1 Proceedings

1. 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. The chair introduced a new member, Sudha Kutty, who will be replacing Rosalind Smith, as a representative of the Ontario Hospital Association. Since there have been some changes, members were asked to provide their current contact information to the coordinator for updating the contact list.

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

The agenda was reviewed and accepted as is. A declaration of conflict of interest was done. Members had no conflict to declare.

2. Progress Report on Reprocessing of Single-Use Devices

Michelle Alfa presented the Panel's perspective on the Stakeholder's meeting of June 9, 2005. She summarised the major concerns raised regarding SUDs. She noted that stakeholders were fully supportive of SAP-RMD recommendations. There was a concern raised about third party reprocessors without proper regulations in place in Canada. Perhaps wider stakeholder consultation would be useful. Panel members requested copies of the presentation material.
Presentation available upon request.

Theresa Burke provided Health Canada's progress report regarding the Panel's recommendations on single-use devices. She advised the Panel members that based on their recommendations and stakeholder feedback HC will be moving forward to setting up a regulatory framework for the reprocessing of single-use devices. The steps involved in a regulatory amendment process were briefly described and estimated timelines provided. For more information on step-by-step process please refer to Part B of the Regulatory Process Guide on Developing a Regulatory Proposal and Seeking its Approval.¹
Presentation available upon request.

A concern was raised regarding Health Canada's advisory letters reaching the intended people. It was suggested that members will provide their contact lists to the coordinator so that these may be reviewed and added to the HC mail-out list.

With respect to importing devices, members were advised that Canadian Regulations cannot be enforced outside of Canada. Therefore, the control of problems with items reprocessed by a foreign reprocessor becomes a border control issue. We can request that all devices crossing the border meet Canadian regulations.

With respect to exporting to the US, as with Canadian regulations, it would be the American regulators' responsibility to enforce what standards they expect from Canadian devices being exported to their country.

Some members expressed a concern regarding the classification rules for devices. They felt that hospitals and HC do not evaluate the classification levels the same way. We need to look at possible ways to categorize single-use devices for reprocessing purposes. Some members suggested that perhaps another stakeholder meeting needs to be held before the regulatory process reaches Canada Gazette Part 1. Others felt that consultation via e-mail would be more practical.

There was a suggestion that hospitals will need to introduce a tracking mechanism to identify single-use devices. However, in order to do that they would require a permanent marking on a device since original packaging is no longer available.

Some users feel that there is a need to regulate all reprocessing of SUDs, not just the high risk ones. Others felt that this would introduce unnecessary burden on users.

Members mentioned a concern about the possible lack of resources needed to implement new regulatory approach. They were informed that the Regulatory Impact Analysis Statement (RIAS) includes the cost analysis for implementing and enforcing new structures within HC as well as a cost analysis for those who will be impacted by the new regulations.

Requirement of acceptable standards was discussed. It was explained that we avoid mandating standards within regulations because this creates difficulty to amend regulations when a standard is revised or becomes obsolete. It was suggested that it would be more appropriate to reference standards in a guidance document that would be updated periodically as changes occur.

The chair advised the Panel members that with this we will conclude the SAP-RMD mandate on reprocessing of single-use devices and move to the second mandate: Reprocessing of reusable devices. HC will continue to provide updates as the regulatory amendment process progresses.

¹ http://www.pco-bcp.gc.ca/raoics-srdc/default.asp?Language=E&Page=publications&Sub=regguide&Doc=regguide_e.htm

Reprocessing of Reusable Devices

3. Overview of the Canadian Medical Device Licensing Process
Nancy Shadeed

Presentation available upon request.

An overview of the Medical Device Regulations was provided. It was explained that the degree of regulatory oversight assigned to a medical device is dependent upon its classification. To determine the classification of a device one must apply all of the rules in Schedule 1 of the regulations. The classification of devices is based on the labelled indications or claims made for a product. The classification rules look at the invasiveness of the device, the duration of use, what major part of the body it is in contact with and whether a device is active or not (uses outside energy sources). Examples of Class I, II, III and IV devices were provided. Members were informed that there is a HC guidance document on the classification rules². It is a risk-based system that is based on European system.

For Class II devices manufacturers are not required to provide instructions for cleaning and sterilization of a product. There is no requirement for validation data. MDB may request cleaning instructions for certain reusable devices, where there has been a problem.

For Class III devices HC checks attestation, but does not do validation. MDB can re-classify a device if a review of the specifications and use justifies it. However, re-classifying a device can present problems when trying to harmonize with other jurisdictions.

Class IV devices require a pre-market submission of pre-clinical and clinical studies, process validation studies, software validation studies, literature studies.

Members asked why the regulations do not require proper documentation for Class 1 devices. It was explained that the classification system was developed as a result of 1992 Hearn report recommendations that a pre-market review should focus on the higher risk devices. These recommendations were implemented in 1998. Class I and Class II devices represent the largest of the classes and in developing the regulations, HC had to take into consideration the resources that would have been required to evaluate them. There are simply not enough resources to review all the devices in those two classes. Members asked if there are any plans to revisit this issue given new technology and new diseases. Members were invited to make recommendations in this regard.

Again, some members expressed a concern that the classification of devices based on classification rules used by Health Canada does not seem to agree with classification used by healthcare providers. There was a suggestion to re-visit the rules in attempt to address this discrepancy.

It was acknowledged that this or any rule system has limitations and cannot accommodate all devices. There may be cases where either a device cannot be classified because of an unusual characteristic or where the resulting classification is not optimum given known hazards associated with the use of the device. In these cases the device may be listed on the table to Rule 16 of the Medical Devices Regulations.

It was explained that the Canadian device classification rules were developed so that they were harmonized with the European Union's device classification rules and the device classifications of the Untied States. It was noted that the rules borrow significantly from those that appear in the European Union's Council Directive 93/42/EEC. Many of the rules and interpretations of terms are either the same as, or similar to, those proposed by the European Union in the supporting documentation to the Council Directive. Therefore, changing any of the rules will be very difficult since it would impact on harmonization.

² DRAFT Guidance for the Risk-based Classification System
http://hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/risk5_risque5-eng.php

4. Issues Raised by Recent Problem Reports on Reprocessing of Reusable Devices
Philip Neufeld

Presentation available upon request.

Every manufacturer of medical devices has to ensure basic safety and effectiveness requirements regardless of device classification. HC has looked at the issue of cleanability of reusable devices and asked healthcare professionals to submit examples of problems. The examples received by HC indicate that many reusable devices are not free of visible soil after the recommended cleaning process. It was noted that in some cases it may not be possible to design devices that can be completely cleanable.

It was stated that hospital reprocessors maintain that "if you can't clean it, then you can't sterilize it." The question is whether it is acceptable to have a sterile residue. Most members felt that this can cause problems. In order to address this issue we need to establish what is the risk involved with sterile residue.

It was noted that there is a big difference between single cycle reprocessing versus repeat reprocessing. There is a build-up of residue over time, which is a big concern. Just because it is sterile the first time it doesn't mean it will be sterile after repeated use. It is not sufficient to prove that it is sterile; there are many other parameters that need to be considered to validate the process.

Panel members felt that sterility should not be the sole factor in determining the safety of a reprocessed device. Cleanliness needs to remain a factor of some consideration, as some patients have shown symptoms that could only be attributed to the fact that there was soil left on the device. Residual protein matter, which may not be fully eradicated through sterilization, will be a factor.

4.1 Investigation Procedures for Voluntary Problem Reports
Maureen Burton

Members were provided with copies of "Medical Device Problem Reporting by Healthcare Facilities, Medical Professionals and other device users", "Whom do I Contact?" and Table of reported incidents for period of July 1, 1998 to September 30, 2005. It was explained that there are two types of reports, mandatory and voluntary. The mandatory reports must be filed by law by the manufacturers if they receive a notice. Voluntary reports are filed by health care facilities, some are trade complaints. Voluntary reports have been steadily increasing which is a positive sign as it means that more people are feeling the need to inform HC of the problems on the market. Members were informed that there will be a guidance document on problem reporting produced by HC posted on the web within the next couple of months.

Problem investigation process overview was provided. Different follow-up measures may be taken depending on a nature of the reported problem. It was explained that when problem reports are verified, the first step is to contact the manufacturer and the manufacturer is asked to contact the users. If they refuse HC then posts a notice to users.

When a report is received device problem reporting databases are searched (i.e. the HC, the EMEA and the FDA) to look at class issues. Currently there is no Canadian public database to access only recall information is publicly available. However users can call HC and request information on any device that is on the market.

Members would like HC to reconsider constructing a public access database. The FDA has a system that presents warnings and problem report histories online.

Members asked if an FDA report triggers an action in Canada. Not always, because the Canadian regulatory system is not identical to the US system, an alert will not naturally trigger an investigation here in Canada. A GMP infraction in the US does not necessarily mean that there is an infraction here in Canada. Often it is a public notice that causes Canada to look into the problem.

The Inspectorate website and details on contact information will be provided to the members.

5. Standards for Reusable Device Reprocessing
Mike Dodd

Presentation available upon request.

CSA develops National standards of Canada using a process accredited by the Standards Council of Canada. Every CSA standard is reviewed at least every five years to make sure they are up-to-date. There are number of standards related to reprocessing of medical devices. CSA standards for device reprocessing are designed to cover the critical points in the life cycle of a reusable medical device. The CSA's main reasons for revising standards are requests from outside users. Document creation takes 18-30 months and the document creation committees are made up from many different areas. For example for a document on sterilization areas considered would be CHICA, the Sterile Processing Associations, HC, Provincial Health Ministries and manufacturers.

Most CSA standards are voluntary unless they are referenced by a government, industry or professional association. Only 7% of Health Standards are mandated.

The differences in sterilization times for devices seems to be a repeated issue however the CSA is not in a position to dictate how long to sterilize for, they can only tell hospitals to sterilize according to manufacturer's validated instructions.

Standards are an essential tool for protecting user and patient safety, but are not mandatory in hospitals. The governments, purchasing agencies, and professional associations need to take responsibility for mandating, or at least encouraging the use of standards in health care facilities, and they should make sure that the necessary standards are available to their stakeholders.

Some members informed the Panel that they have a process in place that requires an equipment form be filled out. In cases where the form is improperly filled out or incomplete such as missing manufacturer guidelines or non-sufficient guidelines then this item will not be purchased.

6. Views From the Central Services of Ontario Association
Jean Richmond

Document available upon request.

The presentation focussed on the standards for reprocessing departments. As technology advances and different surgical techniques are being performed, more complex instrument sets are being used by surgeons. The reprocessing departments require manufacturer's guidelines and validation of testing in order to sterilize the instrument sets for surgery. It was noted that for different manufacturers there are different requirements for sterilization cycles. This inconsistency creates problems for reprocessing departments.

A discussion around the construction of vendor/surgical sets ensued. The design of certain containers and wraps was felt to be inappropriate and this risks the safety and contamination of the items inside. It was suggested that there is a need for national guidelines regarding the reprocessing of instrument sets from vendors, i.e. weight.

7. Challenges Facing Health Care Facilities in Reprocessing of Reusable Devices
Shawn Kenny

Document available upon request.

The reprocessing Challenges Group started in October 2004 and currently has more than 18 Health care Facilities (including GTA, Hamilton and London ). Current challenges facing health care facilities include variation of parameters, increasing complexity of instrumentation/processing, lack of scientific data, inconsistent communication, loaner instrumentation, etc.

Members expressed a concern regarding the difficulty users encounter when requesting validation or sterilization data from the manufacturers. Some felt that the difficulty stemmed from the fact that Canadian regulations do not specify what the evidence should contain, and therefore the manufacturer is using standard recommendations, they do not have detailed information on how hospitals and other users should conduct sterilization or cleaning. It was noted that the US FDA is also encountering similar issues and is approaching the matter in the same way as Canada by working on improving guidance documents, standards and regulations.

When users ask for validation information they have to be able to get it from the manufacturers.

8. Cleaning and Sterilizing Reusable Medical Devices
Stephen Dibert

Document available upon request.

An overview of MEDEC was presented. MEDEC is the national association created by and for the Canadian medical device industry. It represents 70% of the Canadian companies. It was noted that Canadian medical device manufacturers represent 2% of the world market.

In order to address some of the concerns raised by members it was suggested that an open dialogue between HC, members of the SAP-RMD and MEDEC would allow a more clear picture of the needs of the users and manufacturers and would perhaps alleviate issues before they become problematic. MEDEC would be open to discussing presented options as improving the situation would be advantageous to all.

Members asked to be informed when there is a new posting on the HC web. It was agreed that they will be kept informed and a link to any relevant new postings will be provided.

9. Provincial perspectives

9.1 Ontario Hospital Association
Sudha Kutty

Presentation available upon request.

The OHA created a Medical Devices Committee in August 2004 in partnership with OHA and MOHLTC. The committee was created to provide a forum for consultation with key stakeholders on matter of policy related to hospitals and industry that would enable them to help shape and influence policy and procedures that will support Best Practices related to patient safety.

Their overall purpose is to develop and promote patient safety and risk management strategies around the safe and effective use of medical devices.

They are using the information received from physicians such as their concerns and ensuring they are cognisant of the issues related the reuse of medical devices.

Members asked if information could be brought to this committee and any responses could be brought back to the Panel. Once again open lines of communication were requested.

9.2 Manitoba perspective
Susan Hadfield

Presentation available upon request.

An overview of current perspective in Manitoba was presented. In 1998 Manitoba 's Health Minister ordered hospitals to cease reuse of SUD's. No critical reuse was allowed. Currently the Provincial Reuse Committee has been replaced by Regional Medical Device Reprocessing Team. MB Health is a member. Reprocessing issues must first be presented to the team and decisions are made by the team with respect to the approach that will be taken, such as the need for advisory letters to the hospitals and units.

Some problems that have been raised are the cleaning of medical devices. Many sites raise the same issue, that instructions are not detailed enough, not specific enough, that some devices are extremely difficult to clean because of design or that they are not told to disassemble the device for proper cleaning.

Testing devices to verify if there is soil still left on instruments, how much and whether it is thought to be safe to use sterile soil are other matters being looked at by the team in Manitoba .

This team is attempting to standardize best practices and they visit sites and ask to see the more difficult items to clean and/or sterilize.

A recommendation to increase their notices of problems to HC was made.

Members were interested to know the adverse event process that this team has in place, the length of time that was required to input the process and any problems they may have found. The process was briefly described for the members.

9.3 Alberta perspective
Sue Lafferty

Alberta has 10 separate health regions and therefore a provincial perspective was not possible, however an overview of the Capital Health Region was given. The Capital Health Region reprocessing committee created a policy for reprocessing. The SAP-RMD recommendations of the April 2005 meeting were posted to the back of this policy. All sterile processing managers and all endoscopy unit managers are on this committee. They make recommendations to the Steering committee. Part of their goal is to upgrade the standards of the job description of people who reprocess, improve education and setting realistic goals. They aim to implement engineering changes, establish reprocessing procedures and create a medical device tracking system.

They have since received feedback on the policy the Capital Health Region released in June and questions such as how to perform some of the procedures, the request for templates, and issues of costing were also asked. Funds have been approved within the Capital Health Region however it is not clear whether the issue of cost has been dealt with in the other 8 regions.

It was noted that cost avoidance with respect to not cleaning the device to standards was not considered. When considering costing issues, legal liability considerations of reprocessing or not reprocessing must also be factored in.

9.4 Nova Scotia perspective
Linda Jakeman

Presentation available upon request.

On July 30^th 2004, HC issued a letter to the Healthcare facilities on reprocessing of reusable and single use medical devices. Recommendation #4 advised that facilities should validate and regularly review their sterilization processes. What was not considered was that some health care facilities are not equipped to validate. Facilities can, however, check the validation instructions and see if their facilities can achieve required results, and should they not be able to follow instructions, they should reconsider purchasing.

Most centers don't actually have the validation instructions although many complaints have been made with respect to manufacturers' lack of proper instruction. It is very important to check the instructions, ensure to have the instructions and work within the hospitals capabilities to ensure that the instructions are properly followed.

A discussion on consignment sets ensued. The CSA has a document on loaned items and it was felt more work needs to be done in the hospitals to ensure that the cleaning and sterilization can be done to consignment sets on loan. Currently no license is required and some felt that a recommendation for a license requirement should be considered. There is generally no documentation with these sets for replacement items on those sets, implantable screws as an example, and these items often go through many cycles of cleaning and sterilization. It was suggested that perhaps documentation of cleaning and sterilization of the items should be included in the sets.

Some layers in multiple layer sets do not necessarily reach the temperatures required by the sterilization process. Extended cycles of sterilization were felt to be a concern. A user alert should perhaps be released by the CSA or by HC on this matter. It was noted that currently no biological indicators are available to challenge the extended cycles in healthcare facilities.

The Chair summarized issues discussed and noted that:

• It is encouraging to see the commitment being made by HC and that time frames are in place for the next steps in the process - Panel looks forward to being apprised of the progress and status of the "next steps" over the next few months.
• Panel would like to have further discussion on premarket criteria of licensing requirement for reusable devices
• Panel looks forward to the opportunity to make recommendations on how HC can help them do their job better and provide safe and efficient patient care by having a consistent approach to cleaning and sterilizing of reusable medical devices.
• There is a consistent message: the need for written validated appropriate/adequate cleaning and sterilization instructions from the manufacturers of reusable medical devices
• Also the design of same sort of the medical devices needs to be addressed.

The chair thanked everyone for their input. Meeting adjourned for Day 1.

Day 2 Proceedings

The meeting started with the review of the issues that were discussed the previous day. The following items were noted:

1. A dialogue with the industry through the intermediary of MEDEC. The needs of the users and industry would then be heard by both parties. Two-way meetings were suggested, further discussions with the SAP-RMD and MEDEC will be planned. An early notice will be important to permit both sides to prepare in advance. Industry Canada should be contacted in this regard.
2. A recommendation to HC for the harmonization of classifications with health care centers, industry and other international counterparts will be made.
3. A large concern with respect to grandfathering of items was discussed and it was felt that further discussion would be needed.
4. A recommendation on loaner equipment for surgical procedures will need to be made with respect to certain categories and the process that should be taken. All loaned equipment cannot simply be ignored with respect to the reprocessing issue.
5. A suggestion to legislate reprocessing standards was made. In order to proceed quickly on this issue, changing federal policies as opposed to regulation can be considered as an option. As they are not officially part of the regulations, the process can often be completed much more quickly. Policy can still accomplish requirements that manufacturers adhere to certain standards. Policy would allow the process to be linked to post-market surveillance not to regulation. The Inspectorate would be the one to monitor the adherence to the standards. Several standards have been discussed that would be applicable for reprocessing purposes and could be adopted by Canada.

Some members felt that licensing requirement would be the preferred approach so that the reprocessing information is available to the users. Others noted that having instructions is not enough, in some cases the provided information is not clear or adequate for the users to follow.

There was a suggestion to establish long-term goals and short term goals in order to address these issues.

Items on the agenda were reviewed and members were invited to comment on process.

Item 1

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.

Item 2

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.

Item 3

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

Item 4

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.

Members agreed that there is insufficient time to discuss all the items in one day. Various options were discussed. The chair suggested establishing sub-groups for each item and assigning tasks. Most members were equally interested in contributing to all items. It was suggested that perhaps the Panel should address items 1&2 first and than look at items 3&4. It was agreed that Panel will focus on item 1 and continue to work on the rest of the items at the next meeting that will be scheduled in January.

A brainstorming session took place to determine what approach would be taken to:

• 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.
• identify reusable devices that are considered possible to clean but may present difficulties when cleaning.

There was a suggestion to focus on the types of devices rather than individual devices that are difficult to clean, followed by design features and materials that would make reprocessing of devices unsafe. There was an agreement that with this approach it would be possible to approach the manufacturers of those devices and advise them of the problems and suggest revising their cleaning instructions or make changes to their device design.

Some members suggested focusing on classes of devices or features of devices. This would allow the Panel to make recommendations to the Medical Device Bureau about the approach they use to classify devices. Members acknowledged that this may result in possible changes to the classification rules in regulations that will take a number of years to introduce.

Some members felt that a better approach may be putting those devices on a table of exceptions. This will allow a more timely way to introduce items that may require a higher classification level than their current classification.

There was a suggestion to pursue license requirement changes at the same time as we are looking at table of exceptions. Again a concern was expressed about large volume of devices that would need to be looked at when revising classification. This may not be a practical solution.

Another suggestion was breaking down classifications by medical specialty. Members felt that this would perhaps be more appropriate approach as it would help harmonize the process with the one used by US FDA.

Members agreed to start by creating a table that would list problem devices under medical specialty headings.

It was noted that members of the Panel have discussed some of the problem devices already, what needs to be done is a preparation of a list of generic types of devices by medical specialties and list the issues related with those devices. Members suggested proceeding as a group and deciding at the end of the day on next steps.

In order to address item 1 on the agenda in timely manner members suggested to use a document produced by National Coordinating Committee of Therapeutic Goods Administration of Australia entitled "Reducing Public Health Risks Associated with Reusable Medical Devices"³ as a guide and build on it based on Canadian experience.

It was agreed that the chair will contact a TGA to ask permission to adopt some of the information.

Members discussed type of information that needs to be captured for this purpose. There was a suggestion that members identify devices that cannot be reprocessed safely and therefore have to be treated as single-use.

A table was created with the following heading: Examples of groups of reusable devices that have reprocessing issues.

Members agreed that Items will be listed followed by reprocessing issues and whether they are capable of being reprocessed or not.

The following "medical specialty" headings were suggested:

General Instruments
Dental/ENT/Facial maxillary instruments
Flexible endoscopy Instruments
Neurosurgical Instruments
Minimally Invasive Surgery Instruments
Motorized Instruments
Probes (Ultrasound or other)
Needles and cannulae
Ophthalmology Instruments
Orthopaedic, neurosurgical, Spinal instruments
Loaner and Consignment Sets
Suction and related equipment
Suction instruments in general
Implantables
General comments

Members started adding devices to the appropriate headings and describe issues with reprocessing as well as provided a comment whether a particular product could be safely reprocessed.

The compiled draft table will be circulated to the members after the meeting for additional input. The revised table will be an attachment to the record of proceedings of the final meeting of the SAP-RMD.

Issue of consignment instruments was discussed. Members agreed that special training and education is required for proper use of these products.

New items were suggested to add to the agenda for the next meeting:

Item 5: Sterilization of rigid containers and packaging; and
Item 6: Sterilization parameters.

Some members offered to make presentations to the panel on related activities that they are involved in to share information and experience that would benefit the members. This information should be sent to the chair's and coordinator's attention for consideration.

³ Reducing the public health risks associated with reusable medical devices
http://www.tga.gov.au/devices/reusdev_phr.htm