Scientific Advisory Panel on Reprocessing of Medical Devices (SAP-RMD) May 15-16, 2006

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Contact: Policy Bureau Enquiries

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Record of Proceedings

Panel Members Present: Dianne Trudeau (Chair), Janina Berenyi, Susan Hadfield, Linda Jakeman, Sudha Kutty, Sue Lafferty, Colleen Landers, Cheryl Swan, Alice Wong, Timothy Zakutney

Regrets: Michelle Alfa, Michael Gardam, Diane Pinsonneault, Jean Richmond, Mary Vearncombe

Health Canada (HC) Representatives: Jean-Bernard Bitchoka, Theresa Burke, Maureen Burton, Monique Chaîné, Rolande D'Amour, Philip Neufeld, Hripsime Shahbazian

Day 1 Proceedings

Opening Remarks & Welcome

Members of the Panel were welcomed and thanked for the time and effort they have applied to this Panel.

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

The agenda was reviewed. Members were advised that in order to complete the work on the table it was likely that some items would need to be postponed and other items shifted to new times during the meeting.

A declaration of conflict of interest was completed and no conflicts were declared.

Review of previous minutes and final approval

Minutes of previous meeting were reviewed and accepted with minor revision.

Members discussed comments that were made regarding the intent of the table (Reusable Medical Devices: Reprocessing Concerns and Scientific Advisory Panel Recommendations) after the last meeting and felt it was necessary that these be addressed. After a short deliberation it was agreed that instead of responding to these comments within the minutes of this meeting an introductory paragraph would be drafted by members to address the issues raised, and provide a description of the type of information provided in the table.

Progress report on the reprocessing of Single-Use Devices Issue

Members were informed that work is continuing on this matter and it is now submitted for review by the Legal Office. One of the issues raised by Legal Office is the definition of 'sell' in the Food and Drugs Act:¹

"Sell" includes offer for sale, expose for sale, have in possession for sale and distribute, whether or not the distribution is made for consideration.

The Food and Drugs Act is based on sale. Section 19 of the Act states:

19. No person shall sell any device that, when used according to directions or under such conditions as are customary or usual, may cause injury to the health of the purchaser or user thereof.
R.S., c. F-27, s. 19.

Health Canada's authority to regulate actions of manufacturers, importers and distributors is often limited by what is considered a sale. If reprocessing, and reusing a single-use device is not considered a sale, than amending regulations may be difficult based on this interpretation of 'sale'. However, according to section 30 of the Act, the Minister can initiate regulations if there is a significant risk to health:

30.1 (1) The Minister may make an interim order that contains any provision that may be contained in a regulation made under this Act if the Minister believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment.

Members will be kept informed on any new development in this regard. Some members have indicated that there are cases when sale actually takes place when reprocessing devices through third party reprocessors. It was explained that reprocessors don't always return the same devices to the same users. There are times when it is simply a device of the same specifications that they receive, not the exact same device. Based on the definition used in the Act, members believe this would be considered a sale.

HC will be exploring other options such as the new Health Protection Act that may allow regulation of single-use devices.

Members stated that there are two issues to address: reprocessing by hospitals; and reprocessing by third parties.

It was suggested that perhaps HC needs to send an alert to the users regarding proposed regulation of reprocessing of single-use devices. Without an alert, it was felt that some facilities may find it very difficult to comply for various reasons (such as cost implications.)

HC will wait for the response from legal services before initiating a letter to Health Care Facilities regarding up-coming new regulations on reprocessing and reuse of single-use devices. Once a decision is made, HC will send out an announcement regarding the new regulations and would give facilities an advance notice of possible changes regarding processing of these devices, such as the need to send out all SUDs to licensed reprocessors.

¹ http://laws.justice.gc.ca/en/F-27/text.html

Review and recommendations on the endorsement of the ISO 17664:2004 standard: "Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices."

The suggested amendments were presented and reviewed. Members agreed to endorse the use of the ISO 17664 standard with the amendments. It was agreed that an addendum would be created and added as a reference in the HC Guidance Document "Information to be provided by manufacturers for the processing and sterilization of reusable medical devices" as recommendations from SAP-RMD.

It was agreed that members will bring this addendum to the attention of the CSA at the time of their next review of the ISO 17664 Standard.

It was suggested that in order for this to be effective AAMI and the FDA should be lobbied for their support in adopting the International Standard and perhaps incorporating some of the recommendations from the Addendum into the AAMI TIR ST-81.

HC Draft Guidance document on endorsement of ISO Standard 17664:2004

Members were informed that Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents are administrative instruments and don't have force of law and therefore allow for flexibility in approach.

The draft document was presented and discussed. Members provided comments to ensure its completeness and effectiveness.

There was a comment that HC does not have sufficient resources to review information for class I and II devices, therefore will not be able to assess validity of instructions provided by the manufacturers. Members suggested that HC ask for user feedback regarding acceptability of user instructions. Perhaps HC needs to establish a working group through a small user community and ask for their assistance when needed.

Members questioned if HC has sufficient resources to do postmarket surveillance. Perhaps the onus is on the user to bring issues to HC attention. It was noted that the Inspectorate does not have enough resources to follow-up on all reported issues. Establishment Licensing is one area where Inspectorate is active. It was suggested that members work through their respective provincial organizations to bring these issues to the federal government's attention.

Before finalizing the addendum members decided to compare ISO Standard 17664:2004 to AAMI ST 81: 2004. The addendum was endorsed with minor changes. This addendum will be referenced in a guidance document, which will go through the internal approval process prior being distributed for external comments.

The Panel recommends that HC request manufacturers use the template on page 9 of AAMI ST 81 (ISO 17664) to provide the required info to health care facilities.

Before starting the next item, there was a question on whether a company would need to apply for a new licence when they redesign a device to improve safety. The Licencing Division of Medical Devices Bureau was contacted for clarification and the following explanation was provided:

This is a class II medical device and as such an amendment for a design change is not required under current Regulations. The following are the conditions which would trigger a licence amendment for a class II medical device:

1. a change that would affect the class of the device;
2. a change in the name of the manufacturer;
3. a change in the name of the device;
4. a change in the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;
5. in the case of a Class II medical device, a change in the medical conditions, purposes or uses for which the device is manufactured, sold or represented.

Members noted that if there is a new design then the old design has to be recalled. There was a question if manufacturer will replace the old units with new ones free of charge. It was explained that HC has no authority to ask manufacturers to replace units free of charge. There was a suggestion by the panel members that perhaps this concern could be looked at if recommendation was made by the panel. It was explained that the Health Policy Branch is currently considering revisions to the regulations defining the powers of the Minister, and might consider proposals regarding the Minister's authority to order recalls. It was agreed that members will prepare a paragraph in this regard.

A concern was raised with respect to the issue of "sterile crud". Members felt the issue needed a closer look with regard to CJD transmission by blood. This raises the issue of device tracking. It would be very important to introduce a single-use symbol on individual devices. It was noted that companies have not been very helpful in this aspect.

Status of Panel recommendations 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"

Panel members reviewed the recommendations that were prepared at the previous meeting. It was agreed that since this document was not created for the Canadian user it could not be endorsed as is and would need to include additional recommendations suggested by the sub-group. Copyright issues of the original document would make it difficult to introduce any new information into the document and to disseminate it to the users.

A new document was introduced for consideration by the panel members: Ontario Best Practice Manual: Cleaning, Disinfection and Sterilization in All Health Care Settings prepared by the Provincial Infectious Diseases Advisory Committee (PIDAC).² As described in the opening paragraph of the document:

'This document is intended for health care providers to ensure that the critical elements and methods of decontamination, disinfection and sterilization are incorporated into health care facility procedures. The document describes essential elements and methods in the safe handling, transportation and biological decontamination of contaminated medical equipment/devices.'

After reviewing the proposed document members agreed that it is a very comprehensive document and is targeting the Canadian user. It was noted that the PIDAC document has been sanctioned by the Ontario Government and all Ontario health facilities are being asked to comply with the requirements in this document. The compliance period is 2 years. Although still under review, this document is considered an effective tool. It is expected that further changes and revisions will be made to the document after the comment period has ended. Members were invited to provide comments. Comments will be submitted to the working group for their consideration, as well, these suggestions will be brought forward by one of the SAP-RMD members at the next CHICA meeting.

Panel members agreed that the TGA document would remain as a cited reference in the HC Guidance document and recommended endorsement of the PIDAC document for adoption by Provincial Health Ministries.

SAP-RMD recommends HC explore ways and means of bringing the MOHLTC "Best Practices for Cleaning, Disinfecting and Sterilization - in all Health Care Settings" document to the attention of the Conference of Deputies of Health (within the next 6 months) for their consideration for adoption by all the Provinces & Territories.

The chair thanked the sub-group members for their contribution to the review process of the TGA document.

The Life Cycle Management piece created at the previous meeting would remain as a recommendation from the Panel and will be added to the HC Guidance document. SAP-RMD representative will take this document to the CMBES meeting scheduled for June 2, 2006, for their comments. These comments will be brought to the committee at the following meeting.

² http://www.health.gov.on.ca/english/providers/program/infectious/diseases/ic_cds.html

Day 2 Proceedings

Review of the Agenda

The chair reviewed the items on the agenda. Significant changes were made to the agenda in order to provide sufficient time to complete the work on the table. 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
• 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.

Revision of the Table

It was agreed by the members that a statement will be created as an introduction to the Table to ensure that the purpose of the table as a guideline is clear to all potential users. A small group was formed to work on preparation of this statement.

The rest of the meeting was dedicated to the detailed review and revision of the table. Due to limited time available members were unable to complete the review. It was suggested that the same sub-group would continue work on the table through teleconferences to complete the review in time for the next meeting.

The reference binders with device instructions were provided to the members to facilitate revision process. Some group members volunteered to review the contents of the binders to ensure accuracy of references.

Additional issues raised by the Panel

There was a question regarding HC authority to initiate a recall of a medical device that is deemed to be unsafe. Members felt that when devices are redesigned by the manufacturer to address a safety issue HC should have the authority to request a recall and ask manufacturers to replace old devices with the new devices and this should be done free of charge. Members were informed that:

1. Under the present Medical Devices Regulations, the Minister does not have the specific authority to require a manufacturer to conduct a recall or corrective action to address a safety hazard with a medical device that has been sold. (Sections 63 to 65 of the Regulations set out requirements for manufacturers to report a recall or corrective action they undertake, but the decision to initiate the recall still rests legally with the manufacturer, not the Minister).
   
   
2. Often, when a manufacturer undertakes a corrective action to address a safety hazard with a device, the manufacturer will offer to repair or service the device, replace a part, or send the owner of the device a replacement part that the user can install. However, in many cases, the manufacturer will require the owner to pay the cost of the retrofit. Health care facilities often choose not to have the retrofit done because of the cost. Health care facilities have complained to Health Canada that the manufacturer should be required to do the modification at no charge to the owner. The Act does not give HC the power to require a manufacturer to provide this service free of charge.

To address this issue, the Panel endorsed a recommendation to the Health Policy Branch to grant the Minister the power to order a manufacturer to conduct a recall, and to do so at no cost to the owner of the device (see Recommendations below).

Other issues that members felt needed to be addressed were the need to require identifiers on the SUDs and tracking numbers or methods for reusable devices with limited use.

Members questioned the requirements for an Establishment Licence in Canada. They felt that lack of a list of devices sold and the lack of screening for verification that the devices are indeed the classification stated, could prove to be a serious health issue. In Canada, an application for an Establishment Licence need only state the classes of devices being sold. However, HC informed the Panel that all Establishments are advised that they cannot sell and cannot import any Class II, III or IV device that does not have a Canadian Medical Device Licence. Panel members were advised that users may report to the Inspectorate when they suspect that a Class II, III or IV device is being sold without a licence.

In view of the issues discussed above, Panel formulated the following Recommendations:

1. The SAP-RMD recommends the following amendments to the Medical Devices Regulations that would give the Minister the authority to:
   
   
   1. order the manufacturer of a medical device to conduct a recall or corrective action, where such action is deemed necessary to ensure the safety of the device, or to ensure that the device will function as originally intended by the manufacturer; and
   2. require that the action would be taken at no cost to the purchaser of the device, whether the recall or corrective action is undertaken at the manufacturers' initiative or the Minister's order.
      
      
2. SAP-RMD endorses the MOHLTC "Best Practices for Cleaning, Disinfecting and Sterilization - in all Health Care Settings".
   
   
3. SAP-RMD recommends HC explore ways and means of bringing the MOHLTC "Best Practices for Cleaning, Disinfecting and Sterilization - in all Health Care Settings" document to the attention of the Conference of Deputies of Health (within the next 6 months) for their consideration for adoption by all the Provinces and Territories.
   
   
4. SAP-RMD recommends that HC request manufacturers use the template on page 9 of AAMI ST 81 or page 14 of ISO 17664 (Sterilization of medical devices - information to be provided by the manufacturer for the processing of resterilizable medical devices) to provide the required information for reprocessing.

Next steps

Members were canvassed for the next meeting dates. A meeting will be planned for September or October, 2006.

All items not covered at this meeting will be discussed at the next meeting.
A presentation will be made to the Panel by the "Syntegrity Group" as a possible facilitation group for a future meeting between manufacturers and users of single-use and reusable medical devices.

Meeting adjourned.