Health Canada Stakeholders Conference on the Reprocessing of Single Use Medical Devices

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Contact: Policy Bureau Enquiries

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Therapeutic Products Directorate (TPD)

June 9, 2005

REPORT ON PROCEEDINGS

Introduction

The Director General of the Therapeutic Products Directorate opened the meeting by thanking all the participants for taking the time to discuss the reprocessing and reuse of Single Use Medical Devices (SUDs). He indicated that there is increasing concern about the health risks associated with reuse of single-use devices, since improper cleaning may result in transfer of pathogens from one patient to another, and since decontaminating, cleaning and sterilizing of SUDs may affect their functionality.

At issue is what form of control is needed to mitigate health risks and liability associated with the reuse of SUDs, and if so, what role Health Canada should play in this regard. The stakeholder input received at this meeting will be considered (along with other information) in the development of Health Canada's position regarding the issue of reprocessing and reuse of SUD.

The purpose of this meeting was:

• To present the recommendations of the Scientific Advisory Panel on the Reprocessing of Medical Devices (SAP-RMD) on the reprocessing of SUDs
  
  
• To present and obtain comments on Health Canada's Issue Analysis Summary on the Reuse of Single-Use Medical Devices
  
  
• To hear the views of stakeholders on the issue of reuse of SUDs
  
  
• To discuss next steps proposed by HC to address the issue of SUDs.

Current Health Canada regulatory requirements were presented by Philip Neufeld, HC.

Denise Désautels, Canadian Healthcare Association (CHA) provided an overview of the current reuse practices in Canada .

Stephen Dibert, President of MEDEC presented MEDEC's position on reuse of single use devices.

Use of standards for medical device reprocessing activities was presented by Mike Dodd, Canadian Standards Association.

Michelle Alfa presented the role and recommendations of the Scientific Advisory Panel on Reprocessing of Medical Devices (SAP-RMD).

Theresa Burke, HC, provided the international context, and described issues regarding reprocessing of SUDs. She presented an overview of Health Canada's Issue Analysis Summary which was the focus of afternoon discussion session.

Table-group discussions on the proposed risk management options

After the presentations were made the participants were invited to table-group discussions on the proposed risk management options. Participants were provided with workbooks containing the options presented by Health Canada in its Issue Analysis Summary to facilitate the discussion process. The following pages set out the comments noted from the participants' workbooks presented in the order in which the options were assessed.

Options Analysis

There are numerous ways that Health Canada could be involved in a solution to the problems posed by unregulated reuse of SUDs. The following are several options, followed by the benefits and difficulties that may flow from each, if carried out.

The options are discussed in order, from those involving the least intervention by Health Canada to those involving the most intervention. Stakeholders were also told that there would be time given to develop their own option, if ever they felt the options given were not sufficient.

During their deliberations, the participants assessed the options provided. Comments noted from the deliberations are set out below by table-groups.

Option 1. Status Quo: Health Canada does not regulate reuse

Reuse of SUDs has been practised in Canadian health care institutions for at least twenty years, with no federal policies to endorse, ban or regulate it. Concern over the practice was expressed in a Letter to Healthcare Associations and Facilities in July, 2004. Quebec and Manitoba have issued directives on the issue, and there are no accepted safety standards for reprocessing single-use devices by hospitals.

Pros:

The practice appears to be saving hospitals millions of dollars No federal resources would be needed to establish regulations and monitor compliance

Cons:

Although there have been few confirmed cases of infection due to reused single-use devices, the potential for a serious health risk similar to that caused by infected blood cannot be ruled out Reuse places healthcare facilities and health ministries in a vulnerable liability position should patients be injured as a result. The public is critical of the lack of policies to control the risk of disease transmission during hospital procedures, and holds Health Canada responsible to do something about it. The Office of the Auditor General, in its report of March, 2004, recommended that Health Canada address the issue of reuse, and Health Canada has agreed to do so

Analysis of Comments for Option 1

A majority of stakeholders felt that this option was unacceptable. Many stated that they felt that Health Canada should play a role in the regulation of reuse in some form. The comments made, both negative and positive, are listed below.

• Health Canada must play a role in regulation
• In Quebec, Bill 113 (in force since 2003) establishes a duty of disclosure if there is the risk of an accident
• The status quo weakens the quality of hospital care
• The confidence of Canadians in health care systems risks being threatened
• What about patient safety? This option ignores the politics of the provinces
• Policy should be uniform across Canada
• There should be comparable care across Canada
• This option indicates that this issue will only come up again, hence not viable

Option 2. Encourage provinces and territories to develop Provincial/Territorial solutions

Since Provincial and Territorial governments have jurisdiction over the use of medical devices, Health Canada could play a supportive role in helping the Provincial and Territorial governments devise their own solutions for this issue. Such solutions could include Provincial or Territorial regulations incorporating mandatory standards.

Pros:

Concerns about health risks would be mitigated without compromising the jurisdiction of either Provincial, Territorial or Federal governments Health Canada would play only a supporting role in the process of designing, implementing and administering the standards, which would be less costly Provinces would have some autonomy to determine what solution was best-suited to their needs and their existing regulatory systems

Cons:

If some provinces choose to establish voluntary standards instead of regulatory standards, it would result in manufacturers being held to a higher standard than reprocessors. Moreover this could have a negative impact on the health of some Canadians depending on whether they are subjected to a new SUD, a reprocessed SUD (in a province with mandatory standards) or a reprocessed SUD (in a province with voluntary standards) The public (and the provinces and territories) may perceive Health Canada to be avoiding responsibility if it does not take direct responsibility to resolve the problem If standards are left to Provincial / Territorial governments to draft and administer, there may not be consistency in approaches across the country

Analysis of comments for Option 2

With respect to this option, there was one recurring theme: uniformity/consistency.
Stakeholders seemed to want a consistent approach and felt that by leaving it to the provinces and territories, this could generally not be achieved. Stakeholder comments are listed below:

• This raises the issue of provincial versus federal responsibilities.
• Health Canada could play a role in certification. Specifically, it could review safety standards for both use and reuse.
• Historically, Provinces and Territories have not come up with guidelines
• There won't be uniformity if Health Canada leaves Provinces/Territories alone
• This is a complex area, a voluntary standard is not appropriate and won't be achieved
• If voluntary, how is compliance monitored? If guidelines are published, there will be diversity in their interpretation
• This option is not strong enough, since it does not mandate the Provinces and Territories to address the issue of reprocessing. Also, we feel that one uniform standard should be the mandate, not Provincial or Territorial solutions. The standard of health care in all of Canada should be the same
• The group would like a pan-Canadian approach rather than a segmented approach
• This presents disjointed regulation without consistency.
• For this option to be considered further: include all health care facilities not just hospitals, mandated standards may require funding, down the road there might be potential cost implications which are recognized, provide provincial and federal funding, the regulator will be required to do spot audits, self inspection will need to occur, standards must be the same for the hospitals and third parties, smaller hospitals may contract with larger centres

Option 3. Implement a registration regulatory requirement for reprocessors of SUDs including self inspections or audits coupled with an inspectorate inspection program involving spot audits, as permitted under section 23 of the Food and Drugs Act. Reprocessors could be required to comply with Quality System requirements, audits, inspections, and mandatory problem reporting.

Pros:	This would provide increased safety to patients by ensuring that reprocessing is done according to established standards and quality systems A registration scheme would be less of an administrative burden than a licence scheme Cost recovery may be possible
Cons:	It would take time to establish and implement the regulations All the arguments against reuse based on safety, liability and ethics, would still apply to reprocessors

Analysis of comments for Option 3

Though this option was regarded as more acceptable than the first two, there was still a concern about standards being upheld to the same level at all facilities. Many stakeholders felt there would be inconsistencies between sites. Also, it was felt that a cost analysis should be undertaken before this option could be considered viable. Comments made by the stakeholders are provided below:

• Favorable, but reprocessors would be required rather than urged to follow standards
• Looser standards are used to someone's advantage, not to the patient's advantage
• This option is a half way measure - is this a registration system with no way to regulate?
• Industry thinks that this is a possibility - you don't need a pre-market survey to validate the product when you use a third party processor
• This option would allow hospitals to continue doing this
• Without a standard, it would be difficult to comply with this option. This option does not "regulate" to the degree required to ensure a proper, validated and consistent process. Without a regulated inspection program run by Health Canada, compliance on the basis of self-declaration would be questionable
• There is too much chance for inconsistency in the implementation of the standards (between reprocessing and SUDs). This option is almost like the status quo
• There is a cost benefit analysis that needs to be done site to site to look at this
• Once a reprocessor takes on this role, they would have to take on licensing and all quality assurance/quality control(QA/QC) for the product (as if it were a new item)
• It would no longer be the original manufacturer that would be held responsible (liable) for this item
• Certain items should not be reprocessed - ever (this is an overarching principle for all comments)
• Health Canada should take on a role of listing devices that should or should not be reprocessed
• There is registration for each reprocessor, using minimum standards established by the Federal government
• Reprocessors are registered as a facility, but licensed by item

Option 4. Allow only licensed reprocessors to reprocess single-use devices

As has been done in the United States, Health Canada might consider amending the Medical Devices Regulations to require licensing of all SUD reprocessors. Reprocessors could be required to comply with Quality System requirements, audits, inspections, and mandatory problem reporting. Health Canada could establish standards that would be mandatory for reprocessors to follow in order to maintain their licences.

Pros:	This would provide increased safety to patients by ensuring that reprocessing is done according to established standards and quality systems The US regulatory system could be used as a model Cost recovery would be possible
Cons:	It would take time to establish regulations and would be costly to establish and administer a licensing system and enforce compliance All the arguments against reuse based on safety, liability and ethics, would still apply to reprocessors Health Canada may be held responsible for any adverse events arising from the reuse of SUDs that are reprocessed in a licensed facility

Analysis of comments for Option 4:

This option appeared to be one of the more favourable options in the opinion of the stakeholders. Some strong points were made on standards. For example, it was felt that all reprocessors must be held to the same standards and that these standards should be established and monitored by HC. Comments made by the stakeholders are listed below:

• The quality system is on a per-product basis, which leads to the certification of reprocessors
• The company must meet criteria of a new device manufacturer
• Standards must be developed and made available to potential reprocessors to assess the requirements. Licensing provides additional assurance over the registration process as a result of the on-going inspection process. Licensing should be viewed on the same basis as current quality system regulation (ISO audits)
• If this option was considered, we would suggest that reprocessors be held accountable to the same approval standards, licensing requirements as original manufacturers regarding safety, quality control and effectiveness. We would like to recommend that if reprocessing should occur, that it be done on Canadian soil. The rationale being that we have more authority to enforce the regulations and we would not be at the mercy of cross border problems such as security etc.
• Licensing for reprocessors should be the same as it is for the original manufacturers, must prove required "substantial equivalence", the same as the 510K requirement in the US FDA regulations.
• Safety, reliability and sterility (QA/QC) must be proven
• Licensing must protect against reprocessing of SUDs by unreputable companies.
• Reprocessed items should be marked as such

Option 5. Ban the reuse of all single-use devices

In light of the potential health risks posed by the practice, it may be in the best interests of patients for Health Canada to do what several European countries have done: to prohibit reuse of any device that is labelled by the manufacturer as being intended for single use only.

Pros:

This would provide maximum safety to patients It would not be necessary to develop and maintain regulations, safety standards and quality assurance systems for reprocessing single-use devices

Cons:

Legal opinions given to Health Canada indicate that the Department has the authority to regulate reuse under the Food and Drugs Act. Provinces and territories may raise objections because of cost implications, but are unlikely to challenge Health Canada's legal authority Provinces may object to Health Canada's intervention into the area of hospital practice, which has traditionally been their role Buying a new device for every procedure could increase the costs to the Canadian healthcare system by tens of millions of dollars a year. Manitoba's ban on reuse is estimated to be costing that Province an additional $4 million per year If a ban were implemented without providing additional funding to buy new devices, hospitals might be forced to perform fewer procedures, resulting in increased mortality and morbidity in the population Compliance enforcement may pose problems

Analysis of comments for Option 5

This option was considered one of the least favourable by the stakeholders. Increased cost and wait times for the patients as well as it being environmentally unsound were some of the reasons given for this option being rejected by the majority. However, it was noted by many that this option was definitely the safest as there is no risk of improperly cleaned or reprocessed SUDs. Comments made by stakeholders are listed below:

• Consider the impact: e.g., major financial impact
• Public safety and the safety of health workers; a key principle to bear in mind
• Necessarily linked to a cost, so there is an impact on accessability and quality
• cost analysis: devices are expensive to throw out
• could cause increased wait times
• ignores what can safely reprocessed or reused
• environmentally unsound
• This may give manufacturers a window to label everything as a SUD as they will not have to validate this. Costs can be expected to go up.
• Can this be achieved from a cost-benefit perspective?
• Certain devices should not be reprocessed at all
• Increase the standard so that the reprocessing would be virtually impossible to do
• The costs of storage and disposal need to be considered

Comments and other recommendations suggested by stakeholders:

• Develop a Canadian policy that implements regulatory certification requirements for products and the certification of reprocessors and products. Will have to be prepared in collaboration with the provinces, the territories and Health Canada
• Accessibility must be maintained
• Who will have to assume the costs?
• Keep hospitals and companies to the same standard
• If licensing: Set criteria that companies should meet that include quality control, validation research, have the same requirements as the original equipment produced by the manufacturer. Ensure on-going monitoring (annually), set up inspection, compliance, communication mechanisms
• Licence the reprocessed product to the quality of a new device
• New regulation should define the reprocessing of an SUD as a special activity distinct from manufacturing or selling. Require a licence of anyone who wants to reprocess SUDs. The licence holder would be required to meet the criteria of quality systems ie ISO certification, validation of functionality. Include annual site inspection to assess compliance with quality systems or other standards by accredited registrars and include mandatory adverse event reporting for a reprocessed device (we also recommend this occurs for reusable products)
• Specific standards should be issued by Health Canada
• There should be communication and consultation with all stakeholders early and throughout the entire process
• Phased implementation leading to licensing and subsequent compliance
• Unlicensed facilities may continue to reprocess, without complying with the new regulation
• Licence costs may increase costs to the clinics and health care facilities
• Provides the required control of the reprocessing activity
• Health Canada is going to set the standard regarding the reprocessing of SUDs
• The reprocessor will license each and every SUD being reprocessed with Health Canada
• Requirements and standards will be set by Health Canada for reprocessing SUDs wherever it occurs, in-house, third party or in the USA
• The facilities will be required to license each product that they are going to reprocess
• Health Canada will mandate all manufacturers and place a SUD symbol on the instrument itself
• Consistent national standards are important to make it work
• Standards of care would be the same across Canada
• There is optimum patient safety
• There are reduced landfill costs
• The risk of liability for reprocessors
• There is a potential cost of liability to all healthcare facilities and Health Canada
• There is an unknown financial impact

Note: The standard being asked for by the stakeholders would be mandatory, not a recommended standard

Some suggested interim measures:

1. To limit the use of SUDs to the best of the facilities' capabilities.
   
   
2. Health Canada should issue a letter recommending the elimination of the reprocessing of SUDs until such regulation can be provided. Interim position should be established:
   
   
3. Sites should stop reprocessing SUDs unless they can demonstrate validated protocols (either on site or by a third party reprocessor)

Plenary presentation by table-groups

A plenary session followed the group discussions. A designated member from each table summarized the main points and the option favoured by the group. The suggestions and comments showed recurring themes such as public safety, consistent approach, economic considerations, high levels of standards for any and all who decide to reprocess, the fact that some devices should simply not be reprocessed, reprocessed items should be identified/tracked in some way and reprocessing should be limited to Canadian reprocessors. Comments from stakeholders are listed in point form below.

• We see Health Canada taking a leadership role on the issue to ensure common consistent approach
• Ensure consistency and harmonization in North America
• It ensures consistency and continuity within a pan-Canadian framework and also reflects the ethic of Universal healthcare
• It supports the Auditor General's 2004 report stipulating that the Federal government ie. Health Canada take a leadership role on this issue
• Set up compliance, audit and heightened accountability
• Assure the best level of safety without a total ban, taking into consideration economic savings
• Ensure a good balance between the interest of public patient safety and economic realities of the facilities and the provinces
• Improve patient safety through regulation
• The regulations must ensure that reprocessors be held to the same standards as the original manufacturers for licensing approval (including quality, safety effectiveness etc).
• The option provides the safe, quality of care standard we require
• If a product is manufactured as a single use and then reprocessed, the licensing and QA/QC process has to be followed by the reprocessor
• That the regulations "consider" a requirement that reprocessing occur on Canadian soil.
• Some devices should never be reprocessed (either establish a list or tighten regulatory standards enough such that it is not achievable for some devices)

Note: One participant wanted to draw the group's attention to the issue of the reuse of linens, even though it was not the focus of today's discussion. The comment was noted for recording purposes.

Next Steps, Closing Remarks, Meeting Evaluation

The Director of Medical Devices Bureau thanked everyone for their contribution to the day, and invited additional input to this important issue. He informed the participants of the next steps that HC will take to address this issue. He noted that there will be further consultations with a view to developing a comprehensive pan-Canadian mechanism to address the issue of SUDs. He stressed the importance of continued communication with the stakeholders throughout this process.

Meeting Adjourned

* List of stakeholders and HC representatives attending the meeting is attached below

Prepared: June 23, 2005
Revised: August 18, 2005

Health Canada Stakeholders Conference on the
Reprocessing of Single Use Medical Devices
Stakeholder List

Name	Company	Prov
Alfa, Michelle	SAP-RMD/ St-Boniface General Hospital	MB
Ames, Dave	Johnson and Johnson	ON
Bell, Ian	Booth Centennial Healthcare Linen Services	ON
Benoit, Diane	Association québécoise d'établissements de santé et de services sociaux	QC
Berezanski, Joan	Alberta Health and Wellness	AB
Boivin, Paul	Ministère de la Santé et des Services sociaux	QC
Boucher, Michèle	Cité de la Santé	QC
Brown, Adrienne	Joseph Brant Memorial Hospital	ON
Buckley, Tim	Borden Ladner Gervais LLD	ON
Chenail, Robert	Hôpital Montfort	ON
Cortis, Mario	Johnson and Johnson	ON
Desautels, Denise	Canadian Healthcare Association	ON
Dibert, Steven	MEDEC
Di Marzo, Joseph	Tyco Healthcare Group Canada	QC
Dodd, Mike	Canadian Standards Association	ON
Furman, Pam	Association of Medical Device Reprocessors	DC
Galicia, Bernie	University Health Network	ON
Griffiths, Beverley	Dept of Health and Community Services	NL
Harrison, Steven	Ontario Medical Association	ON
Higgins, Ann	Ontario Hospital Association	ON
Houle, Daniel	Centre Universitaire de Santé McGill	QC
Kacz, Gabor	Booth Centennial Healthcare Linen Services	ON
Kamel, Mike	St-Mary's Hospital Center	QC
Kenny, Shawn	University Health Network, TGH	ON
Kilcollins-Jones, Suzanne	NB Dept of Health and Wellness	NB
Kutty, Sudha	Ontario Hospital Association	ON
Laroche, Laurent	St-Mary's Hospital Center	QC
Londei, Dominique	Sterilmed/Medique	QC
MacKinnon, Susan	Queen Elizabeth Hospital	PE
Marquis, Guylaine	CHUM, Hôtel Dieu	QC
McCallum, Don	Dental Industry Association of Canada	ON
Meevis, Tom	St-Joseph's Healthcare Hamilton	ON
Michalyk, Deb	Capital Health	AB
Miller, Mark	Association des microbiologistes du Québec	QC
Mrosek, Teresa	Manitoba Health	MB
Noble, Joanna	Health Care Insurance Reciprocal of Canada	ON
Nuttall, Sandy	Ministry of Health and Long Term Care	ON
Orvidas, Mary Catherine	Hamilton Health Sciences	ON
Pace, Heather	Johnson and Johnson	ON
Pickard, Mark
Ralph, Earl	Sterilmed/Medique	QC
Rawding, Patsy	Department of Health N.S.	NS
Robitaille, Diane	Hôpital Sacré-Coeur	QC
Roth, Virginia	Ottawa General Hospital	ON
Selvey, Don	Alliance Medical Corporation	AZ
Sigouin. Anne
Stevenson, Ruth	St-Joseph's Healthcare Hamilton	ON
Straatman, John	Trudell Medical International	ON
Swan, Cheryl	SAP-RMD/ Atlantic Health Sciences Centre	ON
Swan, Euan	Canadian Dental Association	ON
Trott, Lynne	Ottawa General Hospital	ON
Vanasse, Andrée	Cité de la Santé	QC
Venne, Diane	Cité de la Santé	QC

HC Representatives

Omer Boudreau Director General, Therapeutic Products Directorate (TPD)

Hripsime Shahbazian Office of Science, Policy Bureau, TPD

Monique Chaîné Office of Science, Policy Bureau , TPD

Roland Rotter Medical Devices Bureau, TPD

Philip Neufeld Medical Devices Bureau, TPD

Susan Tainsh Medical Devices Bureau, TPD

Jean-Bernard Bitchoka Medical Devices Bureau, TPD

Theresa Burke Policy Bureau, TPD

Maureen Burton HPFB Inspectorate

Andrew Gaffen Marketed Medical Devices Division, MHPD

Gina Coleman Marketed Medical Devices Division, MHPD

Kendra Hunter Acute care & Health Technology, Health Policy Branch

Raymonde D'Amour, IAF-CPF/FPA Consultant Praxis