Issue Analysis Summary

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The Reuse of Single-Use Medical Devices

THIS IS A DRAFT DOCUMENT

MECS #04-124643-474
Attachment

Contents

1. Issue
2. Purpose/Objective
3. Background
4. Issue Analysis
5. Options Analysis
6. Recommended Approach

1 Issue:

There is increasing concern about the health risks associated with reuse of single-use devices (SUDs), 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. Manufacturers of SUDs are not required to provide any information to Health Canada to demonstrate that their SUDs can be successfully decontaminated, cleaned and sterilized for reuse, or how it should be done. In fact, this information may not exist since, once the manufacturer decides that the device be marketed as a SUD they likely would not continue to look at decontaminating, cleaning and sterilizing and certainly not validate such a process.

At issue is whether there is need for regulation in order to mitigate health risks and liability associated with the reuse of SUDs, and if so, what role Health Canada should play in this regulation.

2 Purpose/ Objective

The purpose of this analysis is:

• to review health risks associated with reuse of SUDs;
• to determine provincial/territorial and federal roles in the regulation of reuse of SUDs; and
• to propose and evaluate ways to mitigate health risks associated with reuse of SUDs.

3 Background

The manufacture and use of SUDs, formerly called disposable devices, began to increase in the 1970s. This proliferation was possible because of advances in technology (particularly in the plastics industry), and reflected a need for hospitals to save reprocessing costs for a large variety of simple and inexpensive reusable devices like syringes, trocars and drainage catheters.

With the introduction of minimally invasive surgery, manufacturers began to produce specialized single-use instruments which had no reusable equivalents. The construction of these new instruments often made them impossible to disassemble for cleaning, and some plastic components could not withstand the heat and chemicals used in sterilization. Since these devices were mechanically complex and often had electrical and optical components, they could cost several thousand dollars each.

Health care institutions facing growing economic pressures found that reusing SUDs permitted significant cost savings, since new devices did not have to be purchased for every procedure. In the 1980s, as part of efforts to reduce costs and environmental impacts, health care institutions began to clean, sterilize and reuse certain high-cost SUDs, such as electro-physiology catheters, angioplasty catheters, hemodialyzers, endoscopes, and biopsy forceps. In recent years, third-party reprocessors have begun providing this service under contract to hospitals.

4 Issue Analysis

4.1 Risks Associated with Reuse of SUDs

The rise in use of SUDs coincided with increasing concern about the transmission of blood borne pathogens, and there has been growing concern about the possibility of cross-patient infection that may result from reused SUDs, particularly those that come in contact with blood and other bodily fluids.

SUDs are often classed as critical, semi-critical, and non-critical, according to a set of criteria known as the Spaulding definitions¹. Under these definitions, critical SUDs are those that are intended to contact normally sterile tissue or body spaces during use. Semi-critical SUDs are intended to contact intact mucous membranes and not penetrate normally sterile areas of the body. Non-critical SUDs are intended to make topical contact and not penetrate intact skin.

Most non-critical devices, like compression sleeves, can be cleaned and reused with minimal risk. Opened but unused sterile instruments can sometimes be re-sterilized, provided the materials can withstand the sterilization procedure. However, some invasive SUDs, especially those with long lumens, hinged parts, or crevices between components, are difficult or impossible to clean once body fluids have entered them.

In addition to the risks of cross-patient infection, there is also the increased probability that the device will malfunction due to the adverse effects of reprocessing on materials or delicate components.

4.2 Legal Considerations

There are several legal concerns that arise indirectly from the health risks discussed above that may lead to hospitals exposing themselves to increased liability under civil law by using a device contrary to the manufacturer's express directions and warnings.

4.3 Regulation in Canada

The delivery of health care and the establishment of policies and standards of practice in patient care have traditionally been the responsibility of provincial and territorial health ministries and hospital boards. Consequently, Canada's Food and Drugs Act and the Medical Devices Regulations have not addressed the way in which a health care facility uses, maintains, or sterilizes medical devices. Furthermore, the Medical Devices Regulations do not address the situation in which a third party reprocesses devices belonging to a hospital and returns them to that facility for reuse.

However, Health Canada, under the Food and Drugs Act helps safeguard the health of Canadians by regulating the sale of medical devices, food, drugs and cosmetics. To this end, regulations could be made, under the authority of the Food and Drugs Act, to oversee the safety of reprocessing SUDs by third party reprocessors.

4.3.1 Provincial and Territorial Positions on Reuse of SUDs

Provinces and territories have traditionally held responsibility for the administration of hospitals and other health care facilities, and for health and safety of patients treated under their respective health care systems². This responsibility includes the authority to establish policies and standards of practice in patient care, along with means to enforce those standards. Therefore, it has been traditionally understood that the provinces and territories have the jurisdiction to regulate the use of medical devices in these institutions.

Manitoba

In 1999, Manitoba ordered its hospitals to stop reusing "critical contact" single-use devices (those that contact the bloodstream or a sterile body cavity).

Québec

In 1991 and 1993, the Conseil d'Évaluation des Technologies de la Santé du Québec (CETS) published guidelines advising that the reuse of cardiac catheters, pacemakers, and hemodialyzers did not present unacceptable risks, provided the hospital had official policies and strict procedures governing quality assurance and staff training. However, in 1996, in response to concerns over the possible spread of Creutzfeldt-Jakob Disease (CJD), the CETS rescinded that advice and declared that it could no longer support the reuse of these devices. In 1997, CETS published an update to their position, stating that cardiac catheters should not be reused if they had come in contact with patients considered to pose a risk of being a vector for CJD. However, if the catheter had been used on patients not considered to be in this category, reuse did not pose an unacceptable risk.

Ontario

The Government of Ontario is proposing to establish a central service for reprocessing medical devices for all Ontario hospitals by June 25, 2005. The service would initially provide reprocessing for SUDs. Later, it may expand to reprocess all types of reusable surgical instruments as well. The reprocessing may be done by a facility in Ontario, or may be provided under contract to a US third party licensed by the US FDA.

British Columbia

British Columbia's Patient Safety Task Force has announced that it will establish a short-term provincial committee to review the reuse policies in each of the Province's health authorities and to make recommendations for the development of a single process at the Provincial level.

Northwest Territories

The Northwest Territories Department of Health and Social Services is planning to revise the Hospital Standards Regulations to include a requirement that a single-use device shall not be used on a patient for more than one procedure and shall not be used on another patient. It is expected that the new regulations will come into force in the Spring of 2005.

4.3.2 Federal regulation of the reuse of SUDs

The manufacture and sale of medical devices is currently regulated under the Food and Drugs Act and the Medical Devices Regulations.

First, one must consider whether the requirements that the Medical Device Regulations impose on manufacturers apply to health care institutions or any other facilities that are reprocessing and reusing SUDs. According to the definition provided in the Medical Devices Regulations, a "manufacturer" is a person who sells a medical device under their own name, or under a trade mark, design, trade or other name owned or controlled by the person, and who is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf. Although cleaning and sterilizing devices may be considered a 'manufacturing' activity, merely carrying out that activity does not make the agent a manufacturer under the legal definition. In order to be considered a manufacturer, the reprocessor would also have to sell the device under their own name, trade-mark, design, trade or other name. If this is not the case (and it is unlikely to be the case), the reprocessor will not be regulated as a manufacturer. Although the Food and Drugs Act and the Medical Devices Regulations do not specifically address reuse of SUDs, existing provisions in the Food and Drugs Act may permit further regulation. Some have suggested that Sections 19 and 20 may be applicable and allow for the regulation of reprocessors.

4.3.3 Other policies, standards and guidances

4.3.3.1 Canadian Council on Health Services Accreditation

Many hospitals in Canada are accredited voluntarily under standards developed and surveyed by the Canadian Council on Health Services Accreditation (CCHSA). The standards for health care services developed by CCHSA are comprehensive, covering all facets of health programs and services and their organizations. However, there are no specific prohibitions against reusing medical devices.

4.3.3.2 Canadian Healthcare Association

The Canadian Healthcare Association (CHA) is the federation of Provincial and Territorial hospital and health organizations across Canada. Its mission is to improve the delivery of health services in Canada through policy development, advocacy and leadership. To this end, in 1996, it published The Reuse of Single-Use Medical Devices: Guidelines for Healthcare Facilities³. This document addresses the key issues surrounding the topic of single-use device reuse, including cleaning and sterilization protocols, cost justification, liability costs and the patient's right to information. It does not take a position for or against reuse of SUDs, but provides a framework to enable a facility to judge the merits of reuse, and to establish the quality systems necessary to ensure that reprocessed SUDs are safe.

In spite of this guidance document, a Health Canada-sponsored study in 2001 found that 37% of Canadian hospitals surveyed reused critical devices, 39% had a system in place to track usage, and only 25% had procedures and reuse committees.

4.3.3.3 Ontario Hospital Association

Member organizations of the CHA, such as the Ontario Hospital Association (OHA) and their members, can ignore, adopt or make stronger the guidelines or policies set forth by the CHA. In January, 2004, the OHA published a report written by its Ad hoc Working Group on Reuse of Single-Use Medical Devices and issued a Position Statement which included the following recommendations:

• Hospitals should not reprocess critical and semi-critical SUDs
• Health Canada should develop regulations for safe sterilization practices in hospitals for reusable and single-use devices
• Health Canada should regulate third-party reprocessors
• Until Canadian regulations are established, hospitals should consider using third-party reprocessors licensed by the USFDA.

4.4 The International Regulatory Environment

4.4.1 United States

The United States Food and Drug Administration (FDA) published a guidance in August, 2000, confirming that third party and hospital reprocessors of single use devices in the United States would be subject to all the regulatory requirements currently applicable to original equipment manufacturers, including pre-market review submission requirements⁴. All regulatory requirements for these parties were fully implemented (via the Medical Device User Fee and Modernization Act of 2002) by August, 2002 and included a registration and listing scheme for reprocessors, inspections under Quality System Regulation, labelling, adverse event reporting, corrections and removals, pre-market clearance and tracking requirements. The FDA published a revised guidance on reprocessing of SUDs in June 2004, which covers the agency's procedures and time-frames for reviewing the validation data submitted to FDA for certain reprocessed SUDs⁵.

4.4.2 Australia

In 2001, the Australian Health Ministers Advisory Council (AHMAC) agreed that the practice of re-manufacturing SUDs should either stop or be regulated by the Therapeutic Goods Administration (TGA) to the equivalent standard as the original manufacturer. In October, 2003, the National Coordinating Committee on Therapeutic Goods (NCCTG) agreed to the implementation of a national regulatory framework for re-manufacturing single use devices. This framework, which came into effect on December 1, 2003 with a two-year transition period, required any facility re-manufacturing SUDs to comply with the requirements of the Therapeutic Goods Act of 1989 and the Therapeutic Goods (Medical Devices) Regulations of 2002 by December, 2005.

Under this regulatory scheme, when a SUD is re-manufactured for reuse, the intended purpose and design specifications for the device are considered to be altered from single-use to reusable. The person responsible for undertaking the reprocessing is considered to be a manufacturer and must comply with the therapeutic goods legislation relating to the manufacture of medical devices. The TGA is in the process of publishing public guidance documents on the regulatory requirements that apply to re-processors of SUDs. The regulation of the re-processors covers all medical devices labeled as single use or single patient use, irrespective of the level of risk associated with its use, but does not include those SUDs that are 'opened but unused'. Essentially, if a health care facility wishes to reuse SUDs, they may either become a manufacturer, find a manufacturer to undertake the re-processing of the SUDs, or adopt a single use policy.

4.4.3 European Union

The legal framework for medical devices comprises three directives; the 1990 Directive on Active Implantable Medical Devices, the 1993/42 Directive Concerning Medical Devices, which is the main directive, and the 1998 Directive on In Vitro Diagnostic Medical Devices. In 2003, the European Parliament published the "Report on the health implications of council directive 93/42/EEC of 14 June 14 1993 concerning medical devices". This report acknowledges that the reprocessing of single-use medical devices is not regulated in the 93/42/EEC directive, but notes that it does regulate the placing on the market and the servicing of products. The Report states that "[a]ction should be taken to ensure that no single-use devices are re-utilised", and encourages all member states to take the necessary measures to ensure that single-use devices are not reused.

4.4.4 United Kingdom

Although the United Kingdom has not instituted a regulatory ban, a strong statement against the practice has been issued by the Medical Devices Agency (MDA) in that country. A bulletin in August, 2000, entitled "Single-use Medical Devices: Implications and Consequences of Reuse"⁶. highlights the hazards and risks associated with reprocessing and reusing single-use medical devices, and outlines the legal issues and regulatory requirements for such actions. The MDA makes it clear in this document that: "[d]evices designated for "single-use" must not be reused under any circumstances".

Although there appears to be no specific regulations governing reuse of SUDs, the General Product Safety Regulations impose responsibility on producers and distributers to comply with basic safety requirements for medical devices, and to ensure that consumers have relevant information to enable them to assess devices on the market.

4.4.5 France

France is one of the few countries that enforces an outright ban on reuse of SUDs. The French Health and Social Affairs Ministry first advised against reuse in a memo to health care establishments in 1994. Judicial decisions in 1999 and 2000 found that reuse was deceptive to patients and that reuse of SUDs was illegal, respectively. A circular on CJD was produced in 2001 that indicated that most SUDs would not withstand sterilization and disinfection procedures, and in June, 2001, the circular was integrated into law.

4.4.6 Germany

Germany regulates reprocessing generally, with its regulation being limited to registration of the reprocessing industry. For the reprocessing of devices that are to be used sterile or aseptically, the ordinance on operating medical devices requires a validated process to ensure health and safety of patients, users and third parties. Adequate processing is assumed if the Recommendation on Reprocessing (which describes particular reprocessing requirements for different risk categories of devices) is followed. The ordinance bans usage that is contrary to the original intended use of the device. Although the regulatory system does not differentiate between single-use and multiple-use devices, it may be implied that if single-use is part of the device's intended use, reuse is illegal (this appears not to be entirely settled).

4.4.7 Sweden

Sweden regulates reuse of SUDs in part. Hospitals that reuse are regarded as manufacturers and must comply with the Medical Devices Directive of the EU. There are no registration or post-market surveillance requirements, but hospitals must obtain informed consent of the patient.

¹ Spaulding, EH, The Role of Chemical Disinfection in the Prevention of Nonsocomial Infections, PS Brachman and TC Eickof (ed), Proceedings of International Conference on Nonsocomial Infections, 1970, American Hospital Association, Chicago, IL 1971:254-274.

² Pursuant to section 92 of the Constitution Act, 1867, provinces and territories have constitutional authority over "[t]he Establishment, Maintenance, and Management of Hospitals, Asylums, Charities, and Eleemosynary Institutions in and for the Province..."

³ The Reuse of Single-Use Medical Devices: Guidelines for Healthcare Facilities,1996 (available at Canadian Healthcare Association website http://www.cha.ca)

⁴ Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, August 14, 2000.

⁵ Guidance for Industry and FDA Staff; Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices. (Available at http://www.fda.gov.)

⁶ Available at http://www.medical-devices.gov.uk

5 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.

5.1 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 (discussed above), 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. (This is hard to confirm, since the hidden operating costs are often poorly estimated.)
• 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 becoming 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.

5.2 Encourage provinces and territories to develop Provincial/Territorial solutions

Since provincial/territorial governments have jurisdiction over the use of medical devices, Health Canada could play a supportive role in helping the provincial/territorial governments devise their own solutions for this issue. Such solutions could make 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 Canadian 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.

5.3 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.

5.4 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.

5.5 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.

6 Recommended Approach

The recommended approach will be decided following the completion of all the steps listed below. These steps are essential to complete the analysis and recommend the best approach.

6.1 What steps have been taken to determine the appropriate solution?

• An advisory letter outlining concerns and identifying the process Health Canada is to follow to address the risks and benefits of reuse was sent to Canadian healthcare facilities in July, 2004.
• TPD has established a Special Advisory Panel on Reprocessing of Medical Devices to advise on the issues surrounding reuse of SUDs. The first meeting was held February 10, 11, 2005.

6.2 Next Steps

• Consult with Provincial and Territorial Ministries of Health to develop consensus on a risk management strategy.
• Review the recommendations of the Special Advisory Panel on Reprocessing of SUDs.
• Hold a National Conference on reuse in Spring of 2005.
• Determine the feasibility of developing Provincial and Territorial standards for cleaning and sterilizing medical devices, based on currently available consensus standards for reprocessing reusable devices. These standards could then be used as the basis for minimum safety requirements for reused single-use devices.