Reuse of Single-Use Medical Devices

03-17-2009 | Modes d'intervention en santé

The various types of single-use medical devices (SUDs) that have emerged on the market over the last few decades help prevent disease transmission to other patients and device malfunction through wear and tear. However, for economic reasons, some health-care institutions have decided to reuse these devices, some of which are quite expensive.

In the early 1990s, Québec’s Ministère de la Santé et des Services sociaux (MSSS) asked the Conseil d’évaluation des technologies de la santé (CETS), the predecessor of AETMIS, to study the reuse of SUDs. Following the release of the CETS reports, the MSSS issued a position statement in 1994 declaring that reuse may “be justifiable and even desirable in some circumstances”. The MSSS subsequently required hospitals wishing to reuse SUDs to develop a policy and procedures governing reuse and to have them approved by their board of directors.

Since then, several organizations and working groups both in Québec and elsewhere in Canada have revisited the issue of reusing SUDs and its potential risks. Two recommendations in particular were issued: to stop reusing critical and semicritical devices or to use a licensed third-party reprocessor. In view of these recommendations, the regulatory gap on this issue and the new legislation on the safe delivery of health-care services in Québec, the MSSS asked AETMIS to re-examine the different issues surrounding the reuse of SUDs. A review of the ministerial position on this issue is in fact addressed in the MSSS’s 2006 –2009 action plan on preventing and controlling nosocomial infections (Plan d'action sur le prévention et le contrôle des infections nosocomiales 2006–2009).

Recommendations

  • Given the conclusions drawn in this assessmentand the general position adopted by Canadian organizations regarding the reuse of critical or semi-critical single-use medical devices (SUDs), and
  • given the considerable requirements associated with the two possible avenues open to institutions opting to reprocess and reuse certain critical or semi-critical SUDs,

AETMIS recommands the following:

  • Health-care institutions should stop their in-house reprocessing of critical or semi-critical SUDs until the requirements for making this practice comply with the highest recognized standards of quality can be met in the Québec context.
  • Institutions wishing to reuse critical or semi-critical SUDs should subcontract reprocessing to a third-party reprocessor certified by a regulatory authority and qualified to supply a final product that meets the standards and requirements applicable to all manufacturers of SUDs, and should ensure that they meet the requirements related to this option.
  • The Ministère de la Santé et des Services sociaux

    • should closely keep track of ongoing federal, provincial and territorial initiatives regarding the regulatory and legislative framework for the reprocessing and reuse of SUDs; and

    • should amend its policy on the reuse of SUDs to make it more precise and better adapted to the contexte prevaling today, and shoulde ensure its implementation.

REF120

Subscribe to our newsletter now

Subscription