Reuse of single-use medical devices: who makes the decision?

The controversy can be resolved by identifying the real risks of cross-infection

This article was published in the 6 May issue of The Medical Journal of Australia. Readers may print a single copy for personal use. No further reproduction or distribution of the articles in whole or in part should proceed without the permission of the publisher. For copyright permission, contact the Australasian Medical Publishing Company

See also articles by Collignon and Brook

- - ©MJA1996

The transmission of infectious agents between patients during medical procedures is a matter of substantial public concern¹ after two widely reported incidents of transmission of HIV infection (in a doctor's office and in a dental practice), and recent episodes of hepatitis B and C transmission.^2,3 The usual explanation for these episodes is a breakdown of standard infection control procedures.

These reports have increased pressure on Australian hospitals and doctors to cease the practice of reusing medical devices labelled by the manufacturers as "single use only". The Commonwealth and most State health departments also recommend that this practice should cease. The National Health and Medical Research Council (NHMRC) established an expert panel on "Re-use of medical devices labelled as single use" and recently has circulated a draft report.⁴ This recommends either a blanket ban on the reuse of such devices or the establishment by the Therapeutic Goods Administration of "a system for the formal licensing of entities wishing to process devices labelled as single use". I believe this could effectively prevent any such reuse. Needless to say the Medical Industries Association of Australia strongly opposes the reuse of these items.

With such formidable opposition it should come as a surprise to many that reuse of single-use medical devices is widespread in Australian hospitals. Reuse was occurring in all 11 hospitals surveyed by the NHMRC panel, and Collignon et al. in this issue of the Journal (page 533) report that 64 of 168 hospitals responding to their survey were currently reusing single-use items; another 33 hospitals had been doing so 12 months previously. With only a 40% response to their survey, the authors believe that they have probably underestimated the extent of reuse.

The results of these surveys indicate a rebellion against expert advice. The rebellion extends to the pages of this Journal, with a recent editorial advocating reuse of cryoprobe tips after mechanical cleaning and glutaraldehyde soaking.⁵ Australian hospitals are reusing a wide range of equipment, including cardiac pacing electrodes, diathermy pencils and colonoscopy snares. Reuse of cardiac catheters has been reported in Australia⁶ and reuse of angioplasty balloons is common in other countries and has been reported to be safe.⁷

The explanation for this resistance by doctors and hospitals against expert opinion and direction from higher authorities is based on two important factors: firstly, there are apparently no reported cases in the medical literature of transmission of infection between patients as a result of the reuse of single-use medical devices; and, secondly, in the absence of any demonstrated adverse effects on patients, hospitals and doctors are not prepared to divert funds from other areas of medical care.

Collignon et al. estimated that somewhere between zero and 40 infections per year may be transmitted as a result of procedures involving reuse of single-use medical devices in Australia, although it is not clear that cessation of reuse would eliminate these potential infections. They also estimated that it would cost an extra $100 million per year (the total annual research grant allocation by the NHMRC is $142 million!) if reuse of medical devices were to cease, and that preventing one new infection (and many of these will be benign) would cost at least $2.5 million, and probably much more.

When there are strongly conflicting views on the best way to provide medical care, a common underlying feature is absence of data. The appropriate professional response is to obtain such data. Concerns about possible transmission of infectious agents as a result of medical procedures would be addressed by establishing an Australian study; for example, this could involve serological testing of large numbers of patients before and after a range of invasive procedures to look for evidence of seroconversion for hepatitis agents. In this way the real risk of transmission could be identified.

In the meantime, what should be done about reuse? Some (especially legal advisers) would advocate a perfect standard, requiring absolute proof of safety for every aspect of medical care. Only a minority of the processes involved in medical care have passed such a test. A more sensible approach might be for all doctors involved in reuse of single-use items to re-examine their own activities to ensure that they comply as far as practicable with current guidelines. If health care professionals believe in "evidence-based medicine" they should add their voices to the call for a proper study in this area before any firm recommendations are made by bodies such as the NHMRC.

Keith Woollard
Cardiologist
St John of God Medical Clinic
Murdoch, WA

1. Robinson M. The patient's right to know. Sydney Morning Herald 22 Feb 1996: 15.
2. Tedder RS, Zukerman MA, Goldstone AH, et al. Hepatitis B transmission from contaminated cryopreservation tank. Lancet 1995; 346: 137-140.
3. Chant K, Kociuba K, Munro R, et al. Investigation of possible patient-to-patient transmission of hepatitis C in a hospital. NSW Public Health Bull 1994; 5: 47-51.
4. National Health and Medical Research Council. Report of the NHMRC Expert Panel on Re-use of Medical Devices Labelled as Single Use. Draft report. Canberra: NHMRC, 26 Oct 1995.
5. Tabrizi SN, Garland SM. Is cryotherapy treating or infecting? Med J Aust 1996; 164: 263-264.
6. Dedman G, Hendricks R, Lane G, et al. Comparative costs of cardiac catheters -- a quality controlled assessment. Aust N Z J Med 1994; 24: 643.
7. Burton J, Tymchak W, Dzavik V, et al. Cost of percutaneous revascularisation. Circulation 1995; 92(Suppl 1): 661. o