Reuse of single-use medical devices in sterile sites: how often does this still occur in Australia?

Comment: The letter by Collignon, Dreimanis and Beckingham about reuse of single-use medical devices (SUDs) in Australian hospitals again brings in to stark contrast the issue of safety and quality of medical devices and the pressing need to provide affordable services to the Australian public. Seven years ago, Collignon and colleagues showed an unacceptably high reuse of SUDs in Australia, especially in public healthcare institutions.1 Since then, the National Health and Medical Research Council (NHMRC) has produced an expert panel report on these devices2 and the Therapeutic Goods Administration has promulgated detailed device regulations.3 There has been continued debate in both the scientific literature and lay press, and the United States Food and Drug Administration has had extensive comments published on this matter.4,5

Given the intensity of this debate, it is surprising that so few hospitals completed the questionnaire. It is also surprising that, despite the overall reduction in the reuse of SUDs, there has been no apparent reduction in their use in large public institutions, 50% of which continue the practice. Collignon and colleagues have not investigated the quality control mechanisms in place in these hospitals. That could well be a subject for further research.

Not so obvious to the casual user is the effect of resterilisation on the materials of the device. The authors allude to the potential for degradation during sterilisation. There is inevitable pressure to use less effective (chemical) means for re-sterilisation.

On the other hand, the waste of an enormous resource that, if safe, could be readily reused must be recognised. The costs of devices are easy to quantify. The costs of resterilisation, not to mention quality control, less so. Collignon et al suggest one example of false economy in the reuse of a low budget but commonly used item — diathermy pencils.

They make a strong case for mandated reporting of resterilisation protocols for all single-use items. Informed consent must be a prerequisite. Tracking systems could well provide beneficial information on the safety and efficacy of procedures for particular devices. Furthermore, clinical audit would provide an early warning mechanism should resterilisation prove inadequate. These are among the main recommendations of the Report of the NHMRC Panel.2

Extensive regulations and controls have been applied to the use of biological products such as dura mater, heterograft and cardiac valves, among others. There is, however, reluctance to apply similar stringent controls to devices which may be contaminated by more pervasive but less obvious biological hazards.

There are only three options:

• cease this practice wherever a viable alternative is available until there is incontrovertible proof of the safety of reuse;

• mandate detailed protocols which include audit and surveillance mechanisms coupled with appropriate informed consent whenever SUDs are reused;2 and

• develop a research and evidence base for improvements in design and materi-al technology so that the "cost efficiencies" of single-use devices could be translated to "nondisposable items".

All three must be adopted.