To the Editor: Single-use devices (SUDs) are in common use, and many are reprocessed.1-7 When examined, these devices are frequently not clean and have residual biological material on or within them.2-4,6 This material may contain viruses or other infectious agents. SUDs are usually made from plastics or other heat-sensitive materials resulting in less effective means being used for sterilisation than can be used for more robust materials — chemical disinfectants can be ineffective in the presence of organic material, and have poor penetration compared with heat (eg, an autoclave).

In 1994 we found that, of 168 Australian hospitals reviewed, 68% were reprocessing SUDs used in sterile sites.1 We repeated this survey (using a similar questionnaire) in 2001, in acute-care hospitals with more than 45 beds. The questionnaire was sent to 461 hospitals — 181 private hospitals (117 with fewer than 100 beds, 59 with 100–300 beds, and five with more than 300 beds) and 286 public hospitals (115 with fewer than 100 beds, 116 with 100–300 beds and 55 with more than 300 beds). Responses were received from 189 (see Box 1). Not all respondents answered all questions and many responded anonymously. Reuse of SUDs still occurred in all states and territories, but compared with 1994 the rate had dropped to 15% (28 hospitals). Large hospitals reused more often than smaller hospitals (see Box 1). Reuse was slightly lower in private hospitals than in public hospitals (13% v 16%). Rural hospitals reused SUDs less often than metropolitan hospitals (12% v 16%).

The commonest SUDs reused were diathermy pencils. Given their low cost ($5), the labour costs of reprocessing would exceed the cost of replacement. Diathermy pencils (Box 2) have spring-loaded buttons, which inevitably become contaminated with blood during surgical procedures. Thus, the potential exists to contaminate the surgeon's fingers during subsequent procedures. We believe that reusing such relatively inexpensive items is inappropriate from both financial and infection control perspectives. An Australian National Health and Medical Research Council (NHMRC) report stated that, after reprocessing and packaging in hospitals, almost all SUDs were contaminated with foreign material (including blood), and several pacing electrodes had damaged insulation.6 Other studies have shown that blood persists on cardiac ablation catheters when structural abnormalities (which occurr frequently and early) are present.3 The reuse of these devices has been reviewed by the NHMRC and important changes have been recommended.6

Reuse of SUDs has been common in many countries. In the United States, reprocessing is frequent (eg, 2.5 million devices by one commercial reprocesser).5 In 2000, the US Food and Drug Administration issued a policy that, for practical purposes, should abolish the practice of reprocessing SUDs in hospitals.4 In Australia, the Therapeutic Goods Administration recently announced that reprocessing of SUDs will be regulated.7 This should have a similar effect.

As the methods and response rates of our two surveys were similar, we believe that the reuse rate has decreased. However, proportionately, fewer large public hospitals responded (only 13 of 55, or 24%, compared with 41% overall), even though they have the highest reuse rate (54%). Therefore, we are likely to have underestimated the actual rate of reuse. Also, those who are reusing may be less likely to admit to this practice, and thus less likely to respond.

Reuse of SUDs in sterile sites remains common practice in Australian hospitals (although the rate is lower than it was in 1994). Most SUDs appear to be unsuitable for reuse as they cannot be adequately cleaned and sterilised. We strongly advise against further reuse of these items.

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.