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

Sandy J Berenger,* John K Ferguson†

* Area Infection Control Consultant (and Clinical Nurse Consultant, Hunter Area Pathology Service, University of Newcastle), † Director, Department of Microbiology and Infectious Diseases, John Hunter Hospital, Locked Bag 1, Newcastle, NSW 2310. sberengerAThunter.health.nsw.gov.au

To the Editor: Collignon and colleagues decry the reuse of “single-use” medical devices.1 Unfortunately, the focus on reuse of items labelled as single-use detracts attention from some of the more serious issues with cleaning of reusable instruments.

All hospitals have cleaning failures that occur because some instruments are virtually impossible to clean. Examples include hollow instruments such as bone reamers, biopsy needles and tissue forceps. The actual sterilisation process (as described under Australian Standard [AS] 41872) is not at issue here. Rather, it is the poor design of instruments, and the lack of any standardised assessment process to determine whether an item is capable of being cleaned against that standard. One study found that most “sterilised” artery forceps had residual tissue, visible by light microscopy, representing an unknown, but real, infection risk.3 Most Australian hospitals do not examine surgical instruments under the microscope for grooves or cracks, and instrument sets remain in circulation for many years.

In contrast, the most common “single use” critical items that are reused in many Australian hospitals are electrophysiological stimulation (EPS) and aberrant cardiac pathway ablation catheters; there have been no reports of significant mechanical or patient safety issues from reuse of a wide range of cardiac catheters, including EPS and ablation catheters.4 The sterilisation process itself has been validated for these items.5 At John Hunter Hospital, the process of reuse is controlled by a quality system that is far more stringent than the existing AS 4187 Standard. Devices are used for a set number of times before discard, and each catheter use is tracked to the specific patient and procedure. After cleaning, each catheter is examined under x 10 magnification to detect defects. The catheters are tested electrically at the point of use and patient consent is obtained before the procedure. The John Hunter Hospital program has operated for 6 years with an estimated cumulative cost saving of $6 million (compared with no reuse). Patient outcomes are monitored, and no adverse events have been detected. Clinicians express a high degree of satisfaction with the program.

The same standard of equipment design, assessment and cleaning should be applied to all instruments that contact sterile tissue. Whether or not a company chooses to label its product “single-use” should not determine whether the item should or should not be reused. More often than not, such labelling serves to benefit financial return rather than patient safety. Hughes entreats us to cease reuse practices until there is incontrovertible proof of the safety of reuse.6 This statement should also apply to routine surgical items. In this era of zero risk tolerance, perhaps the consent process should make patients aware that reusable instruments processed under AS 4187 cannot be guaranteed to be free from human tissue contamination.

Collignon PJ, Dreimanis DE, Beckingham WD. Reuse of single-use medical devices: how often does this still occur in Australia? [letter]. Med J Aust 2003; 179: 115-116. <eMJA full text> <PubMed>
Standards Australia. AS/NZS 4187: 2003. Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities. Sydney: Standards Australia, 2003.
Laurenson IF, Whyte AS, Fox C, Babb JR. Contaminated surgical instruments and variant Creutzfeldt-Jakob disease. Lancet 1999; 354: 1823. <PubMed>
Ayzman I, Dibs SR, Goldberger J, et al. In vitro performance characteristics of reused ablation catheters. J Interv Card Electrophysiol 2002; 7: 53-59. [Many other studies have been referenced; contact authors for details.] <PubMed>
Druce JD, Russell JS, Birch CJ, et al. A decontamination and sterilization protocol employed during reuse of cardiac electrophysiology catheters inactivates human immunodeficiency virus. Infect Control Hosp Epidemiol 2003; 24: 184-190. <PubMed>
Hughes CF. Reuse of single-use medical devices in sterile sites: how often does this still occur in Australia? [letter]. Med J Aust 2003; 179: 116. <eMJA full text>

Clifford F Hughes

Head, Department of Cardiothoracic Surgery, Royal Prince Alfred Medical Centre, Suite 304, 100 Carillon Avenue, Newtown, NSW 2042 (and former Chairman, Therapeutic Device Evaluation Committee). clifford.hughesATemail.cs.nsw.gov.au

In reply: Berenger and Ferguson correctly raise the issue of sterilisation procedures for devices used in surgery. They have also described specific measures taken at their hospital for a specific device and, more importantly, have developed a system to ensure the highest quality of sterilisation process in a medical device.

Of course, the use of any surgical device should be subject to the strictest sterilisation procedures. Most reuseable surgical instruments do have documented sterilisation protocols which include verification of the process used.

All surgical instruments, whether designed for reuse or not, whether used for the first time or the tenth time, should be subject to the scrutiny, surveillance and meticulous records demonstrated by the John Hunter Hospital system. This hospital is to be congratulated on its attention to detail. Were similar stringent protocols in place across all disciplines and in all hospitals, the debate would cease to rage. More importantly, many devices could be safely and efficiently reused. Others may be considered too difficult to resterilise. Nevertheless, asepsis would, once again, be positioned where it belongs, as one of the key principles of surgery.