EVALUATION OF REUSABLE AUTOCLAVABLE SHAVERS AND DRILL BITS FOR ARTHROSCOPIC SURGERY

Abstract

Purpose: Disposable medical devices have several advantages and are widely used. But since the financial burden of disposable devices is however significant for the hospital budget, it would be interesting to reassess multiple use devices in terms of efficacy and safety. The purpose of this study was to determine the safety aspects involved and to assess wear observed in new versions of autoclavable shavers and drill bits used in arthroscopic surgery.

Material and methods: After standard preparation and ten sterilisation cycles, fifteen instruments (shavers and drill bits) were used 10 times each during arthroscopic procedures performed on non-embalmed cadavers. The instruments were used on tissues, cartilage or tendons (shavers) or cancellous bone (drill bits). Duration of use was at least 10 min for each instrument. The instruments underwent standard preparation (decontamination-cleaning-immersion in 1N caustic solution) followed by sterilisation at 134°C for 20 minutes as defined by the regulatory decree (n° 138, 14 March 2001). A tracability sheet was completed at each order for sterilisation. The first phase consisted in an evaluation of the instrument’s resistance to sterilisation treatments, in particular the non-alteration of the cutting surface examined under optical magnification. The second phase was to determine the feasibility and performance level of the cleaning step based on assay of protein residue with UV spectrophotometry as described by Bradford.

Results: One hundred fifty complete cycles were performed. The results of the first phase demonstrated satisfactory instrument resistance to 10 uses with traces of erosion visible on 20% of the instruments after the 5th use. Two instruments were replaced during the study due to mechanical wear. The second phase revealed positive results in 2% of the cases (residual proteins > 8 μg/ml), the positivity threshold defined by the Pr EN ISO 15883-1 normalisation project concerning general requirements for desinfecting cleaners. Analysis of these results demonstrated that 12% of the instruments cleaned with ultrasounds carried traces of protein residues. There was no trace of proteins on instruments cleaned with a washing machine operating on the “endoscope” cycle, i.e. 143 successive cycles.

Discussion: Despite the difficulty in cleaning (double sheath), shavers and drill bits used in arthroscopic surgery can be reused without risk since the traces of residual protein are negligible when the instruments are cleaned with a endoscope-quality desinfecting washing machine. In addition, despite intensive use, wear is acceptable for ten cycles. Extensive use of disposable instruments should be carefully debated due to the financial consequences.