The clinical suitability of laparoscopic instrumentation. A prospective clinical study of function and hygiene.
On the basis of experience gained from 6,000 laparoscopies (73% cholecystectomies) at the Moabit Hospital in Berlin, we carried out a cohort study to analyze the failure rate and decontamination of labeled "tracer" instruments processed in three test trays that were each subjected to 100 cycles. The majority of repairs focused on the functional parts of separable scissors and damaged or lost components. At 4%, the repair index after laparascopic use was less than that of a previously documented investigation period covering 1990 to 1996. A comparison of the costs of disposable and reusable instruments showed that reusable instruments were more cost-effective by a factor of > or =10, indicating that the price gap reported in our previous calculation for 1992 and 1994 has closed only slightly. After 100 cycles, we found traces of proteinaceous material in the eluate on every fourth instrument inspected (eight of 32); half of them (four) gave a positive reading when tested with a hemoglobin pseudoperoxidase test stick. It must be said, however, that similar residual contamination has been found on instruments used in conventional open surgery, with no indication of clinical relevance. This study was designed to examine the clinical suitability of laparoscopic instruments in terms of function and hygiene. Improvements in instrument design and cleanability must focus in particular on the reproducibility of cleaning results, because cleaning is the most important step in processing sterile supplies. As the number of minimally invasive operations has risen considerably, a mere visual check no longer meets the requirements prescribed by modern quality assurance. A multicenter study of residual proteins found on tracer instruments in all surgical fields is now in progress.