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% cholecystec tomies) at the Moabit Hospital in Berlin, we carried out a cohort study to analyze the failure rate and decontamination of labeled "tracer" instrument s 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 cove ring 1990 to 1996. A comparison of the costs of disposable and reusable ins truments showed that reusable instruments were more cost-effective by a fac tor of greater than or equal to 10 indicating that the price gap reported i n our previous calculation for 1992 and 1994 has closed only slightly. Afte r 100 cycles, we found traces of proteinaceous material in the eluate on ev ery fourth instrument inspected (eight of 32); half of them (four) gave a p ositive reading when tested with a hemoglobin pseudoperoxidase test stick. It must be said, however, that similar residual contamination has been foun d on instruments used in conventional open surgery, with no indication of c linical relevance. This study was designed to examine the clinical suitabil ity of laparoscopic instruments in terms of function and hygiene. Improveme nts in instrument design and cleanability must focus in particular on the r eproducibility of cleaning results, because cleaning is the most important step in processing sterile supplies. As the number of minimally invasive op erations has risen considerably, a mere visual check no longer meets the re quirements prescribed by modern quality assurance. A multicenter study of r esidual proteins found on tracer instruments in all surgical fields is now in progress.