A laboratory and clinical evaluation of single‐use instruments for tonsil and adenoid surgery

Abstract

To compare the quality and consistency of single-use adenotonsillectomy instruments available in the UK with reusable instruments and examine their performance in a clinical setting. A laboratory assessment of each reusable instrument created a detailed specification for the respective single-use equivalent. A surveillance system monitored the performance of a selected set of specified single-use instruments. Single-use instruments were withdrawn shortly after their introduction in 2001. Persisting concerns from the Spongiform Encephalopathy Advisory Committee led to an investigation into the feasibility of continuing to use such instruments. The numbers of instruments from each set judged as unacceptable or as good as the original. The number and cause of instrument failure during clinical surveillance. Between 40% and 93% of the instruments on each set were as good as the original and between 0% and 40% of the instruments were unacceptable from six sets of steel and one set of polymer instruments. 4151 procedures were monitored between 1 February 2003 and 31 March 2004 using a total of 41 376 instruments. Problems were reported with 335 (0.8%) instruments, 46% attributable to instrument design, 14% to poor design control and 13% to instruments escaping quality control systems. Following correction of the faults, between 1 January 2004 and 31 March 2004 the problem rate fell to 0.4%. High quality single-use instruments for tonsil and adenoid surgery are available in the UK. Some companies offered inferior instruments not fit for their purpose. The procurement, introduction and subsequent clinical approval of single-use instruments requires a radically different approach to that currently applied to the purchase of reusable surgical equipment. Careful monitoring of their introduction is essential.