A system approach to patient-safe rigid and flexible endoscopes: a microbiologist's point of view

Many scientists have written at length on the myth of surgical sterility, and tried to shift focus from definitions of sterility and disinfection driven by artificial microbiological models to the really meaningful consideration of the patient-safe condition of medical equipment and/or products. J. C. Kelsey said it very well: "Although sterility is in theory an absolute term, in practice it may only be regarded as at best relative and at worst misleading. It is a philosophical concept that can never be unequivocally demonstrated in a real world. Experience has shown that it is virtually impossible, even if it is honest, to change the definition of a term that has been in use for many years; we may need a new term to indicate 'the state of having been sufficiently freed from microorganisms to be deemed safe for some special purpose by some competent body.' The abandonment of the term 'sterility' and the acceptance of some other term would remove confusion and enable the important matter of providing microbiologically safe medical products to be more rationally and realistically considered." The most practical way to produce a patient-safe endoscope is through a careful consideration of the whole processing system as discussed in this article, not by focusing strictly on the differences between high-level disinfectants and sterilants. A sterilant used within a poorly designed processing system could actually result in an unsafe, even microbiologically dangerous, endoscope. On the other hand, high-level disinfectants used within a well-designed and quality-controlled process can and do produce safe, even sterile, endoscopes.(ABSTRACT TRUNCATED AT 250 WORDS)