According to some experts, there is a risk that many types of endoscopes remain contaminated even after conventional disinfection procedures. Traces of potentially infectious material are apparently hard to remove from many types of scopes, which can present a serious safety risk to patients. Researchers have even found traces of bacteria, particles, microbes or other contaminants on scopes that were cleaned according to guidelines.
Yet even more disturbing is a recent article’s suggestion that medical doctors may be aware of that risk, yet use the scopes anyway. The author claims that infection experts have issued warnings in papers and/or speeches for years about the inefficacy of conventional cleaning methods used on endoscopes.
Part of the problem is that better cleaning methods may not have been developed. Scopes generally can’t be sterilized with extreme heat, as would be a surgeon’s knife, due to their more fragile design. Instead, the manufacturer’s cleaning instructions may specify brushing, washing with disinfectants, rinsing and drying. That multi-step process may invite more room for error, as in the case of one outbreak attributed to a disinfectant that was still being used for cleaning after its expiration date.
The U.S. Food and Drug Administration took action several months ago, issuing new approval rules that require a scope manufacturer to produce evidence that disinfection of its product is possible. However, those rules are only prospective, which means that scopes already on the market may continue to infect patients.
As a law firm that focuses on medical malpractice, we know that simply complying with FDA guidelines may not necessarily satisfy a doctor’s duty of care. If a doctor is aware of a potential safety risk, we believe that he or she has a duty to inform patients or applicable authorities of that issue.