Flexible Gastrointestinal Endoscopes," published in the journal
Gastrointestinal Endoscopy in 2011, offers solid guidance (tinyurl.com/amu-
zlh5). Providers should be able to explain the benefits and risks of
ERCP and the warning symptoms of CRE infections, as well as why
patients undergoing other procedures are not at risk.
"Ethylene oxide seems to be the best short-term option we have, to
ensure complete sterilization," says Dr. Kochman, although it presents
a few difficulties. It sidelines your scopes for a couple of days, which
means you may have to acquire more of them at about $50,000 per
device. Because the method presents an environmental and occupa-
tional hazard, many facilities do not have ethylene oxide on site. Plus,
any gas residue remaining in the scope can harm patient tissue, says
the FDA, which does not recommend routine EtO sterilization.
Olympus, the manufacturer of UCLA's scopes, says that its duodeno-
scope is compatible with EtO (tinyurl.com/njqk94h).
On the other hand, "long-term solutions will require a redesign of
the devices," says Dr. Kochman, as the often-overlooked process of
instrument reprocessing becomes a regulatory hot-button issue.
FDA officials say they intend to seek and review evidence for the
effectiveness of scope manufacturers' recommended cleaning and dis-
infection practices, something the agency admits it has not previously
given sustained scrutiny, and will hold the makers of new devices to
higher standards with regard to reliable reprocessing. In letters to cus-
tomers, the leading manufacturers of duodenoscopes — Olympus
(tinyurl.com/nkagd4x), Pentax (tinyurl.com/ovlr9y5) and Fujifilm
(tinyurl.com/nra8tnu) — pledge cooperation with the FDA and other
stakeholders.
That cooperation is a welcome step, says Mary Logan, JD, CAE,
president of the Association for the Advancement of Medical
Instrumentation, which is expecting to finalize ST-91, its new standard
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