The problem of infection-spreading medical devices extends beyond dirty duodenoscopes to include a wide range of reusable instruments found in physician offices and other outpatient settings, according to federal health officials.
In response, the Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) today issued a health advisory urging all clinicians and facilities to double-down on properly cleaning, disinfecting, and sterilizing reusable medical devices. The joint advisory cited a recent rash of infection control lapses that have forced healthcare organizations to test patients for bloodborne pathogens such as hepatitis B virus and HIV.
The advisory did not provide specific examples of contaminated reusable medical devices, but a CDC spokesperson provided several to Medscape Medical News:
- A Joint Commission inspection of clinics operated by Kadlec Health System in Washington revealed “inconsistencies and potential inadequacies” in how reusable devices were disinfected and sterilized, Kadlec announced last month. The finding prompted clinics to suspend some procedures involving such devices.
- The Bellevue Clinic and Surgery Center of Seattle Children’s Hospital notified some 10,000 patients this summer that they could be at risk for infection because of improperly cleaned surgical instruments going back to 2010.
- A community health center in Tucson, Arizona, earlier this year contacted dental patients about testing them for possible infection after discovering that dental equipment had not been sterilized.
- Last year, Pennsylvania authorities found that physicians at a surgery center failed to perform high-level disinfection of sigmoidoscope biopsy ports and to sterilize various forceps.
For the past several years, FDA and CDC concern about reusable devices has centered on duodenoscopes used in endoscopic retrograde cholangiopancreatography. Improper reprocessing of these instruments has been linked to outbreaks of multidrug resistant infections, some lethal, in hospitals across the country.
Today’s advisory is much broader in scope, said epidemiologist Joseph Perz, DrPH, from the CDC’s Division of Healthcare Quality Promotion.
Improper cleaning of reusable devices “is not just associated with the hospital environment,” Dr Perz told Medscape Medical News. “Autoclaves are ubiquitous. They’re in doctors’ offices and clinics.
“We take it for granted, but people are using autoclaves without giving enough thought to doing every single step correctly.”
Give Device Cleaners Enough Time to Do the Job Right
In its advisory, the CDC and FDA recommended that healthcare facilities appoint an expert to assess their device reprocessing procedures and ensure that personnel are given enough time to follow equipment manufacturers’ instructions to the letter.
“Allowing adequate time is one of the key messages,” said Dr Perz.
A facility’s instrument cleaning czar also should double-check the following:
- Personnel responsible for reprocessing should receive training not only when they are hired, but also every year afterward and whenever new equipment is introduced. And they should be required to demonstrate competency to their trainer.
- Healthcare facilities should monitor and document adherence to procedures for cleaning, disinfecting, sterilizing, and storing reusable devices, and should share the results with staff.
- A facility shopping for a reusable medical device should consult with its reprocessing personnel to ensure that “infection control considerations are included in the purchasing decision.” When it comes to cleaning, Dr Perz noted, “some devices are more challenging than others.”
More guidance on disinfecting and sterilizing equipment is available on the CDC website.