Federal regulators Thursday issued final rules regarding the cleaning and disinfecting of reusable medical devices such as the endoscopes that have been responsible for outbreaks of drug-resistant bacteria at a number of hospitals.
Product makers will be required, under the new guidance, to validate that the disinfecting instructions for their medical devices are effective before they can get Food and Drug Administration approval.
Also recommended is that healthcare providers routinely test medical scopes for bacterial growth after they have been disinfected, something a number of hospitals have begun to do in light of the recent contamination involving the devices.
“Despite the recent concerns about multidrug-resistant bacteria infections associated with duodenoscopes, patients and healthcare providers should know that the risk of acquiring an infection from a reprocessed medical device is low” said Dr. William Maisel, chief scientist at the FDA's Center for Devices and Radiological Health, in a statement.
“This guidance is an important step toward further enhancing the safety margin by outlining for manufacturers the steps they should undertake to make their reprocessing instructions effective and clear to the healthcare community that uses them,” he said.
In its recommendations, the FDA stated manufacturers will be expected to submit data of testing that validates that their instructions for the reprocessing of their devices are effective toward reducing the risk of bacterial contamination.
The guidance also recommends that manufacturers consider reprocessing challenges early in device design, an issue in the case of duodenoscopes. The agency has said design issues were a cause for the difficulty involved in properly disinfecting the devices.
The FDA initially issued a draft of its recommendations in 2011. The final guidance follows criticism of the agency after it acknowledged that manufacturer instructions for the reprocessing of duodenoscopes, even when they are accurately followed, may not be sufficient to effectively limit the risk of contamination.
The scopes, used in more than 500,000 endoscopic procedures each year for such purposes as draining fluids from pancreatic and bile ducts, have been connected with recent outbreaks of carbapenem-resistant Enterobacteriaceae, or CRE, that occurred at Ronald Reagan UCLA Medical Center and Cedars-Sinai Medical Center, Los Angeles, between August 2014 and January 2015.
About 250 people were potentially exposed to CRE as a result of contaminated scopes at UCLA and Cedars-Sinai, resulting in two deaths and 11 other infections.
The change in the agency's review protocols of reprocessing instructions comes after FDA Chief Scientist Dr. Stephen Ostroff acknowledged in an interview with the New York Times Feb. 25 that the agency never reviewed the efficacy of manufacturers' instructions for cleaning and reprocessing duodenoscopes but was now requesting evidence from manufacturers that shows their recommended cleaning procedures actually work.
The FDA Thursday also announced one of its advisory committees will hold a public meeting May 14 and 15 to discuss the recent outbreak connected to contaminated scopes in endoscopic retrograde cholangiopancreatography procedures.
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