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| System 83 Plus 2 AER--Courtesy of Custom Ultrasonics |
The FDA is cracking down on poor medical device disinfection following the summer's duodenoscope safety scare that left a stream of dead or sick patients in its wake due to infection stemming from infected devices.
The agency just ordered Ivyland, PA's Custom Ultrasonics to recall all 2,800 of its Automated Endoscope Reprocessors from hospitals and clinics, citing violations of the Federal Food, Drug, and Cosmetic Act. In a safety alert, it told healthcare facilities "to use alternative methods to reprocess flexible endoscopes as soon as possible."
As of Nov. 13, Custom Ultrasonics had 7 days to provide a written a recall proposal to the FDA. This is not a run-of-the-mill voluntary recall.
"We are taking action because Custom Ultrasonics failed to meet its legal and regulatory obligations," said Dr. William Maisel, the chief scientist in the FDA's device arm (CDRH), in a FDA press release. "The FDA's recall order stemmed from the company's continued violations of federal law and the consent decree and is necessary to protect the public health."
According to the safety alert, Custom Ultrasonics entered into a consent decree with the FDA in 2007, but the agency's most recent inspection of the Custom Ultrasonics' facility in April 2015 documented continued violations, including "inability to validate that the AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection."
The FDA said it gave Custom Ultrasonics a chance to correct the correct inspection violations and requested additional validation data, but it appears the company did not seize the opportunity.
"As part of the FDA's ongoing investigation into infections associated with reprocessed medical devices and AER devices used for cleaning and disinfection, the FDA has been reviewing the validation test methods and performance data for all AER manufacturers. To date, Custom Ultrasonics has not demonstrated that its AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection," the safety alert says.
Automated Endoscope Reprocessors are free-standing washers used to disinfect flexible endoscopes and related accessories, so that they can be used in the next procedure. The FDA says Custom Ultrasonics' AERs are intended to clean scopes used for the gastrointestinal and pulmonary tracts.
In a statement posted on its website, the company documented FDA's validation request in greater detail and said it "has been performing testing at independent laboratories since July 2015 and we will continue to perform the required testing until it is completed."
The statement continues: "Custom Ultrasonics will continue to submit data to the FDA as we receive it. Custom Ultrasonics continues to comply with any requests that we receive from the FDA and look forward to a positive resolution to this issue."
Although the company said it "has no safety concerns regarding the safety and efficacy of the System 83 Plus Washer/Disinfector," the FDA's action raises concerns about the disinfection practices of all sorts of endoscopes, not just duodenoscopes, which are specialized scopes for imaging and treatment of the pancreatic and biliary ducts.
The well-documented spread of sometimes fatal infections from duodenoscopes was compounded by faulty design that made the devices difficult to clean. The FDA is working with leading manufacturers Olympus and Pentax Medical on a redesign.
The agency was criticized for being slow to act on the issue, given that reports of infections revealed 142 instances of contaminated duodenoscopes since 2010. A well-publicized outbreak of CRE bacterial infections earlier this year that left two patients dead and 7 injured at a hospital in Los Angeles led the agency to take action, though it continues to stress the benefits of the devices, which enable a critical procedure called Endoscopic Retrograde Cholangiopancreatography.
As well as a crackdown on duodenoscope manufacturers, the safety scare has resulted in a comprehensive and at times heavy-handed review of the disinfection procedures for various surgical devices, as demonstrated by enforcement action against Custom Ultrasonics.
- read the FDA press release
- here's the FDA's safety notice
- here's the company's statement
Editor's Note: This article has been updated with information from a press release issued subsequent to the safety alert.