WASHINGTON -- Three duodenoscope manufacturers received FDA after the agency discovered multiple violations during inspections of facilities in the U.S. and abroad.
One company that received a warning letter, , withheld information for 3 years about infections that may have been associated with their scopes used in 16 patients in 2012, according to the.
Two other companies, and , were cited for problems with the testing, design, and quality control of their scopes.
Duodenoscopes are used in endoscopic retrograde cholangiopancreatography procedures (ERCP) to diagnose illnesses related to the biliary or pancreatic ducts.
In May, an FDA advisory committee concluded after 2 days of discussion that the duodenoscopes that are currently commercially available do not offer "reasonable assurance of safety and efficacy." The agency called for the development of new protocols to ensure that scope reprocessing made them sterile.
However the agency has also repeatedly told doctors not to stop using duodenoscopes, even the Olympus brand.
Most patients will never undergo an ERCP, said , vice president of the American Society for Gastrointestinal Endoscopy (ASGE) who is in private practice at Houston Methodist Hospital in Houston.
"But for those patients who do need it, it is a critical and often life-saving procedure," she told ľֱ in an email.
In the last few years, duodenoscopes have been linked to "superbug" infections at a handful of hospitals including the at the University of California Los Angeles and in Seattle. Over a dozen patients have died from superbug exposure at the two facilities combined.
From mid-March through late April 2015, the FDA inspected four Olympus sites in Japan, Pennsylvania, and California. Last week the agency wrote a regarding 16 patient infections, which the firm appeared to have known about since May 16, 2012 that may have been tied to use of its device, the duodenovideoscope Olympus TJF Type Q-180V.
According to the letter, Olympus waited until 2015 to report the incidents and even then filed a single report for all 16 patients instead of individually documenting each one.
Olympus failed to meet the FDA's 30-day requirement that a manufacturer with information from any source "that reasonably suggests" a device "may have caused or contributed to a death or serious injury," notify the agency, according to the warning letter.
The FDA said the company did not implement a procedure to "establish internal systems that provide for timely transmission of complete medical device reports." The agency noted that such a procedure must detail:
- A method for transmitting all information "reasonably known" to the company for individual events
- A process that includes instructions for obtaining and filing a FDA .
The infections reported to Olympus involved Pseudomonas aeruginosa, a common strain typically found in people with weakened immune systems, such as hospital patients. Serious Pseudomonas infections can lead to severe illness and death, according to the .
The FDA stated that it received an "inadequate" response from Olympus in May to an earlier notice, citing that the firm failed to "adequately develop, maintain and implement written [medical device reporting] procedures."
Olympus has 15 business days to respond to the FDA's most recent letter by providing specific actions the company has undertaken to correct the reported issues "including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again."
, a trustee of the American College of Gastroenterology and director of endoscopy and gastroenterology at Mount Sinai Hospital in New York City, noted that beyond failing to meet reporting requirements, the letters also warned of "deficiencies in the validation of recommended cleaning and reprocessing protocols" and cited "irregularities" related to endoscopy repair.
In a the agency wrote that "the methods used in, or the facilities or controls used for, [duodenoscope] manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820."
Greenwald said he expects that the endoscope manufacturers will pay more attention to FDA regulations and reporting requirements going forward.
Greenwald stressed that any infection related to endoscopy should be reported immediately, while also noting that when manufacturer and multisociety guidelines for reprocessing are followed the products are "quite safe."
"I think that endoscopy does a tremendous amount of good," he said, and high quality processing is important to allow for those benefits to continue.
Woods said patient safety is paramount when it comes to endoscopies and urged clinicians to work with their institutions to "ensure vigilance around cleaning and reprocessing of scopes."
For its part, the FDA "can continue to draw on the advice of medical experts as well as work with companies regarding the best design and instructions for use and care of these devices," she said.
In turn, by collecting meaningful data, government agencies at all levels can continue to help the medical community stay informed about duodenoscope safety, she added.
president of ASGE, said in an email to ľֱ that the society keeps its members informed about duodenoscope safety, including the FDA's recent notice outlining potential additional reprocessing steps, through frequent email updates and a
"We encourage everyone involved in reporting and collecting information about healthcare-associated infections to work together to facilitate connecting the data. This will help guide best practices going forward," he said.