The Food and Drug Administration (FDA) sent warning letters to the three makers of a specialized gastrointestinal scope that has been linked to outbreaks of superbug infections at U.S. hospitals.
In the spring, the FDA conducted inspections of the manufacturing plants for Olympus Medical Systems Corp., Fujifilm Corp. and Pentax Medical and said the companies either did not adequately report infections or failed to provide sufficient evidence that cleaning procedures for the scopes work, the Wall Street Journal reports. The device, the duodenoscope, is inserted through the patient’s esophagus into the top of the small intestine and is used in diagnostic and treatment procedures for cancer and other conditions. Duodenoscopes are used in about 700,000 procedures annually. The FDA has said the devices, which are reused after cleaning, have led to outbreaks of antibiotic-resistant infections even when the hospital followed the manufacturer’s cleaning instructions, the WSJ reports.
The FDA’s warning letters resulted from inspections the agency conducted at manufacturing plants in Japan and the U.S., as well as from bacterial infection incidents. Olympus said it is reviewing FDA correspondence before commenting. Pentax, a division of Hoya Corp., said it is “working closely with FDA to resolve the noted issues and ensuring that our devices meet the highest standards of safety and quality.” Fujifilm also said it is working closely with the FDA “to ensure that our products and processes meet FDA requirements, and pose no risks to the health and safety of the public,” according to the WSJ.
The duodenoscopes have been associated with infection outbreaks and death in hospitals in Seattle, Los Angeles and the Chicago area, and at hospitals overseas. The FDA has been grappling with the complex structure of the devices, which has made them extremely difficult to sterilize before reuse, the WSJ reports.
In the letter to Olympus, the FDA criticized the company for not notifying the agency in a timely fashion after it found that one of its devices “may have caused or contributed to a death or serious injury.” FDA officials said the company became aware of an outbreak involving 16 patients in May 2012, but Olympus did not inform the FDA about the illnesses until this year. Companies are required to inform the FDA within 30 days of such an event. Hoya Corp. was criticized for a number of violations, including not notifying the agency of events that could have resulted in death or serious injury to patients, according to the WSJ. For Fujifilm, the FDA found a range of violations related to manufacturing and complaint handling and said the agency “reviewed your firm’s responses and concluded that they are not adequate.”
Each company has 15 business days from receipt of the letter to respond as to how they have addressed with violations and how they plan to ensure such violations do not occur again.
On Monday, the FDA reiterated its opinion that, despite the infection risks, the duodenoscopes should remain in use because there is no better alternative for many patients. The scopes provide the best diagnostic and treatment options for certain conditions.