The Food and Drug Administration sent warning letters last week to three medical device manufacturers whose endoscopes have been blamed for spreading deadly bacteria. This is the agency's strongest regulatory action yet since outbreaks in Los Angeles, Seattle, and elsewhere made headlines earlier this year.
The devices, made by Olympus, Pentax, and Fujifilm, are used in hundreds of thousands of procedures each year. The FDA says the companies failed to report problems with the scopes as required by law and in some cases failed to ensure that the devices could be adequately cleaned. Olympus and Pentax were specifically cited for failing to relay to FDA reports that their devices "may have caused or contributed to a death or serious injury" within 30 days of learning about the event. Pentax and Fujifilm were cited for failing to make sure their instructions for cleaning the scopes were valid.
Olympus spokesman Mark Miller said in an e-mail that the company is reviewing the warning letter "so that we can provide the required response in a timely manner." Pentax spokeswoman Shannon Coughlin said in an e-mail that the company "is committed to working closely with FDA to resolve the noted issues." Fujifilm spokeswoman Diane Rainey said the company is also working with the agency to make sure products comply and "pose no risks to the health and safety of the public."
In separate letters, the agency told Fujifilm that its latest model of endoscope lacks the necessary permission from the FDA to be marketed in the U.S. The agency is evaluating whether Pentax may be violating the same rule. In the case of Pentax, the FDA asked as far back as July 2013 for records that one of its scopes had the needed clearance, according to the agency’s letter. Fujifilm submitted a new application on August 10, and the FDA has asked Pentax for more information to determine whether a new submission is needed.
In the United States, most medical devices are cleared by for sale if they are considered “substantially equivalent” to previously approved products. The FDA leaves it up to manufacturers to determine when changes to an older model are significant enough to require a new application for clearance, known as a 510(k). The Olympus model scope at the center of several outbreaks also lacks a 510(k) clearance, an issue that only came to light after the outbreaks were reported early this year.
The FDA has already offered hospitals advice on ways to improve cleaning the scopes, which have been linked to at least 13 deaths and dozens of infections at U.S. hospitals. An expert panel convened by the agency in May determined that duodenoscopes, the devices linked to outbreaks at UCLA Medical Center and Virginia Mason Medical Center, aren't reliably safe. But the agency has declined to take them off the market, citing the needs of patients for sometimes lifesaving procedures.
The warning letters, dated Aug. 12 and made public Monday, followed inspections in March and April of the manufacturers' facilities in Japan and the U.S. They suggest companies knew about the problems years before they became public this year. For example, Olympus learned that 16 patients contracted the bacterial infection Pseudomonas aeruginosa after endoscopies in May 2012. Companies are supposed to report such events to the FDA within 30 days. Olympus didn't file a report until 2015, the agency says. Pentax didn't report cases of the deadly superbug known as carbapenem resistant-enterobacteriaceae, or CRE—the FDA learned of the infections from a company that imports Pentax devices instead, according to the warning letter.
The FDA asked the companies to respond with plans to correct the violations within 15 business days.
(Correction: Fixes the spelling of Virginia Mason Medical Center. This post has also been updated with new information.)