FDA Medical Device Safety Tracking System Reform
The Los Angeles Times reports that in recent years, several devices, including certain reusable medical scopes, metal-on-metal hip replacements, transvaginal meshes, and lead wires in heart defibrillators have been recalled. Most recently, Olympus Corp., the manufacturer of 85 percent of the duodenoscopes used in the United States, announced that it would recall and redesign its duodenoscope. Olympus’ recall was prompted by a Senate Report, issued by Senator Patty Murray (D-Wash), which criticizes device manufacturers, hospitals, and the FDA for contributing to “superbug” outbreaks stemming from such scopes. 250 patients were infected in the United States and Europe, alone.
The LA Times reports that although the first outbreak caused by the duodenoscope occurred in late 2012, it was not until 2015 that the FDA began warning hospitals about the risks of using the device. According to the LA Times and Senator Murray’s report, that delay was caused in large part by the FDA’s “losing a key adverse event report and missing relevant international adverse event reports.” Senator Murray, and others, point to this situation as highlighting the serious shortcomings in the antiquated national database used to monitor the safety of medical devices, which even the FDA has long admitted is flawed.
The Albuquerque Journal reports that the Senate Report calls for a new medical device tracking system, which would, among other things, require unique device identification numbers (e.g., bar codes) to be included on every instrument. This could allow for real-time tracking of incidents, and is intended to supplement the industry’s injury reports, which are “often cursory and filed months late.” In theory, tracking device IDs, like the VIN number on a car, may allow regulators to identify patients across the country coming into an emergency room or developing infections after a procedure.
Deborah Kotz, an FDA representative, has stated that the FDA is already working on the Senate Report’s recommendations:
The FDA is committed to establishing a national medical device evaluation system that leverages real-world evidence to help us more quickly identify safety signals.
The LA Times notes that, as a first step, the FDA now makes a disclaimer that data extracted from its database to evaluate medical device safety may be “incomplete, inaccurate, untimely, unverified, or biased.” Additionally, FierceMedicalDevices reports that the FDA has just signed off on two out of the five manufacturers making automated endoscope reprocessors that are labeled for use with duodenoscopes as well as a new version of Olympus’ duodenoscope.
Olympus Sued Over “Superbug” Infections
The New York Times recently reported that 179 patients at the UCLA Ronald Reagan Medical Center were exposed to a potentially deadly “superbug” between October of 2014 and January of 2015. As of February 18, the infection of seven patients was confirmed. UCLA issued a press release in which it stated that the infection was a “contributing factor” in the death of two of those patients.
National news, including the NYT, Washington Post, and Chicago Tribune, rapidly mobilized to report on the deadly “superbug” — “Carbapenem-Resistant Enterobacteriaceae” (CRE). The CDC states that “some CRE bacteria have become resistant to most available antibiotics. Infections with these germs are very difficult to treat, and can be deadly—one report cites they can contribute to death in up to 50% of patients who become infected.”
It quickly became apparent that the infections were due to the use of infected (reusable) duodenoscopes manufactured by Olympus for use in endoscopic retrograde cholangiopancreatography. According to the the LA Times and Chicago Tribune, while such scopes are used in about 500,000 patients annually, they are increasingly being linked to an ever-rising death-count (including, for example, an outbreak 6 years ago in Florida that killed 15).
The LA Times reports that the FDA has been aware for more than two years that the design of Olympus’ scope may be so flawed that “it cannot be properly cleaned.” CNN reports, however, that the problem may have been known for much longer. CNN quoted the president of the American Gastroenterological Association, Dr. John Allen, as claiming that “[t]his problem has been known since at least 1987.” In response, the FDA has stated that, for most patients, the benefits of the procedure using the duodenoscope “far outweigh the risks of possible infection.”
The recent CRE outbreak has sparked a lively debate over the liability of the device manufacturers for such allegedly flawed designs. That debate has recently found a new forum as two suits have been filed against Olympus in California State Court.
The first suit, the LA Times reports, was filed by 18-year-old Aaron Young who was exposed to infected scopes in October and January. Reuters reports that Mr. Young alleges negligence and fraud because the cleaning protocols for the complex device were not updated following a recent redesign. Bloomberg reports that the complaint names Olympus and three members of its endoscopy team as defendants.
The LA Times reports that the second suit was filed by the family of now-deceased 48-year-old Antonia Torres Cerda and alleges wrongful death as well as products liability, negligence, and fraud in selling and promoting a “defective scope.” The complaint names Olympus and several members of its Endoscopy sales group as defendants.
Peter Kaufman, of Panish Shea & Boyle, the attorney representing both Young and Cerda’s family, has been quoted as saying that he expects to file four to six more cases in the next week, three of which will be wrongful death suits.
Share