FDA must overhaul reporting system to avoid repeat of CPAP failure
In the Post-Gazette and ProPublica series “With Every Breath,” reporters uncovered how Philips Respironics was able to avoid a recall of its popular CPAP devices for years, despite complaints that the noise-dampening foam was breaking down inside the devices and posing incalculable risks to patients.
Beyond the manufacturer’s failure to alert the public to the dangers for more than a decade, the reporting also revealed that the Food and Drug Administration’s public database that’s supposed to track device failures is outmoded, egregiously mismanaged, and rarely leads to enforcement — even after the agency shelled out millions to overhaul the system.
The FDA uses a database known as the Manufacturer and User Facility Device Experience, or MAUDE, to detect malfunctions, review them, and hold device makers accountable. The publicly-available database is the backbone of the FDA’s regulatory function, and companies are required to file a MAUDE report within 30 days of receiving complaints of deaths, injuries or break downs that can cause harm. However, the FDA has regularly allowed device makers to submit complaints late (sometimes by years), and then obscure the actual dates they were submitted.
This allowed Philips to alter the timeline for complaints they received regarding CPAP machines: One 2012 complaint describing how the CPAP’s sound abatement foam had degraded was later updated in the public database to say that it was created an entire decade later. Reporters had to rely on a private database for accurate information on how long Philips had been sitting on complaints before handing them to the FDA.
But the database issue extends beyond Philips and its defective CPAP machines. Last year, more than 232,000 complaints, or 1 in 8, were submitted past the 30-day deadline by other medical device makers. An accurate timeline of events is essential to investigating device malfunctions, and allowing companies to tamper with dates undercuts the FDA’s regulatory effectiveness.
This is made even worse by the fact the FDA too often fails to use its regulatory power to demand compliance. The number of warning letters, which the FDA considers the “principal means of achieving prompt voluntary compliance,” dropped to less than 30 last year. In 2012, it sent out 200.
These numbers are especially shocking because complaint reports are skyrocketing. The FDA received 3 million complaints — including reports of injuries and deaths — last year alone. That’s 30 times higher than in 2005. Meanwhile, regulatory action, including warnings, seizures and injunctions, are on a steep decline.
The FDA was supposed to update its reporting tracking system following damning government watchdog reports in 2009 and 2011. The agency gave $3 million to a nonprofit in 2016 to create a central database of medical records and insurance claims and other critical data to augment the MAUDE system. The goal was to track and address device malfunctions in real time.
Eight years and millions of dollars later, the program still hasn’t materialized. Congress must demand actual results from those in charge, including Jeff Shuren, who has led the FDA unit regulating medical devices since 2009. For too long, the FDA has been able to run this vital database like a suggestion box, and not like a regulatory body with a mandate to preserve lives.