The duodenoscope is the most recent example of a risky medical device that was used in tens of thousands of patients before regulators pinpointed a deadly problem in its design. (Robert Gauthier / Los Angeles Times)
An outbreak at a Pennsylvania hospital in late 2012 should have been an early warning that a reusable medical scope was spreading deadly infections and nearly impossible to disinfect.
But staff at the federal Food and Drug Administration lost the report, one of multiple missteps that allowed doctors and hospitals to continue using the scope for three more years even as dozens of patients were sickened.
The missing paperwork, revealed in a recent Senate inquiry, underscores 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.
But the fix called for by the Senate investigators — the speedy implementation of a new system already a decade in the making — has hit a roadblock put up by two powerful opponents who say an essential part of the safety upgrade will cost too much.
“We need to build a better system to find these problems more quickly,” said Dr. Josh Rising, director of healthcare programs at the Pew Charitable Trusts.
Further postponement, he said, “could compromise the safety of millions of Americans.”
The device known as a duodenoscope is only the most recent example of a risky medical device that was used in tens of thousands of patients before regulators finally pinpointed a deadly problem in its design. Regulators did not warn hospitals about its risks until after The Times reported an outbreak at UCLA that killed three patients.
Two days after the Senate report was released last month, Olympus Corp., the scope’s leading maker, said it would recall and redesign the device.
Other devices recalled in recent years include metal-on-metal hip replacements, vaginal mesh used in surgeries and lead wires in heart defibrillators.
To more quickly find the problems, Congress passed a law in 2007 requiring that each device get a unique number, like a bar code, that would correspond to the specific brand and model. The number would be recorded in patient records and medical claims.
Experts say the new system will enable regulators or doctors to quickly check large insurance databases to discover how frequently a device is malfunctioning.
But the law included no deadlines. And it took the FDA until 2012 to finalize rules requiring manufacturers to stamp the “unique device identifiers” on their products.
Manufacturers began putting numbers on some devices — those considered most critical — in 2014. Duodenoscope manufacturers must begin printing the numbers on their products in September.
But with the system moving closer to completion, a trade group of the nation’s hospitals and the Obama administration’s Medicare directors raised objections to a key part of the plan: adding a line to the standard insurance claim form so that the device numbers can be recorded.
Read More – Source: Why it took years for the FDA to warn about infections tied to medical scopes – LA Times