New evidence indicates that problems with contaminated duodenoscopes were apparent nearly four years ago but the FDA dropped the ball, allowing the scopes to be used for three more years, according to the Los Angeles Times.
An outbreak at a Pennsylvania hospital in late 2012 should have been an early warning that the reusable scopes were spreading deadly infections and were nearly impossible to disinfect, but staff at the FDA lost the report––one of several missteps that kept the contaminated devices in use, reporter Melody Petersen writes.
The missing paperwork, discovered in a recent Senate inquiry, revealed the antiquated national database used to monitor the safety of medical devices. Not only is the FDA’s existing database of device injuries and deaths difficult to use, but it relies on hospitals and manufacturers to report problems they are often reluctant to disclose because of the possibility of litigation, Petersen notes. Moreover, manufacturers are allowed to rewrite injury reports before sending them to the FDA’s database.
The FDA now makes a disclaimer when it uses information from its database to evaluate the safety of a device. Recently it noted on its website that data extracted from the system may be “incomplete, inaccurate, untimely, unverified, or biased,” according to Petersen.
Senate investigators have called for quick implementation of a new system, but opponents say an essential part of the safety upgrade would cost too much.
Other medical devices recalled in recent years include metal-on-metal hip replacements, vaginal mesh used in surgeries, and lead wires in heart defibrillators. To identify potential problems more quickly, Congress passed a law in 2007 requiring that each device be given a code number––a “unique device identifier”––that would correspond to the specific brand and model. The number would be recorded in patients’ records and medical claims, Petersen writes.
Experts say the new system will allow regulators or doctors to quickly check large insurance databases to discover how often a device is malfunctioning. But the law did not include deadlines, and it took the FDA until 2012 to finalize rules requiring manufacturers to stamp “device identifiers” on their products.
Manufacturers began putting numbers on some devices in 2014. Duodenoscope companies must begin printing the numbers on their products in September 2016. But a trade group of the nation’s hospitals and Medicare directors has 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. They say reprogramming computers to process the device numbers would be an expensive task, Petersen reports.
Last year, in a letter to two senators, Marilyn Tavenner, then the administrator of the Centers for Medicare and Medicaid Services, wrote that including device numbers on claims “would entail significant technological challenges, costs, and risks to normal claims processing for Medicare and other payers.”
On the other hand, supporters of the new system—including AARP and Aetna—estimate that the nation’s health system would eventually save money by more quickly removing devices that cause injuries, Petersen writes.
Source: Los Angeles Times; February 8, 2016.