A new editorial in the Annals of Internal Medicine singled out devices from medtech giants Medtronic (NYSE:MDT) and St. Jude Medical (NYSE:STJ) as examples of how flaws in the FDA’s review process may allow faulty devices onto the market.
Penned by Sarah Zheng and Dr. Rita Redberg, a vocal healthcare industry activist, the editorial argues that the FDA’s more-stringent premarket approval process fails to be stringent when reviewing modifications to already-approved products. The authors pointed to recalled Medtronic Sprint Fidelis defibrillator leads and recalled St. Jude Riata defibrillator leads, both of which were modified versions of devices that originally went through the PMA pathway.
The modification application process is much lighter than original premarket review, allowing manufacturers to pass minor changes through without having to put up the same levels of clinical data. However, some devices undergo many iterations and modifications until the devices sold on the market hardly resemble the ones that originally underwent robust testing, the authors wrote.
Doctors learning about new devices have at their disposal studies that generally reference only the original iteration of the technology, and may not even know that a device available today is substantially different.
"Almost all PMA devices, which range from orthopedic knee replacements to cochlear implants and infusion pumps, accumulate several – and often hundreds – of supplements," Zheng and Redberg wrote. "Companies are not required to (and generally do not) specify on package labels which supplements apply to the device, and physicians often are unaware of which version they are implanting."
The authors argued for some level of safety and effectiveness data for modified PMA devices, saying that the inclusion of additional review would better ensure the safety of patients. Such measures, they argued, may have prevented some of the high-profile recalls still affecting patients today.
The modified Sprint Fidelis leads, recalled in 2007, were associated with 665 failures and 5 deaths, according to the authors.
"The Fidelis lead had undergone successive changes to the original approved device via several PMA supplements, none of which required clinical data," they wrote. "To this day, caring for more than 150,000 Americans with this lead remains a clinical challenge," they added.
St. Jude’s Riata lead, pulled in 2010, was associated with a 32% rate of failure in the product’s outer insulation.
"From 2002 to 2006, St. Jude Medical received approval of 20 models of defibrillator leads (marketed as part of the "Riata" family) through 6 PMA supplements, none of which required clinical proof of safety and efficacy," according to the article. "More than 227,000 leads were implanted before the Riata family was recalled."
The authors called for new efforts to balance the modification process to ensure timely delivery of new products and address concerns about the safety of modified devices. They urged regulators to consider clinical data for all modifications that aren’t "clearly cosmetic or packaging changes," especially since many PMA devices are implanted and can’t easily be removed when a defect is discovered.
They further called for more informative labels that identify what iteration a particular device represents. The authors also lauded the FDA unique device identifier program, taking effect this year, which will assign unique codes and trackable labels for monitoring medical devices on the market.
"Such registries for implantable cardioverter-defibrillators might have detected the Riata and Fidelis lead problems much sooner," they said.
