Is U.S. medical device postmarketing surveillance lacking? At least one author, writing in The New England Journal of Medicine, seems to think so. And he points to St. Jude Medical's ($STJ) Riata recall as an example of how the U.S. system isn't up to snuff.
In the article titled, "Here We Go Again -- Another Failure of Postmarketing Device Surveillance," author Robert Hauser of the Minneapolis Heart Institute Foundation maintains that U.S. citizens are still exposed to "underperforming and potentially hazardous" FDA-approved medical devices "despite multiple recalls and some tragic adverse events." He singles out the St. Jude recall of its Riata leads as only the latest example of how the U.S. "passive" postmarketing surveillance system is flawed.
In December, the FDA classified St. Jude's voluntary medical device advisory letter to physicians from Nov. 28 relating to its Riata and Riata ST silicone defibrillation leads as a Class I recall, putting it in the most serious category.
However, Hauser is questioning St. Jude's follow-up to the situation. "St. Jude Medical recommends that physicians continue to monitor these leads every 3 to 6 months, rather than replace them prophylactically," Hauser notes. "This recommendation is based on no meaningful data, because in a system notorious for underreporting, no such data exist. Meanwhile, physicians and their patients are in a quandary: Will the lead work when lifesaving therapy is needed?"
He also mentions that St. Jude is marketing the Durata ICD lead, which he says is similar in design to the Riata ST leads. "Thus far, the 85,000-plus Durata leads implanted in patients in the United States appear to be performing well, but we do not have a surveillance system in place that can detect low-frequency failures or adverse clinical events involving Durata leads or any other marketed medical device. So your guess is as good as mine," he writes.
To remedy the situation, Hauser says the FDA must "mobilize available resources now to improve postmarketing surveillance for ... patients."
For its part, St. Jude has a different take on the situation and defends its postmarket surveillance program. "St. Jude Medical has the most active postmarket surveillance program in the industry for these leads," said St. Jude CMO Mark Carlson in an emailed statement to Bloomberg. "St. Jude Medical has a strong history of product safety and reliability, and we remain dedicated to developing technology and products that save and improve the lives of patients."
Hauser is no stranger to taking devicemakers to task over safety problems. He and a colleague called out Guidant in 2005 for safety problems. Two years later Hauser and a team documented safety problems with a lead wire from Medtronic ($MDT) that also was recalled, the Pioneer Press notes.
- read Hauser's take
- check out the Bloomberg story
- see the Pioneer Press report