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Regulatory News | 30 June 2017 | By Michael Mezher
A team of researchers say that better postmarketing data for medical devices could identify safety issues sooner, but they fear that current political headwinds could derail planned device safety efforts.
In a viewpoint published in JAMA on Thursday, Joshua Sharfstein of Johns Hopkins Bloomberg School of Public Health, and Rita Redberg and Alison Jacoby of the University of California, San Francisco Medical Center, point to the recent debate over power morcellators as a prime example of a safety issue that could have been better handled with stronger postmarketing data.
"Until a postmarketing surveillance approach for medical devices is established that can answer essential questions quickly, clinical medicine will remain in data purgatory, vulnerable to the next dispute over the safety of a new device or medical technology," the authors write.
In 2013, The Wall Street Journal first reported on the potential risk for unsuspected uterine sarcoma to be spread by power morcellators. Shortly afterwards, FDA received the first adverse event reports describing the spread of cancerous tissue after procedures involving the devices.
Then, in April 2014, FDA issued a safety communication for power morcellators warning of the risk of spreading cancerous tissue, and following an advisory committee meeting in November of that year, FDA required a boxed warning for power morcellators.
But not everyone agreed with the agency's actions. In 2015, a number of gynecology experts wrote to FDA, arguing that the agency's actions were based on inaccurate data and could lead to more women with benign fibroids to undergo surgery.
"The dispute reveals, in part, that there remain competing views about how regulatory decisions should be made about the use of medical products as evidence emerges on safety risks," the authors write, adding that such disagreements become more heated when there is not adequate pre- and postmarket data to settle them.
And while the authors say there has been progress with postmarketing studies in recent years, "small sample sizes, delays in reaching protocol agreement, and lack of availability of findings still limit the ability of postmarketing studies to be clinically useful."
The authors also say that one of FDA's planned efforts to better track postmarket medical device safety, the National Evaluation System for health Technology (NEST), is years from being implemented and could become a casualty of deregulation under the Trump administration.
Tags: Power Morcellators, Postmarketing Studies, Postmarket Surveillance, NEST