He cited metal-on-metal hip implants, which are not high-risk medical devices. They may damage the bone or tissue of the hip over time.
The U.K., Canada and Australia all noticed this problem and issued medical alerts between 2010 and 2012. The FDA issued a similar safety communication in January of 2013.
“Medical devices vary so much, in what they are and what they do, there’s not a one size fits all policy,” Rising said. “The FDA needs to look at each device that comes through and assess what’s going to be needed.”
Better safety and efficacy information for individual devices would help doctors and patients decide which option is right for them, he said.
The 21st Century Cures Act, passed in the U.S. House of Representatives in July, would make it easier and less expensive for companies to bring drugs and devices to market.
“That’s not going to help, by diminishing the quality of evidence required,” said Dr. Bruce Psaty of the University of Washington in Seattle who serves as vice chair of the FDA Science Board.
The push for lowered evidence standards for approval is part of a move toward “life cycle evaluation,” shifting the burden from before-market approval to continual tracking of safety and efficacy after the device is in use.
“If we maintain this type of ‘life cycle’ evaluation we need to be sure it is not just premarket,” Ross said.
“Perhaps we need to consider requiring more, larger and more robust postmarket studies,” he said.
Postmarket studies would be much easier if each implantable medical device was included in searchable records, which is not the case now.
“For somebody who researches with large insurance databases, I can’t tell which hip device was put in,” Ross said. “You can see that there’s an operation done to put something in but you don’t see which type.”
A proposed unique device identifier code for each device would be a good first step toward better postmarket studies, the experts agreed.