With more scandals and recalls hitting the headlines, the pressure’s on to improve device safety
New research suggests the real problem may lie with post-market studies on devices. Once regulatory approvals have been granted and a device hits the market, post-market studies are conducted to monitor the safety and effectiveness of the device.
The research, published in the Journal of the American Medical Association, finds that so-called post-market studies aren’t thorough enough at present. Doctors and regulators both rely on the studies to make informed decisions.
In the US, the 21st Century Cures Act, a proposal recently introduced into Congress, aims to expedite the development and commercial availability of drugs and devices.
Lobby groups for rare diseases are welcoming this act. However opponents have described it as ‘a huge step backward for FDA standards’.
In an interview with Health News Review, US cardiologist Dr Rita Redberg said: “The emphasis has been on getting drugs and devices on the market quickly, not on making sure that they are safe.”
Redberg also told the New York Times in an opinion piece that the bill would “severely weaken not strengthen, the FDA’s already ineffective regulatory scheme for medical devices. The device industry may stand to benefit from this legislation, but the health of the public does not.”
With all this in mind, it’s likely that in the US market at least, post-market studies would be even more crucial to ensuring patient safety. If pre-market approvals are to be made faster, longevity studies will only be possible post-marketing stage.
The JAMA research finds that some post-market studies will not be finished for another one to eight years, even though the subject devices entered the market in the last three to five years.
The pre-market/post-market safety check system is like a set of scales – and it seems at the moment to be seriously off-balance.