Devices hit market before safety studies’ publication

Medical devices approved by the US Food and Drug Administration (FDA) are often cleared before studies on their safety or effectiveness have been released to the public, a report suggests.

Without published data, doctors and patients may not be able to make informed decisions about whether to use the products, the authors warn.

The FDA defines a medical device as any instrument, machine, implant or other device used to diagnose, prevent or treat a disease or condition. Devices include everything from heart rate monitors to hip replacements, intrauterine devices or new surgical tools.

Lead study author Hani Marcus of the Institute of Global Health Innovation at Imperial College, London told Reuters Health there are two main pathways to get a medical device approved for sale in the US.

The research team searched for studies of new medical devices published between 2000 and 2004 and then looked at FDA databases for information on clearance or approval of those devices.

“If high quality studies of medical devices are not done and published, it is hard for clinicians to make well informed decisions on their clinical use, and to know what patients, if any, would benefit and to know the risks of the devices,” said Rita Redberg, a professor of medicine at the Philip R. Lee Institute for Health Policy Studies at the University of California, San Francisco, by email. —