Medical devices on the market before safety studies are published

The US Food and Drug Administration (FDA) is approving medical devices before studies on their safety or effectiveness have been released to the public, Reuters Health reported

Reuters references a report published in the BMJ which investigated the regulatory approval of new medical devices.

The report highlights that a medical device according to the FDA definition is an, “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article.”

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.

The study displayed that the median lag between publication of clinical studies about new medical devices and the FDA approval of these devices was 2 months, with 43% of the devices in the study being cleared or approved before clinical studies were published.

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

Rita Redberg, a professor of medicine at the Philip R. Lee Institute for Health Policy Studies at the University of California, San Francisco, said to Reuters: “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.

“When we looked at high-risk cardiovascular devices, we found that less than half (49%) had publications to support their safety and effectiveness.”