FDA statement on medical device safety
(CBS News) The following statement by the Food and Drug Administration was sent to "Sunday Morning" in response to Jim Axelrod's report on the approval process for medical devices.
"The FDA's mission is to protect and promote public health. That mission requires us to assure that the medical devices we approve and clear are have a reasonable assurance of safety and effectiveness.
"Medical device safety is critical to protecting the public health but there is a potential risk with any drug or medical device, from aspirin to heart valves. The FDA weighs the benefits and risks of every medical device we review. And, while mitigating risk helps protect public health, we must balance risk with the careful evaluation of patient benefit--this helps promote public health.
"The FDA evaluates thousands of medical devices used by Americans each year. It is an incredible responsibility, and medical devices reviewed by the FDA have a strong track record of safety and effectiveness. Evidence suggests that the vast majority of these devices perform well and improve patient health.
"After FDA approval or clearance, we receive and analyze information about how devices perform in real-world settings. We are constantly looking for ways to better and more quickly identify problems with medical devices. Our surveillance programs allow us to work with manufacturers to correct device problems and communicate information to patients and health care providers so that they can make informed health care choices.
"When needed, the agency convenes independent scientific panels for additional expert advice on complex safety issues and helps manufacturers understand how they should be addressing safety concerns that arise. In some instances, we have taken a targeted approach to addressing problems - including re-evaluating a device's risk level or changing the product's label to better ensure appropriate use.
"For example, last year we directed manufacturers of metal-on-metal hip systems to conduct post-market studies to address specific safety issues related to revision rates and an increase in metal ion levels in the bloodstream. The FDA also directed manufacturers of surgical mesh to conduct post-market studies to address specific safety issues related to its use in women suffering from pelvic organ prolapse.
"Data we receive from these studies will allow us to better understand the safety profile of these devices and their benefits for certain patients.
"In addition, the agency has been considering changing the risk level of metal-on-metal hip systems and certain uses of surgical mesh to reflect what may be greater risks associated with use of these devices for certain patients. This action would require more rigorous data from manufacturers in order to gain FDA approval. It's important to note that by law, changing the risk level of a medical device requires the FDA to engage in a multi-step "rule-making" process - which can take years to implement.
"In 2007, Congress directed the FDA to implement a Unique Device Identification system (UDI), which would require manufacturers to place a unique numeric identifier on all medical devices. This system will allow the FDA, hospitals and care providers, and industry to more rapidly identify problems with a particular device, and target action more directly. The UDI system will also enhance post-market surveillance and help better manage adverse event reports. The agency has created a draft UDI system, and the proposal is going through the government rulemaking process.
"The agency continues to strengthen how we review devices, including the science that supports that review. In addition, we are working on a national post-market surveillance strategy that we expect will bolster the amount and quality of information on medical devices once they are on the market and being used by American patients.
"The FDA will continue to support this country's position as a leader in safe medical device technology and innovation."