From the U.S. Government Accountability Office, www.gao.gov

Transcript for: Watchdog Report: FDA Oversight of Medical Devices

Audio interview by GAO staff with Marcia Crosse, Director, Health Care

Related GAO Work: GAO-11-556T: Medical Devices: FDA's Premarket Review
and Postmarket Safety Efforts

Released on: April 13, 2011


[ Background music ]

[ Narrator: ] Welcome to GAO's Watchdog Report, your source for news and
information from the Government Accountability Office. It's April 13,
2011. The Food and Drug Administration, or FDA, is responsible for
overseeing all medical devices sold in the United States. Marcia Crosse,
a director in GAO's Health Care team, recently testified before Congress
on concerns GAO has identified with FDA's oversight of these devices.
GAO's Jeremy Cluchey sat down with Marcia to learn more.

[ Jeremy Cluchey: ] Can you give some examples of what we mean when we
talk about medical devices?

[ Marcia Crosse: ] Well, medical devices encompasses a huge range of
medical equipment. It's virtually every item in your doctor's office or
a hospital, everything from the examining table to the blood pressure
cuffs, thermometers, all the way up through hip implants, pacemakers,
MRI devices, CAT scans—virtually every piece of equipment used in
medical care is a medical device.

[ Jeremy Cluchey: ] And how does the FDA work to ensure that new medical
devices, like these, are safe when they come onto the market?

[ Marcia Crosse: ] Well there are three broad categories of medical
devices. The low- risk devices—like the paper drapes that you use,
tongue depressors, other kinds of simple things—manufactures just have
to follow certain controls in their manufacturing, and they just have to
notify FDA. For what are called medium-risk devices, there is a process
where FDA has to clear that application before a manufacturer can market
the device. And these are for things where there is already an existing
device like it on the market. For the higher-risk devices, which would
include many, but not all, implanted devices and other really
complicated types of equipment, there is a premarket approval process
where you have to provide clinical data and submit much more extensive
information to FDA, and there is an approval process that's required for
those devices.

[ Jeremy Cluchey: ] GAO looked at these premarket review procedures in a
2009 report and made some recommendations to FDA. What sort of progress
has been made since then?

[ Marcia Crosse: ] Yes. When we looked in 2009 we were looking at those
medium-risk and high-risk devices. Really we were focused on the process
for the medium-risk devices, which is called a 510k Clearance based on
the section of the law. So when we took a look and put out our report on
2009, we found that there were still more than two dozen types of
high-risk devices that were being allowed to be cleared through this
medium-risk device process, the 510k process. They have made a little
bit of progress since our report. They did make it a strategic priority
to address these device types. And they went out in the first steps of
rule making to gather information from companies. So far they've
completed the process for one of these types; but there are still 26
device types that are allowed to be cleared until they complete this
process. Devices are still coming on the market through this process
that we believe, and FDA acknowledges, may require the more stringent
PMA process.

[ Jeremy Cluchey: ] And when a medical device does make it through the
premarket approval process, or is cleared through the 510k process, and
then later found to be unsafe, it's recalled. How common is the recall
process and how does that work?

[ Marcia Crosse: ] Well, recalls can happen, even to the lowest risk
devices. There can be a reason, either there was a problem in the
manufacturing of the device, or there was a problem in the design of the
device, or there was a problem in the instructions for the use that the
manufacturer put out, or there was some unrecognized issue in the way in
which it would be used. All of those things could result in a recall. In
total there are an average of about 700 recalls a year. And usually the
manufacturer, either on their own identifies a problem or they hear from
the users that there's a problem, and they initiate a recall
voluntarily. FDA has the authority to require a recall, but virtually
all recalls are initiated voluntarily by the manufacturer.

[ Jeremy Cluchey: ] For consumers who may be considering or in need of
one of these medical devices, what's the bottom line here?

[ Marcia Crosse: ] If a patient's going to get an implant, something
like a hip implant or a pacemaker or something else, they may want to do
a little checking on their own before that to talk with their physician
about what kind of device, what brand, make, model of a device is gonna
be used to be implanted into their body. And check themselves whether or
not there's a recall notification out for that device.

[ Background Music ]

[ Narrator: ] To learn more, visit GAO's Web site at GAO.gov and be sure
to tune in to the next edition of GAO's Watchdog Report for more from
the congressional watchdog, the Government Accountability Office.