Constant vigilance keeps medical devices functioning

Q. My husband has had a pacemaker for several years. It and he seem to be doing fine. He really hates to go the doctor, so we haven’t had check-ups as regularly as we should have. Who is basically responsible for making sure this pacemaker keeps working right? Is there ever a recall of devices like this?

A. Bottom line, you (or your husband) are responsible for all aspects of your health. That doesn’t mean, of course, that you don’t need the doctor. Your husband’s responsibility is to go to the cardiologist for routine monitoring. The cardiologist checks the battery and the pacemaker.

Medical care is so much more complicated than it used to be. Technology, such as pacemakers, has expanded rapidly. In fact, the Food and Drug Administration lists approximately 1,800 categories of approved medical devices used to treat all kinds of medical conditions.

Medical devices include simple thermometers, heating pads, bandages and wheelchairs as well as pacemakers, intrauterine devices, and kidney dialysis machines — more than 100,000 FDA-regulated items.

Many of the newest of these devices depend on delicate computer software — and computers are not foolproof.

In 2002 alone, the FDA received reports of more than 111,000 adverse events, including serious injuries and deaths, related to medical devices.

Sometimes the device fails because it was poorly designed, sometimes because it was not operated correctly.

The FDA needs to know about all adverse events with medical devices. Consumers and their doctors and hospitals all need to cooperate to be sure problems are recognized and defective products recalled. It takes constant vigilance by everyone involved.

The FDA recommends that consumers take the following steps (with the help of their health care providers) to avoid common problems associated with medical devices:

  • Read and understand the instructions and labeling, and know whether the device is appropriate.
  • Inspect and test equipment prior to use.
  • Make sure that devices are properly maintained and serviced.
  • Avoid using a device that has malfunctioned.
  • Avoid using a device past its suggested expiration date.

The FDA has regular channels through which hospitals and health-care providers must report problems with medical devices.

The agency also has an informal reporting site. It is called MedWatch and is available by telephone, online, or by mail, as follows: (800) FDA-1088, www.fda.gov/medwatch, or MedWatch, FDA, 5600 Fishers Lane, Rockville Md. 20852-9787.

It is important for you as a consumer to work closely and regularly with your health-care providers about any symptoms or problems you may have with a medical device. Your life may depend on it.