Reducing Medical Device Injuries : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 4)

What Is A Medical Device?

Simply defined, a medical device is an instrument, such as a stethoscope or an artificial hip joint, used for diagnosis, treatment or prevention of disease, injury or other condition that is not a drug, biologic or food. The FDA regulates more than 100,000 medical devices ranging from simple thermometers, tongue depressors and heating pads to heart pacemakers, intrauterine devices, and kidney dialysis machines. Some devices, such as bandages, have retained their same basic form and function, while others have become more complex.

Heart defibrillators, for example, designed to deliver electric shocks to restore normal heart rhythms, have progressed from large machines to devices small enough to be implanted inside the chest wall. Other developments include surgical tools that enable surgeons to operate on a fetus while still in the womb. Diagnostic devices also have evolved so that many tests, such as those used to determine whether a woman is pregnant or to detect blood clotting, can be used at home. And some surgical procedures, such as gallbladder removal, can now be done using laparoscopic instruments that require only small incisions, which can reduce hospital stays and help speed recovery. Patient care has improved dramatically as a result of these changes.

Product Problems

Once a medical device goes into widespread use, unforeseen problems can still arise. But through the use of regulatory controls and the device classification process, the FDA provides reasonable assurance that the product will be effective, while not posing unacceptable risks to patients once it is on the market. (See "Class Clarification.")

Postmarket medical device problems — those seen after a device has been approved and is in general use — generally fall into one of three broad categories: device problems, use problems, and clinical problems.

Mechanical, electrical or software-related malfunctions, manufacturing defects in product design or development, or problems with materials are all considered to be device-related problems. Use problems may be associated with inadequate or misleading labeling, confusing instructions, inadequate packaging, design problems that make the device difficult to use, or inadequate training in the use of the device. Clinical problems can occur with a patient who is sensitive or allergic to a device, or who has a pre-existing condition that makes the device difficult or risky to use.

The following simple steps can help consumers and health care providers avoid common problems associated with medical devices:

• Read and understand the instructions and labeling, and know for whom 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 for sterility or shelf life (length of time before the product deteriorates).

Reporting Product Problems

Reporting medical device problems is an important part of patient safety. Concerns about the quality, performance, or safety of any medical device should be reported. Consumers and health care providers using medical devices are in the best position to provide the information that manufacturers and the FDA need to determine whether an adverse event presents a public health risk.

"By reporting adverse events to the FDA," says Suzanne Rich, a registered nurse who works in the FDA's Division of Postmarket Surveillance, "health care providers help to rapidly identify significant health hazards associated with these products, and the FDA can provide timely feedback to the health care community about safety issues involving medical products." This reporting, she adds, translates into patient safety.

The FDA is improving several systems for reporting adverse events that are associated with the use of agency-approved products. These systems advance the public's health by giving the agency quicker and more detailed information on potential problems with health care products.

The key to effective reporting is to understand the difference between the FDA's two complementary systems for national medical device adverse event reporting. Through the Medical Device Reporting (MDR) system, manufacturers and distributors of devices, as well as user facilities (hospitals, outpatient treatment, diagnostic and surgical facilities, and nursing homes) are required to promptly notify the FDA about device-related events that have or may have caused or contributed to a death, serious illness or injury. The manufacturer of Davis' wheelchair, for example, was required under MDR to report the fire associated with her burns.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.