Medical Errors: Part 3

by Food and Drug Administration (FDA)

(Page 3 of 4)

FDA, too, faces the problem of "tremendous underreporting," according to Susan Gardner, Ph.D., deputy director of the Office of Surveillance and Biometrics in the agency's Center for Devices and Radiological Health.

Hospitals, nursing homes, and other facilities that use medical devices are required to report to FDA all deaths caused or possibly caused by devices. "Guess what? They don't report," says Gardner, whose office gets only about 4,000 reports a year from the 40,000 to 50,000 facilities covered by the reporting requirement.

Gardner thinks that simply assuring facilities of confidentiality of reports could go far to increase compliance with the reporting requirement. "If you give incentives to report, they'll report. In many cases, that might simply mean good feedback so they can improve their systems." A published list of previously reported device problems in FDA's database, Gardner says, would enable facilities to benchmark their own experiences. Newsletters could discuss important medical device issues. And strategies could be suggested to avoid potential pitfalls in using a medical device.

With devices, more than with drugs, it can be difficult to determine if an adverse event was a preventable error or an unexpected reaction, Gardner says. Devices sometimes require specific knowledge and training to use the product correctly.

It's the interface between the device and the user, referred to as "human factors," that can complicate an investigation into why something went wrong. The problem usually isn't that the device itself broke, Gardner says, but rather that it wasn't intuitively user-friendly, or the user didn't have instructions on hand or didn't know about a change in the way the device was to be used in a certain setting.

In the agency's Center for Biologics Evaluation and Research, the lack of reporting is characterized by consumer safety officer Sharon O'Callaghan as one of the biggest problems where medical errors are concerned. She says that while manufacturers of biological products, such as blood components and vaccines, must report to FDA certain errors that occur during manufacturing, companies are not sufficiently aware of reporting requirements.

For biological products, manufacturing errors can lead to mistakes in treatment that are potentially serious and even deadly. In blood banks, for example, a blood product that is mislabeled can present a serious threat to a patient if the wrong type of blood is transfused.

"Things happen that we might not hear about," O'Callaghan says. "We want to increase reporting so we can assess what's happening in the industry." To increase reporting of manufacturing glitches, the agency has proposed a rule that would increase the number of facilities that must report errors and other adverse events.

Clinton's proposal to reduce medical errors contains a nationwide, state-based system of reporting medical errors that would include mandatory reporting of mistakes that result in death or serious injury and voluntary reporting of other medical mistakes, including so-called "close calls" or "near misses." Clinton also expressed support for legislation that protects provider and patient confidentiality, while safeguarding the legal remedies of those whose health is harmed.

To Improve Is Human

Woodcock encourages consumers to help prevent errors by being vigilant about their health-care — understanding their treatment, keeping organized records of what doctors they see and what medications they take, and asking questions when things don't seem right. For example, "If your pills look different than they have in the past, they might be the right medication, and they might not. But raise the issue."

Honig calls consumer education the "secret weapon" in the war against medical errors. "It's unfortunate that people research buying a car better than they research health-care decisions. They're willing to tolerate more uncertainty with their health-care than their mode of transportation." He encourages patients to feel comfortable asking more questions about their medical care.

With everyone from pharmaceutical manufacturers to consumers playing a role in improving the safety of the health system, Woodcock believes that the already "very safe" medical system in the United States will become even safer. "There are fixes," she says. "We know that from other industries."

The spotlight on the health system's problems might be just what the system needed to transform itself, says Woodcock. After all, as the IOM report notes, "It may be part of human nature to err, but it is also part of human nature to create solutions, find better alternatives, and meet the challenges ahead."

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.