U.S. Food and Drug Administration - CDRH Mobile
Skip NavigationFDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website
FDA Home Page | CDRH Home Page | Search | A-Z Index U.S. Food and Drug AdministrationCenter for Devices and Radiological Health Questions?
horizonal rule
FDA's Human Factors Program - Promoting Safety in Medical Device Use (photo montage)
Human Factors Home
Information for Manufacturers
Information for Health Care Professionals
Information for Consumers
Presentations and Research
Other Resources
Contact Us

Information for Health Care Professionals and Engineers

Health Care professionals provide an essential role in helping the FDA monitor medical devices. Through timely use error reporting, you provide early and accurate alerts to medical device problems. By assisting in medical device selection and maintenance, you can also help your organization get the optimal level of safe and effective performance of these devices in patient care.

You may also find useful resources at Other Human Factors Resources.


Use Error Reporting

A use error refers to a situation in which the outcome of device use was different than intended, but not due to malfunction of the device. The error may have been due to a poorly designed device, or it may have been used in a situation that promoted incorrect usage. Other users may make the same use error with similar or worse consequences. You can help us identify these errors by reporting the actual events and near misses that occur at your facility.

When reporting an adverse event, reporters often leave out details of the event that can be useful in identifying the factors or conditions that led to the event. Reports are more helpful if you describe the scenario as concretely as you can.

Good example of problem description

“Nurse was changing the concentration of a prescribed medication being infused through a pump. In programming a bolus before the concentration change, she misunderstood the default settings and accepted the bolus concentration as the final dose. As a result, the patient received a three-fold overdose.”

In addition to a full description, other important and helpful information to include in the report is:

  1. Device type, manufacturer, brand name, and lot number if applicable
  2. The exact location of the event
  3. Was the patient or device operator harmed?
  4. Was the problem with the device a defect, malfunction, break, etc.?
  5. Was someone directly “operating the device at the time of the event? If so, who?
  6. Were there other therapies being used on the patient at the time of the event that may have caused or contributed to the event?

You can report problems through two reporting systems:

Medical Device Reporting (MDR)

  • Applies to manufacturers, importers, and user facilities
  • Requires reporting of all significant medical device adverse events

MedWatch

  • Applies to consumers and healthcare professionals
  • Accepts voluntary reports of significant adverse events or problems with medical products

FDA has also developed a pilot program to make reporting and follow-up on adverse events easier through a program called MedSun. MedSun is a partnership between FDA and over 300 hospitals and nursing homes. The MedSun system is used to identify problems and work with the manufacturer to produce a safer product. For more information, see MedSun: Playing a Vital Role in Ensuring Medical Device Safety.

Return to Top


FDA Resources on Human Factors and Medical Devices

FDA investigates and develops information for the public on safe use of medical devices. Some reports of our findings and recommendations can be found by clicking on the links below:

You can check these FDA sources for information about devices that you use now or are considering for your facility:

Return to Top


Selection and Maintenance of Medical Devices

Biomedical and clinical engineers, nurses, physicians, and patient safety professionals can use basic Human Factors techniques to more effectively select, implement, and maintain medical devices for health care facilities. Here are a few web sites where researchers are developing materials specifically for you:

Return to Top


FDA-Developed Training

Return to Top


Patient Safety Web Sites

Return to Top

Updated April 2, 2007

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH