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Information for Health Care Professionals and EngineersHealth 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 ReportingA 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.
In addition to a full description, other important and helpful information to include in the report is:
You can report problems through two reporting systems: Medical Device Reporting (MDR)
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. FDA Resources on Human Factors and Medical DevicesFDA 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:
Selection and Maintenance of Medical DevicesBiomedical 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:
FDA-Developed TrainingPatient Safety Web Sites
Updated April 2, 2007 |
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