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
• FDA Resources on Human Factors and Medical Devices
• Selection and Maintenance of Medical Devices
• Patient Safety Web Sites

 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.

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.

 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:

• Do It By Design: An Introduction to Human Factors in Medical Devices a primer on Human Factors for medical devices (PDF)
• Reuse of Single Use Devices
• Hospital Bed Safety
• Reducing Use Error

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

• CDRH Public Health Notifications
• CDRH Medical Device Recalls List
• CDER: Medication Errors
• Medical Device Safety (Alerts/Recalls, Patient Safety News)

 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:

•  University of Texas’ Center of Excellence for Patient Safety Research Findings and Products, including Medical Device Usability and Safety Assessment Tools
• Sample Web-Based User Interface Evaluation with Questionnaires from Gary Perlman, which can be modified for internal evaluations
• Clinical Alarms Management and Integration, from Annual College of Clinical Engineering

 Patient Safety Web Sites

• Medical Errors & Patient Safety, Agency for Healthcare Research and Quality (AHRQ)
• National Patient Safety Foundation
• ECRI's Medical Device Safety Report
• Medication Safety Alert, Institute for Safe Medical Practices (ISMP)
• Patient Safety, Joint Commission on Accreditation of Healthcare Organizations (JCAHO)