Patient SafetyWorkplace Management

Medical device reporting—a model for patient safety


As a nurse, you’re well aware of medication safety and error prevention initiatives, but do you also know about the Food and Drug Administration’s (FDA) medical device reporting (MDR) program and how it can improve patient safety?

The FDA requires various entities, including manufacturers, importers, and healthcare facilities, to report device problems. (See Who’s required to report?) In addition, the FDA encourages individual healthcare professionals, patients, caregivers,and consumers to voluntarily report concerns and problems with medical devices. (See Examples of voluntary reporting.)

You use medical devices every day, putting you in a unique position to report actual problems and identify potential complications. By reporting incidents like near misses, close calls, or potential for harm, you can help prevent death or serious injury.

What are medical devices?

A medical device is defined as anything (other than drugs, biologics, or food) used for diagnosis, treatment, or prevention of disease, including everything from simple tongue depressors and bedpans to complex programmable pacemakers with microchip technology and laser surgical devices. Other items on that list include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, as well as some electronic radiation-emitting products with medical applications (for example, diagnostic ultrasound products, xray machines, and medical lasers).

How to report

When you see a device that presents a safety concern or is involved in a device-related adverse event, take these steps:

1. Recognize when a device malfunctions and stop using it to prevent possible harm.

2. Remove the device immediately and tag it with a label describing the problem.

3. Report the incident through the appropriate channels per your facility’s policy.

If you are a hospital-based nurse, you can report problems with medical devices through your hospital’s incident reporting system. If, however, you are a private-practice nurse, you can report directly to MedWatch using MedWatch Form FDA 3500, which you can download.

If your facility is part of the FDA’s Medical Product Safety Network (MedSun), you can report directly to your MedSun representative. A hybrid program that includes both mandatory and voluntary reporting, MedSun is a national network of about 300 hospitals that work collaboratively to report device-related adverse events and potential problems.

What to report

When reporting a medical device problem or malfunction, consider these questions:

• How was the device being used?

• What was happening with the device at the time of the event?

• What happened to the patient or caregiver?

In cases of patient or caregiver injury, describe the injury and any follow-up nursing actions. If no one was injured, explain how the device-related adverse event represents a potential for harm and include suggestions for improvement. For example, can the device or its instructions be more user friendly? If the device is disposable, save the packaging for device identifiers (manufacturer name, brand name, model, catalog number, lot number). Another alternative is the use of unique device identification (UDI). The FDA’s UDI system identifies medical devices through their distribution and use. When fully implemented, the label of most devices will include a UDI barcode to facilitate followup and report tracking. For more information about this program.

What happens after making a report?

The FDA’s review staff, made up of nurses, biomedical engineers, medical officers, and other allied healthcare professionals, triage medical device reports based on actual and potential risk to patients, caregivers, and healthcare professionals. The staff reviews reports within the context of the individual event and against previously reported problems. To better understand a reported problem and to develop solution strategies, additional research and information may be gathered from device users, clinical professional organizations, or manufacturers.

Contact from the FDA may prompt the manufacturer to perform an evaluation that results in actions related to production processes or device revisions. For example, a company that makes cardiac monitoring systems may revise software to prevent loss of patient monitoring and telemetry downtime. Or a manufacturer of an umbilical catheter may change its design to prevent leakage. Other possible actions include revising device labels with clearer, larger print, or eye-catching graphics to alert users to hazards or to provide troubleshooting tips, or streamlining instructions so they are more user-friendly.

Sometimes a reported event leads to a medical device recall, defined by the FDA as an action taken to address a problem that violates FDA law. Recalls occur when a medical device is defective, when it could be a health risk, or both. A recall doesn’t always mean that users must stop using the product or return it to the manufacturer; the device may simply need to be checked, adjusted, or fixed. (See When devices are recalled.)

Some reported events involve broader safety issues that affect similar devices from several manufacturers. The FDA works with manufacturers and clinical practice organizations to develop education and outreach on device safety, including newsletters and websites.

Working together for patient safety

Your device reports make a difference. When you recognize and report problems with medical devices, you’re working collaboratively with medical professionals across the country to promote patient safety.

Suzanne Rich is senior project manager and Michael El-Shammaa is branch chief, Clinical Outreach Branch 1, in the Center for Devices and Radiological Health, Office of Surveillance and Biometrics at U.S. Food and Drug Administration in Silver Spring, Maryland.

Selected References

James J. Operating room tables: unlocking problems with table leg locks. MedSun newsletter #118. April 2016.

U.S. Food & Drug Administration. Is the product a medical device? Updated September 12, 2014.

U.S. Food & Drug Administration. Medical device reporting (MDR). Updated November 7, 2016.

U.S. Food & Drug Administration. MedSun: Medical Product Safety Network. Updated September 19, 2016.

U.S. Food & Drug Administration. Neurosurgical head holders (skull clamps) and device slippage: FDA safety communication. February 25, 2016.

U.S. Food & Drug Administration. Reducing risks associated with medical device misconnections. Updated October 7, 2016.

U.S. Food & Drug Administration. What is a medical device recall? Updated June 2, 2014.

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