Healthcare organizations strive to provide patients with a safe environment. Monitoring medical devices goes hand-in-hand with improving safe practice. It is essential to increase awareness of incidents that potentially involve a medical device or technology and to encourage staff to report the events quickly. Often, staff are not aware that almost all the equipment used with patients are considered a medical device – even a bandage.
Healthcare organizations are guided by The Safe Medical Devices Act (SMDA) in monitoring medical device concerns and are required to report medical device problems that result in serious illness, injury, or death. They can voluntarily report problems with devices, such as ‘close-calls,’ potential for harm and other safety concerns. By monitoring reports about problems and concerns before a more serious event occurs, the FDA, manufacturers, and clinicians may work together proactively to prevent serious injuries and death.
The following table provides a sampling of what has been deemed a medical device by the FDA.
Beds, bedrails, scales, wheelchairs, IV poles, infusion pumps, lifts, bathtubs. MRI, Cat Scan, radiology equipment
Needles, syringes, IV tubing, foley catheters, feeding tubes, gloves, ventilator breathing supplies, trocars
Pulse oximetry, glucose machines, surgical staplers
Hip/knee, stents, defibrillators
Cardiac, telemetry, patient call systems
Hardware, software
Laboratory solutions
Bandages, q-tips, towels
We know of the interface between devices and patients, but it is important to consider the device and its many interfaces as well.
When an adverse event occurs, it is importance to consider all the following:
Any, or many, of these aspects of the adverse event or potential events may be the reason or a contributing factor and warrants further investigation.
For medical device equipment:
For all other equipment:
Additional resources:
The following materials have been produced by the FDA and are a great resource for your team.
Willis Towers Watson hopes you found the general information provided in this publication informative and helpful. The information contained herein is not intended to constitute legal or other professional advice and should not be relied upon in lieu of consultation with your own legal advisors. In the event you would like more information regarding your insurance coverage, please do not hesitate to reach out to us. In North America, Willis Towers Watson offers insurance products through licensed entities, including Willis Towers Watson Northeast, Inc. (in the United States) and Willis Canada Inc. (in Canada).
