Medical Device Safety and FDA Reporting

With advanced innovations in healthcare technology and the ongoing evolution of bioengineering, the medical device industry continues to grow significantly. It generates billions of dollars in revenue, with over 6,500 different medical device product categories subject to the oversight of the U.S. Food and Drug Administration (FDA). Yet despite the FDA’s rigorous premarket approval process and regulatory controls, many devices designed and manufactured to enhance patient care and improve health have been associated with adverse outcomes and patient harm. 

Claims Analysis

Coverys claims data shows that 171 claims filed between 2016 and 2020 involved injuries from medical devices and equipment. Of these, 48% were related to alleged user error or improper equipment use while 30% were equipment-related or equipment failures. Nine percent of claims accounted for product liability and another 9% were associated with cautery injuries. A smaller number of claims were associated with failure to inspect or maintain equipment.  
 

Coverys closed claims data 2016-2020 n=176 RM Issues
Note: A claim may have more than one RM issue
 

Medical devices can cause temporary and permanent harm as well as death. Coverys claims data exhibits varying degrees of injury from medical devices and equipment in the graph below.
 

Coverys closed claims data 2016-2020 n=171
 

Reporting safety concerns

According to the FDA, medical devices range in complexity from simple tongue depressors to pacemakers, surgical lasers, and in vitro diagnostic kits. The Safe Medical Devices Act of 1990 expanded the FDA’s authority to regulate medical devices and increased its ability to track device-related adverse patient events. This law ensures the timely removal of hazardous devices from hospitals and other healthcare facilities. It also requires hospitals, health professionals, and other medical device users to report to the manufacturer and the FDA if a device caused or contributed to serious patient injury or death. 

In 1993, the FDA established the MedWatch system to streamline the reporting process and enhance its ability to track adverse events related to medical devices and other FDA-regulated products. MedWatch clearly defines reporting requirements for healthcare professionals and consumers. Safety-related MedWatch reporting enables the FDA and manufacturers to monitor equipment-related events and later issue mailed and online notices of product improvements, safety recommendations, and recalls to healthcare facilities and practitioners. 

It is important for healthcare facilities to promptly act on medical device safety alerts and recall notices. Facilities can either disseminate safety concerns to practitioners using those devices or remove the recalled devices and products from inventory. Depending on organization size, identifying and locating medical devices and equipment can be challenging. Large academic medical centers with numerous campuses, for instance, may use devices in multiple locations. In such cases, implementing efficient and accessible inventory systems can help with the challenges of tracking and locating the many devices and models available.

Responding effectively to medical device safety advisories and recall notices requires coordination between such departments as purchasing, materials management, biomedical engineering, clinical education and risk management. It is important that these departments collaboratively develop a consistent, reliable, and timely process for responding to medical device safety issues. 

Risk Recommendations

Consider the following when implementing effective risk management strategies for medical device and equipment safety: 

• Keep Current. Stay abreast of medical device safety alerts and recalls by promptly opening all notices mailed by the manufacturer or the FDA. Monitor the FDA website for alerts and recalls or sign up for electronic notices. 
• Designate wisely. Identify a responsible person(s) to handle and respond to medical product safety alerts and recall notices. 
• Know the law. Become familiar with FDA requirements for safe medical device operation and reporting requirements.
• Implement policies and procedures. Develop and regularly update policies and procedures that define responsibility and procedures for tracking, storing, and maintaining equipment; handling device and equipment malfunctions; and monitoring device safety and recall notices. 
• Train the staff. Ensure clinicians are fully educated and competent to use medical devices and equipment in accordance with manufacturer guidelines. Ensure staff is educated on all policies and procedures. Document training dates and results of return demonstrations for competency.
• ​Inventory all devices in use. Track all devices and equipment by using a regularly updated log or database. Include manufacturer and product names, model numbers, serial numbers, and usage and storage locations. Implementing an effective inventory system can be extremely helpful, particularly in larger facilities or health systems. Use this system to confirm which devices and equipment are in use and to track and locate devices and equipment affected by safety alerts or recall notices. 
• Maintain equipment and devices. Highlight the manufacturer’s maintenance and service requirements and identify who is responsible for servicing equipment. Incorporating this information in the inventory or logging system is helpful. Document who performs routine equipment maintenance or service and when they do it. Ensure that inspection dates are visible on the device.
• Monitor expiration dates. Pay attention to expiration dates for single-use devices or accessories. Stock inventory from the back so that items with the closest expiration date are used first.
• Track, report, and investigate incidents. Develop an incident reporting process for harm-producing events, serious adverse events, and near misses resulting from medical devices and equipment. Ensure that staff members notify the risk manager or designated administrator whenever they know or suspect that medical equipment and/or devices have caused patient harm.
• Remove and preserve malfunctioning devices or equipment. Immediately remove from service and preserve medical devices or equipment related to adverse events for evaluation and inspection. This may be required as part of an investigation, root cause analysis, or situations with a high likelihood of litigation. Collection of data from a device or equipment to determine timing, clinical parameters, and event details may be indicated as part of an adverse event investigation
• ​Respond safely to equipment malfunctions. If not properly controlled, hazardous energy may seriously injure workers who service malfunctioning devices or equipment. When equipment fails or malfunctions, proper lockout/tagout procedures can protect workers from hazardous energy release. For more information, see the OSHA fact sheet regarding the lockout/tagout process.

Injuries from medical devices and equipment have increased product liability claims against manufacturers, independent testing laboratories, sales representatives, retail suppliers, healthcare facilities, and doctors. A proactive, coordinated risk management strategy is essential for responding to device safety issues before they result in harm to the patients. 


Additional resources:

Medical Device Reporting (MDR): How to Report Medical Device Problems
FDA: How to determine if Your Product is a Medical Device


Copyrighted. No legal or medical advice intended. This post includes general risk management guidelines. Such materials are for informational purposes only and may not reflect the most current legal or medical developments. These informational materials are not intended, and must not be taken, as legal or medical advice on any particular set of facts or circumstances.