Author: Rachel Benway, Product Manager, Reed Tech
It was a rainy couple days in Washington, DC for the Complaints, MDRs, & Recalls Workshop hosted by AdvaMed on February 11th and 12th but that didn’t stop people from all over the world from gathering to discuss these critical topics.
The agenda for the two-day workshop flowed in much the same way as an actual device issue would: Complaints, MDRs, Inspections, and finally Recalls. Many device issues initially get reported to the manufacturer as a complaint from a user or a patient.
If the complaint suggests that the device:
– May have caused or contributed to a death or serious injury, or
– Has malfunctioned and the device or similar device marketed by the manufacturer would be likely to cause or contribute to death or serious injury, if the malfunction were to recur.
(21 C.F.R. §803.50)
Then the manufacturer is required to submit an adverse event report as known as an MDR to the FDA. It was suggested by more than one of the presenters to replace the word “likely” with “could” to match the conservative nature of the FDA better.
The FDA regularly conducts inspections of device manufacturing facilities but they also use a risk-based approach for site selection and targeted inspections based on compliance history, trends in adverse events, and past experience with the manufacturer. So if the FDA sees an upward trend in adverse events or new types of failures for a device, they may choose to do an inspection. This inspection will most likely include a review of the manufacturing facility as well as a review of the quality management system and complaint handling processes. Based on the inspection, a recall may be required or recommended.
By looking at this process holistically, it becomes easy to see how important complaint management is to the health of a product’s lifecycle. One of the most interesting takeaways from the conference was that a complaint could come from many different outlets and they all have to be treated equally. For instance, service requests and regular maintenance of equipment are routine, but comments from the users during those service sessions could be seen as complaints. Thus everyone within the organization must be trained to recognize and log complaints especially service personnel, marketing and sales representatives, and product management teams. Similarly, an organization can only analyze and track trends if the complaint data is maintained and stored in a central location.
Complaint data is not publicly accessible, but as issues bubble up as MDRs and potentially recalls they are published and available to the world through the FDA databases. Troves of safety and quality data exist and can be manipulated to help at any point in the device lifecycle. If the FDA is creating and using signal detection algorithms to find and investigate reported adverse events, you should be too!
To further analysis of this data, Reed Tech has developed Navigator™ for Medical Devices, providing easy access and improved visibility into FDA Approval & Clearance data, Adverse Events (MDRs), Recalls and Warning letters. Manufacturers can view data on their products, competitors’ products and industry averages. From a future development perspective, we are testing the ability to predict recalls (currently with a balanced accuracy of >80%) to support the next wave of AI and the next evolution of the Postmarket Surveillance Role.
What’s Your Approach?
How are you currently tracking complaints, and are you treating it as an essential part of your device’s risk management lifecycle? We would love to hear more about your approach!