In my last post “Who’s watching your MedWatching”, I commented on some of the common issues manufacturers have with their MDR and complaint handling systems. It’s useful to know what people are doing wrong, but I think it is equally important to know how to solve those issues. So in this post, I’m going to point you to two very good resources that I found that give further insight into how to know if you have a problem, and how to fix your system.
The first resource is a presentation that was created for the the FDA Medical Device Industry Coalition. If you work with complaints, you will definitely want to save this presentation and read over it when you have time. It discusses MDR failures and misinterpretations, and offers solutions. One interesting point I pulled out from this was the discussion on the term “caused or contributed”. In MDR reporting, we need to ask ourselves, “Does the information reasonably suggest that a device caused or contributed to a death or serious injury?” Things that “cause or contribute” to the event do not just include malfunctions or failures. Use error can also “cause or contribute” to the event. Usability related issues need to be taken seriously, for their potential impact on the safety of the device.
The second tool is an article written by Pamela Furman. Amongst other topics, she discusses the confusion manufacturers have with determining if a device … “would be likely to cause or contribute to death or serious injury if the malfunction were to recur”. The assessment should not be on the likelihood of the malfunction. We should assume that once a malfunction happens, it may possibly happen again. The thing we need to evaluate is whether or not that malfunction is likely to cause an adverse event. The difference is small, but it is an important one.
There is a lot of information in these two resources that is helpful for all of us who work on complaints. If you don’t have time now, bookmark these links, and come back to them at a later time. What are your company’s main concerns with complaint handling?
- MDR: Failures, Successes and Solutions. Scott Eden. http://fmdic.org/wp-content/uploads/2012/05/Eden-MDR.pdf
- How to Avoid an MDR Disaster: Set up an Effective Reporting System. Pamela J. Furman. http://www.ofwlaw.com/CM/Articles/FurmanMDRarticle.pdf