Quick Tip: 4 questions to ask when confronting a recall
Handling a medical device recall takes a lot of work from a regulatory point of view. But it is also an opportunity to examine and improve your risk management system.
Unfortunately, recalls are common in the medical device industry.
When we are confronting a recall decision, it helps to also review the situation carefully and identify opportunities for improvement. Often, a safety-related product recall also offers key insights into gaps in the risk management and/or quality management system.
As an example, a recall may expose a new risk that was not previously identified. It could be due to a new hazard or a hazardous situation related to the medical device. It may be that we did a good analysis of potential failure modes, but did not find all potential hazardous situations that could arise even when the device was operating as designed.
A careful review can help us identify gaps in our process of risk identification, analysis and evaluation. It can also help us identify additional risk controls needed to improve product safety.
This type of inquiry and analysis helps to create a more effective business process of risk management that leads to continual improvement of the Quality Management System.