Recalls have always been a bit of a double-edged sword. Obviously, companies hate recalls because a recall means their products are defective in some manner, potentially putting users at risk and damaging the brand. They are also expensive to execute. But a lack of recalls can also be a problem, if the underlying quality issues still exist but the companies are simply not conducting recalls. Recalls are necessary and appropriate in the face of quality problems.
Thus, in terms of metrics, medical device companies should not adopt as a goal reducing recalls, as that will lead to behavior that could put users at risk by leaving bad products on the market. Instead, the goal should be to reduce the underlying quality problems that might trigger the need for recall.
What are those underlying quality problems? To help medical device manufacturers focus on the types of quality problems that might force them to conduct a recall, we have used the FDA recall database to identify the most common root causes sorted by the clinical area for the medical device.
Recent Updates
- What CMS's 2027 Fee Schedule Changes Mean for Shared Savings Program ACOs
- CMS Wants to End Certain COVID Requirements, Natural Light in Patient Care Areas: Proposed Rule Would Update CoPs for Hospitals, LTC Facilities, and Other Providers
- The Structural Pressures Behind Senior Living and Long-Term Care Distress
- CMS Proposed Rule to Implement Section 6224 of the Consolidated Appropriations Act
- FDA Finalizes Key Parts of Its NDIN Guidance Related to Identity and Safety Information: What Dietary Supplement Companies Should Know