The failure of medical devices is a high-stakes issue, but unearthing the root cause when breakdowns occur can be difficult, particularly if multiple factors come into play. The website Qmed has therefore assembled a list of the top 10 causes of medical device failure, pointing to the need for comprehensive safety checks across the manufacturing, regulatory, and maintenance ecosystems.
According to editors Brian Buntz and Chris Newmarker, the 10 top causes of medical device failure include:
1. Clinical Trial Devices Can Have Issues
2. Rushing the Product Development Process
3. Piggybacking onto Questionable Products
4. Ignoring Negative Data
5. Having Inadequate Alarm or Warning Technology
6. Ignoring Appropriate Regulatory Requirements
7. Improper Labelling or Instructions
8. Haphazard Design Controls
10. Off-Label Promotion
In the case of appropriate regulatory requirements, the writers point to the infamous Olympus TJF-Q180V duodenoscope, responsible for numerous hospital-associated infections of carbapenem-resistant enterobacteriaceae (CRE) in recent years. The device had not actually received FDA clearance, but remained on the market because of the agency’s concerns that removing it from circulation could cause a shortfall in the number of duodenoscopes available to meet annual clinical demand (approximately half a million procedures per year).
The Olympus duodenoscope also points to the need for distributing appropriate and accurate operating instructions with medical devices. Lawsuits against the manufacturer have alleged that when the TJF-Q180V was redesigned, its cleaning instructions referenced an older model. Such disparities lead at best to confusion, but can also cause serious patient harm.
To read more about each pitfall, visit the Qmed website.