A medical device recall that affects only the provider and physician level sounds like it should be a simpler process than one that impacts the patient level. But these recalls can still involve serious pitfalls, especially when it comes to data – specifically, outdated data.
While a brick-and-mortar hospital doesn’t change sites often, smaller clinics and other facilities may move locations much more frequently. And even within hospitals, physicians and other providers transfer or change jobs quite often. In these cases, the address may be correct, but the person the communication is addressed to is no longer there. The notification is likely to get lost in the shuffle. On top of that, larger hospitals and health systems may share devices among multiple locations, making it difficult to track down exactly where the product is when the recall is issued.
It is important for medical device companies to perform quality checks on their existing data, or work with an outside partner to manage this task. In some cases, companies find that their billing systems are more up-to-date than information on purchase histories. However, the systems often do not talk to one another.
The older the affected device, the more likely the data will be incorrect. And the larger the recall, the more difficult it is to reconcile the conflicting data.
Effectiveness check performed after the notifications have been sent will often catch these issues. But especially in cases where the recall is due to a serious safety issue, it is best to check the data before notifications are sent. Effectiveness checks are necessary either way, but by catching as many discrepancies as possible earlier in the process, companies can better protect patients and mitigate the legal liability involved.
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Our Recall Consultant Amanda Combs will speak at this week's CBI Conference on the topic of Manufacturer Reporting… https://t.co/pmYW5Ci3IH
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