Regulatory Open Forum

How are medical device distributors handling recall effectiveness checks? As distributors, we aren't involved in recall strategy development and in most cases this is not communicated by the OEM.

My instinct is to apply an internal effectiveness check level based on risk communicated by the OEM. For example, Class 1 Recalls would be Level B 70%, Class 2 & 3 Recalls would be Level B 30%.

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Joshua Lust
RiskMitigated.com
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Hello Joshua,

That would be a good approach just to handle internally to the distributor; the FDA has good explanation of effectiveness checks.  There are also some statistical tools which could be used.  Today it is quite important there is good communication between the manufacturer and distributor as more regulators are expecting to see device management through the entire lifecycle.  It might be an opportunity to have a discussion with your manufacturer(s) to determine how communication can be improved.  Thought to be honest, it is quite surprising the OEM would not communicate those type of activities related to recalls/withdrawals as this is something distributors can help recalling firms understand communication with the end user.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 06-Jan-2022 11:41
From: Joshua Lust
Subject: Calling Device Distributors - Recall Effectiveness?

How are medical device distributors handling recall effectiveness checks? As distributors, we aren't involved in recall strategy development and in most cases this is not communicated by the OEM.

My instinct is to apply an internal effectiveness check level based on risk communicated by the OEM. For example, Class 1 Recalls would be Level B 70%, Class 2 & 3 Recalls would be Level B 30%.

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Joshua Lust
RiskMitigated.com
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