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Streamlining the medical device recall process with UDIs

August 13, 2021
From the August 2021 issue of HealthCare Business News magazine

Additionally, clinical in-procedure documentation systems, the electronic medical record, and financial systems rely on syncing data from the MIM, so its accuracy is paramount. The use of the UDI-DI in the MIM would provide a good-in-class practice. A best-in-class practice supply chain would need to capture the complete UDI-DI+PI using an inventory management-IM system. Due to the sheer volume and constantly changing data this is commonly accomplished by a stand-alone IM system, fed attributes by the ERP-MIM. Most IM systems provide alerts for expiration dates, easily accessible reports by various device identifiers such UDI DI+PI, and the location of affected devices. Highly developed ERP and IM systems can flag SC when a recalled item is trying to be ordered or has been inadvertently received.

Public access to recall information
Although the focus of this article is to highlight the benefits of UDIs in the medical device recall process of the supply chain, we would be remiss if we did not address the ramifications of the out-of-hospital experience. Currently, the public relies on notifications from physicians, third-party recall services, enrolling in FDA email notifications or by periodically checking the FDA website. “A public warning may be issued when the medical device presents a serious hazard to health … where other means for preventing use of the recalled product appear inadequate.”

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Barbara Strain
Various patient advocacy groups such as the Breast Implant Safety Alliance, MedTruth, and others help fill the knowledge gap to educate and inform the public while seamless, transparent, track and trace alerting systems continue to be adopted. Based on the way data is collected and communicated sans UDI full compliance, none of the current processes inform the entire “stakeholder chain” for medical device recalls.

About the author: Barbara Strain is the principal consultant with Barbara Strain Consulting LLC. She is also co-chair of the UDI Impacts on Recall Management Workgroup, AHRMM-Association of Healthcare Resource and Materials Managers and Board Strategic Liaison, AHVAP-Association of Healthcare Value Analysis Professionals.


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