From the August 2021 issue of HealthCare Business News magazine
By Barbara Strain
The U.S. has averaged more than 2,900 medical device recalls annually since 2014 and that number does not appear to be going down. In 2020, only 18% of all medical device recalls included the Unique Device Identifier (UDI) and only 24% of those flagged as implant recalls.
The overarching intent by the FDA of the Unique Device Identifier Rule was to provide safety, effectiveness, and traceability of medical devices. The UDI would follow a device from manufacture with the ability to track it from its “born on” date through the phases of supply chain handling-order, receipt, put-away, issue, to the point of use. Ideally, the final step is its documentation in the electronic medical record, thus making it available for timely reaction when alerted to potential harm to patients and the public.
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Each UDI consists of two components; a fixed Device Identifier that indicates the manufacturer and the specific model/version of the device and the variable Production Identifier that includes lot, batch, model or serial numbers, expiration date, manufactured date or a code required for human-based products such as tissue.
Medical device recall process by providers
When official notification is received by a healthcare provider from a manufacturer, distributor, or third-party recall service, the primary coordination for responding to medical device recalls falls to supply chain or biomedical engineering while departments like OR, procedural areas such as cardiology, nursing units, and others assist in looking for affected supplies or equipment to comply with the recall instructions.
As easy as this sounds the steps along the “recall chain” have weak or broken links that slow down compliance or create anomalies that lead to inaccurate reporting. Chief among these links for Supply Chain is the delay in receiving recall notices and the lack of an electronically readable/useable UDI within the recall notice itself. This does not facilitate accurate report generation, rapid location and removal of affected devices, nor timely documentation back to the recall originator.
Delays in receipt of notices start with how the FDA is alerted by the manufacturer. This can be electronically using the FDA eSubmitter process which is a manual entry process that leads to mistyping, or by email. Neither process consistently provides electronically readable or translatable UDIs.
Backbone of a highly functional supply chain
To underscore this significance let us talk about the backbone of a highly functional supply chain, the Master Item Master. The MIM is an integral part of a hospital’s Enterprise Resource Planning-ERP system, which assures accurate processes are followed to capture key data and associated costs. For supply chain the MIM consists of key device ordering elements such as description, manufacturer name, ordering number, units of measure and numerous other characteristics like contract information and where to purchase.