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.
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.
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.”
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.