Supply of Products for Healthcare (SUPPLY)
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Supply of Products for Healthcare (SUPPLY), published by IHE Pharmacy Technical Committee. This guide is not an authorized publication; it is the continuous build for version 0.3.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/IHE/pharm-supply/ and changes regularly. See the Directory of published versions

Use Case 9 - Recall of UDI Devices

This use case shows the use of UDI in the tracking of medical devices that are already in the supply chain.

This use case presents the following:

  • After an internal investigation, the manufacturer of pacemaker discovers that some leads can detach after implantation.

  • The investigation reveals that this problem applies to one batch of a specific device model.

  • The manufacturer issues a recall notice to the customers AND to all the known stock locations.

  • Hospital 1 has the items in consignment.

  • Hospital 1 does a research and finds that one patient has received a pacemaker from the recalled batch.

  • Hospital 2 has purchased three pacemakers and two of them are in their stock, and the third one is implanted.

In different countries, there are different people that will handle the device inventory. It can be a pharmacist and in some countries, it can be the Purchasing department.

Sequence Diagram

Operating Theater - Recall products with UDIDeviceVendorVendor RepHospital 1OperatingDepartmentHospital 1EHRHospital 2PharmacyResponsibleHospital 2EHRInventoryManagerInvestigationInvestigation outcome:Lot XXX has been affectedTrackingFind where impacted devices are sold to.3 devices at Hospital1 (consignment);Responsible=Vendor Rep2 devices at Hospital BNotify Vendor Rep of defect;request recall of batchNotify Hospital 1 of defect;request recall of batchNotify Hospital 2 of defect;request recall of batchRecall Stock at Hospital 1Retrieve impacted itemsfrom stock consignmentScan item 1Scan item 2Confirm items are recalledNotify Stock Recall completeRecall Patients at Hospital 1Find patient implantedwith devices of batch XXXList of patient implantedwith devices of batch XXXUndertake appropriate action.Recall Stock at Hospital 2Query inventory system for all devices of batch XXX and their locationList of devices and inventory locationsRequest withdrawalof devicesRetrieve impacted itemsfrom stockScan item 1Marks as recalledNotify Recall completeRecall Patients at Hospital 2Find patient implanted with devices of batch XList of patient implanted with devices of batch XUndertake appropriate action.