UDI traceability of medical devices with LEOSS WMS

Medical device traceability means knowing which device was received, where it is stored and who received it. It connects the physical flow of devices with the information needed to manage stock, support safe use and respond to recalls.

Reliable identification is the starting point. Unique Device Identification (UDI) helps identify medical devices and their production details. LEOSS WMS supports the capture of identification data and its use during receipt, storage, movement and issue.

Regulatory requirements vary by market

There is no single worldwide law governing UDI and healthcare inventory records. Requirements depend on the country, device category and the organisation’s role as a manufacturer, importer, distributor or healthcare provider.

In the European Union, Regulations (EU) 2017/745 and 2017/746 establish UDI frameworks for medical devices and in vitro diagnostic devices. In the United States, the FDA operates its own UDI system. Requirements for healthcare providers’ records must be assessed under the rules applicable to their market and activities.

A practical implementation should therefore start by defining the devices in scope, the information to retain and the processes that must be recorded. LEOSS WMS provides operational support for traceability within that framework.

What information does UDI contain

UDI has two components:

UDI-DI identifies a specific device model.
UDI-PI identifies production details and may include a batch or lot number, serial number, expiry date or manufacturing date, as applicable.

A product description identifies the type of device. A lot or serial number distinguishes a particular batch or individual device. This distinction is essential when a recall affects only part of the stock.

How to establish traceability with LEOSS WMS

Traceability starts at receipt and continues through every recorded movement and issue.

1 Identification by scanning

LEOSS WMS reads supported composite GS1 barcodes and can extract the product code, lot number, serial number, expiry date and other encoded data. This reduces manual transcription. Actual supplier labels and scanner settings should be checked during implementation; GS1 support does not imply support for every UDI coding scheme.

2 Stock visibility by location and batch

At receipt, stock is associated with a storage location and a lot or serial number. Users can check quantities and locations for a specific batch.

3 Recording movements and issues

Recorded movements and issue documents build a history of device handling. To track deliveries to departments or clinics, these handovers must be included in the agreed workflow.

4 Managing expiry dates

LEOSS WMS supports FEFO control: First Expired, First Out. When configured, it rejects selection of a lot with a later expiry date if suitable stock with an earlier expiry date is available.

5 Connecting to ERP

ERP integration supports the exchange of master data and transaction documents. The fields transferred and the system responsible for each record must be agreed during implementation.

New in version 8.5 is recall management

When a device is recalled, users need to identify affected batches, check remaining stock and find recorded recipients.

LEOSS WMS 8.5 Enterprise introduces a recall overview combining searches for affected issues, access to related documents and batch blocking.

The overview displays:

recipient and related WMS or ERP document,
product code and description,
batch or lot,
expiry date and manufacturing date,
note and document issue date.

Double-clicking a row opens the corresponding document in a separate tab for further inspection.

Finding affected batches

Users can search by product and a manufacturing-date or expiry-date range.

Recall lists can also be imported from Excel, with the product code in column A and the batch or lot in column B. Imported data is stored together with the import date, file name and user. The stored list can be loaded again to review the results later.

Blocking batches and reversing a recall

The action to block all lots marks each distinct batch shown in the overview as recalled after confirmation. The system records the recall date and the user who initiated it.

Further issues are prevented on issue document types where recalled-batch validation is enabled. This control must therefore be enabled on every relevant issue document type.

Recall information is also visible in stock and batch overviews. A recall can be reversed through the relevant action, with the change recorded in the change log.

Connecting traceability and maintenance

Warehouse traceability provides information about receipt, location, movements and issues. Manufacturer instructions, service records and planned maintenance require appropriate records in an ERP, document management or maintenance system.

Implementation should define how documents and maintenance records link to a device model or individual unit. Any patient-level link also requires a separately defined workflow and integration with the relevant clinical system. Traceability extends as far as the events and connections actually recorded.

Why organised traceability matters

Visibility of device locations and quantities.
Less manual transcription of identification data.
Better control of expiry dates.
Targeted searches for issues affected by recalls.
Prevention of further issues of recalled batches when configured.
Operational data to support the organisation’s applicable obligations.

The LEOSS WMS solution

LEOSS WMS connects data capture with warehouse processes from receipt to issue. Support for lot numbers, serial numbers, expiry dates and recall management helps healthcare organisations manage medical devices with greater visibility.

Well-defined workflows and connections to other systems make traceability data useful in everyday work.

Learn more: www.leosswms.com