Background Tracking implantable medical devices (IMDs) by batch number is mandatory under French law for safety issues in case of adverse events or recalls. The pharmacist is responsible for the database of IMDs and health care providers are in charge of matching a given IMD with patient identity after surgery.
Purpose In order to optimise traceability, this study assessed the use of the industrial barcodes printed on device packaging. We wished to avoid having to re-label with our own barcodes upon delivery of the devices to the pharmacy.
Material and methods We used a healthcare program (PHARMA, Computer Engineering) able to read international standardised barcode systems (HIBC, EAN/GS1, DataMatrix) and print/read its own barcodes containing the required regulatory information (reference, batch number, expiry date). This specific pharmacy barcode is pasted by the pharmacy on each corresponding IMD. During a 2-month assessment, the industrial barcode of devices implanted during radiology interventions was scanned, in order to add the information to the patient records. In case of failure, the pharmacy barcode was used.
Results Eighty-nine IMDs were implanted in 20 patients. Nineteen products from 10 suppliers were tested. Traceability was recorded in all cases: the industrial barcode was read successfully for 32 IMDs (36.0%) whereas the pharmacy label was used in 57 cases (64.0%). The following main difficulties restricted the use of industrial barcodes: (1) related to the industrial barcode itself (40.3% of IMDs had no barcode, no standardised barcode or lacked information such as the lot number), (2) user-related issues e.g. confusion with several barcodes (35.1%) and (3) software inability to recognise an industrial barcode (17.5% of the devices).
Conclusion Awaiting a unique device identification (UDI) system for medical devices as stated in the recommendations 2013/172/UE, the relabeling method seems to be the best option to ensure the traceability despite the extra workload on the pharmacy team.
References and/or acknowledgements No conflict of interest.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.