You may have heard a lot recently in the healthcare environment about the three items listed in the title above. The following is intended to give you a brief understanding about what each of them are and let you know what we are currently doing here within Mölnlycke Health Care to meet the requirements being developed within these areas.
UDI helps to identify medical devices within the supply chain giving a much needed traceability system for tracking our products through to use on the customer. UDI System comprises of two parts – physical marking of products and provision of product master data into a Database. The UDI itself is a unique number which is allocated to each packaging level of a product. This is then applied along with production information (eg, Expiry date, lot number, serial number) in both human readable and machine readable format (barcode) onto the relevant packaging level of the item. To allocate the numbers you need to use an ISO and (in the US) FDA approved standards organisation. GS1 is the ISO standards organisation and system chosen by Mölnlycke Health Care.
The GS1 system uses unique numbers called GTINs (Global Trade Item Numbers (previously known as EAN or UCC/UPC Codes)) to identify products at specific packaging levels within the supply chain. This is done by allocating GTINs to each packaging level of a product and displaying it in the form of a barcode on the relevant packaging level so that it can be scanned in and out of various points within the supply chain. GS1 also offer a number of certified data pools where specific product information (such as the data required for UDI) can be stored and transferred to other stakeholders within the supply chain.
In April 2014 the Department of Health released the NHS e-Procurement Strategy. This strategy not only puts expectations onto suppliers but also actually mandates the use of GS1 standards within trusts.
At Mölnlycke Health Care we are working very closely with GS1 and the Department of Health on the eProcurement Strategy and we are involved within a number of initiatives within their supplier engagement process. We are also involved within the Eucomed UDISC (Unique Device Identification Supply Chain) Task Force working with the regulatory authorities on the development of legislation within the EU. The below diagram summarises where Mölnlycke Health Care is within this process.