We are all used to seeing the checkout operator scan the barcodes on our tins of food and drink at the supermarket. The scan provides the product price and links back to stock and other databases. Until recently, the European Article Numbering Association (EAN) provided these product codes to manufacturers for tracking products through manufacturing to the consumer's plate.
Worldwide, product traceability is becoming the norm in many industries including aerospace and biotechnology, due to health and safety legislation and improved quality standards. In the United States, Item Unique Identification (IUID) codes are currently a requirement on almost all equipment purchased by the US Department of Defense.
The medical manufacturing market in the UK is undergoing a similar transformation. In 2005, a new standard came into being, known as GS1 that impacts on the medical and orthopaedic supply chains. It was formed from EAN International and its local member organizations, including the UCC from the USA. GS1 is an independent global standards body which provides its members with an international system of unique identification numbering, already used widely in the pharmaceutical, retail and supply chains sectors. These numbers are generally applied via conventional bar codes, two-dimensional Data Matrix codes and radio frequency identification (RFID) tags. GS1 UK is providing its unique numbering systems and support to all NHS organisations.
Roger Lamb, healthcare manager for GS1 UK, explained the work of the new authority in more detail. “GS1 is a not-for-profit initiative that is part of the wider Department of Health initiative “Coding for Success - simple technology for safer patient care”, a commitment to quality that was launched a year ago. A lot of work has been done looking at raising standards across the board. There are 109 GS1 member organisations and we now have 1.25 million members in the world.”
GS1 is the issuing authority for numbers that form part of the unique codes applied via different symbologies. Hospitals apply to GS1 UK for a membership number and use this in different ways. Particular number series are used for different items. For example, assets and traded items will have different types of numbers. GS1 members are given advice and training on how to use standards, so that they are able to comply with quality guidelines on producing the code - ie colour, size, pattern, etc.
Lamb says: “A number of hospitals have signed up in the last six or nine months. The codes are used to keep track of loan-sets as well as instruments held in stock.”
Charlie Plain-Jones (left), traceability solutions manager of Pryor Marking Technology, said: “We now have a new standard, which is exciting. What a great idea - we can now share NHS standards for data presentation. We shall be able to move forward with confidence that individual items will be traceable in the medical sector.”
Use of the new GS1 code is not yet mandatory in the surgical field, but it is best practice, according to Plain-Jones. However, for specialist areas such as tonsillectomy and neurosurgery, the use of the code is mandatory on surgical instruments.
Best practice will inevitably become law, it is just a matter of time, and those leading the field of manufacturing specialist items for orthopaedic surgeons know this and are already implementing high standards in traceability. Comis Orthopaedics Ltd, Rotherham, UK is a privately owned business set up in December 2005 to design, develop, manufacture and market implants and instrumentation for Minimally Invasive Surgery (MIS). Its innovative product range includes the patented Minimally Invasive Hip Resurfacing or Comis MIHR®, that is deliverable as an open surgery implant; the Comis Leg Length System which provides an initial datum measurement of the joint position prior to dislocating a hip joint; and the MIS Retractor System, designed for near assistant-free use in hip resurfacing and total hip arthroplasty. The company makes a range of other devices and surgical instrumentation, manufactured on site at its factory in Rotherham, with implant production sub-contracted to specialists LPE Medical. UK market distribution is handled by JRI Ltd.
From the start, Managing Director, Shaun Palmer and his colleague Ryan Taylor, General Manager, knew that they would need to ensure full traceability on every part they made. The company decided to implement high-tech laser marking as the indust