NHS England announced late last year that it plans to roll out a barcoding scheme for medical implants such as breast implants and hip replacements. Although only in trial form, the scheme is designed to help reduce the incidence of errors that can put patients at risk and reduce costs by improving and streamlining the supply process.
Back in 2014 the Department of Health (DoH) started to make initial forays into the issue of tracking medical implants, supplies and instruments. As part of the Scan4Safety program the DoH mandated that all 154 acute trusts become GS1 members. GS1 standards are used in many different industries such as retail, food and logistics, and distribution. They define unique identification codes—GS1 identification keys—that may be used by an information system to refer unambiguously to a real-world entity. These entities may be locations, items, documents or even service relationships.
GS1 data capture standards currently cover radio-frequency identification (RFID) data carriers, which allow GS1 Identification Keys to be applied directly to a physical object. In healthcare they allow for identification of each person, drug or device, and location within the NHS.
The program is currently being piloted in six NHS trusts in Derby, Leeds, Salisbury, Cornwall, North Tees and Plymouth, England. Derby Teaching Hospitals NHS, who implemented GS1 standards in general surgery, imaging and catheterization labs, already report saving at least £25,000 per month in consumables since implementation.
Manufacturers also report benefits and U.S. manufacturer BD (Becton Dickinson and Company) introduced GS1 standards at each step from manufacturing to patient bedside with significant results, including a 30% reduction in days payable outstanding, a 73% reduction in ordering discrepancies, a reduction in calls to customer service, and fewer stock outs as a result of nurses being able to scan barcodes at the bedside.
The Scan4Safety scheme currently in trial focuses on breast implants and hip replacements. Hip and breast implants are in fact among the most commonly implanted medical devices and this new technology could reportedly save the NHS £1 billion.
The idea of providing unique identifiers on medical devices is therefore not novel in itself, although rolling it out is seen as a pioneering move to bring the NHS in line with expected changes in the EU regulatory framework. In fact, as the new Medical Device Regulations (MDR) rolls out across Europe, Unique Device Identification (UDI), a system used to identify medical devices through their distribution and use, will become a requirement for all medical device manufacturers.
The £12 million scheme sees universal barcodes being attached to medical supplies, equipment, patients and even nurses and doctors in order to dramatically reduce instances in which wrong implants or blood transfusions are administered. An audit trail showing transparently who administered treatment or performed surgery will thus be easily accessible at all times. It will also become far more simple to track devices that degrade or cause damage to patients, such as those releasing chemicals in the bloodstream, over time.
So what are the five key measures that manufacturers can put in place to ensure they continue supplying the NHS and are ready for compliance when UDI becomes mandatory under the new MDR?
1. Grasp first-mover advantage
Immediately start to make the move to introduce UDI. Although the requirement is not yet in place, commentators agree that it will be a key part of the new MDR. Strategies put into place now will position your business as a first-mover, allowing you to trial the system while others will find themselves playing catch-up later.
2. Understand the benefits
It may seem like a huge investment to become UDI compliant, especially when it is not mandatory yet, but the benefits that medical device manufacturers can reap are significant: First and foremost are improved inventory control, potential for increased sales, more time to identify imminent issues, improved billing accuracy and reduced instances of fraud. In addition, when UDI becomes an integral part of systems, device manufacturers may achieve significant cost savings from improved inventory control.
UDI also allows manufacturers to re-evaluate product portfolios. Having a database of every manufactured device means a business can determine whether certain out-dated products should be removed from its catalogue or updated. This more transparent approach is also likely to result in cost savings from better inventory tracking and improved recall management.
UDI information can also help during the mergers and acquisitions process by providing the acquiring company with all the tools required to perform a thorough risk assessment.
3. Put a team in place
Although some medical device manufacturers have grasped the importance of making moves towards UDI readiness, too many fall over at the first hurdles. Cost of implementation is proving a stumbling block, especially if managers are struggling to get senior management on board. Costs are driven up by the need to set a team of resources to work on outlining a UDI strategy and on delivering it. If staff is already fully engaged in their existing roles, the result will be an unproductive conflict of priorities with day-to-day workloads and a poor implementation. Similarly, the right set of skills to bring the project to delivery will also be required.
4. Map out the process
Managing the project carefully and setting a schedule for implementation is a particularly tricky stage as it will need to take into account availability of resource, the presence of a capable, preferably experienced project manager, and any potential obstacles that could cause a bottleneck or even an out-right stand-still.
5. Don’t be afraid to call in reinforcements
For businesses that find themselves lacking in skills, experience or simply are under-staffed, outsourcing the process can be highly cost-effective and provides rapid, seamless implementation. With UDI compliance making its way further to the top of the agenda and becoming ever more a topical issue, UK and European manufacturers, need to put a UDI implementation plan in place as soon as possible whether they have capacity and skills in-house or whether they need to outsource them. Playing a waiting game is a losing game and manufacturers simply can’t waste time.