The news that NHS England plans to roll out a trial scheme involving barcoding of medical implants has made headlines with commentators hoping it will help reduce dangerous mistakes and cut costs. The system, called Scan4Safety, is to be trialed in six NHS trusts and focuses on breast implants and hip replacements—both among the most commonly implanted medical devices. This new technology is reported to have the potential to save the NHS £1 billion.
 
The industry is, of course, not new to the concept of providing unique identifiers on medical devices and it is expected that 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.
 
NHS England can thus be considered a pioneer in this movement to make all stages of treatment traceable. Under the £12 million plan, universal barcodes will be 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. As such, it will be possible to easily find out who administered treatment or performed surgery and track devices that degrade or cause damage over time.
 
In 2014, the Department of Health mandated that all 154 acute trusts become GS1 members and announced the Scan4Safety program. GS1 standards are used in many different industries, but in healthcare, they allow for identification of each person, drug or device, and location within the NHS. The program is being piloted in six NHS trusts in Derby, Leeds, Salisbury, Cornwall, North Tees, and Plymouth. Derby Teaching Hospitals NHS, which implemented GS1 standards in general surgery, imaging, and catheterization labs, already reports saving at least £25,000 per month in consumables since implementation.
 
Savvy medical device manufacturers are already making moves toward UDI readiness, but many fall over at the first hurdles. The most important challenge is, of course, the cost of implementation. This is followed by the need to establish a team of resources to work on outlining a UDI strategy and setting a manageable and realistic timeframe for smooth implementation. Although a business may want to implement UDI, if the staff resources are not there or are 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.
 
Managing the project carefully and setting a schedule for implementation is a particularly tricky stage. This aspect will need to take into account the real availability of resources, the identification of a capable (preferably experienced) project manager, and the recognition of any potential obstacles or challenges that could slow or derail the objective. For businesses that find themselves lacking in skills, experience, or staff, outsourcing the process can prove highly cost-effective and provides rapid, seamless implementation.
 
Despite the investment required to become compliant, the benefits that medical device manufacturers can reap are significant. First and foremost, meeting compliance standards early in the implementation process enables them to trial the system and outpace less prepared competitors. Additional specific business advantages include potential for increased sales, more time to identify imminent issues, improved billing accuracy, and reduced instances of fraud. Further, when UDI becomes an integral part of systems, device manufacturers may achieve significant cost savings from improved inventory control.
 
UDI also allows manufacturers to closely evaluate their product portfolios. Having a database of every manufactured device means a business can determine whether certain outdated products should be removed from its catalogue or updated. As a result, manufacturers stand to achieve significant cost savings from improved inventory tracking and management of recalls.
 
Another interesting benefit of implementing UDI is related to mergers and acquisitions. Once a proposed merger or acquisition is announced, both companies involved must perform due diligence. UDI information can help the acquiring company evaluate the transaction and perform a very thorough risk assessment.
 
UK and European manufacturers, therefore, should appropriately prepare to embark on their journey to UDI compliance as soon as the full requirements of UDI [PDF] are confirmed within the new MDR. Medical device manufacturers that put a UDI implementation plan in place as soon as possible will stand to benefit, while the risk of losing sales to better-organized competitors is not worth delaying compliance. The healthcare industry and public at large are also set to benefit greatly from improved billing accuracy, a reduction in adverse events, and a reduction in fraud that UDI can bring.