Cracking the code: Barcoding in the medical device sector

Peter Rose, Maetrics takes a look at NHS barcoding and its importance for the medical device sector.

In December 2016 the NHS announced that it was going to implement a trial scheme involving rolling out barcode technology across NHS England in a new push towards reducing error and to cut costs. Six NHS trusts are currently going to trial the scheme, which is called Scan4Safety. As part of the scheme that barcodes will be attached to medical supplies and equipment – as well as to patients, nurses and doctors and in theory, at each stage of a patient’s treatment the codes will be scanned.

In the past serious mistakes have included implantation of incorrect implants, or the wrong blood transfusion being administered to patients. In terms of patient safety, the Scan4Safety scheme aims to substantially reduce this type of risk. The cost-cutting benefits for the NHS could also prove significant as initial results from the six pilot trusts suggested this scheme could save the NHS £1 billion. 

The medical device industry is no stranger to the idea of labelling and issuing medical devices with a unique identifier. As the new Medical Device Regulations (MDR) are finalised across Europe, it has become apparent that Unique Device Identification (UDI) (a system which is used to precisely identify medical devices through distribution and use) will ultimately become a requirement for all medical device manufacturers.

Scan4safety and what it means

Barcodes in the NHS are not new and many have been using GS1 barcodes for the last few years. GS1 standards are used in many industries but in healthcare they allow for a global identification of each person, product or drug and place within the NHS. These barcodes are also system agnostic, which means that they allow the exchange of information between different care providers and systems.

Scan4safety is currently being trialled across six NHS trusts in Derby, Leeds, Salisbury, Cornwall, North Tees and Plymouth. These sites have already noticed that they are reducing unnecessary waste and that they are effectively managing staff stocks. Not only is risk being reduced, but staff time is being saved. Typically (on average) it has been recorded that one hour a day of a nurse’s shift in the UK is spent searching for stock. This is time that  can instead be spent caring for patients.

Applying barcodes to devices will enable hospital staff to track hospital goods, implement an automatic ordering system ready for when stocks are running low and be alerted when a product is out of date and needs to be removed from an inventory.

The benefits of the trial scheme Scan4safety will have such an impact on the medical device industry by improving patient safety and streamlining the health system. Human inventory errors will be prevented, patients will be provided with the most suitable device/medication. Not only this, but the system can be used to see how effective different equipment is, for example if one type of hip implant wears out more quickly than another, then hospitals will have the information (and evidence) to make repeat purchases of the more durable unit.

Unique Device Identification and its benefits

With the imminent publication of the MDR, having unique identifiers on all medical devices is going to be a prerequisite for all medical device manufacturers. When UDI is fully implemented manufacturers will be well positioned to reap the long-term benefits. If UDI is ingrained into systems with the view to restructure operations in order to adopt more thorough tracking and inventory systems – manufacturers too, will achieve significant cost savings. Other business benefits are improved inventory control, increased sales, more time to identify potential issues, improved billing accuracy and reduced fraud.

There are further benefits that come with running an updated platform for tracking, cataloguing and entering information for UDI compliance – manufacturers could see a reduction in counterfeit products entering the market thanks to more efficient tracking processes. Also, having a database of every previously manufactured device means it is apparent when out-dated products need to be removed from a business catalogue.

Another interesting benefit of implementing UDI is the effect it will have on company mergers and acquisitions. Once a proposed merger or acquisition has been announced it is important for both companies to perform due diligence before proceeding. Using UDI information can help ensure a seamless transition as it will facilitate the acquiring company when performing its risk assessment.

The medical device manufacturers who implement processes as soon as possible to become UDI compliant will reap the benefits. Specifically, meeting compliance standards early on means that manufacturers can trial the system at a pace that works for them and can put themselves ahead of competitors. In order for manufacturers to avoid any stumbling blocks during and after the implementations process, it is advisable to appoint a strong team and project manager who has extensive knowledge on the UDI framework and could become invaluable towards helping to avoid fines, recalls, rejections and other unnecessary delays.

Conclusion

Despite the initial upfront costs for implementing UDI – there are substantial benefits that come along with it. UK and European manufacturers should not delay in meeting UDI compliance standards, especially once the full requirements of UDI have been laid out in the new MDR. UDI will benefit all aspects of the healthcare industry: hospitals, patients and manufacturers. Hospitals will be able to efficiently manage their inventory and link devices to patient files, reduce manual errors and increase patient safety. Manufacturers will gain better traceability and efficiency in recalls, and improved quality of information through the standardisation of data across the industry.