The National Health Service (NHS) in the UK came up with its own version of UDI through the Department of Health e-procurement strategy, which was published in 2014. The reason behind the NHS introducing UDI has been to set out a range of measures to enable transparency and efficiency in NHS procurement to help support patient safety.
With the imminent publication of the Medical Device Regulations (MDR) in Europe, UDI is expected to become a prerequisite for all medical device manufacturers. The manufacturers who are already in the process of implementing UDI for the U.S. and the UK NHS have, however, come across significant challenges. Yet, despite the effort required to implement UDI, medical device manufacturers stand to gain significant long-term benefits (including influencing the manufacturers’ bottom line) if they ensure they are meeting compliance standards early on in the implementation process. Specific business advantages are improved inventory control; potential increased sales; lead-time to identify imminent issues; improved billing accuracy; and reduced levels of fraud.
When it comes to the introduction of UDI throughout Europe, there are significant lessons, which European manufacturers can learn from the U.S. and the UK.
Expectations of UDI in the U.S.
Prior to the implementation of UDI, the medical device industry could already track and identify its products; it was, however, lacking a global unified system to track device name, model, and other product information. In 2006, the American Hospital Association for Healthcare Resource and Materials Management (AHRMM) requested the FDA to develop a mandatory UDI system for medical devices. It was later recognized that a standardized medical device tracking system would facilitate the early detection of device issues, product recalls, and help with manufacturers’ post market surveillance activities.
In September 2007, the UDI system was written into law as part of the FDA amendments act of 2007. Later, in 2012 Congress required that an insurance claims database, Sentinel Initiative, expand to include medical devices. In 2013, the FDA published The Final Rule, which imposed a series of compliance dates for UDI requirements. However, the FDA, the manufacturers, and the healthcare providers all had varying interpretations and opinions concerning UDI.
In order to assign the UDI codes the FDA brought in third parties such as the GS1, a global barcoding organization, the Health Industry Business Communications Council (HIBCC), and the ICCBBA, for medical products of human origin. The FDA developed a seven-year rolling timeline for the UDI system to take effect, so that manufacturers could take a staged approach to implementation. They also ran the Global Unique Device Identification Database (GUDID), which was created as a single repository to house device identification (DI) attributes within a single system.
For manufacturers, there were mixed feelings when it came to the new UDI regulations. Some manufacturers were opposed to the FDA’s new level of oversight; others presumed that the FDA launched UDI to ensure the medical device industry would catch up with the pharmaceutical industry’s anti-counterfeit and serialization methods. Most of the negativity towards UDI was due to the labeling and operational over-haul, which would be required to implement UDI. However, for all the manufacturers that were showing resistance to UDI, there were others who were championing it. These manufacturers saw UDI as an expansive measure toward global regulatory harmonization—for European manufacturers, this is a crucial point to take on board.
Manufacturers were not the only ones being skeptical; many healthcare providers were initially arguing that implementing UDI would be cost-prohibitive and very technically challenging. However, UDI implementation had the potential to offset much of the initial cost. The healthcare industry wanted a method to accurately identify products to improve procurement and inventory management, improve patient safety, and enhance billing accuracy to reduce fraud.
The Benefits for the EU
When UDI is implemented properly, manufacturers will be well positioned to reap 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, device manufacturers may achieve significant cost savings from improved inventory control and other business measures.
Running an updated platform for tracking, cataloguing, and entering information for UDI compliance can generate significant benefits, which go far beyond merely meeting FDA compliance regulations. Manufacturers might see a significant reduction in counterfeit products and better management of “trunk” inventory and consignment product as a result of a more efficient tracking process. UDI allows manufacturers to closely evaluate their 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. Improved medical device traceability improves patient safety in many ways. For cases that involve contaminated devices, hospitals could track which devices hospital staff used on patients based solely on UDI information.
UDI is also going to provide tremendous help when it comes to mergers and acquisitions. Once a proposed merger or acquisition is announced, both companies involved must perform due diligence before continuing. Using all the information from the UDI can help to ensure a seamless transition. Having a definitive list of all manufactured products on hand allows the acquiring company to evaluate the transaction and perform a very thorough risk assessment.
If a manufacturer fails to comply with federal regulations, they risk facing severe legal consequences—even delayed compliance poses serious business ramifications. The FDA takes non-compliance very seriously and can prohibit the non-compliant manufacturers from selling their products across state lines—and for European manufacturers the prohibition of importing devices into the U.S. And, in very extreme circumstances, customers might not accept a product without a UDI; sometimes, the manufacturer might have to abandon the product altogether.
The benefits are worth the time, money, and resources, which manufacturers will need to invest to prepare the company for meeting UDI compliance regulations. It is advisable that manufacturers conduct a thorough readiness assessment to determine whether all products are compliant or will be compliant by the deadline. In order to avoid problems, make sure a strong team and project manager are appointed—this could be an external consultant who has extensive knowledge on the UDI framework and could become invaluable towards helping avoid fines, recalls, rejections, and unnecessary delays. It is advisable to manufacturers to develop a company-wide strategy, by assigning labellers who are responsible for the GUDID account; contacting an issuing agency to obtain a complex prefix; obtaining appropriate Dun and Bradstreet (DUNS) numbers or verify that your current information in the D&B database is correct; creating, transmitting, and tracking GUDID submission data to meet UDI requirements; and determining a GUDID submission option, either GUDID Web Interface or HL7SPL submission.
Despite the initial upfront costs for implementing UDI, there are significant short-term and long-term benefits that come along with it. Manufacturers stand to achieve significant cost savings from improved inventory tracking and management of recalls. The healthcare industry and public at large relatedly benefit from improved billing accuracy: a reduction in adverse events and reduction in fraud.
From a European perspective, manufacturers should take full advantage of becoming UDI compliant as quickly as possible, once the full requirements of UDI are confirmed within the new MDR. Medical device manufacturers that launch an all-encompassing UDI implementation plan as soon as possible will garner the best rewards. The risk of losing sales and damaging reputation is not worth delaying compliance. Companies that are proactive are set to gain competitive advantage and will reap the rewards more quickly. Using the example of the implementation of UDI in the U.S., there are significant lessons which Europe can learn—most importantly, being proactive and prepared when it comes to UDI compliance.