Earlier this year, medical device manufacturers could only speculate about the impending changes of the new European Medical Device Regulations. Now that the draft versions have been released, manufacturers are in a better position to prepare before the regulations are formally adopted. The texts confirm that among the new measures to be implemented is unique device identification (UDI), a system to precisely identify medical devices through distribution and use. Introducing UDI to Europe is no small feat. However, manufacturers do not have to start from scratch – they can draw from the experiences of the medical device industries in the U.K. and the U.S.
In 2013, the Food and Drug Administration (FDA) published the final rule setting out a series of compliance dates for UDI requirements in the U.S. To allow manufacturers to implement UDI in stages, the FDA set out a seven-year rolling timeline. The U.K. National Health Service (NHS) provides a second model for manufacturers, with the Department of Health publishing its e-procurement strategy in 2014, imposing its own version of UDI.
Like the NHS, the FDA brought in third-party issuing agencies to assign UDI codes. These organizations are GS1, a global barcoding organization; the Health Industry Business Communications Council (HIBCC); and the International Council for Commonality in Blood Banking Automation (ICCBBA) for medical products of human origin. The FDA also runs the Global Unique Device Identification Database (GUDID), which was created so that every medical device with a device identifier (DI) could be logged into a single system.
By launching UDI measures, both the FDA and the NHS sought to increase patient safety and improve transparency and efficiency of hospital care. In addition to these benefits, manufacturers stand to benefit in several ways by meeting UDI requirements, offsetting the costs that implementation entails.
Where to begin
Preparing for UDI is a process requiring considerable time, money, and resources. Careful planning from the outset will help avoid unnecessary, avoidable costs.
Manufacturers should begin by conducting an assessment of existing products to find out if they are already complying with UDI regulations or if they will be compliant before the deadline. They should then develop a companywide strategy to achieve compliance rather than isolating UDI activities, as the compliance process should involve multiple departments and functions.
The strategy should include:
- Assigning labelers responsible for the GUDID account
- Contacting an issuing agency to obtain a complex prefix
- Obtaining appropriate Dun and Bradstreet (DUNS) numbers or verifing that database information is correct
- Creating, transmitting, and tracking GUDID submission data to meet UDI requirements
- Determining a GUDID submission option, either GUDID web interface or HL7SPL submission
Proper implementation will produce significant benefits for manufacturers, so appoint a dedicated team and project manager with external support where necessary. An external consultant with comprehensive knowledge of UDI can help prevent fines, recalls, rejections, and unnecessary delays.
The overarching aim of integrating UDI into company systems is to adopt more thorough tracking and inventory procedures, and the advantages go beyond compliance with regulations. Creation and management of a platform for tracking, cataloging, and entering information required for UDI compliance will improve all internal processes.
Efficient tracking platforms will increase the visibility of counterfeit products, while enabling better management of trunk stock and consignment inventory. In addition, a database of every manufactured device allows closer scrutiny of product portfolios, making it easier to spot outdated products that should be removed.
Comprehensive databases will prove invaluable in the event of mergers and acquisitions. Both companies involved in a proposed union can use UDI information to perform preliminary checks and risk assessment, likely speeding up the process while giving peace of mind about the transaction.
Patient safety is strengthened by improved medical device traceability. One illustration is that hospitals can use UDI data to verify which devices are used by staff on individual patients. In cases involving contaminated devices, for instance, hospitals can quickly identify and treat affected patients.
Finally, UDI will contribute significantly to post-market surveillance activities. When products have to be recalled, the absence of sufficient data prevents manufacturers and medical staff from gaging the full extent of the problem. UDI will allow faster and more precise identification of defective devices.
Pitfalls of non-compliance
Implementing UDI in the U.K. and the U.S. has raised technical, operational, and administrative challenges. This is why, in the early stages of UDI proposals in the U.S., there were mixed opinions among medical device manufacturers.
Negative reactions were fueled by the scale of labelling and operational changes which UDI implementation requires. Some manufacturers did not like the extent of oversight now afforded to the FDA, while others considered the UDI measures an effort to bring the device industry up to par with the pharmaceutical industry’s anti-counterfeit and serialization methods.
Complacency toward UDI is not an option, as tardy compliance may have serious commercial consequences. In the event of non-compliance, the FDA can fine culprits or even ban manufacturers from selling their products across state lines, and it can prohibit European manufacturers from importing devices into the U.S. These sanctions can lead to a loss in sales and damaged reputations. In extreme circumstances, customers might not accept a product without UDI, and sometimes the manufacturer might have to abandon the product all-together.
In light of the consequences of non-compliance – and the potential benefits to be reaped from implementation – medical device manufacturers should not hesitate to kick-start a UDI plan. Each business should consider how it can address its specific needs in this evolving environment. Correct and early implementation of a UDI system will help manufacturers keep up with existing and new products.
As UDI improves post-market surveillance, proactive companies will be able to address glitches faster and gain a competitive advantage. Establishing UDI systems with a view to bolstering existing processes, such as post-market surveillance, will produce the most gains. The long-term returns of UDI are expected to outweigh the initial investment.
About the authors: Steve Cottrell is president of Maetrics and can be reached at 610.458.9312 or firstname.lastname@example.org. Madris Tomes is CEO of Device Events and can be reached at 240.424.8562 or email@example.com.