Preparing for UDI in Europe

By Steve Cottrell, Madris Tomes
September 1, 2016


• Categories: 03-Manufacturing Execution, 04-Product Design & Development, 05-Quality/Regulatory

A draft version of the new Medical Device Regulations (MDR) has been released in Europe and medical device manufacturers should start preparing for the adoption of Unique Device Identification (UDI). To have a better grasp of what it really means to be “UDI compliant”, it is worth looking at exactly how the program was rolled-out in the United States to understand their approach to the new process, what challenges occurred and what business benefits ensued.

When UDI was first announced, there were varying interpretations and expectations surrounding its introduction in the United States: The FDA, medical device manufacturers and the healthcare sector had differing views. The healthcare sector was hoping for a more accurate method for the identification of the products, the medical device industry was looking forward to improved inventory control, and the FDA hoped for a unique and adaptable solution.

Varying Interpretations

FDA Perspective. The FDA intended to replace the barcoding system with one that facilitates global identification, namely UDI. This process has two main elements: A device identifier (DI), which is a mandatory, fixed portion of the UDI that identifies the labeller and the version or model of device; and a production identifier (PI), which is a variable portion that identifies lot or batch number, serial number, expiration date, manufacture date, etc.

To assist manufacturers with compliance with the new system, the FDA established a seven-year timeline, which was divided in stages, with five different deadlines depending on the Class of the device. This system is intended to lower the financial impact for manufacturers.

The FDA also administers the GUDID (Global Unique Device Identification Database), a publicly available database.  This was created to house the device identification (DI) attributes in a single system. Medical device manufacturers must submit information to GUDID by specified compliance dates, primarily based on risk class.

Healthcare Perspective. The main concern of healthcare providers was the high costs and the technical difficulties that the implementation of UDI would have brought. Mercy Health conducted a demonstration project for the FDA in which it implemented prototype UDIs for cardiac stents in its electronic data systems for safety surveillance and research purposes. Mercy Health reported that its inventory tracking system requires serial numbers. Manufacturers already use a lot of numbers, which subsequently created more confusion. The study also found that device descriptions were not standardized, so Mercy Health had to use multiple descriptions for each UDI. Conversely the study reported that an inventory check at one Mercy Health facility indicated an $800,000 value. After it implemented the UDI system for six months, it found an inventory value of about $1.5 million.  This resulted in significant cost savings from curbing excess inventory.¹

Manufacturers’ Perspective. Initially medical device manufacturers upheld a significant amount of negativity towards UDI adoption, especially because of a required labeling revision as well as several other processes that would need to be adopted in order to meet UDI compliance standards.

However, some manufacturers could see that UDI is not only a regulatory compliance process, but also a stepping-stone towards global regulatory harmonization, and they saw the chance to garner positive results and substantial business benefits from its implementation.

In fact, one global device manufacturer stated that the early standardization of labels saw duplicate items/stock keeping units reduced by 15%. Labeling content management firm Kallik reported that a U.S.-based life sciences company that specialized in medical devices and implants needed to make 10,000 labeling design changes to comply with UDI’s compliance date in 2014.²

Non-Compliance Ramifications

Manufacturers that do not adopt UDI should be aware of the severe consequences of not meeting compliance standards. The FDA can determine to not only fine manufacturers, but also to ban them from selling their products across state borders. The agency can also prohibit the importation of medical devices into the United States from particular European manufacturers that do not comply with UDI.

Customers can also reject devices that are not equipped with UDI; and in extreme cases, the manufacturer might abandon the product all together. It is not hard to imagine the strong negative impact that these consequences can have on a business, such as a loss in sales and damage to reputation. In light of these factors, implementing UDI is not an option, and companies should start incorporating it into their business as soon as possible.

Business Benefits of Prompt Compliance

Manufacturers will achieve long-term benefits from prompt adoption of UDI (i.e., significant savings thanks to having an improved inventory control on hand). Also a more efficient tracking process can bring a reduction in counterfeit devices and will help towards better administration of ‘trunk’ inventory. Moreover, a directory of every manufactured product allows manufacturers to easily identify outdated products and to remove them from the catalogue.

The incorporation of UDI into procedures for MDR generates more transparency and improves public safety. Patient safety also benefits, because hospitals can use UDI data to check and verify which devices the staff uses on which patient. Thanks to this system, a faulty device can be identified quickly, and the patient’s treatment will be more efficient.

Another advantage comes from a broad database that speeds up the process in the case of company mergers and acquisitions. The companies involved in this activity can use the data provided from UDI to perform their preliminary checks and risk assessments.

Thanks to UDI, post-market surveillance activities will be much more efficient, as it enables faster and more accurate product identification, which in turn accelerates the process of recalling defective devices.

What’s Next?

In order to implement UDI, a few essential steps can help manufacturers go through the calculated process without encountering significant difficulties. First, it is worthwhile for the business to check if there are existing products that are already adopting UDI regulations and find out if they will be compliant before the deadline. Then, manufacturers should plan a strategy that involves the entire company, as the most effective UDI process must extend across multiple departments.

It is important to understand that only when UDI is implemented correctly will it lead to consistent benefits for each manufacturer. For this reason, it is advisable to name a dedicated project manager who can also be supported by an external consultant with significant experience in this field, in order to be well positioned to prevent unnecessary problems or delays.

Conclusion

Thanks to the lessons that European manufacturers can take from the United States, the process to achieve full compliance for UDI requirements should be more streamlined.

After overcoming the initial obstacles, medical device manufacturers will experience significant benefits (conversely, in the case of non-compliant manufacturers, there are serious business ramifications). As demonstrated in the United States, the most proactive manufacturers stand to gain the greatest rewards, and the returns outweigh the initial expenditure.

References

1. Drozda, JP, et. Al. (December 2013). “Advancement of innovative methodologies and medical device specific infrastructure for evidence-based regulatory science and public health surveillance: implementation of unique device identification demonstration projects”, final report.
2. Goldie, A. (April 14, 2014). “Delivering ROI from UDI”. Retrieved from: Kallik.com.