Tips and tricks for medical device manufacturers to ensure they meet the upcoming UDI deadline.
Steve Cottrell and Madris Tomes
The American Hospital Association (AHA) saw the need for the medical device industry to have a single identification system for all medical devices. Even though previously it was possible to track and identify various medical devices, a global unified system was lacking.
In 2007 Unique Device Identification (UDI) was implemented by Congress in line with the FDA Amendments Act, which was then followed by the publication of the final rule in 2008. In order to be able to correctly identify medical devices through their distribution and use, the FDA used the final rule to implement different compliance dates for all new UDI requirements.
Despite the significant efforts required by manufacturers to properly implement UDI, there are benefits that come with it too, particularly for manufacturers who comply early. The advantages are increased sales, improved inventory control and medical billing accuracy, as well as more time for the identification and resolution of product issues.
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In order for manufacturers to get the most out of UDI implementation, it is important for them to remember that the rigid requirements are not only a regulatory compliance process but also provide an open door for harmonized global regulation that will create advantages for patients and companies alike.
Implementing UDI as soon as possible and ensuring that all deadlines are being met will generate significant business benefits for manufacturers. The next compliance date is fast approaching--September 24, 2016.
Here are 8 tips that will help manufacturers to both meet the next UDI deadline and reap the benefits of prompt compliance:
Using UDI labels in diagnostic instrument systems will allow FDA and in vitro diagnostic (IVD) manufacturers to identify any problems with medical devices that are being used for clinical purposes. Despite the plethora of advantages, there are a few challenges, particularly in the confusion around labelling the products. For example, with blood diagnostic equipment, one manufacturer may register the machine as a whole unit whereas another manufacturer may label each entity separately. It is still being decided which method is correct.
Exemptions to UDI
Products that have been manufactured and labeled before their compliance dates are exempt from the UDI labeling requirement, according to FDA. These devices are exempt from this requirement for three years with the condition that the data is filed with the Global Unique Device Identification Database (GUDID). Another possible condition for UDI exemption is when the requirements don't look technically feasible. Other cases of exemption could be for products that are meant to be solely for research or educational purposes and also for custom and investigational devices.
It is important to clarify that the inventory and labeling exemptions should not be used by manufacturers to postpone UDI or as a way to avoid the system all together. Adopting this mind-set will have negative repercussions on the competitive aspect of the business, because hospitals and healthcare companies might already have implemented an inventory system which conforms to UDI requirements and they might decide not to accept products that don't have a UDI label.
Another aspect that must be considered is that FDA will have to handle a huge number of exemption requests; which could bring about significant delays. If FDA later denies the exemption request, then that labeler will have to act quickly in order to meet the UDI compliance deadlines. This is not a process which people can rush through.
Serialization & Submissions
Any high-risk device that previously required a serial number must continue to retain a serial number with UDI. Due to high-profile safety concerns, the healthcare and medical device industries have strongly stressed that a more detailed identification system for re-used devices is needed.
Any device manufacturer's labeler must enter a range of data for a GUDID submission. This information includes: company name, contact information, device count, model and/or catalog number, device description, commercial distribution status, quantity per package (if applicable), device status (human cell or tissue, kit, or combination product), FDA listing, and more.
Even though FDA is currently not collecting information for certain fields which are required for UDI it is a good idea for manufacturers to continue to collect all data required by the UDI final rule as there could be a change in the GUDID submission fields or the manufacturer could come under audit.
FDA's classification of medical devices depends on patient safety risk. For this reason a Class I product can be subjected to lesser controls than a Class III device, which will more than likely face a high level of scrutiny. CMS also defines risk under its own terms, based on fraudulent claims, billing of counterfeit products, and other associated infractions.
It is apparent that serious action needs to be taken to reduce fraud in the healthcare sector. Not only would it substantially benefit the healthcare and medical device industry, but it would also have positive ramifications on the public. For this reason, any effort instigated to reduce fraud should be closely followed. Asking for a UDI with a serial number for any high-risk device before payment should reduce fraud and also resolve the issue of the "pay first and investigate later" system.
It is ideal for medical device manufacturers to include UDI in all operations for Medical Device Reporting (MDR) complaints, corrections, service reports, and recalls. This should enhance a manufacturer's postmarket surveillance activities as well as aid any recall processes.
The benefits from a correct tracking process are significant; these can range from a decrease in the production of counterfeit products to better administration of "trunk" inventory and consignment products.
Manufacturers should introduce UDI into every process for MDR as soon as it becomes required on device labels. This will generate more transparency and will increase overall public safety.
Mergers and acquisitions (M&A)
UDI can also be extremely helpful when it comes to business acquisitions. When both parties involved are conducting their due diligence, having access to the information provided by UDI makes this process much easier and as seamless as possible.
Don't slack on compliance deadlines
In order to comply with UDI and avoid any unnecessary delays, it is necessary for manufacturers to have a deep understanding of what exactly is involved in the process of becoming UDI compliant.
Before any manufacturer commits to making significant changes within their business, they should conduct a proper readiness assessment to understand if any devices are already meeting any of the existing requirements. Appointing a project manager is also recommended, as that person can create a strong team that will use their expertise to avoid unnecessary errors and take responsibility for the entire process.
The long-term benefits that will come from implementing UDI range from better product traceability, more transparency for complaints handling, and a system-wide reduction in counterfeit products. Implementing UDI into systems should be seen as the perfect opportunity to restructure organizations to achieve maximum benefit.
It is easy for manufacturers initially to be put off by the hefty costs that come with implementation, but the benefits for the bottom line and the business as a whole will far outweigh the initial monetary investment.
The cost of noncompliance can cause ongoing issues for manufacturers and open the door to a continuous legal battle. Manufacturers need to understand the intent of the final rule. Manufacturers who launch a comprehensive UDI implementation plan will garner the biggest rewards in the long run.
Steve Cottrell is the president of Maetrics and is responsible for the client service delivery, growth, and overall performance of the company.
Madris Tomes is CEO and founder of Device Events, a web-based software platform that is focused on the medical device domain and provider space, to intelligently search large data sets.
[Images courtesy of ATIBODYPHOTO/FREEDIGITALPHOTOS.NET, MAETRICS, AND DEVICE EVENTS]
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