As we look toward the New Year, many medical device companies are considering the implications of the recently released UDI requirements, and are either planning or managing their implementations. Some companies that started the implementation process prior to the release of the Final Rule will still struggle to meet the timelines. The companies that are starting now, just putting together their plan and timeline, are anxiously applying each milestone to their plan. Implementing UDI or any project, we always look at the value the project will provide for the company.
Yes, UDI is the law and must be implemented, but let’s look at the value it can provide if implemented correctly:
- More accurate reporting on adverse events, and reduced time to retrieve and analyze information by your complaint group
- More accurate and timely information for your Corrective Action and Preventive Actions (CAPAs), leading to quicker resolution
- Reduced medical device errors (which is everyone’s objective: patient safety)
- Better analysis of devices in the market
- Better identification of devices, which will drive more efficient recalls
- Improved supply chains, reducing or eliminating counterfeit devices
Medical device companies, along with doctors and patients, will realize benefits from the UDI regulation. In fact, one of our experts was recently interviewed by Patient Safety Monitor Journal to discuss the value of UDI; the article can be accessed here.
The Final Rule is, well, final; so, the only exceptions have already been addressed in the rule. But, if you’re still wondering if additional changes will follow, understand that there is one factor that will change: TIME. The amount of time for your company to implement UDI and comply with the regulation is counting down, much as we’ll count down to the New Year.
Happy New Year!