Wednesday, September 19, 2012
Down to Details at the UDI Conference
It was down to details – and you know what they say about who’s in the details – at the UDI Conference Summit in Orlando this week. With the publication of the proposed UDI rule in July, this year’s conference was, not surprisingly, packed, mostly with global manufacturers. In fact, when Jay Crowley - senior advisor on patient safety for the FDA’s Center for Devices and Radiological Health –the FDA’s point man on UDI – asked who was in attendance, only one manufacturer said it was focused solely on the US market. That means the rest of them have to prepare not only for the US final rule, expected out next spring, but also comparable regulations in other countries. The European Commission is expected to issue its draft UDI directive this fall. But this week, it was all about the U.S.
Jay led the audience through the details of the proposed rule, some of which were a surprise, even to those of us who have been following the regulatory process ever since Congress included language mandating a UDI system in the FDA Amendment Acts of 2007.
If you need a primer on the basics of the proposed rule, check out the various posts on UDI in the Healthcare Hub. We also released the first video in a multi-part series on UDI yesterday. Watch it on YouTube.
Here are some things you might not know:
- While the proposed rule does not mandate a specific auto ID carrier, e.g., linear bar code, 2-D matrix, RFID, etc., Jay cautioned manufacturers to be “extremely cognizant” about the technological capabilities of providers when deciding which one to use. In other words, do your customers have the right technology, e.g., the scanners or RFID systems, to read the labels? Lack of the necessary technology is blamed for the relatively low utilization of barcodes on medications, which were mandated in 2006. As I have said before, if we don’t actually capture the unique identifiers, we will simply be adding regulatory burden, not value, to healthcare.
- The proposed date format (ex: SEPT 19 2012) is likely to change in the final rule. Jay said the FDA recognizes that the format can be very problematic for global manufacturers that have to comply with different ways of presenting the date in other countries. He called on concerned parties to provide suggestions as to better alternatives, or in other words, not just to complain about the proposed format.
- Using the new date format- whatever it ends up being- will be required for ALL medical devices (Class I, II and III) one year after the final rule is issued, not just covered products and not just when they need to comply with other aspects of the regulation.
- The FDA will release (likely in the next few weeks) a list of products that need to comply within 24 months after the final rule is issued; these are products that were described in the FDA Safety and Innovation Act as “implantable, life-saving, and life sustaining.” They are the second batch of products to be covered by the rule, the first being Class III devices that must comply one year after the final rule is published.
- There are a number of products that would be exempt from the rule as currently proposed, including ALL over the counter products, not just those in Class I as many people understood. Also, Class I products are not required to carry production identifiers (things like lot, serial number, and/or expiration date). The FDA has also exempted any products in the national stockpile, based on its general “hands off” policy in this area. Based on what I heard in the hallways, we can expect some provider organizations to take exception to these exceptions.
- The whole issue of direct part marking (DPM)– where a unique identifier would be required directly on products that are implanted in a body longer than 30 days or that need to be resterilized before reuse – is another area likely to be changed before the rule is finalized. Manufacturers expressed concerns about the potential impact on product quality or whether providers will even care; providers, meanwhile, said the fact that the DPM ID # can be different from the actual UDI # is contrary to the FDA’s intent to reduce ambiguity in how medical devices are identified. There’s further ambiguity around manufacturer requests for exemptions to the requirement. The FDA says it does not plan to respond if it is okay with such requests. Manufacturers say they want greater clarity, but I suspect, most just want the requirement to go away.
Clearly, UDI is a work in progress. Even when the final rule is out, there will be more to come, especially around how the UDI will be used for post market surveillance and supply chain security. Check out last week’s blog post about the role of UDI in the FDA’s newly released preliminary report on “Strengthening our National System for Medical Device Post Market Surveillance.” Jay clarified that the UDI rule in and of itself is NOT about enhancing and facilitating traceability of medical supplies, but once it is in place, those who make and use medical devices should expect the FDA to begin pursuing many of the same activities around epedigree and serialization currently underway in the pharma world.
In other words, the final rule will be anything but final….