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| Under the FDA's newly enacted UDI rule, devices must be shipped with a unique identification label. (Click to expand.)--Courtesy of the FDA |
The FDA originally proposed requiring implantable medical devices to bear a unique device identification code on their surface. But industry protested that part of the proposed rule, so the agency ultimately opted to rely on packaging as the surface for UDIs. However, some orthopedics are removed from their packaging well before surgery or implantation, forcing the FDA to make a change on the fly.
The agency delayed the UDI labeling deadline by two years to Sept. 24, 2016, for single-use orthopedics that are intended to be sterilized before use. The Regulatory Affairs Professional Society points out that the agency previously issued an extension for Class III contact and intraocular lenses, but this one affects a far greater number of devices.
Orthopedics are often stored in nonsterile sets so that surgeons can correctly, quickly and efficiently identify the necessary implant. However, those implants present unique challenges to the UDI system because they are separated from their packaging during cleaning. As a result, they are not accompanied by their UDI label or package with UDI label up to the point of implantation, the FDA said in a letter on its website.
In general, the agency is relying on UDIs to be on an implant's label or packaging, but that will not be the case for nonsterilized metal surgical mesh, spinous process plates, intervertebral fusion devices, and the lengthy list of other affected devices specified in the letter.
The letter specifying the policy change mentioned a meeting with medical device trade association AdvaMed and industry bigwigs Medtronic ($MDT), Stryker ($SYK), Smith & Nephew ($SNN) and Johnson & Johnson's ($JNJ) DePuy.
During the August meeting, AdvaMed presented strategies that can be used to achieve the goals of unique device identification--such as device monitoring and improved recalls--for orthopedics organized in nonsterile sets. One of the strategies is direct marking of the UDI onto the implant's surface, according to the presentation's slides. That would harken back to the FDA's original idea for displaying the device identification code.
According to AdvaMed presentation slides, the overarching concern expressed by clinicians is, "do not lengthen surgical time and continue rapid access to implantable devices."
Whatever solution the FDA and industry come up with must now be implemented by 2016.
- read the FDA letter (PDF)
- here are the AdvaMed presentation slides (PDF)
- here's Regulatory Focus's take on the news