Ortho Companies challenge the FDA’s directive on Unique Device Identifications (UDIs)
Orthopedics company Globus Medical asks FDA to exempt already-distributed implant inventory from the Unique Device Identifier (UDI) labeling rule.
The long shelf life and uncommon business model of orthopedic implants is presenting a hitch in implementing FDA’s Unique Device Identification (UDI) labeling rule. Orthopedics company Globus Medical Inc. recently sent a Citizen Petition to the agency asking for exemption from the rule for some of it implants.
FDA’s UDI rule requires that a UDI be included on medical device packages and labels, though the rule is being phased in gradually, with different deadlines for different classes of devices. Companies have until September 24, 2015 to add a UDI to “implantable, life-supporting, and life-sustaining devices,” and until September 24, 2016 to put a UDI on labels and packages of Class II devices.
Globus Medical sells devices that must meet either of these two compliance dates, but has asked that FDA consider devices distributed but not yet sold by the deadlines to be exempt from the rule. The company explained in its petition, “UDI labeling would be applied to all products in accordance with the FDA schedule and existing inventory would be consumed without relabeling for UDI. The reason for this request is that the distribution model for orthopedic implants is unlikely to result in complete inventory consumption within the allotted three year post implementation deadline.”
The stumbling block lies in the fact that Globus’ orthopedic implants are distributed to hospitals, but are not billed for or sold until the implant is actually used in a patient. Kelly Quick, senior group manager of Business Processes at Globus, wrote in the petition, “Implants such as those manufactured by Globus are provided in surgery sets and the surgeon chooses the options they need from the set to implant a single device or build a construct based on the patient anatomy, size, or other patient needs. Once the implant is used, it is documented and the facility bills the patient. Globus in turn, bills the user for the devices consumed. Neither the institution nor the surgeon purchases the implants prior to use and then re-bills. This means at any given time, there is a significant portion of Globus‘ inventory which is in commercial distribution, but remains owned by Globus as it has not yet been consumed.”
Quick also noted that implant sets are reused after used inventory is replaced in the set and unused parts are resterilized. “Replenishments for the parts that were used are shipped from Globus to the hospital or field sales to complete the set once again. These replenishment parts would contain appropriate UDI labeling on or before the compliance dates . . .”
FDA has acknowledged Globus’s request, but has not yet made a response or issued a decision on the matter.
Another orthopedic company, Orthofix Inc., wrote a petition to FDA a year ago with a similar request. Orthofix requested that its Class I reusable devices labeled before September 24, 2018 be exempted from the rule, in part because such instruments are loaned to doctors and it would take a recall to get all the products back for re-labeling.
FDA sent an interim response to Orthofix seven months later, in mid-December, saying that the agency has not reached a decision “because it raises issues requiring further review and analysis by agency officials.”
Marie Thibault is the associate editor at MD+DI. Reach her at firstname.lastname@example.org and on Twitter @medtechmarie.