In addition, respondents estimated they'd have to spend $2.8 billion in total to recall and reconfigure non-compliant equipment.

Retail exceptions

In addition to the timeline, GPOs and manufacturers are also somewhat split on the issue of medical products sold at drug stores. The FDA's proposed rules contain an exception for requiring UDI labels to products sold at retail outlets.

AdvaMed thinks the FDA should keep the rule as-is, and that all non-prescription retail products should be able to use the ubiquitous Universal Product Code "as an adequate unique device identifier." The group says that the UPC does what the UDI is meant to do and enables products to be accurately tracked.

But GPOs seem wary, at least in part. "Some of these retail products include automatic external defibrillators, insulin syringes and glucometers," Premier said. While Premier said the UPC could count as a UDI, they should still be subject to the UDI requirements, such as reporting to the product database.

Novation also backs limiting or doing away with the retail exception. "Novation does not believe a blanket exception of Class I devices sold in a retail setting is appropriate, nor in the best interest of patients," the GPO said in its release.

More exemptions

The manufacturers also want the FDA to create a specific list of devices that would ordinarily require direct marking, such as implantable devices, but are exempted from the requirement. Under the proposed rule, companies can "self-exempt" products that can't be directly marked, but the manufacturers worry that without a clear, explicit list of exempted devices they could be challenged by FDA field inspectors and receive citations or warning letters.

"We're requesting and have submitted a list of devices that are intrinsically unmarkable, and we go into details of what that would entail," Jeff Secunda, AdvaMed's VP of technology and regulatory affairs, said on a press call. Examples would include small dissolvable objects like absorbable sutures or amorphous ones like bone putty.

They also want to expand an exemption for lower-risk products sold in dispensing packs. Under the proposed rule, Class I items sold in boxes need a UDI for the box, but not each individual product. AdvaMed wants to expand this to all devices.

More broadly, the group questions the wisdom of direct marking implantable products in general, arguing that it makes more sense to have the packaging labeled, which would then be scanned before the device is implanted, with the scanned information getting logged into a patient's electronic health record.

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