Devices & Diagnostics

Unique identifier system should launch sooner and include unclassified and OTC devices

UDI is the missing link to protect patient safety. Tracking medical devices electronically in the supply chain will improve product recalls and adverse event reporting. Premier has these suggestions for getting the system right.

Premier strongly supports the implementation of a unique device identifier system and commends the FDA for issuing the proposed rule. UDI is the missing link to protect patient safety. Enabling healthcare providers to track medical devices electronically in the supply chain will improve the speed and accuracy of product recalls, as well as adverse event reporting. In addition, automating the now manual process of tracking of medical devices is projected to save the healthcare industry approximately $16 billion each year from greatly improved efficiencies.

Among other comments, Premier underscores that the proposed seven-year implementation timeframe is far too long, especially since we have already been waiting five years for UDI.

The seven year timeline applies to unclassified devices, many of which play roles akin to those of class II or III devices and raise important patient safety issues. Premier comments that such unclassified devices should not be treated any differently than comparable class II or III devices. Premier’s comments stress that the recently enacted FDA Safety and Innovation Act clearly demonstrates congressional interest in seeing relatively prompt implementation of UDI requirements. Premier urges FDA to complete the implementation of UDI requirements for all affected devices (with respect to labels/packaging) within two years of the effective date of the final rule.

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Additional highlights of Premier’s comments include:

All classes should be completed with UDI on label/package in two years and direct marked on device in three years.

· The proposed seven year staged implementation timeline is too long.

· All classes should be completed with UDI on label/package in two years and direct marking on implantable and other key devices in three years. Unclassified devices, many of which play roles akin to those of class II or III devices, should not be treated any differently than comparable class II or III devices in meeting implementation timeline requirements.

Providers need to be excluded from UDI labeler requirements

· The proposed UDI requirements would apply to device labelers. While this is normally the device manufacturer, in some cases a labeler could be considered a specification developer, single-use device reprocessor, convenience kit assembler, repackager, or relabeler.

· Hospitals, healthcare systems, and other entities that repackage devices, assemble kits, or reprocess single-use devices for internal use only should not be subject to UDI-related requirements, even when the repackaged products, assembled kits, or reprocessed devices must cross state lines in the process (for example, because the healthcare system includes facilities in more than one state).

Items in convenience kits need UDIs

· FDA proposes that a combination product whose primary mode of action is that of a device would be subject to UDI labeling requirements, and each device constituent part of a combination product would need to have its own UDI unless it is not possible for the device constituent part to be used except as part of the use of the combination product.

· FDA also proposes to require a UDI on the label and device package of each convenience kit, as well as a distinct UDI for each device in a convenience kit, unless an included device is intended for a single use. To ensure patient safety, any item within a combination product that may be used independently or any item within a convenience kit that may be used more than once (whether or not intended for single use) should be individually labeled with a UDI.

Retail and over the counter products should not be excluded from UDI

· The proposed rule provides an exception to the UDI requirements for devices that are sold at retail establishments, such as drug stores, and this proposed exception would apply even when such devices are sold directly to a hospital, nursing home, or other healthcare facility. Some of these retail products include automatic external defibrillators, insulin syringes and glucometers.

· These products should be subject to UDI requirements, including submission into the GUDID, but their UPC should be deemed to be the UDI for this purpose.

GUDID product entries should include recall status upfront

· Under the proposed rule, FDA would establish the GUDID, which would contain critical information submitted by device labelers on the attributes of medical devices and which would be publicly accessible without charge.

· In the final rule, FDA should provide more information about how device recalls will be handled in the context of the GUDID, and what the responsibilities of FDA, manufacturers and others will be in this process.

· Recall information should be readily accessible through the GUDID. When a hospital accesses the listing or entry for a device in the GUDID, it should be readily and immediately apparent if a recall applies to that given device. In addition, FDA should ensure that all device recall notices sent to hospitals and others include the UDI(s) of the product(s) being recalled.

Date Format needs to be ISO (yyyy-mm-dd and not Oct 18, 2012)

· FDA proposes a standard formatting for dates provided on medical device labels: Month, Day, Year, with the month shown as a three-letter abbreviation, the day shown in modern Arabic numerals and the year shown in modern Arabic numerals (e.g., JAN 3, 2012 and SEP 30, 2012).

· FDA should instead mandate adoption of the International Standards Organization (ISO) date standard (e.g. yyyy-mm-dd). This alternative is preferable given the global nature of device distribution and because dates in this format can be more easily sorted by computers.

Support FDA’s proposed UDI ruling on direct part marking but acknowledge that there are exceptions:

· FDA proposes that implantable devices intended to remain implanted continuously for a period of 30 days or more, devices intended to be used more than once and sterilized before each use, and stand-alone software that is considered a device, would all need to be directly marked with a UDI in addition to a UDI on the device’s label and package.

· FDA should modify its proposal to require all implantable devices (with certain exceptions) that will be implanted for 24 hours or more should be subject to direct marking requirements, not just those slated to remain implanted for 30 days or more. FDA should also provide further clarity on how direct marking will work in the case of stand-alone software. Additionally, direct marking of devices should be required within three years of the effective date of the final rule.

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