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A variety of hospital and medical device stakeholder groups praised the Food and Drug Administration for issuing a proposed rule that would require devices to carry a unique device identifier (UDI), but offered vastly different suggestions on how the agency should implement the rule.
The American Hospital Association, the Premier healthcare alliance, a patient safety coalition group, and two major device groups praised FDA for taking a risk-based approach to implementing the rule.
Hospital and provider groups told FDA in comments submitted to FDA ahead of a Nov. 7 deadline that the agency should speed up its implementation of the proposal, while device makers urged the agency to take its time.
FDA is required to issue a final rule six months after the comment period closed. The proposed rule would phase in over seven years the requirement that many device labels and packages include a UDI based on international standards. According to AHA, Premier, and the Advancing Patient Safety Coalition, that is too long.
“The country should not have to wait until 2020 (seven years after the publishing of a final rule in 2013) to realize the patient safety benefits of a fully implemented UDI system,” AHA wrote in a letter, referring to the date when the final class of devices is covered.
According to Premier, “UDIs must be adopted as quickly as possible for all devices in order to achieve the intended benefits in a sufficiently timely way. We urge 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.”
Premier said direct marking on implantable and other key devices should be required within three years of the publication of a final rule. Unclassified devices, many of which play roles akin to those of class II (moderate risk) or III (highest risk) devices, should not be treated any differently than comparable class II or III devices in meeting implementation timeline requirements, Premier said.
The Healthcare Supply Chain Association (HSCA), which represents group purchasing organizations, noted that proposed rule requires a standardized format for dates appearing on medical device packaging and labels. HSCA said FDA should adopt the ISO (International Organization for Standardization) standard for the date format on device labels, which is the year-month-day order.
FDA said it is proposing a risk-based, phased-in approach to implementation, focusing on the highest-risk (class III) medical devices first and exempting low-risk devices from some or all of the requirements, which all the groups praised.
Yet the Advanced Medical Technology Association (AdvaMed), along with the Medical Device Manufacturers Association, told FDA they would like for the agency to institute a two-year effective date for class III devices, instead of one year as proposed.
“A two year effective date would provide a considerably better time period for an orderly and uninterrupted transition to UDI for these important and FDA approved class III devices,” AdvaMed wrote.
MDMA suggested that not only should FDA allow two years after the final rule before requiring class III product information to be included in the FDA database, but all other deadlines should be extended accordingly by one year.
MDMA said FDA underestimated the costs to the health care system from implementing UDI, and said the two-year delay is necessary “to ease the economic burden to comply in these economically challenging times.” In addition, MDMA said the agency should reissue the proposed rule with changes before finalizing the UDI regulation.
The UDIs were first required under a 2007 law, but that law did not establish a deadline for FDA to issue a regulation. A law signed by President Obama in July (Section 614 of the FDA Safety and Innovation Act) established a schedule for issuing a proposed and final UDI rule.
FDA July 3 released its proposed plan to label medical devices with UDIs. A UDI is a unique numeric or alphanumeric code that includes a device identifier, which is specific to a device model, and a production identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number, and/or expiration date (6 MELR 442, 7/11/12).
During a Nov. 8 call with reporters, Janet Trunzo, executive vice president, technology and regulatory affairs at AdvaMed, called the UDI proposal “one of the most complex rules” to come out of the agency in some time. As a result, Trunzo said “it is imperative for FDA to get it right.”
The UDIs will enable FDA to access data maintained by government agencies, insurers, and hospitals to determine which devices have a high degree of failure. That information will be accessible to all stakeholders, including patients, doctors, regulators, and consumer advocates, FDA said.
Despite the different recommendations for implementation, a UDI system would be helpful for providers as well as device manufacturers.
According to Premier, “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, Premier noted that automating the now-manual process of tracking of medical devices is projected to save the entire health care industry approximately $16 billion each year from greatly improved efficiencies.
The proposed rule cited the many benefits that will accrue to patients, ranging from ensuring that the right device is available, to ensuring that patients receiving recalled devices are notified and treated, and allowing for better postmarket surveillance. According to AHA, information about UDIs also can be incorporated into electronic health records (EHRs).
“Hospitals are committed to using the UDI and have been investing in barcoding and other technologies to track medical devices, pharmaceuticals and laboratory specimens, and to ensure that patients receive the right items and services,” AHA wrote. “Hospitals also will be increasing these investments in coming years due to federal requirements under the Medicare and Medicaid EHR Incentive Programs to use these technologies as part of their electronic medication administration records.”
According to the proposal, the UDI would need to be displayed on the label and package of medical devices, and a different UDI would be required for each version or model of a device.
Certain devices for which the labeling requirement alone might not be sufficient would also be directly marked with a UDI, allowing accurate identification even when the device is no longer accompanied by its label or package, FDA said.
The types of devices that would be subject to the direct marking requirement are:
• implantable devices;
• devices intended to be used more than once, and which are intended to be sterilized before each use; and
• stand-alone software.
FDA's rationale for requiring individual marking of these devices is that they are in use for long periods of time and are likely to be separated from their labels and packaging. The proposed rule would require direct marking only of implantable devices that are intended to remain implanted for 30 days or more.
AHA urged the agency to require direct marking of all implantable devices and all devices intended for more than one use, not just those that must be sterilized before each use.
AHA also recommended that FDA remove the 30-day qualification. “Direct marking is important for patient safety. Faulty devices, whether implanted for three days or 30 days, pose significant safety risks that must be addressed as quickly as possible,” AHA wrote. “It also would be easier to administer a requirement that applies to all implantable devices, rather than using an arbitrary time frame such as 30 days.”
The Advancing Patient Safety Coalition also recommended that all implantable devices be subject to direct marking requirements.
“We believe this would be preferable from a patient safety perspective and simpler and easier to implement than the proposed approach of allowing the FDA commissioner to determine, on a case-by-case basis, whether devices implanted for periods of less than 30 days must be directly marked,” the group wrote.
AdvaMed said FDA has not provided a clear definition of direct mark and what may be construed as a direct mark. “This will create an intolerable state of uncertainty whereby a FDA field inspector may challenge an exception leading to regulatory sanctions despite a company's good faith analysis of §801.50(e),” which allows for exceptions to the direct marking requirement.
AdvaMed recommended that FDA add to the final rule “categorical exceptions” for certain types of implants that are unable to be directly marked and subsequently read by scanner or human: e.g., absorbable implants (such as absorbable suture); amorphous devices (such as bone cement); devices the surface of which must remain undisturbed to function properly (such as contact lenses or drug coated devices); and implantable devices that are remodeled or encapsulated by the body (such as internal surgical tape).
By Nathaniel Weixel
More information about the UDI is at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm.
Comments from AHA are at http://www.aha.org/advocacy-issues/letter/2012/121106-cl-fda-2911n-0090.pdf.
Comments from AdvaMed are at http://advamed.org/NR/rdonlyres/80D3EA2E-019B-448B-9CD3-1618AD87F820/0/101182012PDFMark.pdf.
Comments from MDMA are at http://op.bna.com/hl.nsf/r?Open=nwel-8zuua3.
All comments are at http://www.regulations.gov under docket FDA-2011-N-0090.
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