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
“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
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
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,
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
intended to be used more than once, and which are intended to be sterilized
before each use; and
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
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
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
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