As the provider community stresses prompt implementation, manufacturers call for clarifications to the proposed UDI regulation and extended compliance timelines.
By David Vaczek, Senior Editor
While industry generally supports the objectives of a unique identification system for medical devices, implementing it will take longer than envisioned by FDA in its proposed regulation, according to some device manufacturers responding to the agency on the proposed rule.
In comments submitted to the agency (www.regulations.gov
; Docket No. FDA-2011-N-0090) by a November 7 comment deadline, companies expressed support for FDA’s neutral position on AIDC (automatic identification data capture) technology, the risk-based implementation schedule, and the goal for a globally harmonized system.
But manufacturers advised they will need additional guidance and opportunity to review and respond as the final regulation is developed, as they face substantial investment and costs associated with UDI marking and data reporting.
“The objectives of the UDI system as described in the proposed rule are extremely ambitious. Successful implementation of the entire system will take years and the concerted effort and cooperation of FDA, industry, and device users,” wrote AdvaMed.
“We believe that by far the most daunting aspect of the UDI system will be the collection, verification, validation, and transmission of device data to the UDI database (Global Unique Device Identifier Database, GUDID),” AdvaMed said.
GS1 and the GS1 Healthcare Workgroup reported differing opinions among users on the ability to meet the implementation dates. “GS1 and GS1 US would simply note that based on its discussions with its user community, further widespread and detailed education by the FDA is strongly recommended due to the complexity of the rule and the interchangeable and developing relationship between its parts.”
Companies weighed in on a scope of rule provisions that FDA will need to firm up for the planned issuance of a final regulation by May 2013. Among them: timelines for compliance, the rule’s application to existing inventory, exception processes, when model changes require a new UDI, which devices will require direct part marking, marking for combination products, kits, and higher packaging levels, and data requirements and timelines for reporting to the GUDID.
FDA last month amended the proposed rule to require UDI on implants, life-supporting, and life-sustaining devices two years after the final rule, conforming with recent Food and Drug Administration Safety and Innovation Act (FDASIA) requirements.
The amendment defines a subset of Class II devices falling into the category for which a two-year rather than three-year time line applies. (FDA has listed product codes for devices in the category in docket FDA -2011-N-0090 (Ref. 12)). The amendment doesn’t affect Class III devices for which UDI labeling is required one-year after final rule.
Companies called for extending UDI coding timelines for the device risk classes, and indicated broad support for extending the effective date for a standard date format beyond the proposed one year after final regulation.
TIMELINES FOR UDI LABELING
Arguing for a more gradual implementation, B. Braun said the proposed effective dates for UDI for Class III and Class II devices and for the standard date format are insufficient. “The one and three year implementation times for Class III and Class II devices respectively are not adequate time frames to complete these tasks.”
Abbott and Zimmer joined other firms calling for extending the timeline for Class III devices from one to two years after final rule.
Zimmer proposes extending effective dates by class, with corresponding date extensions for direct part marking (DPM) and GUDID submission. Class III marking would be required two years from the final rule, rather than one year, with DPM and data base compliance four years after publication. The timeline for Class II devices should be pushed from the proposed three years to four-years, except for Class II implantables and life-sustaining devices now requiring the UDI two years after final rule.
Terming the current effective dates for UDI labeling as “generally reasonable,” AdvaMed also urges an extended effective date for Class III devices from one to two years.
“Phasing in UDI requirements over several years allows all parties—FDA, device labelers, hospitals, other device user facilities, and healthcare professionals to prepare for and implement the requirements in an orderly manner,” AdvaMed wrote.
Distributors and providers commented favorably on the implementation dates, or sought tigher deadlines. Group purchasing organization Novation noted that companies have had more than five years since the law was passed to prepare for a UDI system.
“Novation contends that given the previous notice and preparation time, the deadline for implementation should be accelerated . . .” with implementation for all devices three years after the final rule, with one year after for Class III, and two years after for Class II.
Manufacturers broadly support synchronizing the date format deadline—required for all devices one year after final rule—instead with the UDI effective date for each class.
“In general, the proposed effective dates for UDI provide adequate time to meet the rule’s requirements with the major exception of the standardized date requirement,” wrote Covidien.
“The requirement for all classes of devices to be labeled with the date formatting one year after the publication of the final rule would place a burden on manufacturers to perform two label changes, independent of each other. . . . Once a standardized date format is selected, the implementation period should coincide with the implementation date for the class of the product in question,” Covidien said.
“For many companies, the new date format will require revalidation of existing manufacturing software and hardware. . . ,” commented Johnson & Johnson.
“The one-year implementation timeline is not sufficient to complete the required activities by the proposed implementation date, especially for global companies like ours manufacturing thousands of individual device models. . . . Label changes across portfolios of thousands of products are very costly. . . .” J&J said.
FDA has said it will reevaluate its date format proposal after companies advised that a format unique to the United States would be a burden to firms doing business globally.
Said J&J: “The proposed format is not consistent with the internationally recognized standards ISO 8601 and ISO 15223, which utilize the year-month-day order. (Clear and unambiguous human readable dates of manufacture and/or expiration) can be achieved by a flexible regulatory approach that allows for both alpha-numeric and numeric presentation of the human readable date format. The final rule should allow for multiple date formats, provided they are self-explanatory.”
LeMaitre Vascular, Inc. follows EU Medical Device Directive 93/42/EEC, Annex I 13.3.(e) and ISO 15223-1:2012 requirements for date formatting. The proposed format will require creating two labels for the US and international markets. “This will double the inventory since the products for the US market won’t be interchangeable with the same products for international markets anymore, and drive up the production cost substantially. It (will be) particularly burdensome to a small business such as our company.”
The proposed rule is robustly designed for allowing labeling exceptions and alternatives consistent with a risk-based approach, says Jay Crowley, senior advisor for FDA’s Center for Device and Radiological Health (CDRH).
“We have provided exceptions (for example) for Class I devices where you don’t need to put a UDI on individual bandages. Some Class II devices will likely fit in that category. I’m sure we will get exceptions for not putting the UDI on individual items but instead on the next higher level of packaging," Crowley says.
“There may be some device types for which UDI or parts of it are not appropriate such as where you can’t accommodate both a bar code and plain text due to space constraints,” he says.
“It was not really practical or possible to prospectively describe the enormous array of device types. We will develop exceptions based on case history going forward in the different device spaces as firms send in requests and we evaluate whether the UDI is practical or useful,” Crowley says.
Exemptions to the UDI labeling requirement named in the proposed rule include non-prescription devices sold at retail and Class 1 devices FDA has exempted from cGMP requirements.
The rule additionally allows for labeling exemptions to be granted on a case-by-case basis such as where UDI labeling is deemed not technologically feasible. FDA would provide information on these granted exceptions on its Web site.
The proposed rule requires direct part marking (DPM) for implantable devices, and devices intended to be used more than once and that are to be sterilized before each use. Standalone software will also need direct marking, as proposed. DPM is required two years after the device is required to have a UDI on its label.
Devices may qualify for DPM exemptions in cases including where direct marking is deemed to interfere with devices’ safe and effective use or is not technologically feasible. Companies determining a device qualifies for an exception would document the request in the device Design History File (DHF), and, in cases where the issue is safe use or technology limitations, send a notice to FDA. The rule suggests that FDA does not intend to routinely respond to DPM exemption requests.
Manufacturers are asking for a more defined process for handling DPM exemptions, with exempted devices posted to a web site, and certain device categories exempted in the final rule.
Covidien commented that FDA should provide a written response regardless of acceptance or denial, and define a formal process for how it will respond to DPM exemption requests.
Boston Scientific said that device types that clearly fit DPM exception criteria should be listed in the final rule, terming the outlined process “overly burdensome and impractical as it requires each manufacturer to submit exception notices for each applicable device or type of device.”
“We believe a more practical approach consists of FDA proactively listing product codes of devices, or types of devices that readily meet the exception requirements.
“. . . All coronary bare metal and drug eluting stents should be proactively exempted from the direct marking requirements . . . . Likewise, all absorbable or resorbable implantable medical devices should be proactively exempted, as any direct marking on such devices will disappear with time, defeating the stated purpose of the direct marking requirements,” Boston Scientific said.
Johnson & Johnson commented that exempt devices should include: certain types of implant devices such as absorbable implants, implants that do not meet the size requirement, amorphous/liquid devices that are either implants or reusable devices such as bone cement, or devices that must be visually clear to function (contact lenses).
“The direct marking requirement should apply only to devices that have an available flat contiguous marking area of at least 3 mm x 3 mm. This size limitation is based on the GS1 Data Matrix (2-D bar code), which is the smallest AIDC technology available that could fit the device identifier plus one production identifier,” J&J said.
“There is a swell of push back that FDA should maintain a list of products on a web site for which they have granted exceptions," says Peter Tomicki, Zimmer.
“If a manufacturer’s situation is agreed on as an exception, the entire pro code (product code) or product type or category would be considered for similar exemptions and would be published on web site as being granted. It is cleaner that way, removes variability in how exemptions are granted, and also how they are declared or enforced by FDA and manufacturers.”
“Alternative placement will be heavily exercised, given space constraints and the challenges associated with marking different surface types," Tomicki continues.
“Companies will encounter challenges to meet the objective of clear, appropriate, standard-based, compliant UDI marking on devices and/or their packaging,” he says.
Boston Scientific, Abbott, St. Jude Medical, and AdvaMed argued that implantable devices should be exempt from DPM, noting that direct marking will require modifying device designs, devices may not be amenable to direct marking, and explanting devices to view the direct marking is unlikely.
Also, implants can be tracked through e-health records.
“Should a recall situation arise that would require a physician to weigh the patient’s options for an implantable device (e.g., removal and replacement or not), it is highly unlikely that a physician would conduct surgery and remove the implant just to verify whether the patient has been implanted with a device impacted by the recall. Rather, physicians will rely on the patient’s medical records and implant cards,” Boston Scientific said.
The value of direct marking on a device is diminished as implantable medical devices are not separated from their packaging until immediately before they are used due to sterilization requirements, said St. Jude Medical.
Novation asserts that “. . . exceptions for implantable, life-saving, or life sustaining devices should be limited to instances where meeting the requirements would potentially have a negative impact on patient safety.”
FDA needs to address the application of UDI effective dates to existing, non-compliant inventory held in warehouses, at distributors, and in consignment models where the manufacturer owns the inventory on hospital shelves, companies urged.
“Right now the understanding is that UDI applies to all products that have not entered into interstate commerce. In the medical device space (where consignment is widely used), the point in time when a product has entered into interstate commerce is different than in another more common model, where a product enters distrbution post manufacturing," says Tomicki.
“The impact of not creating an exception for existing inventory amounts to effectively recalling all devices intended for the U.S. market for rework to meet UDI requirements by the effective dates. Or, at the risk to patient safety, not enabling these products to be on the market until forward production has flushed the supply chain with compliant product,” Tomicki says.
“The clear proposal is for FDA to make an exception where only products manufactured on or after the effective date must comply,” he adds.
Boston Scientific said the current requirement would result in enormous waste as manufacturers retrieve product to relabel or repackage. The effective date for each class should reflect when the device was manufactured, not placed into commercial distribution.
CHANGES REQUIRING A NEW UDI
The proposed rule defines instances when the manufacturer must use a new UDI; including changes in the quantity in a device package, the addition of a new device package for a new quantity, and a change from a nonsterile package to a sterile package or from a sterile package to a nonsterile package.
“We have defined a few changes but not to the extent we are trying to limit what the (UDI) issuing agencies do. The idea we want people to walk away with is: If there is a significant difference with the new product—and the user needs to know the difference--then you need a new UDI,” Crowley says.
Manufacturers commented the new UDI requirement is too broadly defined, and will result, according to one responder, in device modifications leading to hundreds of thousands of new device identifiers annually.
“We do not believe it is necessary to define when a change results in a new device or model. . . .Limit the proposal to address situations in which assignment of a new UDI is required,” Abbott said.
Said St, Jude Medical: “The proposed rule states a UDI is required if a change is made to the device that has the potential to affect its safety or effectiveness. If this is narrowly interpreted, it could mean that a new UDI would be required any time there is a manufacturing process update or a minor design change.”
“The device industry uses the terms version and model as well as revision level for many different purposes and for business reasons. It often makes sense to retain these identifiers even after (device modifications) have been made. As long as the device is identified with a UDI, don’t dictate version and model changes,” said Roche Diagnostics.
Zimmer commented the definitions for when a new UDI would be required are overly burdensome.
“(A) change in ‘specifications, performance, size, or composition to an extent greater that the specified limits’ is overly specific and a change that ‘could significantly affect the safety or effectiveness of the device’ is not specific enough. Responsible entities should be given the flexibility to allocate new DI (device identifiers) at their discretion when a new model or version is introduced,” Zimmer said.
GS1 describes how a new GTIN is assigned when there are variations in form, fit, and function.
“FDA’s critera (for a new DI) are similar but not the same as the GTIN rules. They are more or less a subset of those rules. Some elements of the proposed rule are being challenged and some elements in the GTIN allocation rules are evolving. As long as the UDI regulation remains a subset of the GTIN rules, and does not conflict with them, then those who follow GS1 rules should be fine,” says Zimmer’s Tomicki.
DATA BASE REPORTING
Crowley said FDA is working through comments on its GUDID pilot.
Manufacturers commented they need longer timelines for GUDID submission and more opportunity for input on the data base content requirements.
Citing an enormous work load involved in defining data elements, ensuring secure transmission, and system validation, AdvaMed said an implementation guide needs to be developed as a roadmap for GUDID and a basis for FDA guidance.
“The proposed rule significantly underestimates the timeline required by companies to accurately and comprehensively populate the UDI Database for every medical device. Larger companies with thousands of unique device models will need to implement a significant information systems program in order to source, validate, and manage this type of data. . . .” said Boston Scientific.
Companies advised against over populating the database with product attributes, saying the launch of the data base should focus on the quick identification of devices.
“(With expanded database attributes) the database would be positioned to give healthcare users a false sense that it is an adequate surrogate for full labeling. For example, the proposed rule requires indicating whether a device is labeled as containing natural rubber latex and may lead users of the database to believe it is a comprehensive source of safety information,” said Boston Scientific.
Wrote Zimmer: “There is information proposed to be required in the GUDID that is not necessary to ensure the adequate identification of a medical device. Information regarding sterility, latex, single-use, contains human tissue, kit and combination products, and quantity of medical devices in a group that is itself a medical device--these are all product attributes, but are not necessary for adequate identification of a medical device. The device identifier alone provides sufficient differentiation between items with these characteristics.”
Zimmer said GUDID compliance will take more time than proposed. “Systems cannot be designed until the design parameters of the GUDID are understood. Industry will need further input on the data elements associated with product attributes," Tomicki says.
“In the proposed rule, we see the attribute titles but none of the detail associated with them. The people responsible as the sources of this data need to know the details associated with the data to be able to comment and articulate whether that data is appropriate and/or possible. It would be reasonable for FDA to release guidance or some documentation that will be open for another public review and comment period with all the attributes and data element details.”
FDA proposes using DUNs numbers for identifying companies. “The DUNS number was not mentioned in the proposed rule; companies that did not participate in the pilot may not even have any idea about this requirement. The attribute detail needs to be well vetted. Is the DUNS number the best mechanism to identify the manufacturer? Why or why not? That is a conversation that needs to be had,” Tomicki says.
Some attributes are defined by “List of Values” such as clinically relevant size, storage conditions, and market status. “Defining clinical size is one layer of vetting. The List of Values for clinical size that FDA selects may or may not make sense for your products. Whether predefined clinically relevant sizes are appropriate needs more analysis and comment,” he says.
While device manufacturers will comprise the majority of companies providing data to the GUDID, companies that are reprocessing, repackaging, and kitting, will also be subject to allocating identifiers and database submissions, depending on the scope of the final rule.
“It takes a lot of effort to define, design, build, test, validate, populate, and transfer data from these systems to the GUDID. It is laborious to even find the information to populate the data base, let alone construct the data base with specific details and pull it all together in a validated system. The timelines for GUDID compliance are an extreme challenge for manufacturers. These (other) folks may not even know what is coming,” Tomicki says.
Despite the hurdles and costs associated with implementing a UDI system, the benefits are far reaching, according to some commenting organizations and individuals.
Novation and AIM (Association For Automatic Identifiers and Mobility) described that a UDI system, besides improving patient safety, will yield economic benefits throughout the supply chain.
“It will be useful for FDA to point out to the medical device manufacturers and users that there are economic benefits to be gained from AIDC that go beyond the public health and patient and customer benefits enumerated by FDA. We strongly believe that the intelligent use of AIDC technology and systems in the device manufacturer’s business operations will prove to add tremendous business value to the medical product manufacturing community,” AIM said.
UDI will improve product identification accuracy for improved patient safety, more efficient recall management and adverse event reporting, and reduce costs through supply chain efficiencies, Novation said.
“Our views are driven by the needs of the healthcare providers we serve. If the UDI system is implemented correctly, improvements to patient safety and efficiencies in the health care supply chain will be realized almost immediately. These improvements are not only well within reach, but also long overdue.”
Said Geisinger Health System: “The rapid and accurate identification of medical devices and associated attributes is an imperative that can no longer be ignored. . . . GHS believes FDA should continue to support the rapid adoption of an efficient UDI system.”