November 09, 2012
by Brendon Nafziger , DOTmed News Associate Editor (FiDA highlight)
Group purchasing organizations want the Food and Drug Administration to hurry up its timeline for implementing new medical device labels and a tracking system that could make recalling products easier and more efficient, while medical device companies fret that the process needs more time.
The groups submitted comments to the FDA this week as the comment period for the new unique device identifier (UDI) proposed regulation ended Wednesday.
Janet Trunzo, a senior executive of regulatory affairs for AdvaMed, a medical device manufacturer trade group, called the project "one of the most extensive and complex regulations to be issued in recent memory."
Based on a recent survey commissioned by the group, AdvaMed estimates UDI implementation could cost manufacturers millions in setting up new production equipment and possibly billions if they were forced to recall and destroy lots of old devices.
"Because of the cost and impact of this rule for companies we believe it is imperative that FDA get it right the first time," she told reporters on a press call Thursday.
What is the UDI?
The UDI itself is a two-part system, wtih an alphanumeric code that identifies the device model and and production identifier that gives the serial, lot or batch number, and an expiration date. The UDI would appear on device labels and packaging in plaintext, intelligible to humans, and a machine readable format, such as a barcode. The other major element is the Global UDI Database, an under-construction public online database that could help the government or providers track products during a recall.
The UDI rule, long championed by patient advocates, has been in the works for several years, but was given a push this summer when Congress passed an FDA user fee renewal bill that included language forcing the FDA to come up with proposed rules by the end of the year. The FDA released those rules in July.
For stakeholders involved in this immense, multi-year project, one of the key issues is when they'll have to comply with the final rules, which are expected next year.
Under its proposed rules, published this summer, FDA put in place a staggered timeline, with higher-risk (Class III) devices expected to have UDI labeling on packaging or devices within one year of the publication of the final rule, intermediate-risk devices (Class II) within three years, and lower-risk (Class I) and unclassified devices in five years.
Some products, like implantable devices and software, require the UDI printed directly on the device itself, in a process called direct marking. This will be required from three to seven years after the final rule is published, with riskier devices getting direct marking first.
Medical device manufacturers, perhaps unsurprisingly, disagree, and they stress the expense and cost of switching over to the new system: they will have to buy and install new labeling machines in factories, implement and validate production software and train staff.
In its comments submitted to the FDA, AdvaMed urged the agency to delay Class III requirements by one year, for a two-year post-final rule effective date. "There is no direct device safety and effectiveness issue that is compromised by extending the effective date for Class III devices by one year, and doing so will assist regulated persons and those in the health care community to integrate the UDI into their daily practices effectively," the group wrote.
The lobby also wants to clarify what they say could be one of the biggest troublemakers with implementing the system: what to do about devices that were created before the regulations take effect. That's why AdvaMed is asking that the rules be prospective, and only apply to devices produced after the effective date.
"The cost of applying UDI requirements to existing inventory once an effective date is reached is huge," AdvaMed said in its comments. "For example, sterilized devices cannot, in all cases, be safely and economically re-labeled, re-packaged and re-sterilized, and therefore, must be destroyed. Other devices that arguably could be reprocessed would present such large expense that doing so would be impractical. More importantly, such massive reprocessing would interfere with other device production, thus threatening potential shortages and an endangerment to public health."
AdvaMed has tried to come up with some figures to show how costly implementing UDIs would be to the industry, specifically focusing on the impact of direct marking.
According to an Accenture survey of 18 companies commissioned by the lobby and released Thursday, three-quarters expect significant costs for switching production lines to direct marking. The total associated costs per packaging line averaged around $125,000, according to the survey. All told, about 44 percent of respondents said they'd have to spend upwards of $1 million to purchase new manufacturing equipment, and the complete one-time cost of putting the system in place for all respondents was nearly $80 million.
n addition, respondents estimated they'd have to spend $2.8 billion in total to recall and reconfigure non-compliant equipment.
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.
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.
"During, or just prior to, surgical implantation of the device the UDI is entered into the patient's EHR providing a permanent link between the patient and the implanted device," the group said in its comments. "This information will be available to all those who are authorized to access the patient's EHR and will not require a surgical procedure to extract the device and scan the UDI. Postmarket surveillance is conducted non-invasively on EHRs databases."
Under the FDA user fee renewal bill, final UDI rules would have to be issued within six months of ending the comment period -- that is, in May.