GAITHERSBURG, MD 02 March 2009—Just as all pharmaceutical products must carry National Drug Code ( NDC ) identification numbers, FDA is preparing to develop similar identification rules for medical devices ranging from infusion pumps to syringes.
The Food and Drug Administration Amendments Act of 2007 called for the creation of rules to make it easier to track the distribution and use of medical devices. FDA officials are gathering information in order to create the unique device identification rules.
FDA held a public workshop in Gaithersburg , Maryland , on February 12 to hear from various stakeholders about how the pending rules should be formed, said Jay Crowley, a senior adviser for patient safety with the agency.
“This is complicated, this is new,” Crowley said of creating a uniform identification scheme for medical products. “We all need to figure this out.”
Among the most central issues being discussed are which type of identification system to use and how to handle tiny devices that are too small for bar codes or radio frequency identification (RFID) tags. The information on marked medical devices would include details about the manufacturer, make, and model, as well as serial and lot numbers.
The unique device identification rules are intended to help to prevent counterfeit products from reaching the marketplace, improve supply chain efficiency, and make product recalls easier, Crowley explained.
While the NDC rules for pharmaceutical products is a useful model, it is not an ideal fit for the vast array of medical devices, some of which may be stored or used in hospital pharmacies, Crowley said. Syringes and sharps containers are among the medical devices that may fall under the unique device identification rules.
“We’re not trying to recreate the NDC number,” Crowley said.
The 2007 law allows exceptions for certain devices, though it is too early in the process to determine how size will play a role. At the very least, a unique device identifier number will likely be placed on cases or packs that contain collections of smaller items. Kits might use one identifier number to cover all associated parts in the container.
Crowley said that patient safety is a driving force behind creating the device identification rules.
In 2007, there were 66,000 adverse-event reports linked to medical devices, while half of the products involved lacked either an identification or lot number, he said. Without this identifying information, it can be difficult to issue effective product recalls, he said.
Jane Sargent, who works on supply issues for UK Healthcare, a two-hospital system in Lexington , Kentucky , said unique identification systems should improve patient safety as well as the efficiency of health care delivery.
Sargent said departments in her hospitals, including pharmacy and clinical laboratories, are moving toward bedside bar-code scanning. These plans made her wonder how similar tracking systems could help with medical supplies in other areas.
UK Healthcare is working on ways to make it easier to assess the movement of products throughout the system.
Ideally, uniform device identification should allow for tracking of products from manufacturer to distributor to hospital, she said. Further integration should allow details of each device used on a patient to go on a medical record, and where appropriate, to the billing department.
A more uniform identification system for medical devices would also be useful when a product recall is issued. Hospitals would prefer to quickly look at a list to determine whether products from the affected lots ever reached the facility instead of forcing employees to scour patient and supply rooms in search of recalled items.
While there is much potential for efficiency, health care systems must also be vigilant against making the system more complicated, said Sargent, who also represents the Association for Healthcare Resource and Materials Management of the American Hospital Association.
Hospitals would not be the only group to benefit. The rules could improve FDA’s postmarketing surveillance efforts for medical devices, said Rick Naples, vice president of corporate regulatory affairs for Becton, Dickinson and Company.
A standardized way to identify medical devices should also help reduce inefficiency throughout the health care system. But not every device may be worthy of a unique identification number. Naples suggested that FDA take a risk-based approach to target devices that are more likely to be recalled.
Steve Phurroughs, of the Centers for Medicare and Medicaid Services ( CMS ), agreed that a unique device identification system would hold many benefits.
This will “play a vital role in patient safety,” he said.
But as of the date of the meeting, CMS did not yet have a new administrator and consequently had no official position on how the agency would like to see FDA proceed with creating the unique device identification rules, he said.
Once FDA has created a set of proposed rules, there will be several opportunities to provide comments before the final version takes effect.
