By Toni Clarke
Sept 20 (Reuters) - The U.S. Food and Drug Administration
issued a long-awaited rule on Friday requiring companies to
include codes on medical devices that will allow regulators to
track the products, monitor them for safety and expedite
recalls.
The codes, known as unique device identifiers, or UDIs, will
be entered into a database that the agency will maintain as a
publicly searchable reference catalogue.
"A consistent and clear way to identify medical devices will
result in more reliable data on how medical devices are used,"
Dr. Jeffrey Shuren, director of the FDA's medical device
division, said.
The FDA plans to phase in the UDI system over several years,
focusing first on medical devices that carry the greatest risk
to patients such as pacemakers, defibrillators, heart pumps and
artificial joints. Many low-risk devices will be exempt from
some or all of the requirements.
Josh Rising, director of the Pew Charitable Trusts' medical
devices initiative, said the new rule will help improve safety,
but added it is just the first step.
"To fully realize the new system's benefits, hospitals,
health plans and physicians must integrate these codes into
patients' health records and insurance billing transactions," he
said.
The FDA relaxed some of the requirements it had initially
proposed based on industry concerns. It removed its initial
requirement that companies directly mark implants. It also
provided a three-year exemption for products currently held in
inventory.
The agency also removed a proposal that would have required
UDIs on individual items within a pack of single-use products
such as bandages. Now only the package will require the code.
Janet Trunzo, a senior executive at the Advanced Medical
Technology Association, which represents medical device
companies, said in a statement that while the organization is
still reviewing the details of the final rule, it "commends FDA
for addressing many of the concerns industry raised."
"Implementation of a UDI system will be a costly and
challenging endeavor, affecting all medical technology
manufacturers," she said. "It is imperative that it is
implemented correctly the first time."
Companies will be required to integrate the UDI into
existing information systems, test barcode printing software and
train employees. They will also have to redesign device labels
to incorporate a barcode and install equipment needed to print
and verify the UDI on labelers.