Coalition urges Hamburg, FDA to hasten UDI adoption

The Advancing Patient Safety Coalition is urging Dr. Margaret Hamburg, head of the Food & Drug Administration, to immediately issue a proposed rule establishing a so-called "unique device identification" system for medical devices.

The coalition, comprised of 25 prominent medical associations including the American Health Assn., the American Nurses Assn. and several specialists’ associations, calling it a "critical" issue for patient safety, the implementation of electronic medical records and healthcare reform.

In a July 7 letter (PDF) to Hamburg, the coalition wrote that the FDA has been too slow in issuing a rule on the UDI system, which Congress approved in 2006.

"While the Coalition recognizes and appreciates the work and interest of the FDA on UDI,
it is taking the agency an unreasonable amount of time to publish a proposed rule," according to the letter. "With each
day that elapses without a UDI system in place, patients’ lives are put at needless risk."

The system would increase patient safety by creating a means of tracking medical devices — a capability that doesn’t exist today, according to the letter. Citing recall and “device correction” statistics, the coalition wrote that “providers often must use manual and imprecise systems to identify if they have any recalled products.”

The UDI system is also "essential" to the $20 billion push for EMR adoption contained in the American Recovery & Reinvestment Act, according to the letter, because EMR systems "require that data standards, including
those for medical devices, are in place and used by all institutions to transfer information.
Having a UDI system for medical devices is a basic requirement that must be in place before
automated identification systems are fully effective."

And adoption of a UDI system would increase efficiencies in the healthcare supply chain that could potentially save $16 billion a year "because providers will be able to track
recalled products more accurately and improve the quality, safety and affordability of care they
provide their patients," according to the coalition.

Here’s the full text of the letter:

Dear Commissioner Hamburg:

As members of the Advancing Patient Safety Coalition, we write to urge the Food and Drug Administration (FDA) to issue a proposed rule immediately that establishes a unique device identification (UDI) system that supports both national and global needs through the GS1 system. The Coalition membership, which includes prominent hospital, physician, nursing, research, quality and patient advocacy organizations, believes the proposed rule must be published now as UDI is critical to patient safety improvement initiatives as well as implementing electronic health records (EHRs) and the delivery system reforms included in the recently enacted health reform bill. Additionally, the efficiencies gained through UDI will save the healthcare system billions of dollars, which providers could reinvest in initiatives to improve the quality and safety of care.

While the Coalition recognizes and appreciates the work and interest of the FDA on UDI,
it is taking the agency an unreasonable amount of time to publish a proposed rule. As you
know, it has been three years since Congress passed the “The Food and Drug Administration
Amendments Act of 2007,” which included language requiring the FDA to promulgate
regulations establishing a national UDI system for medical devices. Moreover, the FDA
has been working on this issue for years before the legislation was passed. With each
day that elapses without a UDI system in place, patients’ lives are put at needless risk.

Improving patient safety:

Unlike medications, and virtually every other product in commerce, medical devices cannot
be identified in a systematic and consistent manner. The resulting ad hoc approach results
in increased clinical risks to patients. These clinical risks include implanting a defective,
counterfeit, or recalled product; inability to track the recipient of a faulty product if it is recalled;
and inability to appropriately track adverse events. UDI is the missing link to protect the safety
of patients by improving processes for device recalls and corrections.

The rapidly rising number of device recalls points to the need for UDI for effective management.
More than 700 medical device recalls were issued in 2008, including more than 100 Class 1
recalls (defined as dangerous or defective products that predictably could cause serious health
problems or death). Manufacturers also issue many “device corrections” that can have serious
consequences for patients if not handled correctly. Because of the absence of UDI, providers
often must use manual and imprecise systems to identify if they have any recalled products.

Realizing the value of EHRs and goals of health reform:

Since the FDA Amendments Act of 2007 was passed, Congress has also enacted stimulus
legislation that included over $20 billion to incentivize providers to adopt EHRs. UDI is
essential to maximizing the value of EHRs. The EHR will require that data standards, including
those for medical devices, are in place and used by all institutions to transfer information.
Having a UDI system for medical devices is a basic requirement that must be in place before
automated identification systems are fully effective.

The Patient Protection and Affordable Care Act (PPACA) signed into law this spring included
numerous quality improvement provisions and payment delivery system reforms that encourage
collaboration among providers. These initiatives, such as accountable care organizations
(ACOs), depend on providers working together to improve the overall health status of defined
populations of patients. Technology will be an important part of this collaboration, but the data
being shared on medical devices must be accurate and dependable.

Realizing efficiencies:

UDI will also greatly benefit the U.S. healthcare supply chain through increased efficiencies and
improved order accuracy, which will result in substantial savings. Patients will be the ultimate
beneficiaries of a more efficient supply chain system because providers will be able to track
recalled products more accurately and improve the quality, safety and affordability of care they
provide their patients.

In 1996, the Efficient Healthcare Consumer Response (EHCR) released a study
entitled “Improving the Efficiency of the Healthcare Supply Chain” stating that $11 billion
of supply chain costs each year are avoidable process costs, which could be saved through
improved efficiencies. These savings were tied to the adoption of a healthcare identifier,
universal product number, identification standards and electronic data interchange and bar
coding. This study was recently updated by Arizona State researchers and now estimates supply
chain savings at a total of $16 billion annually.

Additionally, a 2009 comprehensive survey entitled “The State of Healthcare Logistics”
conducted by researchers at the University of Arkansas found that the average healthcare
provider spends more than $72 million a year on supply-chain functions, which is nearly one-third
of their annual operating budget. UDI is key to the ability of providers to lower their supply
costs.

In closing, we again thank you for the work of the FDA on this important issue and reiterate we
cannot wait any longer. A regulated, mandatory UDI system that is globally harmonized will
ultimately improve patient safety, reduce medical errors, facilitate device recalls, improve device
adverse event reporting and recognize the full potential of EHRs and delivery system reforms.

Sincerely,

Alliance for Advancing Nonprofit Health Care
American Academy of Orthopaedic Surgeons

American Gastroenterological Assn.

American Hospital Assn.

American Medical Student Assn.

American Nurses Assn.

American Urological Assn.

Assn. for Healthcare Resources and Materials Management

Assn. for Professionals in Infection Control and Epidemiology

Catholic Health Assn. of the United States

National Assn. for Continence

Novation

PeaceHealth

Premier

Society for Cardiovascular Angiography and Interventions

Society for Healthcare Epidemiology of America

Texas Health Resources

The Hip Society

The National Assn. of Public Hospitals and Health Systems

The North American Spine Society

University HealthSystem Consortium

VHA Inc.

West Penn Allegheny Health System

West Virginia United Health System

White River Medical Center