Unique Device Identification

A patient today faces a significant risk that a recalled medical device could be used in his or her treatment because there is no way for a hospital to quickly and reliably identify a recalled device. Moreover, without an appropriate identification and tracking system, a defective device could remain undiscovered for a longer time, which is a significant patient safety concern. The ability to assess a device’s effectiveness is compromised today because, unlike other products in America, no uniform, unique identification system exists for medical devices.

Unique device identification (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, accelerated by the increasing complexity and variety of medical devices, points to the need for UDI for effective management of recalls. 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, hospitals often must use manual and imprecise systems to identify if they have any recalled products. As one hospital executive stated, “This creates a significant work load impact, but more importantly, there is a significant risk of missing a patient who may have received a defective device. This is of tremendous concern to the caregivers.”

UDI will strengthen the ability of the Food and Drug Administration (FDA) and manufacturers to monitor

adverse events related to medical devices. A national UDI system would create a common vocabulary for reporting and enhance tracking abilities. Currently, analysis of adverse event reports is limited by the fact that the specific devices involved in an incident are often not known with the required degree of specificity. Without a common vocabulary for medical devices, meaningful analysis based on data from existing voluntary systems is extremely problematic.

UDI is essential to maximizing the value of electronic health records (EHRs). EHRs will require that data standards, including those for medical devices, are in place and used by all institutions to transfer information. Having a UDI for medical devices is a basic requirement that must be in place before automated identification systems are fully effective. A common vocabulary for medical devices is necessary for healthcare providers to be able to effectively document devices in patient records.

In 2007, Congress included a UDI-related provision in the Food and Drug Administration Amendments Act of 2007 (H.R. 3580), which became Public Law 110-85. More specifically, section 226 of the legislation requires the Secretary of Health and Human Services to promulgate regulations establishing a UDI system for medical devices requiring the label of devices to bear a unique identifier. The UDI language was spurred by a May 7, 2007 letter to the FDA from Reps. Mike Doyle (D-PA), Pete Sessions (R-TX) and 24 of their colleagues asking the agency to move forward as soon as possible on a national UDI system.

Overview

Unique Device Identification

HealthcarePolicyPositionStatements

In January 2009, the FDA issued a Request for Comments and posed a series of questions for stakeholders to provide input on how to establish a UDI system for medical devices. The FDA also announced it will hold a one-day public workshop to help the agency better understand some of the issues involved with implementing a UDI system. However, it was more than five years ago that the FDA issued a final rule requiring electronically readable bar codes on the packaging of hospital-administered drugs, biologics and blood products. Despite the recent action, it is long past due to move forward expeditiously on a similar system for medical devices which will require the adoption of a UDI for medical devices similar to the National Drug Code for pharmaceuticals. Other industries have embraced this concept with the grocery industry leading the way on uniquely identifying products through the use of bar codes over 30 years ago. On June 26, 1972 the first bar coded product (a 10-pack of Wrigley’s Juicy Fruit gum) was scanned at a check-out counter at a Marsh supermarket in Troy, OH. Since its inception, use of the bar code has grown well beyond the grocery industry so that today, there are over one million companies in more than 100 countries in over twenty different industry sectors enjoying the benefits of scanning bar coded products. It is time the healthcare sector followed suit.

The Premier alliance is a founding member of the Advancing Patient Safety Coalition, which is committed to improving patient safety through the establishment of a national UDI system. The coalition’s membership includes prominent hospital, physician, nursing, research, quality and patient advocacy organizations, such as AARP, the American Hospital Association, the American Nurses Association, the American Medical Association, the National Rural Health Association, the American Heart Association, the American Association of Orthopaedic Surgeons and the Joint Commission. The APS coalition worked closely with congressional champions and the FDA on the 2007 legislative language.

Recommendations

The Premier alliance:�Strongly supports the mandatory unique identification

of medical devices, as the transmission and translation of critical data has vast potential for improving patient safety and supply chain efficiency.

�Strongly urges the FDA to proceed on issuing a UDI regulation as soon as possible.

�Urges Congress to keep pressure on the FDA to ensure the UDI regulation is implemented in a timely manner.

Unique Device Identification

A LONG TIME IN COMING

2003NAHIT task force reached a recommendation for FDA on Bar Coding Standards for Patient Safety

Feb. 26, 2004 Final regulation creating NDC for drugs FDA agrees to revisit issue of devices

Oct. 27, 2005Meeting to discuss UDI for devices

Mar. 22, 2006Eastern Research Group Final Report on UDI for Medical Devices

Oct. 25, 2006Public Meeting on UDI

Sept. 27, 2007FDAAA of 2007 signed into law – requires FDA to create UDI for medical devices

Feb. 12, 2009Public Meeting on UDI

???Proposed rule on UDI

Jan. 15, 2009 Federal Register Request for Comments on UDI

Feb. 27, 2009Comments due in writing

Jan. 19, 2006 CDRH report: Ensuring Safety of Marketed Medical Devices – “we will champion the development of a system to provide unique device identification”

Aug. 17, 2005 ECRI/FDA white paper Automatic Identification of Medical Devices

Aug. 11, 2006Federal Register Request for Comments on UDI

2003 2004 2005 2006 2007 2009