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Bar coding of drugs, biologicals, devices; UDI
Health industry adoption of the bar code for improved patient safety, quality of care and clinical innovation

Bar code final regulation - drugs and biological products

The Food and Drug Administration (FDA) issued a final rule effective February 26, 2004, requiring bar codes on the labels of thousands of human drugs and biological products by 2006. The measure was intended to help protect patients from preventable medication errors and reduce the cost of healthcare. It also represents a major step forward in the department's efforts to harness information technology to promote higher quality care. A long-time advocate of bar coding, Premier believes that industry adoption represents a critical advance in the hospital community's efforts to improve patient safety and delivery of care.

As numerous studies have demonstrated, bar coded medications in care settings go far toward guaranteeing the critical "five rights" the right patient, the right drug, the right dosage, the right time and the right route of administration. In a study conducted at a Veterans Affairs Medical Center employing a bar code scanning system, 5.7 million doses of medication were administered to patients with no medication errors. (Sullivan ES, et al., 2004)

Current requirements

The bar code rule calls for linear bar coded labels on most prescription and certain over-the-counter drugs that are commonly prescribed and used in hospitals. Each bar code is required to contain, at a minimum, the drug's existing encoded National Drug Code (NDC) number. Companies also may include information about lot number and product expiration date, a move Premier strongly urged during the comment period.

The rule also requires the use of machine-readable information on bar coded labels of blood and blood product containers. The FDA estimates that the bar code rule, when fully implemented, will help prevent nearly 500,000 adverse events and transfusion errors in 20 years. The economic benefit of reducing healthcare costs, patient pain and suffering, and lost work time is estimated at $93 billion over the same period. The final rule applies to most drug manufacturers, re-packagers, re-labelers, private-label distributors and blood establishments. New medications covered by the rule must include bar codes within 60 days of their approval. Most previously approved medicines and all blood and blood products will have to comply with the new requirements by 2006, a change from the originally proposed three-year implementation period.

Medical device identification moves closer on horizon

When the FDA first set out in 2002 to promulgate a rule, it solicited comments on the bar coding of medical devices, as well as drugs and biologicals. Ultimately, however, the FDA decided to take one step at a time to address the bar coding of drugs and biologicals first because of the perceived difficulty to implement such a far-reaching a regulation.

Hospitals and other industry stakeholders believe in the potential of technology like the scannable, universal identification enabled bar code, radio frequency identification (RFID) and other forms of "auto ID" to bring about sustained quality-of-care improvement, as well as greater cost and supply chain efficiency through a merger of private sector initiatives and public policy. Numerous inter-disciplinary studies have documented that patient safety may be significantly improved and reinforced, beginning at the supply chain level, through the industry-wide adoption of a standardized system of linear (i.e., electronically readable) codes on all medication packages and containers and medical devices. Technological advances in the last few decades have been such that greater, more comprehensive data can be imbedded within a bar code, making the coding of even the smallest packages or devices possible.

Background efforts to move to UDI

In 2005, a series of letters from hospitals, members of Congress and the FDA demonstrate the continued interest in moving beyond the 2004 FDA rule to revisit bar coding of medical devices. Hospital groups note that comprehensive data on emerging health practices, products and services, and the ability to rigorously compare and evaluate are essential for both clinical and economic decision-making. Data captured and managed through the supply chain via bar coding and related technologies would enable providers to evaluate emerging healthcare practices, products and services for improved safety and quality.

Hospitals noted that medical devices original, reprocessed, repackaged, refurbished, or 'multiple-use' should be labeled in accordance with industry-standard data formats to connote device type, manufacturer, lot number, etc. Ready access to specifications and an explicit accounting of devices are critical for successful recalls, especially involving implantables like hip/knee prosthetics, stents, defibrillators and CRM pacers. Many hospitals believe that bar coding would vastly improve upon device tracking in the event of safety, efficacy or functionality concerns.

The FDA's response observed that adoption of a unique identification system for devices, powered by a universal database has potential for improving the cost-effectiveness of care and facilitating the collection of public health, patient safety, and research data. The FDA expressed interest in discussing with the hospital community data collection that relates unique identification of devices to improvements in patient safety and quality of care. The October 27-28, 2005, FDA meeting with representatives from hospitals, hospital associations and health care alliances including Premier, marked the beginning of these discussions. A final summary of the meeting is posted on the CDRH's website. It includes comments made by CDRH staff regarding their desire to pursue an Advance Notice of Proposed Rulemaking and includes the text of a hospital coalition letter led by Premier.

The FDA's CDRH also worked on recommendations to improve its postmarket surveillance ability of medical devices. On January 18, 2006 the CDRH released its report and an executive summary of the Medical Device Postmarket Safety Program and included several references to the need for the unique identification of medical devices (UDI) The summary states, "We will champion the development of a system to provide unique device identification, a standardized and globally accepted nomenclature for devices, and mechanisms and incentives for device users to include this information in healthcare records." Download the report.

Hospitals moved forward on the adoption of technology, but given the current lack of a national standard, they have had to invest millions of dollars to create internal tracking systems for devices. According to a recent American Hospital Association survey of its members, more than half of all hospitals have adopted bar coding technologies for at least one purpose (i.e., match patients to their laboratory specimens and drugs, better management of supplies). And while it is clear this investment improves quality and supply chain efficiency for the hospital, a national unique identifier system would accelerate these efforts that ultimately benefit patients.