Premier as champion of health industry bar code adoption
A history of advocacy
2005 - 2007
Spearheaded by Premier, seven major hospital groups forwarded a letter (.pdf) (804 KB) to the Food and Drug Administration urging it to take swift action on a February 2002 pledge to require the bar-coding of medical devices. (Requirements for the bar coding of drugs, biologicals and blood products were passed in 2002). "It is a commonsense next step in our shared goal of improving quality of care, promoting patient safety and innovation, and encouraging cost effectiveness and supply chain efficiency," the letter stated. "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." In a separate letter (.pdf) (87 KB) to the FDA, prompted by Premier and allied hospital groups, several members of Congress weighed in similarly. "Data captured and managed through the supply chain via bar coding technologies would enable providers to evaluate emerging healthcare practices, products and services for improved safety and quality," the House lawmakers' letter said.
The FDA responded (.pdf) (111 KB) affirmatively to the hospital community's letter in June, stating that recent meetings of device manufacturers, research and trade associations, and other federal agencies had yielded general agreement that the adoption of a unique identification system for devices, powered by a universal database, could improve the cost-effectiveness of care and facilitate the collection of public health, patient safety, and research data. The FDA expressed particular 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 now posted on the CDRH's web site. It includes comments made by CDRH staff regarding their desire to pursue an Advance Notice of Proposed Rulemaking (.pdf) (107 KB) and includes the text of a hospital coalition letter led by Premier.
The CDRH has also been working 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 (UID) 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 (.pdf) (213 KB).
Hospitals are moving 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. Due to strong hospital interest in this issue, Premier continues to lead a collaborative effort with all the major hospital associations in Washington to promote the UID of medical devices throughout 2006 and into 2007.
Premier's 2006 Recommendations
Premier 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.
Premier recommends the federal government, through regulation or legislation, require standardized bar code labeling on all appropriate hospital-administered/implemented medical devices and implantables. Specifically, Premier strongly encourages the FDA to move toward a mandatory approach for the UID of medical devices through the Advance Notice of Proposed Rulemaking regulatory process.
Premier Position Statement on bar coding of medical devices (.pdf) (32 KB)
December 2004
Premier encourages lawmakers in the House and Senate to reintroduce legislation they introduced two years ago to help hospitals and nursing homes acquire and implement new patient safety and information technologies, including bar code-enabled bedside verification systems, physician order entry (CPOE), and electronic medical records. The Medication Errors Reduction Act of 2003 (S. 1729/HR. 3035) would establish a ten-year, $1 billion competitive grant program designed to curb the prohibitive costs of Health IT deployment. Its premise is bolstered by a new Institute of Medicine report—Patient Safety: Achieving a New Standard for Care—which argues that the federal government should pursue a robust patient safety agenda all facilitated by "health providers' investment in EMR and other information technologies.
February 2004
The FDA issues a final rule requiring bar code labels on hospital-administered drugs, biologicals and blood products, for which Premier expresses strong support. The non-profit hospital alliance issues a statement calling the new requirements "a victory for patients and hospitals…and a valuable opportunity to enhance the overall safety of care and reduce medical errors. In expressing support for the final bar code rule, Bob Hamon, Premier's senior vice president of Group Purchasing Services, urges the FDA to extend its reach further, applauding the agency's action, noting that a compelling patient safety interest also lies in requiring medical devices to be similarly bar coded. Premier strongly encourages the FDA to make wider application of the rule its next strategic move.
June 2003
As a longtime champion of industry adoption of the UPN bar code, Premier expresses strong support for the Food and Drug Administration's (FDA) March 2003 proposed rule. The regulation would require that all drugs, biologicals and blood products be outfitted by manufacturers, wholesalers and/or distributors with machine-readable bar codes, down to the single-unit dose, within three years. As such, Premier believes that the proposed rule represents a victory for patients and hospitals — and for the sustained improvement of patient safety and medical error reduction.
January 2003
Premier makes unit-of-use bar coding of medications a requirement for new and renewed group purchasing contracts signed from this date forward, as part of its commitment to patient safety and supply chain process improvement.
March 2003
FDA publishes proposed rule to require scannable bar code labeling of all hospital administered drugs and biologics, down to the single-unit dose.
February 2003
At Premier’s urging, the House Energy and Commerce Committee includes in its Patient Safety and Quality Improvement Act (HR. 663) language requiring bar codes on all hospital-administered drugs and biologics. (The Committee-approved legislation is awaiting House Floor action.)
October 2002
At Premier’s urging, the House Energy and Commerce and Senate Health, Education, Labor and Pensions (HELP) Committees include language requiring bar codes on drugs and biologics as respective components of the Patient Safety and Quality Improvement (HR. 5478) and Patient Safety Improvement and Medical Injury Reduction Acts (S. 3029).
July 2002
Premier vice president for contracting Bert Patterson testifies before the FDA in support of the agency’s proposed promulgation of a federal regulation to require the bar code labeling of drugs, biologics, and medical devices.
May / June 2002
Premier co-founds the National Alliance for Health Information Technology (NAHIT), a 40-member consortium representing a broad and diverse spectrum of organizations dedicated to the promotion of healthcare technology. Premier CIO Joe Pleasant spearheads the alliance's formation of a cogent position on health industry adoption of the UPN (Universal product Number) bar code.
April 2002
Premier participates in an industry-wide forum on bar coding, organized by the Healthcare Leadership Council (HLC). Hospitals, group purchasing organizations (GPOs), pharmaceutical and medical device manufacturers, and health insurers are strongly represented.
January 2002
Premier spearheads advocacy efforts among hospital organizations in support of the Bush Administration’s intent (via FDA) to propose a regulation on the bar coding of drugs and biologics.
July 2001
Premier vice president for contracting Bert Patterson testifies in support of industry adoption of the UPN bar code before a Senate Commerce Subcommittee on e-health and consumer empowerment.
June 2000
Premier President and CEO Rick Norling accepts chairmanship of the Healthcare Leadership Council (HLC) Patient Safety Task Force, an initiative dedicated to the development and pursuit of error reduction reform, including the implementation of UPN bar codes. Premier teams up with other healthcare GPOs and e-commerce companies to adopt and promote industry data standards for electronic supply chain transactions.
1999
Premier re-engineers its business practices to incorporate the UPN as product identifiers. At its urging, legislation is introduced to promote use of the UPN on Medicare reimbursement provider claims.
1998
Premier develops a comprehensive Handbook for Implementation of Bar Coding and Universal Product Numbers, a tool-based "road map” for successful implementation, education, and consultation.
Mid-1990s
Premier Purchasing Partners, LLP, supports and advocates for industry adoption of the UPN as a standard universal product identifier in the healthcare marketplace.