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Key documents and resources

2006-07 Resources - Unique Device Identifier (UDI) for medical devices

The Food and Drug Administration (FDA) is exploring implementation of a unique device identifier (UDI) for medical devices and solicited input from stakeholders. On August 11, 2006 FDA published a Request for Comment with comment due by November 9, 2006 on how a national UDI system should be structured and how it will improve patient safety, reduce medical errors, facilitate device recalls and improve device adverse event reporting. Premier facilitated working with other organizations and the FDA to promote the adoption of a UDI. Selected materials and resources are provided below.

Premier's key talking points on unique device identifier (UDI)

Download talking points developed in October 2006 to address FDA's request for comment
(.pdf) ( 35 KB)

House Members call for UDI to improve patient safety

House Members call for unique medical device identification to improve patient safety (5/10/07)

Congressional letter to FDA (May 2005)

House lawmakers urge FDA to advance medical device bar coding, backed by hospital industry support, (.pdf) (86 KB)

FDA reports

FDA Web site on unique device identification

The FDA maintains a special Web site on unique device identification
http://www.fda.gov/cdrh/ocd/udi/

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Bar Code Label Requirements For Human Drug Products and Biological Products; Final Rule

Federal Register. Vol. 69, No. 38; February 26, 2004.

The U.S. Food and Drug Administration (FDA) issued a new rule that requires certain human drug product labels and biological product labels to have bar codes. The bar code for human drug products and biological products (other than blood and blood components) must contain the National Drug Code (NDC) number in a linear bar code. The rule will help reduce the number of medication errors in hospitals and other health care settings by allowing health care professionals to use bar code scanning equipment to verify that the right drug (in the right dose and right route of administration) is being given to the right patient at the right time. The rule also requires the use of machine-readable information on blood and blood component container labels to help reduce medication errors.

Download

Go to Press releases for updated information on Premier's position on healthcare industry bar coding.

Go to the FDA site for additional fact sheets and information on the 2004 bar code rule. http://www.fda.gov/oc/initiatives/barcode-sadr/default.htm

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Industry white paper: The effect of barcode-enabled
point-of-care technology on patient safety

White paper distributed by Bridge Medical with a forward by Michael R. Cohen, RPh, MS, DSc, FASHP. Includes the issues, benefits, barriers and five case studies using five different bar-code-enabled point-of-care-systems (BPOC). Includes a summary table comparing medication error prevention systems in terms of cost, implementation time line, etc.

The effect of barcode-enabled point-of-care technology on patient safety: A literature review. Bridge Medical, Inc. October 2002. (.pdf) (250 KB)

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Health Industry Business Communications Council (HIBCC)

The primary function of the industry-sponsored and supported non-profit organization is to facilitate electronic communications through the development of appropriate standards for information exchange among all healthcare trading partners. Critical areas include electronic data interchange (EDI) message formats, bar code labeling data standards, universal numbering systems and the provision of databases which assure common identifiers. More information may be found at the following Web site.

http://www.hibcc.org

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Health Industry Business Communications Council® Database Services

HIBCC offers a number of services that support industry standards, and facilitates EDI by providing common identifiers for computerized contract administration. The listed Web site provides a complete description of the following important databases and services.

http://www.hibcc.org/

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Health Care EBusiness Collaborative (HCeC)

(formerly the Healthcare EDI Coalition)

HCEC is a non-partisan, non-profit association for the collaborative improvement of electronic business (eBusiness) efficiencies in the healthcare industry. The Collaborative's mission is to enable healthcare organizations to understand and leverage the efficiencies of eBusiness strategies and technologies, and to reduce implementation and operations costs by providing education, resources and support. Membership includes healthcare providers, GPOs, manufacturers, distributors, government agencies, technology and software suppliers, and database and network services firms.

http://www.hcec.org

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Health Insurance Portability and Accountability Act (HIPAA)

Final rules published by the Department of Health and Human Services (HHS) set standards for the exchange of electronic data under the Administrative Simplification provisions of HIPAA The law mandated the adoption of standards (from among those already approved by private standards developing organizations) to govern multiple electronic health transactions, including claims, enrollment, eligibility, payment, and coordination of benefits. The standards must also address the security of electronic health information systems and personal medical data.

http://www.cms.hhs.gov/hipaa/hipaa2/default.asp

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The National Alliance for Health Information
Technology (NAHIT)

The National Alliance for Health Information Technology is a partnership of leaders from all healthcare sectors working to advance the adoption and implementation of healthcare information technology to achieve measurable improvements in patient safety, quality and efficiency. In collaborating with government leaders, the Alliance is working to shape the policy environment and accelerate the implementation of world-class, standards-based information technology aimed at creating the most effective, safe, unified and inclusive health system possible. The Alliance assumed a leadership role in advocating for the creation of the National Coordinator for Health Information Technology Office, creating the Certification Commission for Health Information Technology and developing bar coding and electronic health record (EHR) standards.

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American National Standards Institute (ANSI)

This institute is a private, nonprofit organization that administers and coordinates the US voluntary standardization and conformity assessment system. ANSI does not develop standards but facilitates development by establishing consensus among qualified groups. HIBCC is an ANSI-accredited organization.

http://www.ansi.org

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The National Coordinating Council on Medication Error
and Reporting (NCCMERP)

NCC MERP is comprised of 23 national healthcare organizations collaborating to address the interdisciplinary causes of errors and to promote the safe use of medications. The Council continues a nationwide campaign for medication error reporting and prevention that promotes recommendations to colleges, schools, and state associations of medicine, pharmacy, and nursing; national professional associations; managed care organizations; and third-party payers. The council was conceived by the U.S. Pharmacopeia's Center for the Advancement of Patient Safety.

Publications describing how bar coding can be planned as part of an overall strategy (prepared by the California HealthCare Foundation):

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