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Key documents and resources

2006-11 Resources - Unique Device Identifier (UDI) for medical devices (MDI)

The 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. The most recent activity of the ASP coalition was a letter sent to the Office of Management and Budget (OMB) requesting a release the proposed rule on the unique device identification (UDI) system for medical devices. Selected materials and resources follow, to provide background work leading up to the current status (2011) of the MDI/UDI.

FDA reports

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.

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.

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.

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 website.

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 website provides a complete description of the following important databases and services.

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.

HHS Office of the National Coordinator for Health Information Technology Office

The former National Alliance for Health Information Technology was 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. The Alliance mission was completed in 2009 with the creation of the HHS’s Office of the National Coordinator for Health Information Technology and the Certification Commission for Health Information Technology, developing bar coding and electronic health record (EHR) standards.

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. The Health Industry Business Communications Council (HIBCC) including its Health Industry Bar Code Standards is an ANSI-accredited organization.

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. See the U.S. Pharmacopeia's Healthcare Quality and Safety website.

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

 

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