The Food and Drug Administration's unique device identification initiative: Standardizing device identification throughout distribution and use

Journal of Clinical Engineering

Volumn 36, Issue 2, 2011, Pages 65-67

  Mathews, Anie ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOMEDICAL ENGINEERING; COMPUTER PROGRAM; DATA BASE; DEVICE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE PLANNING; HUMAN; INFORMATION PROCESSING; MEDICAL EDUCATION; MEDICAL INSTRUMENTATION; SHORT SURVEY; UNIQUE DEVICE IDENTIFICATION;

EID: 79953841402     PISSN: 03638855     EISSN: None     Source Type: Journal    
DOI: 10.1097/JCE.0b013e318214300d     Document Type: Short Survey

References (8)

1. US FDA/CDRH. Food and Drug Administration Amendments Act (FDAAA) of 2007. September 2007. http://www.fda.gov/RegulatoryInformation/Legislation/ FederalFoodDrugandCosmeticActFDCAct/ SignificantAmendmentstotheFDCAct/ FoodandDrugAdministrationAmendmentsActof2007/default.htm. Accessed December 1, 2010.
2. GHTF. Unique Device Identification (UDI) System. November 2010. http://www.ghtf.org/ahwg/ahwg-proposed.html. Accessed December 5, 2010.
3. Samore MH, Evans SR, Lassen A, et al. Surveillance of medical device - related hazards and adverse events in hospitalized patients. JAMA. 2004;291:325-334. (Pubitemid 38101605)
4. Subhan A. Technology management interpreting codes and standards, part 4: ANSI/AAMI EQ56: recommended practice for medical equipment management programs. J Clin Eng. 2010;35(4):169-170.
5. US FDA/CDRH. Unique Device Identification public workshop. April 2009. http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm133162.htm. Accessed December 5, 2010.
6. US FDA/CDRH. Prototype UniqueDevice Identifier Database report.November 2009. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ UniqueDeviceIdentifiers/ucm191770.htm. Accessed December 13, 2010.
7. US FDA/CDRH. FDA pilot activities to explore opportunities and challenges with the implementation of a unique device identifier system. December 2010. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ UniqueDeviceIdentifiers/ucm235962.htm. Accessed December 13, 2010.
8. US FDA/CDRH. Unique Device Identification request for use cases. December 2010. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ UniqueDeviceIdentifiers/ucm235963.htm. Accessed December 30, 2010.