domingo, 9 de agosto de 2015

AHRQ Patient Safety Network ► Heparin-containing medical devices and combination products: recommendations for labeling and safety testing. Draft guidance for industry and Food and Drug Administration staff.

AHRQ Patient Safety Network



PSNet header image



Heparin-containing medical devices and combination products: recommendations for labeling and safety testing. Draft guidance for industry and Food and Drug Administration staff.

Federal Register. Washington, DC: US Department of Health and Human Services. Baltimore, MD: Food and Drug Administration. July 9, 2015;80:39440-39441.

Heparin is a high-alert anticoagulant that has been associated with patient harm due to issues with administration and contamination. This draft guidance seeks to engage insights from the field to help improve labeling practices. The deadline for submitting comments is October 7, 2015.

Information icon indicating hyperlink to external website
Free full text (PDF) icon indicating hyperlink to external website
Related news article icon indicating hyperlink to external website



Related Resources
MULTI-USE WEBSITE
Human Factors and Medical Devices.
Human Factors Engineering Team, Center for Devices and Radiological Health, Office of Communication, Education, and Radiation Programs (OCER), Division of Device User Programs and Systems Analysis (DDUPSA), 1350 Piccard Drive, HFZ-230, Rockville, MD 20850.
NEWSPAPER/MAGAZINE ARTICLE
Action needed to prevent dangerous heparin-insulin confusion.
ISMP Medication Safety Alert! Acute Care Edition. May 3, 2007;12:1-2.
AUDIOVISUAL PRESENTATION
Preventing Medical Errors.
Food and Drug Administration (FDA) Patient Safety News. Show #79. September 2008.
View all related resources...

No hay comentarios: