Document Detail


Improving patient care by reporting problems with medical devices.
MedLine Citation:
PMID:  9866489     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Healthcare practitioners are the primary users of medical devices for direct patient care. As such, they are in the best position to recognize problems that result from the use of medical devices. The outcome of a device-related adverse event or product problem, as with any other medical product, can be serious and result in illness injury, or even death. The sooner that FDA learns about a problem, the sooner the agency can take action to protect patient and user safety. Healthcare practitioners are major contributors to the knowledge base related to device use and safety through astute monitoring, rapid identification of device-related problems, and reporting these problems. An understanding of the voluntary and mandatory mechanism of reporting will ensure that device problems are reported appropriately and in a timely manner. As the primary users of medical equipment for direct patient care, health care professionals have the training and expertise to improve patient care by reporting actual and suspected problems with medical devices.
Authors:
G G White; M D Weick-Brady; S A Goldman; T P Gross; D L Kennedy; B S Lucas; K Merritt; C Naschinski
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  CRNA : the clinical forum for nurse anesthetists     Volume:  9     ISSN:  1048-2687     ISO Abbreviation:  CRNA     Publication Date:  1998 Nov 
Date Detail:
Created Date:  1998-12-31     Completed Date:  1998-12-31     Revised Date:  2005-11-16    
Medline Journal Info:
Nlm Unique ID:  9109511     Medline TA:  CRNA     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  139-56     Citation Subset:  N    
Affiliation:
Food and Drug Administration, Rockville, MD 20857, USA.
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MeSH Terms
Descriptor/Qualifier:
Adverse Drug Reaction Reporting Systems*
Equipment and Supplies / adverse effects*
Humans
Patient Care / standards*
Product Surveillance, Postmarketing / standards*
Quality Assurance, Health Care / organization & administration*
United States
United States Food and Drug Administration

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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