Literature DB >> 28163555

FDA Flags Inconsistent Hospital Reporting Of Medical Device Problems: Hazy Reporting Rules Beget Confusion.

Stephen Barlas.   

Abstract

The National Evaluation System for Health Technology will be developed over the next five years to upgrade and improve the reporting of medical device adverse events. However, participants using the new system will incur significant capital costs.

Entities:  

Year:  2017        PMID： 28163555      PMCID： PMC5265235     

Source DB:  PubMed          Journal:  P T        ISSN： 1052-1372


  2 in total

1.  Characterization of Device-Related Malfunction, Injury, and Death Associated with Using Elastomeric Pumps for Delivery of Local Anesthetics in the US Food and Drug Administration MAUDE Database.

Authors:  Richard Teames; Andrew Joyce; Richard Scranton; Catherine Vick; Nayana Nagaraj
Journal:  Drug Healthc Patient Saf       Date:  2020-12-23

Review 2.  Requirements and Study Designs for U.S. Regulatory Approval of Influenza Home Tests.

Authors:  Tony Yang; Larry G Kessler; Matthew J Thompson; Barry R Lutz
Journal:  J Clin Microbiol       Date:  2021-12-15       Impact factor: 11.677
  2 in total

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