Regulatory Affairs Syndicator

Managing medical device hazards and recalls. ECRI’s guide for setting up an effective program.

Health Devices. 2004 Feb;33(2):33-43

Authors:

Each year, healthcare facilities are confronted with hundreds of medical device hazard reports and recalls. To ensure that appropriate actions are taken in response to all such reports, facilities must have an effective medical device hazard and recall management program in place. Such a program should ensure that hazard and recall information is received and communicated to the appropriate personnel and that the required action is taken and documented. This Guidance Article was developed to serve as a resource for healthcare facilities that wish to set up–or, more likely, refine–a hazard and recall management program. We have divided the discussion into three sections: The first part of this article addresses the role that hazards and recalls play in improving patient safety, focusing on the U.S. Food and Drug Administration’s (FDA) role in the recall process and on healthcare facilities’ responsibility to deal with hazards and recalls. The second part guides hospitals through the process of setting up an effective in-house hazard and recall management program. In the final section, we review some of the ECRI resources and tools you can use to develop and refine your program.

PMID: 15054916 [PubMed - indexed for MEDLINE]

Facilities’ responsibilities after notification of a medical device hazard or recall.

Health Devices. 2004 Sep;33(9):339

Authors:

PMID: 15532863 [PubMed - indexed for MEDLINE]