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Adverse events





What is a Serious Adverse Event? - Food and Drug Administration

11/18/2014
06:07 | Author: Kayla Henderson

Adverse events
What is a Serious Adverse Event? - Food and Drug Administration

An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be.

Report if suspected that the patient was at substantial risk of dying at the time of the adverse event, or use or continued use of the device or other medical product might have resulted in the death of the patient.

Report if the adverse event resulted in a substantial disruption of a person's ability to conduct normal life functions, i.e., the adverse event resulted in a significant, persistent or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities and/or quality of life.

An adverse event is any undesirable experience associated with the use of a medical product in a patient.

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Adverse Events Home

9/17/2014
04:46 | Author: Emma Coleman

Adverse events
Adverse Events Home

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Guidance on Reviewing and Reporting Unanticipated Problems

7/16/2014
02:19 | Author: Brandon Powell

Adverse events
Guidance on Reviewing and Reporting Unanticipated Problems

Adverse events encompass both physical and psychological harms. They occur most commonly in the context of biomedical research, although on occasion.

A. Reporting of internal adverse events by investigators to IRBs.

B. Reporting of external adverse events by investigators to IRBs.

In OHRP’s experience, most IRB members, investigators, and institutional officials understand the scope and meaning of the term adverse event in the research context, but lack a clear understanding of OHRP’s expectations for what, when, and to whom adverse events need to be reported as unanticipated problems, given the requirements of the HHS regulations at 45 CFR part 46.

However, other adverse events that are unexpected and related or possibly related to participation in the research, but not serious, would also be unanticipated problems if they suggest that the research places subjects or others at a greater risk of physical or psychological harm than was previously known or recognized.

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Adverse Events Washington State Dept. of Health

5/15/2014
12:12 | Author: Emma Coleman

Adverse events
Adverse Events Washington State Dept. of Health

The National Quality Forum (NQF) defines these errors, which are also called serious reportable events. It lists 29 adverse events as reportable errors.

Washington State law (Chapter 70.56 RCW) requires healthcare facilities to report to the Department of Health whenever they confirm an adverse event. Facilities required to report are: hospitals, psychiatric hospitals, child birthing centers, Department of Corrections medical facilities and ambulatory surgical facilities according to Chapter 246-302 WAC. The department manages aggregate data on adverse events and posts quarterly reports on this website. Nicole Fernandus Phone:

Adverse events are medical errors that healthcare facilities could and should have avoided. The National Quality Forum (NQF) defines these errors, which are also called serious reportable events. It lists 29 adverse events as reportable errors. The events may result in patient death or serious disability.

For people with disabilities, Web documents in other formats are available on request. To submit a request, please contact: Web Management Team.

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What is a preventable adverse event?

3/14/2014
02:25 | Author: Kayla Henderson

Adverse events
What is a preventable adverse event?

Most adverse events are multifactorial, resulting from an overlap of system and human errors. Some adverse events may be new or unanticipated, due to.

Preventable or avoidable adverse events are a direct result of failure(s) to follow recognized, evidence-based best practices or guidelines at the individual and/or system level. These accepted standards of care are the expected performance for the average, competent practitioner or healthcare system managing the specific medical condition. Physicians and healthcare systems, as patient advocates, are held responsible for the continuous monitoring, implementation, enforcement, and upgrading of the applicable standards.

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