Assignment 8.1 - Patient Death
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Indiana University, Bloomington *
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MISC
Subject
Medicine
Date
Feb 20, 2024
Type
docx
Pages
3
Uploaded by HighnessTurtle12764
1
Why is the hospital required to report this patient’s death to the medical examiner/coroner? Do medical examiners and coroners have the right to receive patient information needed to investigate a case? The hospital is required to report the patient’s death to the medical examiner and coroner because
not only do they have the skills and credentials to determine who died or the time of death, they also have the capability to rule out the cause of death in the case of when a death is sudden or unknown. “A medical examiner is a physician who determines the cause and manner of a death for individuals whose deaths fall within a given geographical jurisdiction” (Atherton & Gardner, 2023, p. 2). Typically, the physician has pathology training in addition to standard training. Atherton and Gardner (2023) define coroners as, “public officials, either appointed or elected, who are publicly charged with inquiry into the circumstances regarding how a death occurred and for documentation of information pertinent to the death” (Atherton & Gardner, 2023, p. 2). To answer the second question in this section, yes, medical examiners and coroners have the right to receive medical information needed to investigate a case. They can do so without authorization and may also have subpoena powers to collect such information. What additional required reporting must be done by Wesley Glen and the hospital in regard to the patient’s death? Additional required reporting that must be done by Wesley Glen and the hospital regarding the patient's death would be the restraints and sedation used at both facilities. “It is a federal regulation for the hospital to report any death to the CMS Regional Office that is potentially related to restraint or seclusion using form CMS-10455” (HHS, 2020). The hospital should be very descriptive of the bruises that were found on the patients’ body and mention the cardiac defibrillator, and the patients’ behavior.
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Who is responsible for notifying the hospital that a medical device in use may cause harm to patients? If the patient’s death was attributed to the cardiac implant defibrillator, what is the hospital’s responsibility for reporting the death to the FDA? How is the death reported? In the case of a medical device causing harm to patients, the medical device manufacturing company is responsible for notifying the hospital that the medical device is experiencing defects. They are also responsible for placing that device under recall so facilities can know that the device have the potential to harm or even worse, cause death. If the patient’s death was caused by the implanted cardiac defibrillator (ICD), the hospital is required to report the patient’s death to the FDA and the manufacturer within 10 working days. “The Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA” (FDA, 2023). The information that needs to be reported is the user facility
report number, name and address of the device manufacturer, device brand name and common name, product model, catalog, serial, and lot numbers, and a brief description of the death (Brodnik et al., 2017). The death is reported through the Safety Information and Adverse Event Reporting Program called MedWatch. “This form can be completed online, or the facility can download the form or call 1-800-332-1088 to request a reporting form, and complete and return to the address on the pre-addressed form” (FDA, 2023).
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References
Atherton, D. S. & Gardner, E. A. (2023). Forensic science in the united states. II: Forensic pathology and the medical examiner/coroner systems.
Forensic Science Review
,
35
(1), 2–
6. https://web-s-ebscohost-com.suscorp.idm.oclc.org/ehost/pdfviewer/pdfviewer?
vid=3&sid=b1cb373b-05e6-42d1-bcbe-1618ba827c48%40redis
Brodnik, M. S., Reynold, R. B., & Rinehart-Thompson, L. A. (2017). Fundamentals of law for health informatics and information management
, 3
rd
ed.
Chicago: AHIMA. Centers for medicare & Medicaid services. (2020, July 8). Hospital restraint/seclusion deaths to be reported using the centers for medicare and Medicaid services (CMS) form cms-
10455, report of a hospital death
. U.S. department of health and human services. https://www.hhs.gov/guidance/document/hospital-restraintseclusion-deaths-be-reported-
using-centers-medicare-and-medicaid
U.S. Food and Drug Administration. (2023, July 27). Medical device reporting (MDR): How to report medical device problems.
U.S. department of health and human services. https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems
.
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