Questions 1-3 Questions 1-3 On Thursday a 75-year-old patient at Wesley Glen Sen
ID: 126689 • Letter: Q
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Questions 1-3 Questions 1-3 On Thursday a 75-year-old patient at Wesley Glen Senior Living Facility became agitated and physically abusive to himself and others, so he was placed in wrist and ankle restraints. An hour later, staff found the patient unconscious and called the EMT squad for assistance. The patient was taken to the medical center emergency department (ED), where he awoke and once again became physically abusive. The physician ordered the patient to be restrained to protect the patient and others while the physician examined the patient. Upon examining the patient the physician noted that the patient had multiple bruises on his back, buttocks, and thighs. In addition, the patient had a cardiac defibrillator implanted during his last inpatient visit. The hospital had received a medical device alert regarding the implant device and was notifying patients with the device to contact their physician for follow-up. The patient was sedated and the restraints removed. However, 15 hours later the patient expired. The hospital reported the death to the medical examiner/coroner's office. Consider the following: 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? 2. What additional required reporting must be done by Wesley Glen and the hospital in regard to the patient's death? 3. 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?Explanation / Answer
1. The hospitalis required to inform the coroner with relevant clinical history as death has occured within the hospital premises and is unnatural. The coroner will need this information to ascertain cause of death.
2. Additional reporting of injuries 9that is present on the back, buttocks and thighs) is must. Efforts must be made to ascertain what were the predisposing causes that lead to injury and to exclude physical abuse among inpatients. Also all patient files with respect to cardiac debfibrillator procedure should be presented to the coroners office.
3. The company manufacturers, government health authorities and the surgical team must be aware of the complications that can arise from insertions of medical devices. This information should also be made available to patients, relative and guardians concerned so that appropriate care can be taken. Also internal inquiry should be conducted by the hospital and theses details should be provided to FDA. Death may be reported as complication arising from medical device.
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