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:
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?
What additional required reporting must be done by Wesley Glen and the hospital in regard to the patient’s death?
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?