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?
Expert Solution Preview
Introduction: The case scenario involves the death of a 75-year-old patient in a hospital after being restrained due to physical aggression. The patient had bruises and a cardiac defibrillator implant, and the hospital received an alert regarding the device. The following questions will discuss the hospital’s reporting requirements and responsibilities in this situation.
1. The hospital is required to report the patient’s death to the medical examiner/coroner because it is a sudden or unexpected death occurring in a hospital, and the cause is not immediately clear or natural. Medical examiners and coroners have the authority to receive patient information needed to investigate a case, including medical records, autopsy reports, and witness statements.
2. Wesley Glen and the hospital must report the patient’s death to the state’s department of health or other designated agency. They also need to report to the Centers for Medicare and Medicaid Services (CMS) within 24 hours of the patient’s death. The hospital must conduct a review of the patient’s death, also known as a mortality review, to evaluate the quality of care and identify any opportunities for improvement.
3. The manufacturer or distributor of a medical device is responsible for notifying the hospital that a device in use may cause harm to patients. If the patient’s death is attributed to the cardiac implant defibrillator, the hospital has a responsibility to report the death to the Food and Drug Administration (FDA) within ten days of becoming aware of it. The FDA’s adverse event reporting system is used to report the death, which includes information about the device, the patient, and the adverse event.
