How to distinguish between medical device adverse events, medical device quality incidents and medical malpractice

Adverse events of medical devices refer to various harmful events that occur under normal use of medical devices of qualified quality approved for marketing, which lead to or may lead to human injury. Medical device adverse events are mainly caused by product design defects, inaccurate or insufficient instructions for use that have been registered and audited.

Medical device quality accidents mainly refers to its quality does not meet the registered product standards and other regulations caused by the accident.

Medical incident refers to the medical institutions and their medical staff in medical activities, violation of health care management laws, administrative regulations, departmental rules and regulations and diagnosis and treatment norms and routines, negligence caused by the patient's personal injury accidents.