CAUSES OF PATIENT INJURIES AND MEDICAL DEVICE ACCIDENT CLASSIFICATION

Before we discuss the topic of human error further, let us examine the causes ofpatient injuries and medical device accident classification because both subjectsdirectly or indirectly relate to the occurrence of human error.

Over the years, professionals working in the medical field have identified eightfundamental mechanisms, as shown in Figure, through which patients (or Medical Device Reliability and Associated Areaspersonnel) may be injured or killed.


The understanding of these mechanisms orcauses is essential to determine the extent to which a device’s design or use mayhave contributed to the occurrence of an accident.

Medical device accidents may be classified into seven categories: operator orpatient error,manufacturing defect, design deficiency, abnormal or idiosyncraticpatient response, faulty preventive maintenance, repair or calibration, random componentfailure, and sabotage or malicious intent.