Risks in the application of medical devices: human factors in the medical environment

The more complex a medical device is, the more difficult it is to control the hazards associated with its use. A substantial percentage of harm or injuries to patients resulting from treatment can be attributed to errors. No one knows exactly how many victims have been claimed by medical errors. Studies from the United States and other countries show that 3% to 4% of all hospital patients suffer harm or injuries. This text is intended to provide a practice-oriented approach to the discussion of targeted improvement opportunities in connection with a superficial consideration of the sociotechnical system comprising the manufacturers, the medical devices, and the users in the health facilities.

Analysis of the risk reports received by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) in connection with undesirable events involving the use of medical devices. Supplementary consideration of additional data from previous human factors research in the field of medicine. The evaluation period for the primary data focuses on the years 2005 to 2008. A differentiation is made between the error causal factors, man, and device.

A substantial percentage of the incidents that occurred can be attributed to human blunders. Within the scope of an evaluation of more than 16 000 risk reports in connection with medical devices, 5000 risk reports could not be directly attributed to the failure of a medical device. The lack of an error culture seems to be a considerable problem.

The safe and reliable development and use of medical devices requires efficient and consistent risk management. Until now, human factors are not sufficiently considered when identifying sources of errors in sociotechnical systems. The useful data required for an extensive risk assessment are missing. An interface-overlapping method of solution is required which permits system-analytical and unbiased error handling and integrates all stakeholders.