Medical Device Operator Errors

Many operator-related errors occur during the operation or maintenance of medical devices/equipment. The chief ones are as follows [23]  

Incorrect decision making and measures to critical situations Misinterpretation of a failure to recognize important device outputs Errors in setting device parameters 

Inadvertent/untimely/inappropriate activation of device controls Failure to follow specified instructions and procedures 

Overreliance on a medical device s automatic features, alarms, or capabilities 

Wrong selection of devices in regard to the clinical requirements 

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No system is error free and detecting system faults during live operation is an entirely predictable event. Healthcare organisations therefore need to ensnre that the necessary processes are in place to support users when a fault is detected. Similarly, manufacturers need the infrastructure to respond to reported faults, prioritise them accordingly and institute a resolution. It is in this prioritisation phase where CRM plays an important role. Standards such as the UK s ISB 0129/0160 specifically require organisations to undertake CRM activities on reported faults [1, 2] and Medical Device manufacturers are likewise obligated to carry out post-marketing surveillance on their products. 

With the increase in complexity and sophistication of medical technology, the occurrence of human errors in medical technology use has increased quite significantly [23,24]. One study reported that over 50% of medical device failures were due to operators, actions taken by involved patients, maintenance, and service [25]. Some important factors for the occurrence of human errors in medical technology are as follows [2] ... 

The occurrence of human errors in the area of medical devices has become an important issue, as operator errors account for over 50% of all technical medical equipment problems [4]. Furthermore, as per Refs. [5-7], human error is considered to contribute up to 90% of accidents both generally and in the area of medical devices. 

Chapter 10 is devoted to medical device usability. It covers topics such as medical device users and use environments, medical device user interfaces, an approach to develop medical devices effective user interfaces, guidelines to reduce medical device user interface-related errors, guidelines for designing hand-operated devices with respect to cumulative trauma disorder, and useful documents for improving usability of medical devices. Chapter 11 presents three important topics relating to patient safety patient safety organizations, data sources, and mathematical models for performing probabilistic patient safety analysis. 

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