JMIR Publications

ABSTRACT

Background:

The use of medical devices is rapidly expanding. Despite this, there is a huge gap in the literature surrounding the use of devices in healthcare and the adverse events occurring. Given that these errors can be life-threatening, it is imperative to have a thorough understanding of the problem in order to improve patient safety.

Objective:

To conduct a Rapid Review to identify the frequency, types and causes of medical device-related errors which are reported in published peer-reviewed literature.

Methods:

Following PRISMA guidelines, a literature search strategy was developed. Databases searched until 23 February 2018 included Pubmed, International Pharmaceutical Abstracts and Cinahl. Articles were included if they: defined medical devices, reported the frequency, causes and types of errors, were published in peer-reviewed literature. Articles were screened and discussed by two authors.

Results:

Database searching yielded 7,559 unduplicated articles. After two rounds of screening, 24 articles were included in the Review. Device types included cochlear implants, defibrillator leads, anaesthetic & intensive care devices, surgical equipment, automated external defibrillators, radiation oncology devices, ambulance stretchers, breast pumps, cardiovascular devices, orthopaedic devices, and patient controlled analgesia devices. The frequency of errors was 3.83-33.0%. The most common causes were user error, malfunction and design error.

Conclusions:

This Review identified a range of device types associated with errors. The frequency of errors was lower than published literature. User error was confirmed as a leading cause, alongside malfunction and design error. Future research should examine near-miss events and expand the device types studied.