Definition & Classification
Medical errors occur in the context of medical treatment. They result when a correct action is not undertaken or when an incorrect action is performed. Focusing on medical device errors, there can be numerous reasons that these errors occur. Medical device errors can be due to manufacture-related error, which is further subcategorized as manufacturing errors or device-design errors.
The other main type of medical device error is practice in use errors. Manufacturing-related errors occur during the device manufacturing process and result when the device specification (which describes the detail of the device to be made) has not been properly implemented. More specifically, manufacturing-related errors are due to inappropriate device sterilization practice or a failure to manufacture the device in the proper dimensions.
“Device-design errors occur when the device specification is inappropriate. These may include, for example, designing a device which is insufficiently robust to withstand the full range of use conditions or designing one which fails to fulfill its basic performance requirements.”
“Use errors occur when the user is at fault. These may be caused by: psychological factors such as tiredness or stress, physical factors such as insufficient dexterity or poor eyesight, training-related factors such as insufficient or incorrect training, and also negligence.”
In the world approximately 14,000 firms produce over 100,000 different brands of medical devices in 1700 different product categories.3 Under-reporting in the U.S. can be as high as 80% af true value in an investigation of device-related errors which resulted in fatalities.
In 1998, manufacturers submitted reports of 980 device-related deaths in the U.S. In the year 2000 the FDA received 90,000 reports on device-related errors; another FDA report suggests that one third of these involved use-related errors.
For manufacturing errors, between 1983 and 1988 the FDA investigated 1664 incidents involving a variety of device quality problems. The FDA’s report published in 1990 indicated that 47% of these were due to manufacturing-related errors, such as inadequate process controls, the purchase of substandard components and labelling mix-ups. Between 1988 and 1991 the FDA estimated that 30% of device-related reports were design-related.
- Aronson JK. Medication errors: definitions and classification. Br J Clin Pharmacol. 2009;67(6):599-604. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2723196/ Accessed November 6, 2018
- Medical Device and Diagnostic Industry. Eleven keys to designing error-resistant medical devices. Available from: https://www.mddionline.com/eleven-keys-designing-error-resistant-medical-devices Accessed November 6, 2018
- Ward JR, Clarkson PJ. An analysis of medical device-related errors: prevalence and possible solutions. J Med Eng Technol. 2004;28(1):2-21. Available from: https://www.researchgate.net/publication/8972731_An_analysis_of_medical_device-related_errors_prevalence_and_possible_solutions_Journal_of_Medical_Engineering_and_Technology_281_2-21 Accessed November 6, 2018
- Haro D, Fennigkoh L. Human factors and the control of medical-device related error. Available from: https://www.nxp.com/filesstatic/microcontrollers/doc/brochure/HumanFactorsMedicalError.pdf Accessed November 6, 2018
- Amoore JN. A Structured Approach for Investigating the Causes of Medical Device Adverse Events. J Med Eng. 2014;2014:314138. Available from: https://www.hindawi.com/journals/jme/2014/314138/ Accessed November 6, 2018