USE error and medical device recall

FDA's definition of USE error though the word USE error is not used officially.

“Act or omission of an act that results in a different outcome than intended by the manufacturer or expected by the USER, which may result from a mismatch situation between USER, man-machine interface, task and/or environment.” AAMI HE74:2001
Many research suggests that the frequency and consequences of medical device use errors may far exceed those arising from device failures

•A study of patients 65 and older found that those who couldn’t understand basic written medical instructions were much more likely to die within six years than those who had no problems. The difference in death rates “was much higher than we expected.”
Ref - Dr. David Baker, Chief of General Internal Medicine at Northwestern University’s Feinberg School of Medicine, 2007
•Most people have difficulty understanding pharmaceutical label instructions, regardless of their cultural background and level of education.
Ref - Mining Complex Clinical Data for Patient Safety Research, George Hripcsak, M.D., 2002


•Recent FDA reports show that more than 1/3 of medical device incident reports involve use error, and More than 1/2 the recalls due to design problems can be traced to design of the user interface. Hence design of user interface and the labelling is one of the main causes of recall.
To get out of the problem FDA suggests manufacturers go for Human Factor Engineering and also follow the guidance documents provided as below.

•Guidance on Medical Device Patient Labeling: Final Guidance for Industry and FDA Reviewers
•Do It By Design: An Introduction to Human Factors in Medical Devices
•Human Factors Principles for Medical Device Labeling
•ANSI/AAMI HE75: Human factors design principles for medical devices (adopted by the FDA later part of 2008)
http://marketplace.aami.org/eseries/scriptcontent/docs/Preview%20Files/HE48preview.pdf