CDRH staff suggested to the then chairman of ANSI Z79, Dr. Leslie Rendell-Baker, that he contact AAMI to propose establishing an AAMI Human Factors Committee to write a human factors design guideline for medical devices similar to the military standard. Right, which gives advice about writing medical device labels and instructions for use. What is new, however, is the Center's recent decision to focus more attention and resources on its human factors program. This is prompted by a growing body of evidence that shows medical device use error is an even more significant factor in patient deaths and injuries than was previously thought. It is increasingly clear that errors in the use of medical devices result in hundreds, if not thousands, of patient deaths and serious injuries each year.
People make mistakes.
Even the most experienced, conscientious, and disciplined people make mistakes. When these people are health care givers and the mistakes involve their use of medical devices, the results too often are patient death or serious injury. Poor human factors designs of devices is a significant contributing cause. Too many devices employ features or operate in ways that encourage error. In addition, many devices lack features known by human factors experts to be effective in protecting against or reducing the chance of error.