Adverse event reporting: making the system work.

Abstract

111 Anurse inadvertently connects a blood pressure cuff to an intravenous line, pumping the patient full of air. A portable infusion pump delivers the wrong dose of medication. An arthroscopic irrigation pump shoots fluid with too much pressure, permanently damaging a patient’s knee. In each case, a patient was injured or killed because of mistakes involving medical devices. Such incidents are not as rare as we’d like to think. An Institute of Medicine report published in 2000 estimated that up to 98,000 people die in hospitals each year as a result of medical mistakes. Approximately 1% to 2% of these cases involve medical devices. The FDA is informed of approximately 100,000 malfunctions of medical devices each year. Adverse event reporting is one strategy that has been used to learn from the mistakes that people make and the equipment failures that occur. “The first rule of medicine is to do the patient no harm,” says Marvin Shepherd, PE, a clinical engineer and accident investigator with Devteq Publishing and Consulting. “The goal in investigating an incident and reporting on the results of that investigation is to make corrections to prevent it from ever happening again.” Matt Baretich, PE, PhD, a clinical engineer and accident investigator with Baretich Engineering, agrees. “People will always make mistakes, and there will always be human error. Our ultimate goal is to try to learn what we can to reduce the likelihood of mistakes.” What is the role of clinical engineers and biomedical equipment technicians in adverse event reporting? What can they do to become involved in the process and improve it? BI&T interviewed experts in the field and found that a great deal remains to be done to strengthen the role of clinical engineers and biomeds in the process and to improve the process itself.