Risk assessment, medication errors

For a number of reasons, including the difficulties inherent in proving a direct causal relationship between fatigue and adverse medical events and the lack of systems for reporting various types of adverse events and errors, few studies to date have examined the specific contribution of sleep deprivation to actual medical errors. Several recent studies, in attempting to unravel this relationship, have employed a number of different methodologies to assess prevalence, type, and risk factors for medical errors. For example, in one recent study of anesthetic... 

People with low health literacy may not understand the health risks associated with errors in medication management. Shame or embarrassment about their low literacy may deter them from seeking help with medication instructions. Pharmacists can assess health literacy using nonobtrusive screening tests such as the Test of Functional Health Literacy in Adults (TOFHLA), which is available in English and Spanish versions. This test includes items that assess the patient s ability to understand labeled prescription vials, blood glucose test results, clinic appointment slips, and financial information forms. 

According to the JCAHO medication error is one of the most important patient safety risk factors. The medical literature describes different models of risk assessment that can be used to identify the causes of medication errors. This is important because without such knowledge no actions would be effective, and furthermore identifying the wrong cause would result in an inappropriate or suboptimal action plan (Weinberg, 2001). 

Barriers to medication error reporting should be eliminated and a non-punitive culture encouraged. This will allow a well-developed medication error reporting system to be developed to collect vital information for root cause analysis and risk assessment. 

Organisations still frequently rely on retrospective techniques such as incident reporting and complaints to drive safety management [21] and healthcare has been slow and sporadic in adopting predictive safety assessment techniques to detect medical error [22]. Twenty two percent of people in the UK believe, when asked, that they have been the victim of medical error [23]. Nevertheless continually striving to protect patients at vulnerable points in their lives is stiU clearly the right thing to do and a move from reactive to proactive risk reduction wiU surely pay dividends in the future. 

Therefore, the estimation of a medical device s safety lies the determination of the probability that a medical device would become hazardous for the user or patient, resulting in safety problems and harm. This activity is known as risk management and is regulated by International Organization for Standardization (ISO) standard 14,971 [63,64]. This process is divided in two activities, risk analysis and risk evaluation, that assist in a detailed assessment of the risks associated to the medical device s entire life cycle, from manufacturing to disposal. The estimation of the risk is a complex procedure that considers the probability of device failure or nonconformity, software, user errors, and type of injury possibly resulting to people or users. 

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