Particularly recommended for TE’s is the FMEA methodology, because it is easy to use and moreover, because of the factor of detectability added to severity and occurence. In tissue and cell banking this is often the factor that is easiest to influence to bring about improvements in safety and quality. The severity is generally difficult to influence.
The FMEA method was developed in the aviation industry in the middle of the 1960s. The FMEA model is widely used in the medical and pharmaceutical field. In 2001, the American ‘National Center for Patient Safety developed the Healthcare Failure Mode and Effect Analysis (HFMEA).
In 2011 in the Netherlands the national safety management programm of the Ministry of Health has introduced and ' prescribed' the FMEA to all Dutch hospitals as the selected method for prospective risk assessment. The safety management programm has started with the goal to reduce the number of avoidable deaths and diseases of patients in hospitals. An elaborate toolbox is part of the programm for the hospitals.
The FMEA model has been used in an adapted from for medical risk assessments, as has been presented at EATB 2009 by BISLIFE.