ICSI station. TS150 JRS scientific instruments/The Table Stable Ltd.
Benchtop incubator. Planer PLC.
If “safety” is theoretically interpreted as “without risk,” then this is a situation that does not exist in the daily life of an IVF embryologist. The ISO 14971 norm presents a more realistic definition of “safety”: “freedom from unacceptable risk.” Risk evaluation or rating is made up of two factors: severity and likelihood of frequency/recurrence. The earthquake case report above provides an excellent illustration of these principles:
In terms of severity, an earthquake is clearly classified without hesitation as catastrophic or significantly catastrophic (4 or 5 on the scale of severity).
The likelihood of frequency/recurrence is related to the geographical location of the clinic, and would be rated as 5 in Japan, and 1 in Belgium.
Evaluation of risk assessment/rating is not always easy, and a risk management team or working party has the task of enumerating risks and rating them by means of quantitative and repeatable metrics that will ensure a consistent method of evaluation. The major task of the group is to devise SOPs that define how events are to be handled. A risk matrix (Fig. 12.2) is a helpful tool, but should not be used in isolation: always remember that people are the drivers of the system.
Matrix used to assess risk factors on a scale of 1–5.
Conclusion
Once we truly know that ART is difficult – once we truly understand and accept it – then ART is no longer difficult, because once the principle is accepted, the fact that it is difficult no longer matters.
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