Biomedical Engineering Reference
Box 11 is simple: changes you have made to reduce risk may have a knock-on effect. You
may have inadvertently introduced new risks. This box forces you to look at that outcome.
Once you have completed a form for each hazard you will need to produce a risk analysis
report, one that contains each and every completed FMCA table - and you will have many.
These individual forms are collated and together they define whether your device has any
residual risk that is not acceptable. The front page of this report summarizes this statement,
but someone competent must sign it of and the “sign off” must contain a statement confirming
that the clinical benefits of the device outweigh any risks due to its use.
9.3 Criteria-Based Evaluation
It is very important to recognize that a full evaluation of your design is mandatory in both
EC legislated countries and under the FDA. Furthermore it should be recognized that many
issues highlighted in the risk analysis, described previously, cannot be addressed without
performing some form of evaluation on the device itself. The recent version of the European
Medical Devices Directive has made a clinical evaluation mandatory, see MedDev 12.2/6 for
more information (EC, 2010). The FDA has guidance in their “Control of Design” guidelines
for manufacturers ( FDA, 1997 ). In all cases you have an obligation to show that your device
meets both your design inputs and the requirements to be called a medical device. Just
performing a controlled design process without this final stage is not enough. Furthermore,
CASE STUDY 9.3
During the manufacture of a hypodermic syringe it was identified that some material may have
originated from a warehouse in Japan. Assess the risk of this potential hazard.
Any FDA registered organization would have received an official letter from the FDA in 2011.
This letter requested that the organization check that no materials had been sourced from
Japan; this letter was specifically concerned with the nuclear reactor failure that followed the
2011 tsunami and hence potential radioactive contamination of any materials.
What is the potential hazard?
From Annex C, though this is debatable, the potential issue is 2.4.3:
2.4 What materials or components are utilized in the medical device or are used with, or are in contact
with, the medical device? Factors that should be considered include:
2.4.3. Whether characteristics relevant to safety are known
From Table 9.2 the hazard is clearly ionizing radiation. The effect is injury to the patient, to the
end-user, and possibly to the environment. Hence there are two potential effects:
1. Injury to the patient and/or end-user.
2. Contamination of the storage environment, which in turn can lead to injury to the end-user(s).