Page 77 - Safety Risk Management for Medical Devices

56 Safety Risk Management for Medical Devices

1. Conformance to a harmonized product safety standard. When such a standard
specifies technical requirements addressing particular Hazards or Hazardous
Situations, together with specific acceptance criteria, compliance with those
requirements can establish a presumption of acceptable risk.
2. In the absence of an applicable harmonized standard, basing the risk reduction
end-point on a recognized international standard would also constitute
acceptable risk. Depending on where the medical device is going to be
marketed, it is also possible to apply a similar strategy which is specific to a
geography. That is,it’spossiblethata particular country has a national product
safety standard. Therefore compliance to that standard would establish accept-
ability of risk in that country.
3. Where no harmonized standard, international or national standard, or similar publi-
cation is available, the manufacturer can use other sources such as historical data,
best medical practice, and SOTA as means of specifying risk reduction end-points.
Methods of determination of end-points must be described in the risk management
process.
4. Lastly, risk reduction end-point can be defined as when further Risk Control
measures do not reduce risk, or improve safety.

It must be noted that if advancement in technology and practices that exist, and
are feasible at the time of design of a medical device, permit the reduction of risk
beyond the SOTA, it is incumbent upon the manufacturer to apply such new knowl-
edge and methods and further reduce the risks of the medical device.
The RMP for each medical device must provide the specific criteria for risk acceptability
consistent with the manufacturer’s policy for determining the criteria for risk acceptability.
Although Ref. [22] is a tremendous improvement over Ref. [7] and greatly reduces
the ambiguity of Ref. [7], it still leaves some unclarity. For example, Ref. [22] says if
“death or serious deterioration of health is unlikely to occur...” then “the risk shall be
considered acceptable.” What does “unlikely” mean? There is no guidance on how to
decide. Also, the guidance from Ref. [22] doesn’t prompt the manufacturer to reduce
risks to lower levels than the SOTA, when new technologies feasibly allow doing so.
The BXM method offers a risk reduction end-point logic that is consistent with,
and an improvement over Ref. [22]. It gives more clarity on how to decide on risk
reduction end-points where there is a SOTA, and also where there is no SOTA.
Fig. 11.2, is applicable when there is a SOTA. The logic should be applied to all
Hazards and repeated until no further risk reduction is called for.
Fig. 11.3 shows a condition where there is no SOTA. The logic should be applied
to all Hazards and repeated until no further risk reduction is called for.
For some medical devices of small significance, there may not be any published
scientific literature reporting clinical studies of those devices and the corresponding
safety outcomes. In such cases, it may not be feasible to determine SOTA. An