Page 76 - Safety Risk Management for Medical Devices

Risk Management Process 55

The policy for determining the criteria for risk acceptability could apply to the
entire range of a manufacturer’s medical devices, or be specialized for different group-
ings of the manufacturer’s medical devices. The manufacturer can take into account
the applicable regulatory requirements in the regions where a medical device is to be
marketed.
The relevant International Standards for a particular medical device, or an
intended use of a medical device can help identify the principles for setting the crite-
ria for risk acceptability.
Information on the SOTA can be obtained from review of published scientific
literature. Also, information on similar medical devices that the manufacturer has
marketed, as well as medical devices from competing companies can serve to identify
the SOTA.
With respect to stakeholder concerns, many sources can be utilized, including:
news media, social media, patient forums, key opinion leaders, as well as input from
internal departments such as regulatory, clinical, and marketing who have knowledge
of stakeholder concerns.
Criteria for risk acceptability provide guidance for determination of end-points for
risk reduction. ISO 14971:2007 [3] requires the reduction of residual risk to As Low
As Reasonably Practicable, while EN ISO 14971:2012 [7] requires reduction of
residual risk to As Far As Possible, which also sometimes referred to as As Low As
Possible, without regard to economic considerations.
The NBRG Consensus Paper [22] disputes the assertion of Ref. [7] on no allow-
ance for economic consideration. The NBRG consensus paper [22] states that
“Although economic considerations will always be relevant in decision-making pro-
cesses, the safety of the product must not be traded off against business perspectives.
For transparency, the manufacturer must document the end-point criteria of risk
reduction based on his risk policy.”
The requirement of Ref. [7] that risks be reduced to as low as possible for accept-
ability creates both a nebulous and an impractical criterion for risk acceptability
because first, it is difficult to know when the lowest possible risk level has been
reached (short of total elimination), and second, trying to achieve this mark could
restrict patient access to safe and affordable medical devices. In response to Ref. [7],
Ref. [22] provides a practical interpretation of the Standard [7], as follows:
If “death or serious deterioration of health is unlikely to occur in normal
operation or due to device malfunctions or deterioration of characteristics or perfor-
mance, or any inadequacy in the labeling or instructions for use”, then “the risk shall
be considered acceptable” [22].
Otherwise the risk must be reduced. Ref. [22] offers some options to determine
end-points for risk reduction: