Page 187 - Safety Risk Management for Medical Devices

166 Safety Risk Management for Medical Devices

18.4 INFORMATION FOR SAFETY AS A RISK CONTROL MEASURE
Information for safety can take many forms. For example: screen displays, IFUs, labels
attached to the device, and online help.
The release of EN ISO 14971:2012 [7] created a lot of confusion and controversy,
particularly with respect to Annex ZA, section 7, which states: “.. . information given
to the users does not reduce the (residual) risk any further.”
The problem was that in some cases there is no other option but to inform the
user on how to use a device safely. Example: Reusable surgical instruments need to be
cleaned and sterilized before each use. Since this action is performed by the user, pro-
viding information on how to clean and sterilize the device is the main way to ensure
the safe reuse of the surgical instruments.
In 2014 the Notified Bodies Recommendation Group (NBRG) released a
Consensus Paper [22] that provided guidance to Notified Bodies on how to interpret
and apply Annexes Z in EN IS 14971:2012 [7]. In this Consensus Paper a distinction
is made between Disclosure of Residual Risk and Information for Safety.

Disclosure of Information in the accompanying documents on risks
residual risks remaining after all Risk Control measures have been taken
Information Instructions of what actions to take or to avoid in order to
for safety prevent a Hazardous Situation from occurring
The Consensus Paper [22] advises the Notified Bodies that: “Any information for
safety comprising instructions of what actions the user can take or avoid, in order to
prevent a Hazardous Situation from occurring may be considered a risk control
measure.”
Disclosure of the residual risk enables a user to make an informed decision as to
whether to use a medical device. Whereas, information for safety enables a user to
safely use a device after he/she has decided to use the medical device.
The disclosure of the residual risk can also be used by the user of the medical
device to better prepare for possible side effects or hazards that can occur during or
after the use of the medical device.

18.4.1 Criteria for information for safety
If you choose to use information for safety as a Risk Control, there are certain consid-
erations. The information for safety must be perceivable, comprehensible, and action-
able by the user, and be effective in reducing risk.
Guide 51 [1] states “The content of an instruction should provide product users
with the means to avoid harm caused by a product hazard that has not been elimi-
nated or reduced, enable product users to make appropriate decisions concerning the
use of the product.. .”