Page 186 - Safety Risk Management for Medical Devices

Risk Controls 165

The manufacturer is required to consider all the options and implement as many
of the options as possible [7].
Consider if it is possible to eliminate a Hazard. If so, change the design so that the
device is inherently safe from that Hazard. If elimination of the Hazard is not possible,
then consider if protective means in the design, or the manufacturing process could
protect the patient/user from Harm. Additionally, if providing information for the
safe operation and use of the device could help with reducing the risks of the device,
provide such information.
Document the Risk Control option-analysis and the decisions made on the selec-
tion and implementation of the Risk Controls.
After the first pass through risk analysis, it may be determined that additional Risk
Controls need to be implemented. For every additional Risk Control that is imple-
mented determine if any new Hazards are introduced or if the any of the current risks
are increased.

18.3 DISTINCTIONS OF RISK CONTROL OPTIONS

Sometimes it may not be easy to identify the type of a particular Risk Control mea-
sure: inherently safe by design, or a protective measure, or information for safety. The
different options are distinguished as follows:.
Safe by Design—The device behaves in a safe manner without any action or knowl-
edge required by the user. The user cannot easily defeat the Risk Controls.
Example: Elevators have an automatic braking system that arrest the movement
of the elevator in the case of mechanical or electrical failures. The user of the
elevator doesn’t need to know anything about the workings of the elevator, and
cannot easily defeat the Risk Control.
Example: In a car with automatic transmission, it is possible to start the car only if
the gear shift selector is in Park, or Neutral positions. This prevents the operator
from starting the engine in gear and causing possible unexpected vehicle movement.
Protective Measure—Device behaves in a safe manner without the need for user
intervention, but the protective measure(s) can be easily defeated by the user.
Example: Hypodermic needles come with a protective cap. The user does not
need to take any action to make the product safe, as it is delivered. However,
the user can easily remove the protective cap.
Information for Safety—Provides knowledge to the user and requires action by
the user.
Example: Instruction for cleaning and sterilization of a reusable surgical tool
provides knowledge to the user and requires action from the user in order to
use the device safely.