Risk analysis, or hazard analysis, is a structured tool for the evaluation of potential problems which may be encountered in connection with the use of a medical device. Manufacturers are expected to identify possible hazards related with the design in both normal and fault conditions. If any risk is identified as unacceptable, it should be reduced to acceptable levels by appropriate means. To control risk there is term called as Risk Control.

Risk Control: Process through which decisions are reached and protective measures are implemented for reducing or maintaining risk within the desired level.

Risk control and monitoring activities: A fixed hierarchy of risk controls should be examined in the following order:

• Inherent safety by design
• Protective measures within the device or its manufacture
• Information for safety, like warnings, maintenance schedules, etc.
• Production, complaints, customer feedback, should be used as a part of this monitoring.

Risk Control Measures: Many measures require intervention.

• The correct response for the circumstances, e.g. a patient-specific response

Some potential hazards which have to be evaluated include flammability, toxicity, and reactivity of raw materials and wastes; sensitivity to environmental factors like humidity, temperature; mechanical or electronic hazards; and human factors associated with the operator-device interface. The patient-device interface can also be hazardous because of unsafe or ineffective delivery of energy, administration of medicine or drugs, or control of life-sustaining functions. Also, inaccurate information could lead on to a misdiagnosis or wrong treatment or therapy being ordered.

Definition of Benefit as per ISO 14971:2019- A positive impact or desirable outcome of the use of medical device on the health of an individual, or positive impact on patient management or public health.

A risk-benefit analysis is a comparison between the risks of a situation and its benefits. The prime goal is to find out whether the risk or benefit is most significant.

 

To carry out a risk-benefit analysis, we should follow the three steps for both the Risks and Benefits,

 

A.     Estimation of Benefits: The benefits of a medical device are related to its indented purpose. Benefit can be estimated from below:

 

1. Performance expected during its clinical use
2. Clinical outcome from that performance
3. Other treatment options
4. Target groups

B.     Quantification of Benefits: Benefits are quantified by considering the target patient population and duration of effect.

1. Target patient population: The benefits experienced only by a small proportion of patients in the target population or occur frequently in patients throughout the target population.

 

Large benefit experienced by a small population, considered to be significant enough to outweigh risks, and in the same way, a small benefit may not, unless it is experienced by a large population of subjects.

 

2. The duration of effect:
   • The duration of a treatment’s effect

• The age of patients

 

C.     Evaluation of Clinical Risks

• Intensity of the risk
• Life threatening or not
• Medical necessity