Risk criteria development flowchart - …

1 Created by Marcelo Antunes, Version 4 - 11-07-18. Policy for determining criteria for risk acceptability Risk criteria development flowchart Determine the need to establish risk criteria . What risk decisions will be aided by the criteria ? [m1] Coment rio: Having this option Determine the risks to be addressed (Risk to will enable use of other types of what ?) risk(environmental, cybersecurity). Determine/classify the populations to be addressed Determine which risk criteria to develop. Individual, societal, or other type of risk? [m2] Coment rio: Having this option will enable use of other types of risk Will there be a criterion defining de minimis (environmental, cybersecurity).

2 Risk? [m3] Coment rio: Some regulations may not allow the use of de minimis risk (Broadly acceptable, not requiring further reduction). Determine philosophy for continuing risk [m4] Coment rio: This will enable use of differing approaches for risk reduction reduction ( , ALARP, ALARA, AFAP) based on regulations Develop individual Develop societal Develop societal risk criteria (based risk criteria (based risk criteria (based on policy) on policy) on policy). Qualify/Validate risk criteria Periodically revalidate risk criteria Created by Marcelo Antunes, Version 4 - 11-07-18.

3 Develop individual risk criteria flowchart From Risk criteria development flowchart Develop individual risk criteria (based on policy). Identify possible criteria or basis of criteria in [m5] Coment rio: Regulations may applicable regulatory have specific criteria or indications to develop criteria requirements Identify possible criteria or basis of criteria in applicable international [m6] Coment rio: International standards may have specific criteria or standards indications to develop criteria Identify state-of-the-art regarding intended use of device, including medical alternatives Identify known stakeholder concerns, including public [m7] Coment rio.

4 Risk perception may include scale of possible incidents, perception of risk Tolerance of the Commonplace/Fear of the Unusual, Control Over the Risk. Voluntary vs. Involuntary Risk., Patient tolerance of risk and other factors Identify probability Identify additional criteria /severity criteria Define overall risk criteria Goes back to Risk criteria development flowchart Created by Marcelo Antunes, Version 4 - 11-07-18. Examples Example Policy for determining criteria for risk acceptability - Company X defines the following as our policy for determining criteria for risk acceptability related to our medical devices: Our policy for determining criteria for risk acceptability related to medical devices we manufacture shall be define by top management and will guide all organization activities towards risks related to our medical devices.

5 Our policy for determining criteria for risk acceptability shall be reviewed from time to time to make sure that it is in consonance with expectations from the stakeholders involved in our medical devices lifecycles. The definition of our criteria for risk acceptability, and all other risk management activities related to our medical devices, shall be performed only by personnel with adequate competence. Our criteria for risk acceptability shall take into consideration applicable regulations from target markets in which our devices are marketed. Different or contradicting expectations from different regulations will be treated on a case- by-case basis and will be duly justified.

6 Our criteria for risk acceptability shall take into consideration relevant international standards. The risk acceptability criteria for each device or family shall clearly define how international standards will be treated as part of the risk management process. Our products shall have at least risk control measures detailed in all applicable international standards, and when risk control options are not defined in international standards, we will implement risk control measures that reflect current practice and current perceptions of all involved, including all regulatory expectations.

7 Our products shall always have a degree of safety comparable to, and if possible better, than other treatment solutions on the market, including similar devices in the market. Our criteria for risk acceptability shall identify known stakeholder concerns, including public perception of risk. This includes concerns from user and patient, besides others. Created by Marcelo Antunes, Version 4 - 11-07-18. Example Risk criteria development flowchart 1 - Determine the need to establish risk criteria . What risk decisions will be aided by the criteria ? Risk criteria will be used to show that risk related to medical device X are acceptable.

8 The criteria will aid in the decision of: - When identified and reasonably foreseeable individual risks related to the medical device are to be considered acceptable - When the aggregate risks related to the medical device are to be considered acceptable 2 - Determine the risks to be addressed (Risk to what ?). Risk of harm to patients, user and, where applicable, other persons 3 - Determine/classify the populations to be addressed Individual patients, user, or other persons. The device is not expected to cause harm to groups of person at a time. 4 - Determine which risk criteria to develop.

9 Individual, societal, or other type of risk? Will there be a criterion defining de minimis risk? Individual risk - the risk to a person in the vicinity of a hazard. In particular, the individual risk type to be used will be the maximum individual risk (the individual risk to the person(s) exposed to the highest risk in an exposed population), for patient because blahblahblah. There won t be a de minimis criteria . 5 - Determine philosophy for continuing risk reduction ( , ALARP, ALARA, AFAP). ALARP will be used as philosophy for risk reduction. 6 - Develop individual risk criteria (based on policy).

10 Created by Marcelo Antunes, Version 4 - 11-07-18. See below Example Develop individual risk criteria (based on policy). 1 - Identify possible criteria or basis of criteria in applicable regulatory requirements Applicable regulations require that risks are acceptable when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety. There s no different or contradicting expectations in the applicable regulations. 2- Identify possible criteria or basis of criteria in applicable international standards Device has applicable international safety product standard that can be used as basis (ISO XXX or IECXXX).