Page 226 - Safety Risk Management for Medical Devices

Risk Management for Clinical Investigations 205

There are many factors that determine the type of clinical study:
• Premarket, postmarket
• Exploratory, confirmatory, or observational
• Interventional, noninterventional
In the earliest stages of medical device development, it may be necessary to evalu-
ate the merits and limitations of a new device, prove a concept, or test a new indica-
tion for an existing device. These are premarket, exploratory, or feasibility studies
performed on a small number of participants and require risk management.
If the exploratory studies produce good results, a confirmatory pivotal clinical inves-
tigation can be performed to collect data on the safety and efficacy of the device on a
larger group of participants. Pivotal clinical investigations also require risk management.
After the device is approved for market release, postmarket confirmatory clinical
investigations can be performed on the device in order to collect data on the clinical
performance, safety, and efficacy of the device. Risk management may be necessary
depending on the objectives of the CIP.
Another type of clinical investigation is the observational postmarket study, where
the device is used within its labeled indication. This type of study collects data on
large groups of patients to evaluate specified outcomes on patient populations, and
serves scientific, clinical, reimbursement, or policy purposes. Often these are registry
studies where the decision to use the medical device is clearly separated from the deci-
sion to include the subject in the clinical study. Observational postmarket studies do
not introduce any additional risk on the study participants and risk management is not
required prior to the start of the study.
Ref. [33] notes that the term “noninterventional” is synonymous with “observa-
tional,” and that “postmarket clinical investigation” is synonymous with “postmarket
clinical follow up.”

26.3 MAPPING OF RISK MANAGEMENT TERMINOLOGIES

ISO 14155 [33] defines SAE as an event that: “

a. led to death,
b. led to serious deterioration in the health of the subject, users or other persons
defined as an adverse event resulting in one or more of the following:
1. a life-threatening illness or injury, or
2. a permanent impairment of a body structure or a body function, or
3. in-patient or prolonged hospitalization, or
4. medical or surgical intervention to prevent life-threatening illness or injury
or permanent impairment to a body structure or a body function,
c. led to fetal distress, fetal death or a congenital abnormality or birth defect”