Page 226 - Assurance of Sterility for Sensitive Combination Products and Materials

Risk to the patient—Quantifying assurance of sterility 205

Control (CDC) surgical site infection relates in comparison with conserva-
tive infection rates from sterilized medical devices has been published [7].

7.5 Risk acceptability—Bringing it all together, the real risk
to the patients

Stakeholders, that is, physicians, patients, and regulators, understand that the
use of health-care products entails some degree of risk. The acceptability
of a risk to a stakeholder is influenced by the likelihood of occurrence and
the severity of the outcomes and by the stakeholder’s perception of the
risk. The decision to use a medical device requires the residual risks to be
balanced against the anticipated benefits of the procedure. Such judgments
should consider the intended use, performance, and risks associated with the
medical device, as well as the risks and benefits associated with the clinical
procedure or the circumstances of use.
Risk acceptability is determined by the manufacturer. Methods of de-
termining acceptable risk include, but are not limited to, the following:
(a) Using applicable standards that specify requirements which, if imple-
mented, will indicate achievement of acceptability for the applicable de-
vice relative to particular risks. This is the case with packaging, aseptic
processing, and terminal sterilization as per the standards analyzed above.
−6
In the case of terminal sterilization, a PNSU* of 10 is deemed an ac-
ceptable risk (ISO 14971, EN 556-1 and AAMI ST67) based on the use
of a recognized sterilization standard (see, for example, Table 7.4).
(b) Comparing levels of risk evident from medical devices already in use.
Devices processed aseptically with UCBs as per Section 7.3.3 are
deemed acceptable when terminal sterilization cannot be achieved.
(c) Utilization of clinical study data, especially for new technology or new
intended uses, to demonstrate new benefits outweighs risks.
(d) Considering the state of the art and available information such as tech-
nology and practice existing at the time of design. “State of the art” is
used here to mean what is currently and generally accepted as good
practice.
Methods (b), (c), and (d) require an analysis of risk vs benefits.
Acceptability is achieved with a favorable risk-benefit analysis.
Stakeholders may weigh risks and benefits using the following factors:
(a) Uncertainty
Uncertainty in the estimates of benefits and risks can be weighed.
Consideration of the estimates for the occurrence of harms and the
potential benefits of a new technology or device can be considered.