Page 227 - Assurance of Sterility for Sensitive Combination Products and Materials

206 Assurance of sterility for sensitive combination products and materials

(b) Patient Impact
Risk to the patient may be increased if the device treatment or tech-
nology is not available.
(c) Product availability
Availability of a product or technology should be considered. Patients
may benefit from new treatment modalities and technologies not
currently available due to limitations based on sterilization methods.
Patients and caregivers may prefer access to the device or technology.
(d) Types of benefits
The value that patients place on the benefits of new devices and tech-
nologies should be considered. New devices may address unmet needs.
(e) Magnitude of benefits
Consideration of the magnitude of the benefits should be considered.
For example, the use of alternate PNSU*s could lead to more innova-
tive products being available to patients.
(f) Probability of the patient experiencing one or more benefits
Different patient populations may experience more or fewer benefits.
Benefits may vary across patient subgroups. New technologies may
benefit subgroups with unmet needs.
(g) Duration of benefits
Duration of the benefit may vary. Consideration of the benefit achieved
vs the risk should be considered.
(h) Consideration of the potential harms, for example, infection, sepsis, or
even death should be considered. Are other complications possible?
How likely is the infection to be treated?
(i) Patient factors
Consideration for the patient’s willingness to accept the probable risks
of the device or technology in exchange for the probable risks should
be weighed. Use of Patient Preference Information, PPI, when avail-
able should be used. Consideration for the patient’s understanding of
the risks and benefits should be weighed.
(j) Alternative treatments
Consideration for other therapies and their availability to the patient
and their effectiveness should be considered.
(k) Benefits to health-care professionals (HCPs) and caregivers
Access to new technologies or improved designs can improve device
ease of use, and thus lower the potential for use errors. This is signifi-
cant considering the increase in device usage by patients and caregivers.