Regulatory Open Forum

Device stability considerations after repeated sterilization cycles should be certain to evaluate device integrity with respect to key attributes such as the device's chemical, physical, performance, therapeutic, and toxicological attributes.  The goal is to show that repeated sterilization doesn't cause the subject device to be susceptible to degradation with respect to its critical attributes.  It is up to the sponsor to substantiate the number of repeated sterilization cycles that it claims can be used.

A meaningful re-sterilization stability protocol should involve a) the establishment of specifications and acceptance criteria related to important device/packaging properties and characteristics, and b) testing procedures intended to evaluate the key properties before and after repeated sterilization.  It may be possible to achieve this, at least in part, via a paper-based analysis depending on device risk.  For example, AAMI TIR17 contains some neat tables showing material compatibilities with respect to various sterilization methods and may be a useful resource.  But the safest bet is to do actual re-sterilization studies followed by device stability testing.

Device stability considerations after repeated sterilization cycles should be certain to evaluate device integrity with respect to key attributes such as the device's chemical, physical, performance, therapeutic, and toxicological attributes.  The goal is to show that repeated sterilization doesn't cause the subject device to be susceptible to degradation with respect to its critical attributes.  It is up to the sponsor to substantiate the number of repeated sterilization cycles that it claims can be used.

A meaningful re-sterilization stability protocol should involve a) the establishment of specifications and acceptance criteria related to important device/packaging properties and characteristics, and b) testing procedures intended to evaluate the key properties before and after repeated sterilization.  It may be possible to achieve this, at least in part, via a paper-based analysis depending on device risk.  For example, AAMI TIR17 contains some neat tables showing material compatibilities with respect to various sterilization methods and may be a useful resource.  But the safest bet is to do actual re-sterilization studies followed by device stability testing.

Device stability considerations after repeated sterilization cycles should be certain to evaluate device integrity with respect to key attributes such as the device's chemical, physical, performance, therapeutic, and toxicological attributes.  The goal is to show that repeated sterilization doesn't cause the subject device to be susceptible to degradation with respect to its critical attributes.  It is up to the sponsor to substantiate the number of repeated sterilization cycles that it claims can be used.

A meaningful re-sterilization stability protocol should involve a) the establishment of specifications and acceptance criteria related to important device/packaging properties and characteristics, and b) testing procedures intended to evaluate the key properties before and after repeated sterilization.  It may be possible to achieve this, at least in part, via a paper-based analysis depending on device risk.  For example, AAMI TIR17 contains some neat tables showing material compatibilities with respect to various sterilization methods and may be a useful resource.  But the safest bet is to do actual re-sterilization studies followed by device stability testing.