- Find Regulatory Requirements for your country
- GHTF
- Validation Requirements
- Medical Device Software
- Sterilization
|
SUBSCRIBE (always Free) |
|
Biological Indicator Reduced Incubation Time (RIT) Study
Medical Device ethylene oxide sterilization is monitored by the use of biological indicators (BIs) using Bacillus subtilis species. The common “off the shelf” recommendation for incubation by most manufacturers is 7 days or more. However, there is a way to reduce the incubation time to as much as 24 hours.
Reducing the BI incubation time can be a big financial asset to an organization bent on reducing inventory. Other benefits including being able to matching customer demand and just having better overall control with regards to timing.
A lot of factors take part in the RIT including the sterilization cycle and the Challenge Pack (developed to mimic the device packaging – either equaling or making it more difficult for gas penetration). When a manufacturer decides to reduce the BI incubation time the method chosen to validate the process is very crucial in ensuring a) a successful time reduction and b) ensuring that the process is adequately validated to meet FDA requirements.
FDA Requirements
The FDA has proposed a method for validating a RIT. In summary the process works by subjecting a Lot of BIs to a Fractional cycle (or sublethal cycle – since the exposure time is significantly reduced). If done correctly a number of BIs will grow out. It is critical that the number stay within a range. The FDA recommends 30 to 80 percent survival.The following is an excerpt taken from Premarket Notifications [510(k)] for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities; Draft Guidance for Industry and FDA Reviewers
You can read the document online at:
http://www.fda.gov/cdrh/ode/guidance/1320.html#tablenote_1