Warning Letter February 9, 2011
Steris Corporation
“Chemical Indicators (Verify SixCess Class 6 Challenge Packs and Chemical Indicators) Should Not Replace Biological Indicators (BIs)”
Comment
Steris Corporation has developed chemical indicators that have been approved by the FDA to “monitor physical conditions”. While the FDA has approved this use, they recently issued this Warning Letter because the Steris literature appears to imply that their indicators remove the need for Biological Indicators. Biological indicators, as noted above by the FDA, measure the sterility assurance of the removal of microorganisms.
“The… FDA has reviewed several brochures and other promotional materials as well as the website for STERIS Corporation’s Verify SixCess Class 6 Challenge Packs and Chemical Indicators. Chemical indicators are devices within the meaning of section 201(h) of the Federal Food, Drug and Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) Cosmetic Act. The labeling originally submitted by Steris to the Office of Device Evaluation (ODE) in the 510(k)s for the Verify Chemical Indicators and Challenge Packs included the following claim:
“The performance of the Verify (specific name) indicator exceeds that of biological indicator kill and meets the requirements of ANSI/AAMI/ISO 11140 for Class 6 steam indicators.”
The records for these 510(k)s indicate that ODE advised you that chemical indicators should not replace the use of biological indicators. Our records also show that you were asked to revise the indication for use, product labels and 510(k) summary, and did in fact provide revised documents removing the comparisons to biological indicators. As such, the labeling that was cleared by FDA for the devices listed above did not contain the incorrect statement noted above in italics.
Comment
The FDA, in their review of the labeling originally submitted by Steris, reminded Steris that chemical indicators should not replace biological indicators. Steris revised the labeling as requested and FDA subsequently cleared the product for market. However, see below!!
The performance of chemical indicators is different from that of biological indicators. Biological indicators monitor the microbicidal function of sterilizer cycles and chemical indicators do not. The Steris Verify Chemical Indicators cannot be said to “exceed” the performance of biological indicators. However, our recent review of your labeling, brochures and other materials used to promote your products and your website http://www.steris.com/healthcare/1 finds that you are making claims that were determined to be unacceptable during the review of your 510(k) submissions. These claims represent a major modification to both the Intended Use and Indications for Use of the device. The objectionable claims include the following:
Comment
The FDA indicates that “Biological indicators monitor the microbicidal function of sterilizer cycles and chemical indicators do not.” The FDA also advises the “…indicators cannot be said to “exceed” the performance of biological indicators.” The FDA also indicated that the Steris “claims represent a major modification to both the Intended Use and Indications for Use…” Issues with the functioning of sterilizer cycles often may not be detected by a chemical indicator and include 1) lack or incomplete sterilization vacuum cycles, 2) lack of steam within the autoclave, 3) too much moisture within steam, 4) cycle too short (aborted), 5) air within the autoclave and 6) other autoclave malfunctions.
• The Verify SixCess 270F Package Insert:
Performance Characteristics
“…steam sterilization cycles with an exposure time of 4 minutes and may be used to release all loads.” [emphasis added]
• Brochure:
“the next generation”
•Reduce the wait; immediate release of all loads
•Reduce the risk; eliminate “blind” release
•Reduce the work; no readers or incubation required
These statements imply that the Steris Verify Chemical Indicators can be used to replace the use of biological indicators, an Indication for Use that was not cleared by FDA for these devices.
Comment
Releasing a sterilized load “with an exposure time of 4 minutes” is highly unusual and difficult since BIs have a “D-value” of typically 1.5 – 3.0 minutes (see USP) and which would suggest that to obtain a minimum SAL of 6 logs, the absolute minimum sterilization time would be 9 minutes.
“Your goal is 100% successful sterilization…The Verify SixCess indicator products are designed to measure Sterility Success”
Chemical indicators do not measure “Sterility Success,” they measure only that a particular sterilizer cycle met the designated physical parameters for that cycle.
• Flyer:
3 Myths of Class 6 Technology
Class 6 Myth #1
“you cannot use Class 6 emulating indicators to release loads with implants.”
Fact
“The FDA is very straightforward on this issue. Verify SixCess Chemical Indicators are cleared for the release of all loads & all items in the load, regardless of content.”
The FDA did not clear the Steris Verify Chemical Indicators to be used for the release of loads with implants.
Comment
All sterility loads need to have their minimum and maximum sterilization exposure times based upon the load configuration and verified to assure a SAL (106). Load content and configuration can markedly impact the time required to achieve biological sterilization.
Promoting the Verify SixCess Challenge Packs and Chemical Indicators for uses other than the monitoring of the physical parameters of the specific sterilization cycles for which they are labeled constitutes a new intended use requiring the submission of a new 510(k) as described under 21 CFR Part 807.81(a)(3)(ii). Your claims for these devices cause them to be misbranded within the meaning of section 502(o) of the Act, because information regarding the modification in the intended use of the devices were not provided to FDA as required by 21 CFR Part 807.81(a)(3)(ii) and not found to be substantially equivalent to a predicate device.
In addition, your representation of FDA’s position as stated in the “3 Myths” flyer is misleading, as that is not FDA’s position. All language implying otherwise should be removed from all promotional materials.
Comment
There has always been an industry goal to release products following terminal sterilization as expeditiously as possible. This has become a reality as noted within the various AAMI parametric release procedures that have existed for many years. Various test methods to include both chemical and biological have also been promoted to shorten the biological incubation requirements. Unfortunately, they have not been successful.
Has the FDA inquired with any of the hospital sites that trialed the Steris Class Six product and read the feedback reports that Steris provided those customers?