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Steris Corp. Warning Letter about misleading
product statements
Steris Corporation 2/9/11 Department of Health and Human Services Public Health Service
Food and Drug Administration10903 New Hampshire Rd
Silver Spring, MD 20903FEB 9 2011 Warning
Letter
Via United Parcel Service
Walter M. Rosebrough, Jr.
President and Chief Executive Officer
STERIS Corporation
5960 Heisley Road
Mentor, Ohio 44060-1834 Re: Verify SixCess Class 6 Challenge Packs and Chemical Indicators
Dear Mr. Rosebrough:
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (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 Cosmetic Act. The FDA granted your company marketing clearance
for several chemical indicators and challenge packs which contain these indicators. The five submissions covering 11 devices
are as follows: Chemical Indicators
K070461: Verify 250F30; Verify 270F15; Verify 270F3-10
and Verify 240F4
K071895: Verify 275F3
K083643: Verify 275F3-10 and Verify 275F10 Challenge
Packs
K070895: Verify 270F4 and Verify 275F3
K073683: Verify 270F4 and Verify 275F3 The
cleared intended uses for the devices are summarized as follows: K070461: The Verify Steam Indicators
are emulating indicators intended for use in steam sterilization. The Verify Steam Indicators change color from yellow to
blue/purple when exposed to the appropriate cycle temperature, type, and duration. The clearance letter indicates the appropriate
ranges of temperature, type, and duration. K071895: The Verify 275F3 Indicator is a chemical
indicator intended for use by health care providers to accompany products being sterilized through a sterilization procedure.
The Verify 275F3 Indicator is an emulating indicator intended for use in steam sterilization. The
indicator changes color from yellow to blue/purple when exposed to 275°F (135°C) pre-vacuum sterilization cycles for
3 minutes. The clearance letter contains a chart that indicates the correct cycles. K083643:
The Verify 275F Gravity Indicators are chemical indicators which meet ANSI/AAMI 11140-1:2005 for emulating indicators intended
for use in steam sterilization. The Verify 275F Gravity Indicators change color from yellow to blue/purple when exposed to
275°F (135°C) and to the appropriate cycle type, and duration. K070895: The Verify Challenge
Packs are test packs consisting of an emulating indicator surrounded by a steam penetration barrier, intended for use in steam
sterilization. The Verify Challenge Packs indicators change color from yellow to blue/purple when exposed to the appropriate
cycle temperature, type, and duration. The clearance letter contains a chart with the appropriate specifics. K073683: The Verify Challenge Packs -Version 2 are test packs consisting of an emulating indicator surrounded
by a steam penetration barrier, intended for use in steam sterilization. The Verify Challenge Packs indicators change color
from yellow to blue/purple when exposed to the appropriate cycle temperature, type, and duration. Again, the clearance letter
contains a table with the appropriate specifics. 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.
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: • 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. “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. 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.
You should take prompt action to
correct these violations. Failure to promptly correct these deficiencies may result in further regulatory action by FDA without
additional notice. These actions include but are not limited to seizure, injunction and/or civil penalties. Please notify this office in writing within 15 working days of receipt of this letter of the specific steps you
have taken to correct the cited violations. Your response should also include all steps taken to address the information currently
in distribution and in the market place and actions to be taken to prevent similar violations in the future.
If
you cannot complete a corrective action within 15 working days, we ask that you provide the reason for the delay and timeframe
for when the corrections will be completed. Your response should be sent to Ms. Valerie A. Flournoy, Branch Chief, General
Hospital Devices Branch, Center for Device and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue,
WO66 Rm 3526, Silver Spring, MD 20993. If you have any questions concerning the contents of this letter, you may contact Ms.
Flournoy at (301) 796-5770, or you may forward a facsimile to her at (301) 847-8137, or email her at Valerie.Flournoy@fda.hhs.gov. The violations discussed in this letter do not necessarily constitute an exhaustive
list. It is your responsibility to ensure that your promotional materials for Verify SixCess Challenge Packs and Chemical
Indicators comply with each applicable requirement of the Act and FDA implementing regulations. Sincerely
yours, /s/ Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health
FDA Revises Steris System 1E Rinse Water Language | Clearance letter explains water treatment process, leaves it up to facilities
to determine where SS1E fits with their protocols. | | | | | | In
yet another revision to its clearance letter for the Steris System 1E liquid chemical sterilant processing system, the Food
and Drug Administration has included more specific language about the treatment of rinse water used in the system and how
facilities should determine where the device fits into their instrument processing protocols. The SS1E, designed to be a successor to the phased-out
Steris System 1, was first cleared in April 2010, but language in the original FDA clearance letter has left many in the healthcare community perplexed. The letter originally stated that devices processed in the SS1E, which uses a peracetic acid germicide called S40, are rinsed
with potable water that, despite going through a 3-step treatment process that involves filtration and exposure to ultraviolet
rays, is not sterile. Now,
the FDA has revised this language to better explain the SS1E's rinse water treatment: "The treatment method eliminates bacteria/fungi/protozoa from the
water. Studies with the test virus MS2 (EPA recommended surrogate for waterborne viruses) showed a 6 log reduction."
The letter no longer
states that devices processed in the SS1E "cannot be assured to be sterile," but it does state
that, as with all liquid chemical sterilant processing systems, devices should be "used immediately or stored in a manner
similar to that of high level disinfected endoscopes" after emerging from the SS1E. So when should the SS1E be used? Only to process heat-sensitive
semi-critical and critical devices that are validated for use in the system, says the FDA. The agency's revised letter puts the onus squarely on you, the healthcare provider, to "verify
with the individual Original Equipment Manufacturers that their devices are compatible with the SS1E" and to evaluate
the FDA's description of the system's "liquid chemical sterilant processing and rinse water element and determine how
the device fits with [your] infection control programs." |
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