Guidance for Industry and FDA
Reviewers Content and Format of Premarket Notification [510(k)] Submissions
for Liquid Chemical Sterilants/ High Level Disinfectants Document issued on:
January 3, 2000:
III.H.3. Potency Tests 2) Worst case conditions for a reused germicide - a
germicide from a production run, stored to expiration, stressed to the end
of its claimed reuse life, and diluted to its minimum recommended or
effective concentration, if necessary. Incorporate into the simulated reuse
protocol any factors that may impact the performance of the germicide, such
as an organic load, dilution, water quality, temperature variation, and pH
changes.
FOOD AND DRUG ADMINISTRATION SECOND ANNUAL CDRH/CBER MDUFMA STAKEHOLDER
MEETING Gaithersburg, Maryland Thursday, November 18, 2004
Comments of
Steve Turtil, scientific reviewer in the Office of Device Evaluation:
So again we took a real close look at what sort of artificial soils were
used and the simulated use protocols, then we took a look at the
cleaning validation protocols to make sure that they were really worst
case, and we wanted to see finally all the details for the test
protocols, cleaning end points, and other information. The cleaning
validation protocols should support and confirm the effectiveness of the
routine cleaning instructions and should include consideration of --
and again this is very, very abridged, we spent a lot of time with
this, it's very elaborate, the details we were looking at, very device
specific, but we'd want to see that the soil that's used,
artificially soilees(?), represents intended clinical exposure.
Guidance for
Industry and FDA Staff - Medical Device User Fee and Modernization Act of
2002, Validation Data in Premarket Notification Submissions (510(k)s) for
Reprocessed Single-Use Medical Devices: Document issued on: September 25,
2006: III. Specific Validation Data Recommendations
Describe the cleaning endpoint used in the tests and the rationale for the
endpoint. Describe the sensitivity, specificity, reproducibility, accuracy,
and precision (as applicable) of the analytical test methods for determining
that the endpoint is achieved, (i.e., the device is clean).
Note: Tests demonstrating a reduction in contamination levels alone are
insufficient as an endpoint. Although the common definition of a clean
device is one that is visually free of contamination, this condition should
be translated by the reprocessor into an objective and measurable endpoint
specification. The endpoint should have a visual component but should be
supplemented with chemical, microbiological, and/or other physical
parameters with tolerances. Devices should not have an endpoint based on
visual examination alone. Tests should demonstrate that the cleaning
endpoint is achieved independently of subsequent process steps. Test methods
may utilize simulations of contamination under controlled lab conditions;
however, actual contamination should be used to complete validation testing.
Guidance for
Industry and FDA Staff - Medical Device User Fee and Modernization Act of
2002, Validation Data in Premarket Notification Submissions (510(k)s) for
Reprocessed Single-Use Medical Devices: Document issued on: September 25,
2006
12. How does FDA interpret the scope of validation data required under
MDUFMA? FDA interprets validation data as broad in scope, including
information about processing at the point of use to the completion of
packaging and sterilization, and other post-process considerations. This
guidance provides more discussion on validation data in Section III.
Cleaning, sterilization, and functional performance validation of
reprocessed SUDs include aspects of both design validation and process
validation. Design validation, in this case, should incorporate both the
design of the product and the design of the processes to be used in
reprocessing the device. FDA interprets the cleaning process to include all
steps to remove, inactivate, or contain contamination, beginning immediately
after clinical use of the device, and all subsequent steps to decontaminate
and clean a device up to packaging and prior to the first step of the
sterilization process. This includes all quality control tests. A clean
device, as specified by the reprocessor, should be the input for the
sterilization process. FDA interprets the sterilization process as beginning
after packaging and any preconditioning other than cleaning (e.g.,
prehumidification for ethylene oxide (EO)) to the end of any post-process
conditioning. Manufacturers should assess functional performance after the
cleaning and sterilization process validations. Successful process
validations then support the overall design validation. The results of the
cleaning and sterilization validations provide objective evidence that the
particular requirements for a specific intended use can be consistently
fulfilled and are equivalent to those of the predicate device.
Guidance for
Industry and FDA Staff - Medical Device User Fee and Modernization Act of
2002, Validation Data in Premarket Notification Submissions (510(k)s) for
Reprocessed Single-Use Medical Devices: Document issued on: September 25,
2006: III. Specific Validation Data Recommendations
Process Validation: The purpose of process validation is explained above.
There are three steps used in process validation that can be adapted to a
cleaning process, including both equipment and manual procedures. These
steps are installation qualification, operational qualification, and
performance qualification. The submission should provide a summary of each
of the process validation steps as they apply to the reprocessing of the
specific device: The installation qualification can be briefly summarized.
For purposes of a 510(k), FDA is primarily interested in a summary of the
operational and performance qualification where test and actual loads or
sample runs are evaluated. The operational qualification summary data should
demonstrate that the cleaning equipment is capable of delivering the
specified process within defined tolerances. The performance qualification
summary should demonstrate that multiple consecutive runs of the cleaning
process with the specific type of device achieve the specified outcome.
Explain any failures of the process and means to correct the process. The
qualification should demonstrate effective and safe reprocessing after the
defined number of iterations specified by the reprocessor.
CDRH/CBER MDUFMA STAKEHOLDER MEETING PRESENTATION SLIDES, November 18, 2004,
Washingtonian Marriott, Gaithersburg, Maryland: Reuse of Single Use Devices
CDRH/CBER MDUFMA Stakeholder Meeting Presented by: Barbara Zimmerman
Cleaning Process:
Cleaning Instructions should specify: Point-of-Use Decontamination
Disassembly, if possible Automated or Manual cleaning, or a combination –
time, temperature, brushing duration, etc. Ultrasound – time, temperature,
setting (high, medium, low) Detergents, Enzyme Detergents – time, temp.,
concentration, cycle limit (replenishing) Intermediate Rinse Steps – time,
temp., particular water quality specifications.
FDA and CDC PUBLIC HEALTH ADVISORY: Infections from Endoscopes Inadequately
Reprocessed by an Automated Endoscope Reprocessing System, September 10,
1999
FDA has also requested that the labeling of the AER include instructions for
reprocessing specific models of endoscopes. The instructions should be based
on the results of validation studies with the specific endoscope models. The
1993 FDA guidance for AER manufacturers recommended that the AER labeling:
list all brands and models of endoscopes that are compatible with the AER;
identify the AER’s limitation to process certain brands and models of
endoscopes and accessories, or identify the endoscopes and accessories that
cannot be reliably reprocessed in the AER; and be compatible with the
endoscope manufacturer’s cleaning and disinfection instructions.
CDRH/CBER MDUFMA STAKEHOLDER MEETING PRESENTATION SLIDES, November 18, 2004,
Washingtonian Marriott, Gaithersburg, Maryland: Reuse of Single Use Devices
CDRH/CBER MDUFMA Stakeholder Meeting Presented by: Barbara Zimmerman
Cleaning Validation Protocols
Should Include WORST CASE consideration of: Automated, Manual or a
combination – time, temperature, brushing duration Ultrasound – time,
temperature, setting (high, medium, low) Detergents, Enzyme Detergents –
time, temp., concentration, cycle limit (replenishing). Intermediate Rinse
Steps – time, temp., particular water quality specifications.