From the Desk of Lisa Thomas, BSN
Happy Holidays to All!
Certainly, recent months have seen a flurry of activity
surrounding "Infection Control". As if the ASC industry
isn't reeling from the changes subsequent to CMS's
416.51 Conditions of Coverage/Standards for Infection
Control effective May 18th, 2009 the FDA's
announcement last week regarding the SS1
processors is just 'one more thing' to be concerned
about! If you are an AORN or APIC member you've
seen the email blasts for the FDA's news and Steris'
response.
"Facilities using the SS1 should transition to an
alternative method as soon as possible", says the
FDA.
Be sure to include your Infection Control
consultant/designee in your 'plan' and include
your 'alternative method', staff education, etc in your
Infection Control meeting minutes, ensuring it gets
back to your Governing Board!
The FDA Notice is as follows:
Steris System 1 Processor: FDA Notice and
Recommendations -Announcement Dec 3, 2009
Audience: Hospital risk managers, surgical service
managers, infection control professionals
FDA notified healthcare facility administrators and
infection control healthcare professionals of important
information regarding the regulatory status of the
STERIS System 1 Processor (SS1) used in surgical
and endoscopy suites for reprocessing, i.e., sterilizing
or disinfecting, medical devices.
STERIS has significantly modified the SS1 and FDA
has not approved or cleared this modified product.
Thus, FDA has not determined whether the SS1 is
safe or effective for its labeled claims, including
claims that it sterilizes medical devices. Use of a
device that is promoted to sterilize or disinfect a
medical or surgical device, but that does not properly
perform these functions, poses risks to patients and
users. Improperly disinfected or sterilized instruments
may transmit pathogens to patients and healthcare
staff, or expose them to hazardous chemicals.
Improper sterilization or disinfection may also
adversely affect the quality and functionality of
reprocessed instruments. FDA has received some
reports of malfunctions of the SS1 that had the
potential to cause or contribute to serious injuries to
patients, such as infections. There have also been
reports of injuries, mostly burns from exposure to the
sterilant solution, to healthcare facility staff operating
the device.
FDA recommends that if a facility has an acceptable
alternative to the SS1 to meet sterilization and
disinfection needs, the facility should transition to that
alternative as soon as possible to ensure continued
patient safety. If an acceptable alternative to the SS1 is
not available, the facility should promptly assess its
patient-care needs and sterilization and disinfection
requirements and take steps to obtain legally-
marketed substitutes for the SS1.
User facilities, including hospitals, are required to
report suspected device-related deaths to FDA and the
manufacturer, and serious injuries to the
manufacturer or to FDA, if the manufacturer is
unknown (see http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/PostmarketRequireme
nts/ ReportingAdverseEvents/default.htm). Also, FDA
solicits voluntary reports of adverse events from
healthcare professionals. Adverse events may be
submitted online.
Read the complete MedWatch 2009 Safety summary, including a link to the FDA letter to healthcare facilities, at:
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Greetings!
If you have been attending our Infection Control
webinars, you will find this newsletter issue an
important addendum to the
information that you have already received from us
regarding CMS Infection Control Changes and
upcoming audits.
If you have not yet registered for one of our webinars, I
encourage you to check us out and register today.
This will be the perfect opportunity to ask questions of
our Infection Control consultant that you may not be
able to get answered easily from other sources.
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Flashing -Short Cycle Containers |
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Many organizations have found Amsco Sterilization
Containers from Steris to meet the 'short cycle'
requirement needs. They are approved for terminal
sterilization and flash sterilization as well. There are
special instructions that come with them for use in
flash sterilization, so keep the instructions on site for
surveyors! They come in a variety of sizes. The price
vary - (9"x14", 11"x16", 11"x19", 12"x12", or 12"23") -
$500 - $600 depending on any contracts you may have
with Steris.
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Special Patient Safety Alert |
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Other Things to Think About? |
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- Are you using disposable water bottles for
endoscopy? How are you " high level
disinfecting/sterilizing" the water bottle
lids/connectors?
- Are you following the manufacturer guidelines
for "Minimal Effective Concentrate" testing? Do you
have the documentation/logs to validate this?
- Does your ASC log the 'loaner scopes' in a log
book?
- Does your processing room sink have a magic
marker 'line' to denote the 'fill line' in order to ensure
the correct level of water is added to the 'cleaning
product' you are using? Based on the manufacturer
guidelines of course!
- Did you know that the National Institute for
Occupational Safety and Health (NIOSH) is
considering a revision to its gluteraldehyde
recommended exposure limit? While OSHA does not
have an exposure limit, about 10 states do have
permissible exposure limits. For example, California
in 2006 reduced it's permissible exposure limit from
0.2 parts per million (ppm) to 0.05. Check with YOUR
state's requirements and stay tuned for NIOSH's
revisions!
- Is your ASC planning a construction project?
Including painting, wall covering, or other activities
which do not generate dust or require cutting of walls
or access to ceilings? Are you planning to install
additional telephone or computer cables where dust
migration might occur?
- How about the sanding of walls as prep for
painting, or any activity that cannot be completed within
a single workshift? Be sure to complete an Infection
Control Risk Assessment by collaborating with your
infection control consultant/designee! Remember that
certain precautions must be taken during the
construction project and then upon completion of the
project!
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NPSG.07.05.01 |
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Many questions have been asked about patient follow-
up, antibiotic efficacy and timing, and hair removal.
Visit www.jcaho.org for the complete NPSG.07.05.01
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Read on for exert... |
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AAAHC 2010 Standards |
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Recent comments by a AAAHC surveyor indicate the
2010 AAAHC standards will include Chapter 7 as
dedicated to "Infection Control". Expect to see AAAHC
post their 2010 standards sometime as early as late
February or March! You can expect Excellentia to be
one of the first to have them and to inform you of the
availability. However, check AAAHC regularly in 2010.
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AAAHC website |
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Inservice Dates 12/17, 1/7, 1/12, 1/20 and 1/27/2010 |
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If you haven't already attended one of our "Infection
Control Changes for ASC's" webinars, we have
several more dates to pick from in the next 30 days.
Our webinars give you a wealth of information as well
as the opportunity to ask questions of our expert. Each
participant will receive a Certificate of Completion.
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Click to Register... |
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