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What You Might Not Know about Meeting High-Level Disinfection Training Guidelines.
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Barbara Trattler, RN, MPA, CNOR, NE-BC Director, Clinical Education

(Barbara, dressed in professional attire and either seated or standing).

Hello, I’m Barbara Trattler, Director of Clinical Education for ASP. Welcome to this edition of the ASP Hot Topic Webisode series. In this installment, we’ll address some commonly-asked questions by our customers: How do I train my staff to meet guidelines requirements for high-level disinfection...more specifically, CIDEX OPA Solutions? What tools are available to help ensure this?

These issues are hot topics for healthcare facilities and our customers, as many of you have been asked these questions by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) surveyors. In order to address them, we’ll look closely at what the guidelines say.

(Transition to Patti, dressed in professional attire)

Thank you, Barbara. Hi, I’m Patti Fritz, Senior Clinical Education Consultant for ASP. I’m going to share with you some key reasons why association guidelines say it’s important to train your staff prior to using any high-level disinfectant. Most importantly, all staff should follow manufacturer’s Instructions For Use (IFU). Later on, we are going to share some tools available from ASP to simplify training and education of your staff in order to help you follow these guidelines.

First, let’s look at the Multisociety Guideline from the American Society for Gastrointestinal Endoscopy (ASGE). It states, “Improper use of high-level disinfectants can pose safety hazards to both patients and instrument reprocessing staff. In addition, Guideline 31 says: “All personnel using chemicals should be educated about the biological and chemical hazards present while performing procedures that use disinfectants.”

How often should you evaluate your staff’s competency?

ASGE Guideline 30 says: “Competency testing of personnel that reprocess endoscopes should be performed and documented on a regular basis (e.g., at the start of use, annually). Temporary personnel should not be allowed to reprocess endoscopes until competency has been established.”

This stresses the importance of having your staff be properly trained before they begin using high-level disinfects. It is necessary to perform regular competency testing to ensure proper procedure is being followed at all times.

So, how important is staff training for those that are testing these solutions?

The Joint Standard from the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI) note that staff who are responsible for using chemical monitors and test strips should be fully trained.

Lastly, we’ll explore the Society of Gastroenterology Nurses and Associates, or SGNA’s, standard.

The SGNA’s “Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes” says, “Ensuring your staff is properly trained is also a key component in the fight against healthcare-associated infections (HAIs), as failure to follow proper reprocessing protocol can lead to the survival of
microorganisms and an increased risk of infection.”

That is why it is so important to work with a manufacturer that provides tools and resources to support the training of your staff. At ASP, we have a number of tools to help make the process of training your staff as smooth and easy as possible.

(Show In-Service Kit…inside of the binder and highlight the CD. )

For example, ASP provides an In-Service Kit for CIDEX® OPA Solutions which includes materials designed to be your resource in training your staff on on-going basis. The Kit includes everything you need to properly use and test CIDEX® OPA Solution for high-level disinfection, including a CD that provides education and instructions in a convenient binder.

This in-service kit can help address many of the common questions that we hear from our customers. For example, many of you have asked about what types of materials and medical devices can be used with CIDEX® OPA Solution (Show tab 3 to show the Technical Information). The Technical Information included in the In-Service Kit lists all materials that CIDEX® OPA Solution has been tested for, including a variety of metals, plastics, elastomers and adhesives.

(Show the log book). Customers are also curious about how to use CIDEX® Test Strips. These are used to ensure the minimum effective concentration (MEC) required for high-level disinfection, and it is recommended that you test CIDEX® OPA Solution prior to each usage. To help with this process, the kit also includes a data sheet and IFU for CIDEX® OPA Solution Test Strips, as well as a log book to record your test results (Show a log sheet within the log book). On this sheet you can record your quality controls, temperature reads and test results.

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What You Might Not Know about Meeting High-Level Disinfection Training Guidelines.

Barbara Trattler, RN, MPA, CNOR, NE-BC Direc...

What You Might Not Know about Meeting High-Level Disinfection Training Guidelines.
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Barbara Trattler, RN, MPA, CNOR, NE-BC Director, Clinical Education

(Barbara, dressed in professional attire and either seated or standing).

Hello, I’m Barbara Trattler, Director of Clinical Education for ASP. Welcome to this edition of the ASP Hot Topic Webisode series. In this installment, we’ll address some commonly-asked questions by our customers: How do I train my staff to meet guidelines requirements for high-level disinfection...more specifically, CIDEX OPA Solutions? What tools are available to help ensure this?

These issues are hot topics for healthcare facilities and our customers, as many of you have been asked these questions by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) surveyors. In order to address them, we’ll look closely at what the guidelines say.

(Transition to Patti, dressed in professional attire)

Thank you, Barbara. Hi, I’m Patti Fritz, Senior Clinical Education Consultant for ASP. I’m going to share with you some key reasons why association guidelines say it’s important to train your staff prior to using any high-level disinfectant. Most importantly, all staff should follow manufacturer’s Instructions For Use (IFU). Later on, we are going to share some tools available from ASP to simplify training and education of your staff in order to help you follow these guidelines.

First, let’s look at the Multisociety Guideline from the American Society for Gastrointestinal Endoscopy (ASGE). It states, “Improper use of high-level disinfectants can pose safety hazards to both patients and instrument reprocessing staff. In addition, Guideline 31 says: “All personnel using chemicals should be educated about the biological and chemical hazards present while performing procedures that use disinfectants.”

How often should you evaluate your staff’s competency?

ASGE Guideline 30 says: “Competency testing of personnel that reprocess endoscopes should be performed and documented on a regular basis (e.g., at the start of use, annually). Temporary personnel should not be allowed to reprocess endoscopes until competency has been established.”

This stresses the importance of having your staff be properly trained before they begin using high-level disinfects. It is necessary to perform regular competency testing to ensure proper procedure is being followed at all times.

So, how important is staff training for those that are testing these solutions?

The Joint Standard from the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI) note that staff who are responsible for using chemical monitors and test strips should be fully trained.

Lastly, we’ll explore the Society of Gastroenterology Nurses and Associates, or SGNA’s, standard.

The SGNA’s “Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes” says, “Ensuring your staff is properly trained is also a key component in the fight against healthcare-associated infections (HAIs), as failure to follow proper reprocessing protocol can lead to the survival of
microorganisms and an increased risk of infection.”

That is why it is so important to work with a manufacturer that provides tools and resources to support the training of your staff. At ASP, we have a number of tools to help make the process of training your staff as smooth and easy as possible.

(Show In-Service Kit…inside of the binder and highlight the CD. )

For example, ASP provides an In-Service Kit for CIDEX® OPA Solutions which includes materials designed to be your resource in training your staff on on-going basis. The Kit includes everything you need to properly use and test CIDEX® OPA Solution for high-level disinfection, including a CD that provides education and instructions in a convenient binder.

This in-service kit can help address many of the common questions that we hear from our customers. For example, many of you have asked about what types of materials and medical devices can be used with CIDEX® OPA Solution (Show tab 3 to show the Technical Information). The Technical Information included in the In-Service Kit lists all materials that CIDEX® OPA Solution has been tested for, including a variety of metals, plastics, elastomers and adhesives.

(Show the log book). Customers are also curious about how to use CIDEX® Test Strips. These are used to ensure the minimum effective concentration (MEC) required for high-level disinfection, and it is recommended that you test CIDEX® OPA Solution prior to each usage. To help with this process, the kit also includes a data sheet and IFU for CIDEX® OPA Solution Test Strips, as well as a log book to record your test results (Show a log sheet within the log book). On this sheet you can record your quality controls, temperature reads and test results.
What You Need to Know About The Updated SGNA Guidelines - Webisode 5

...

What You Need to Know About The Updated SGNA Guidelines - Webisode 5
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Got Laryngoscopes? Get Answers with the ASP Hot Topic Webisodes!

in this Webisode, we will look at the issue o...

Got Laryngoscopes? Get Answers with the ASP Hot Topic Webisodes!
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in this Webisode, we will look at the issue of what to do with anesthesia laryngoscope blades when it comes to reprocessing them. We will give an overview of the new standards issued by the Joint Commission and then discuss practical solutions, based on the application of the standards.

First, the CDC’s Healthcare Infection Control Practices Advisory Committee known as (HICPAC) classifies laryngoscope blades as “semicritical” items. “Semicritical” items are defined as “items that directly or indirectly contact mucous membranes of the respiratory tract. They should be sterilized or subjected to high-level disinfection before reuse.”

On October 24, 2011, The Joint Commission issued a new standards-related FAQ addressing the processing and storing of laryngoscope blades in perioperative-care settings, and following on November 3, AORN informed its members of the new standards-related FAQ.

What did the FAQ say and what does it mean for you? The FAQ emphasizes that Joint Commission surveyors will evaluate processes related to laryngoscope blades to ensure that they are safe for use on the next patient. This will include checking that laryngoscope blades are processed properly, either with sterilization or with high-level disinfection, and packaged and stored in such a way that would prevent recontamination.

The FAQ stated that the CDC’s 2008 Disinfection & Sterilization Guideline does not address the issue of packaging, however an earlier standard does have a specific recommendation which states that appropriate rinsing, drying and packaging is strongly recommended and supported by well-designed experimental, clinical or epidemiologic studies.

While appropriate packaging is recommended, it is important to note that HICPAC guidelines do not specify the manner in which laryngoscope blades should be packaged, only that the packaging prevent recontamination.

According to the Joint Commission, compliant methods of storage include, but are not limited to: a peel pack post-steam sterilization for long-term, or wrapping in a sterile towel for short-term. Noncompliant methods include storing unwrapped blades in an anesthesia drawer or on top of a code cart.

Because laryngoscope handles are considered contaminated after use, they must also be processed prior to use on the next patient. Many manufacturers suggest a low-level surface disinfectant be utilized on the surface of the handle, but check your manufacturer’s indications for use (IFU) as processes vary by manufacturer. In addition, some state laws require additional processing, so check your state for any additional applicable laws or regulations.

Okay, now that we have looked at the new standards and guidance from the Joint Commission, let’s talk about practical solutions and best practices to the proper reprocessing, packaging and storage of your laryngoscope blades.

From our perspective the best option for reprocessing your laryngoscope blades is through terminal sterilization, such as STERRAD® Technology, where you can use a peel pack for visibility.

In addition, reprocessing should always be done in the sterile processing department or operating room/sub-sterile core. It’s also a good practice to make sure your staff is educated on processing reusable medical devices, including those outside the sterile processing department, such as nurses and physicians.

An alternate option is to process the blades using high-level disinfectant and rinse with demineralized water. Then dry the devices completely, package securely and store until they are ready for use.

Additionally, remember to disinfect or sterilize battery handles and always clean the battery charger stands, as it can be exposed to dust and bacteria. It is not recommended to store blades for the long term (states in previous page can store for short term in sterile towel) in absorbable materials, such as towels. Also, remember not to store blades wet in a sealed pouch or container.

The STERRAD® Systems from ASP help you address changing standards like this one and be more prepared to pass Joint Commission surveys. All of ASP’s STERRAD® Systems are equipped to terminally sterilize laryngoscope blades using a peel pack for visibility. As always, please reference the device manufacturers’ IFU for processing instructions.

ASP STERRAD® Systems are approved to process a number of other reusable medical devices, such as
fiberoptic laryngoscopes, optical stylets, flexible intubation endoscopes and video intubation endoscopes.

As a STERRAD® Systems customer, you can conveniently check the STERRAD® Sterility Guide (or SSG), a frequently updated, easy-to-use online tool designed to help you identify which devices fall within STERRAD® Systems cleared claims for sterility. The guide can be accessed on your computer or smartphone at www.sterradsterilityguide.com. For more information on dev ices cleared for reprocessing in STERRAD® Systems, please contact the Medical Device Manufacturer’s Program at ASP at mdmprogram@its.jnj.com .

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How Am I Supposed to Clean and Sterilize My Devices?

In this Webisode we will address one of the m...

How Am I Supposed to Clean and Sterilize My Devices?
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In this Webisode we will address one of the most common questions asked by our customers today. “What information should I follow to determine approved cleaning and sterilization instructions?”

This issue of IFU compliance is a hot topic and area of focus for many healthcare facilities right now, and we are going to explore this subject today, looking closely at what the AAMI standards have to say. In addition we’ll also discuss some practical options for you and your facility.

First, let’s look at the amendment to AAMI standard ST79 for sterilization. In section 7.2.2 it states:

“The written IFU of the device manufacturer should always be followed. The reusable medical device manufacturer is responsible for ensuring that the device can be effectively cleaned and sterilized…The manufacturer’s written IFU should be kept on file and periodically reviewed for any updates. If there are no specific written IFU instructions in the labeling, then the manufacturer should be contacted directly to provide a documented method.” 1

AORN also supports AAMI ST79 and state in their AORN Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment that “The manufacturer’s written, validated instructions for handling and reprocessing should be obtained and evaluated to determine the ability to ade¬quately clean and reprocess the equipment within the health care facility before purchasing surgical instruments and powered equipment.” 2

Because the Joint Commission and other agencies want to make sure you are following the most updated standards and instructions, it has become the facility’s responsibility to comply with the latest IFUs. Medical device manufacturers, or MDMs, are continually updating IFUs to meet regulatory guidelines; so even an IFU that is only two to three years old may already be out of date.

How can you streamline this process of being up to date with IFUs?

In this dynamic environment and increasing focus on IFU compliance we are pleased to report that STERRAD® Systems are currently listed in IFUs by many device manufacturers for terminal sterilization. At ASP, we work closely with many Medical device companies to make sure we maintain the most current IFUs for instruments listed in our online reference tool, the STERRAD® Sterility Guide, also known as the SSG. Every device listed in the SSG is backed by an acknowledgment from the device manufacturer in their labeling or instructions for use.

It’s worth noting that we are constantly adding new devices to the SSG. In fact in the last two months alone, we added thousands oflistings. As a general purpose sterilizer, STERRAD® Systems can process many stainless steel accessories and instruments, as well as the critical devices listed on the SSG.

Visit SSG http://www.sterradsterilityguide.com/.

Or for more information, visit ASP at http://www.aspjj.com.

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Privacy Policy

Last Updated: August 2013

Advanced Sterilization Products, Division of Ethicon US, LLC. is concerned about privacy issues and wants you to be familiar with how we collect, use, and disclose information. This Privacy Policy describes our practices in connection with information that we or our service providers collect through the Web site or Web property (including, for example, a mobile Web site or application) operated and controlled by us from which you are accessing this Privacy Policy (each, the “Site”). By providing personal information to us or by using the Site, you agree to the terms and conditions of this Privacy Policy.

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We also use information from or about you:

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We also disclose information collected through the Site:

to our affiliates for the purposes described in this Privacy Policy. A list of our affiliates is available here (click on the link for Form 10K, Exhibit 21, under “SEC Filings”). Advanced Sterilization Products, a division of Ethicon US, LLC. is the party responsible for the management of the jointly-used Personal Information;
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We may change this Privacy Policy. Please take a look at the “LAST UPDATED” legend at the top of this page to see when this Privacy Policy was last revised. Any changes to this Privacy Policy will become effective when we post the revised Privacy Policy on the Site. Your use of the Site following these changes means that you accept the revised Privacy Policy.

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If you have any questions about this Privacy Policy, please contact us by e-mail at contactASP@its.jnj.com., or please write to the following address:

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