© Copyright 2015, Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or
registered trademarks of Cardinal Health. 1 © Copyright 2016, Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. Activity # 3820
How do you choose your surgical gown?A guide to AAMI barrier protection standards
Sandy Albright MSHM BSN RN CNORe A. Name
Sr. Clinical Consultant
June 6, 2017
© 2016 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.2
Welcome
Sandy Albright MSHM BSN RN CNOR
Sr. Clinical Consultant
Cardinal Health
Hospital Sales and Service
© 2016 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.3
Objectives
Discuss the importance of managing infection risk in the OR
Describe the purpose of AAMI and its gown standards
Outline the four AAMI barrier protection levels
Know the 3 questions you should ask yourself before choosing a gown
Review how clinicians and materials management should collaborate to improve gown purchases
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© 2016 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.4
About Cardinal Health
Recognized leader in healthcare supply chain transformation
• Top ranking for transforming the healthcare value chain to meet new
challenges around costs, revenues and outcomes
Unparalleled understanding of healthcare value chain
• Supplier and leading manufacturer of med/surg products
• Leader in providing supply chain services with 40+ years experience
Industry-leading manufacturer of surgical gowns*
• Simple way to support your reputation of delivering quality care,
while lowering costs at the same time
*2016 GHX data.
© 2016 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.5
Two main purposes of surgical gowns
1. Protect patients from microorganisms carried by surgical
team or patients themselves
2. Protect healthcare providers from contact with infectious
microorganisms harbored by patients
© 2016 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.6
Why focus on the risk of infection?
• New pathogens and drug-resistant organisms
• Clinical emphasis on reducing healthcare-associated infections (HAIs)
• Renewed efforts to improve patient and staff safety
– Support quality outcomes
– Enhance patient and staff satisfaction
– Protect reimbursements (help avoid “never events” and minimize 30-day readmission
penalties)
© 2016 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.7
Consequences of underestimating risk
• Pathogens transmitted through blood, fluids and skin cells can cause
dangerous infections
– Human Immunodeficiency Virus (HIV)
– Hepatitis B and C viruses
• Surgical site infections are the most common infection type*
– $11,000 - $35,000 cost per incident
– $3 billion - $10 billion annual cost industrywide
*The Direct Medical Costs of Healthcare-Associated Infections in U.S. Hospitals and the Benefits of Prevention. Centers for Disease Control,
http://www.cdc.gov/HAI/pdfs/hai/Scott_CostPaper.pdf, Table 4 and Table 5
© 2016 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.8
What is the AAMI?
• AAMI = Association for the Advancement of Medical Instrumentation
• Nonprofit organization founded in 1967
• Nearly 7,000 members with clinical, manufacturing and regulatory
expertise
• Primary source for medical device standards
© 2016 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.9
What are AAMI surgical gown standards?
• ANSI/AAMI PB70:2012 - A set of surgical gown standards that all
manufacturers must meet
• Adopted by U.S. Food and Drug Administration (FDA) as testing
standard manufacturers must follow
• Outlines testing requirements for four different AAMI levels of barrier
protection
© 2016 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.10
Look for AAMI label
• FDA discourages use of vague words such as “impervious” or
“impermeable”; easily misinterpreted and potentially misleading
– Lacks specificity regarding performance and test methods
– ANSI/AAMI PB70:2012 developed to address these issues and provide clarity
• Rely on AAMI level on gown label
© 2016 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.11
How are barrier protection levels defined?
• Depends primarily on potential exposure to and level of protection from:
– Blood
– Bodily fluids
– Other potentially infectious materials (OPIM)
• Classification of barrier performance based on the “hierarchy of risks”
• Risk levels organized by the type/volume of fluids and duration of exposure
© 2016 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.12
What are four AAMI levels?
• Barrier protection ranked on a scale of 1 – 4
– #1 minimal protection
– #2 low protection
– #3 moderate protection
– #4 high protection
*AAMI levels determined per ANSI/AAMI PB70:2012
© 2016 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.13
AAMI Levels 1 - 2
As Noted in the AAMI Technical Information Report (TIR), No. 11:2005
-Selection and use of protective apparel and surgical drapes in health care facilities
*Suggested guidelines are not a substitute for clinician professional judgment and experience
*AAMI levels determined per ANSI/AAMI PB70:2012
© 2016 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.14
AAMI Levels 3 - 4
As Noted in the AAMI Technical Information Report (TIR), No. 11:2005
-Selection and use of protective apparel and surgical drapes in health care facilities
*Suggested guidelines are not a substitute for clinician professional judgment and experience
*AAMI levels determined per ANSI/AAMI PB70:2012
© 2016 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.15
How are surgical gowns tested?
• Range of factors used to establish
barrier effectiveness
• Includes materials’ resistance to
water/blood penetration
• Typically four different areas must
pass within the critical zones
• Two in front, two on the sleeve
© 2016 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.16
3 questions to choose your next gown
1. How much fluid do you expect to be present
during the procedure?
2. How long will this procedure last?
3. What is my role in the procedure?
© 2016 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.17
Collaboration is key
• Clinicians and materials management should work together to improve
gown purchasing—weighing such factors as:
– Risk of surgical site infections
– Cost control: don’t use more protection than needed
– Clinicians’ personal preference and comfort
• Use AAMI standards to determine product mix needed at each facility
(avoid over- and under-protection)
• Streamline product and vendor selection to maximize safety and cost-
effectiveness
© Copyright 2016, Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. 18 © Copyright 2016, Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. Activity # 382018 © Copyright 2016, Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. Activity # 3820
Q&ASandy Albright MSHM BSN RN CNOR
Sr. Clinical Consultant
Cardinal Health
Hospital Sales and Service
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