How do you choose your surgical gown? A guide to AAMI barrier protection standards

Transcription

1 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 Copyright 2015, Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or 1 registered trademarks of Cardinal Health. 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

2 Welcome Sandy Albright MSHM BSN RN CNOR Sr. Clinical Consultant Cardinal Health Hospital Sales and Service 2

3 Objectives 1 Discuss the importance of managing infection risk in the OR 2 Describe the purpose of AAMI and its gown standards 3 Outline the four AAMI barrier protection levels 4 5 Know the 3 questions you should ask yourself before choosing a gown Review how clinicians and materials management should collaborate to improve gown purchases 3

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. 4

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 5

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) 6

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, Table 4 and Table 5 7

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 8

9 What are AAMI surgical gown standards? ANSI/AAMI PB70: 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 9

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 10

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 11

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:

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:

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:

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 15

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? 16

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 costeffectiveness 17

18 Q&A Sandy Albright MSHM BSN RN CNOR Sr. Clinical Consultant Cardinal Health Hospital Sales and Service 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 # 3820