Continuing Education • STERIS Corporation is an approved provider of continuing nursing education by CBRN – provider # CEP 11681 and an approved Administrator Education Unit (AEU) Provider by BASC – provider # 1417. • This program is approved for: – 1 hour(s) of GI Specific content credit by ABCGN (American Board of Certification for Gastroenterology Nurses), – 1 AEU(s) by BASC (Board of Ambulatory Surgery Certification), and Introduction to Low – 1 contact hour(s) of continuing education credit • ACI (Association for Advancement of Medical Instrumentation (AAMI) Credentials Institute) Temperature Sterilization • CBRN (California Board of Registered Nursing); • CBSPD (Certified Board for Sterile Processing and Distribution); and • IAHCSMM (International Association of Healthcare Central Service Materiel Management). • Participants must be present for the entire presentation/seminar to receive continuing education credit; partial credit will not be given.

Disclosures Objectives • STERIS Corporation is providing the speakers and continuing Upon completion of this presentation, you will be able to: education credits for this activity. Presenters are employees of STERIS Corporation and receive no direct compensation other • Articulate the history and types of low temperature sterilization than their normal salaries for participation in this activity. processes

• Commercial products referred to or seen during this presentation • Identify important considerations when selecting a low temperature do not constitute a commercial support by the speakers. sterilization process • Prepare for implementation of a low temperature sterilization process

Purpose of Sterilization Goals of Sterilization To destroy all living microorganisms • Render medical devices safe for patient use • Prevent infections CDC 2014 Statistics Types of Devices Reprocessed • In the US, approximately 2,000,000 admitted patients per year, will Utensils Plastics develop a healthcare associated infection

• Healthcare associated infections account for 14% of the diseases suffered by in-patients

• 90,000 will die as a result of these infections Rigid Instruments Complex Flexible Scopes • Over $4.5 billion is spent each year for additional costs of treatment related to these infections

Incompatibility Leads to Damage Methods of Sterilization • Thermal Thermal Damage Chemical Damage ‒ Steam ‒ Dry Heat • Chemical ‒ ‒ Peracetic Acid ‒ ‒ Vaporized Peroxide with and without Gas Plasma ‒

Low Temperature Sterilization Historical Overview of … is sterilization of medical devices using sterilants that Low Temperature Sterilization in Healthcare operate at temperatures typically below 60° C/152° F. 1950s 1988 2003 2009 • EtO used for • Peracetic Acid • OPA for health health care Liquid Chemical care applications • Ozone for health applications Sterilization care applications

1960s 1993 2007 2014 • VH O without Gas • Glutaraldehyde 2 2 • Hydrogen • VH2O2 with Gas plasma for health used for health peroxide with plasma for health care applications care applications care applications ozone for health care applications Sterilization is a Process not a Sterilizer or Sterilant Liquid Chemical Sterilization Decontamination Device Prep Sterilization Glutaraldehyde • Mode of Action

• Remove debris • Proper instrument • Equipment maintenance ‒ Fixation creating cross linking of proteins • Ensure no residual preparation • Quality control checks soils or cleaning • Proper placement • Correct connectors • Critical Parameters of Sterilization chemistries • Proper drying • Correct device loading • Critical parameters ‒ Temperature • Validated packing OrthoPhthalaldehyde (OPA) materials QUALITY CONTROL ‒ Concentration of Glutaraldehyde or OPA

• Cleaning indicators • Product testing • Biological and chemical ‒ Time • Cleaning verification • Device inspections indicators • Equipment tests • Cycle printouts

Aldehydes Peracetic Acid Liquid Chemical Sterilization

Pro’s Con’s Peracetic Acid • Mode of Action • Broad range of devices • Very long soak times (5-36 hours) ‒ Uses oxidation to interrupt cellular • OPA has a low profile • Unwrapped; no storage functions

• Point-of-use • Devices must be immersed • Critical Parameters of Sterilization

• Patient and staff sensitivity ‒ Temperature

• Personnel monitoring ‒ Concentration of Peracetic Acid

• Neutralization prior to disposal ‒ Time

Liquid Peracetic Acid Ethylene Oxide Sterilization Pro’s Con’s • Mode of Action • Rapid cycle time • Unwrapped; no storage Ethylene Oxide ‒ of protein, DNA and RNA • Broad range of devices • Devices must be immersed • Critical Parameters of Sterilization • No environmental monitoring • Quick connects for devices with channels ‒ Temperature • Point-of-use ‒ Concentration of Ethylene Oxide

‒ Time

‒ Humidity Ethylene Oxide

Pro’s Con’s • Relatively low cycle cost • Cycle length/aeration • Sterile storage capability • EtO/HCFC blend/ozone • Superior penetration depletion • Materials compatibility • Flammability/toxicity • No lumen restrictions • Installation requirements • Non-corrosive • Personnel monitoring, record keeping • Easy-to-load

Simplified Hydrogen Peroxide Cycle Profiles Hydrogen Peroxide Sterilization Vaporized Hydrogen Vaporized Hydrogen Vaporized Hydrogen (with and without gas plasma) Peroxide with Gas Peroxide Only Peroxide with Ozone Plasma Hydrogen Peroxide • Mode of Action 1. Conditioning 1. Conditioning 1. Preconditioning ‒ Oxidation 2. Sterilization occurs 2. Sterilization occurs 2. Sterilization occurs • Critical Parameters of Sterilization through pulses of through pulses of through pulses of ‒ Time vaporized H2O2 vaporized H2O2 / vaporized H2O2 3. Aeration with gas plasma followed by ‒ Temperature injection of ozone catalytic converter 3. Aeration with ‒ Hydrogen peroxide concentration catalytic converter 3. Aeration with ‒ Pressure catalytic converter

Hydrogen Peroxide & Hydrogen Peroxide with Ozone Sterilization Hydrogen Peroxide Gas Plasma • Mode of Action Pro’s Con’s Hydrogen Peroxide ‒ Oxidation/Free Radicals • Rapid cycle times • Moisture sensitivity • Critical Parameters of Sterilization • No venting • Items must be dry ‒ Time • No toxic by-products • Material compatibility ‒ Temperature Ozone • Easy installation • Loading considerations ‒ Sterilant Hydrogen Peroxide and Ozone

• Sterile storage • Lumen Restrictions • Vacuum level Hydrogen Peroxide with Ozone Sunsetting of Ethylene Oxide in Health Care Pro’s Con’s • Easy installation • Moisture sensitivity • Sterile storage • Items must be dry • No venting • Material compatibility • No toxic by-products • Loading considerations • Lumen Restrictions • External source • Specific set or load temperature

Hospital & Environmental Concerns The Perfect Sterilization Process

Hospital Environmental • EPA Restricted Load Sizes • EtO/HCFC blends deplete the ozone layer • Long cycle times Proper Fit Safety Cost • HCFC blends to phase out 2030 • Potential Exposure to Personnel • EtO by-product toxicity • Costly EtO disposal venting systems

• EtO by-product toxicity Effective

The Sterilizer Fits When It Meets And it Meets Productivity Needs Sterilization Needs • Sterilization Productivity • Immediate use or sterile storage • Low volume or high volume

• Instrument submergibility • Load size flexibility

• Instrument sterilization cycle requirements • Load content flexibility

• Instrument compatibility • Total cycle time (including aeration or rinsing)

• Container and tray inventory sterilization requirements • Sensitivity to instrument conditions

• Quality history or facility experiences Safety for the Patients & Staff Safe for the Environment • Risk of sterilant contact • Toxicity during disposal

• Automated system or manual process • Toxic by-products from environmental exposure

• Risk of contact with by-products • Utility consumption

• Alarm to identify process parameter failures • Recyclability of necessary disposable accessories

• Monitoring devices to confirm process effectivity • Manufacturing sustainability practices

• Preventive measures for exposure

Within Capital Budgets (Short Term) Within Consumable & Service Budgets • Air handling equipment (Long Term)

• Exhaust management/ reclaimer equipment • Per cycle cost or by time period cost (typically annual)

• Cost of trays and containers • Cost of chemical sterilant

• Sterilizer • Cost of necessary disposable accessories

• On going cost of chemical sterilant disposal

• Cost of additional utilities (electric, facility oxygen, etc.)

Establishing a Balance Implementation Starts with an 10 10 10 Inventory Census 9 9 9 • Inventory all items to be processed through the sterilization process 8 8 8 7 7 7 ‒ Confirm sterilization requirement/compatibilities 6 6 6 ‒ Contact device manufacturers 5 5 5 4 4 4 • Obtain compatible and validated containment devices 3 3 3

2 2 2 ‒ Confirm accessories are also compatible and validated

1 1 1 Fit Safety Cost Fit Safety Cost Fit Safety Cost • Review Automated Endoscope Reprocessor history and programs 0 0 0 Process A Process B Process C ‒ Confirm that the AER program accepts the required parameters ‒ Ensure compatibility of equipment ‒ Review repair history Special Considerations When Converting Next, Write Policies & Procedures • Sterilization platforms are not interchangeable • Cleaning and drying of devices, containment devices, reusable accessories, etc. • Device model compatibility may be affected by device manufacture date • Prep and pack • Repair history must be reviewed for non-compatible parts or materials • Sterility assurance and quality monitoring • Interactions between residual chemistry and the new chemistry • Sterilization records to maintain

• Sterilization, transport and storage until use

• Equipment operation and preventative maintenance

Installation Implement • Identify equipment requirements • Training

‒ Utilities • Follow-up through observation

‒ Ventilation • Continued monitoring to defined matrices ‒ Room specifications

• Installation Qualification testing

• Product Testing

• Personnel Monitoring (OSHA)

Select Low Temperature Sterilization Processes References • Association for the Advancement of Medical Instrumentation. (2012). ANSI/AAMI ST41: 2012. Arlington, VA: Author.

• Association for the Advancement of Medical Instrumentation. (2013). ANSI/AAMI ST58: 2013. Arlington, VA: Author.

• Association of periOperative Registered Nurses. (2017). Guidelines for Perioperative Practice. Denver, CO: Author.

• Centers for Disease Control and Prevention. (2014). HAI Data and Statistics. Retrieved from: https://www.cdc.gov/hai/surveillance/index.html References, continued References, continued • Dufresne, S., Richards, T. (2016). The first dual-sterilant low- temperature sterilization system. Canadian Journal of Infection • Magill, S. S., Edwards, J. R., Bamberg, W., Beldavs, Z. G., Control, 31(3), 169-174 Dumyati, G., Kainer, M. A., . . . Fridkin, S. K. (2014). Multistate point-prevalence survey of health care-associated infections. New • Environmental Protective Agency. (2007). National Emission England Journal of Medicine, 370(13), 1198-1208. Standards for Hospital Ethylene Oxide Sterilizers ACTION: Final rule. (40 CFR Part 63 [EPA–HQ–OAR–2005–0171; FRL–8512–1] • McDonnell, G. E., Fiorello, A., Fisher, C., Shaffer, D., Svetlikova, RIN 2060–AM14), Washington, DC: US Government Federal Z., & Jackson, M. (2010). Glutaraldehyde and other aldehyde Registry resistant bacteria associated with the use of washer-disinfectors • Fisher, C.W., Fiorello, A., Shaffer, D., Jackson, M., & McDonnell, used in the reprocessing of flexible endoscopes. The Journal of G. E. (2010). Aldehyde-Resistant Mycobacteria Associated with Hospital Infection, 76, Supplement 1, S19. the Use of Endoscope Reprocessing Systems. American Journal of Infection Controls, 40(9), 880-882

References, continued Questions • Perkins, J. J. (1983). Principles and methods of sterilization in health sciences (Second ed.). Springfield, IL: Charles C. Thomas Publishing.

• Rutala, W. A., Weber, D. J., & Healthcare Infection Control Practices Advisory Committee (HICPAC) (2009). Centers for Disease Control and Prevention. Guideline for Disinfection and Sterilization in Healthcare Facilities.

Go to:university.steris.com http://university.steris.com Join thousands of your colleagues who earn over 80,000 CE hours each year with STERIS University! Revision History Date Revisions Revised By: Notes 4/1/2018 • Initial Release H. Ames None