Medical Devices Reprocessing: Back to the Future - ASP University
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ASP 2024 WEBINAR SERIES#5 ON

ASP SUMMIT Webinars are back!

Medical Device Reprocessing: ​The Back to the Future

WE ARE BACK! ​
BACK TO PUSH INNOVATION FORWARD! ​
BACK TO SHARE VALUE INSIGHTS!
BACK TO THE FUTURE!​

Elisabetta Anzanello MSc, Md photo

Elisabetta Anzanello MSc, Md

The Challenges behind Outsourcing your MD Reprocessing
30/05
Dr. Philippe Destrez photo

Dr. Philippe Destrez
Mr. Wouter Meert

ISO 22441 - The new standard for H2O2 sterilization​
27/06
Mr. Olegs Tucs photo

Mr. Olegs Tucs

Innovations in Airway Devices Reprocessing
26/09
Eng. John Prendergast photo

Eng. John Prendergast

Evolution of Uro-Genital MD reprocessing
31/10
Victoria McCreanor MSc, PhD. photo

Victoria McCreanor MSc, PhD.

Sustainability & Economic considerations behind MD reprocessing technologies
28/11
organizer-image
DR. CARLOS PALOS
ASP SUMMIT - SCIENTIFIC DIRECTOR

INFECTION CONTROL & ANTIMICROBIAL STEWARDSHIP

LISBON, PORTUGAL


WEBINAR #1
The Challenges behind Outsourcing your MD Reprocessing
Elisabetta Anzanello MSc, Md photo

Elisabetta Anzanello MSc, Md

Experienced Consultant for Decontamination and Sterilisation projects, Protocols and Certifications

Perugia, Italy

SYNOPSIS:

The reprocessing of medical devices answers the needs of millions of procedures and enhances the quality, safety of care, and sustainability.

​As high standards in Central Sterile Services Departments are essential for quality, safety, and sustainability, this has also made the healthcare waste produced worldwide rise.

New trends in reprocessing could solve some of the existing challenges.​ ​Improved water and energy-efficient sterilization technologies have a significant impact on reducing greenhouse gases promoting sustainable reprocessing.

Off-site reprocessing boosts quality and reduces organization errors in small-scale operations. However, it requires investments in MD, monitoring, traceability, and transportation for efficient turnaround and quality process.

​Improving endoscopic reprocessing, in urogenital and respiratory settings, is vital. A potential reclassification of endoscopes in the Spaulding classification and improved reprocessing methods are needed to overcome identified deficiencies and enhance patient safety.

 

MAIN TOPICS

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What is Outsourcing
of the MDs Reprocessing?
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Hospital Needs
Assessment
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Project and Service organization
through different steps
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Procedures, Traceability
and Certifications
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Integration between Outsourcer
and Healthcare Team
questions

QUESTIONS:

  • Why is an outsourcing service needed?
  • How to get the right one for the Hospital needs?
  • How to create the service?
  • How to guarantee a safe and effective service?
  • How can we make the outsourcing process work?
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WEBINAR #2
ISO 22441 - The new standard for H2O2 sterilization​
Dr. Philippe Destrez photo

Dr. Philippe Destrez

R&D EMEA, ASP Strasbourg, Montesson

France

Mr. Wouter Meert

Process-Project Manager CSSD, Head Instrument Management

UZ Leuven, Belgium

SYNOPSIS:

How do you build in a new standard within your daily operations of your CSSD?

Every CSSD needs to work with a certain quality system. Today hydrogen peroxide becomes an official part of the group sterilization methods with the application of the ISO 22441. Within the CSSD you need to have a system to follow new developments according to regulations and standards.

How can you make sure you don’t miss anything and how do I know what’s important?

Is reading the standard yourself sufficient or do you need to find extra information from other sources?

In this webinar we will talk about validation, final release (parametric or CI/BI supported), instrument compatibility and considerations when buying a new hydrogen peroxide sterilizer.

 

MAIN TOPICS

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The new standard: ISO 22441
– understanding the new standard.
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ISO 22441: Releasing Loads
– applicability to release the loads.
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ISO 22441: Equipment Validation
– how to validate my H2O2 sterilizer.
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ISO 22441:
MD compatibility and buying a new hydrogen peroxide sterilizer
questions

QUESTIONS:

  • What can we find in the new ISO 22441 standard?
  • A new norm has arrived, how to learn its content?
  • How to validate the process & release the loads?
  • How to check the compatibility of a medical device with the sterilization process?
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Register for the webinar to learn more
WEBINAR #3
Innovations in Airway Devices Reprocessing
Mr. Olegs Tucs photo

Mr. Olegs Tucs

Associate Science Lecturer with Technological University Dublin

Dublin IRELAND

SYNOPSIS:

Medical devices used in airway management, examination and treatment are irreplaceable components of modern healthcare employed in wide variety of inpatient, outpatient, emergency, and care settings. Correct use, maintenance and best instrument reprocessing practices are essential for preventing healthcare associated infections and improving patient outcomes.

In this webinar, we will discuss common types of airway devices, examine how are the devices used in patient treatment, explain why airway devices can become vehicles for transmission of pathogenic microorganisms and use scientific evidence to explore reprocessing challenges, device associated infection outbreaks, and chart the way forward to safer, more sustainable use of airway devices with the ultimate goal to ensure patient and healthcare worker safety.

 

MAIN TOPICS

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Airway devices
Overview
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Outbreaks associated with
Airway devices
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Reprocessing options
for Airway devices
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Barriers to properly reprocessing
Airway devices
questions

QUESTIONS:

  • Which is the largest exposed surface of a human body?
  • How can pathogenic organisms enter the airways?
  • Which is the most critical step in decontamination cycle?
  • Are there specific guidelines for reprocessing airway devices in your country?
  • What is the biggest challenge to safe reprocessing of instruments?
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WEBINAR #4
Evolution of Uro-Genital MD reprocessing
Eng. John Prendergast photo

Eng. John Prendergast

Principal Decontamination Engineer

Wales, United Kingdom

SYNOPSIS:

Historically standards used to decontaminate flexible endoscopes have promoted high level disinfection as the acknowledged level. Should we be looking at different levels dependent on the hierarchy of risk? Are risks appropriate and where is the evidence of harm? Should we determine the level of decontamination based upon clinical consequence? Should we look at differing standards of decontamination for ‘higher risk’ devices such as duodenoscopes, bronchoscopes, ureteroscopes and cystoscopes? Are we doing enough to overcome known issues such as biofilm within scopes and drying of endoscopes post processing?

Should we evolve into utopia, ‘Sterilization of Endoscopes’? What are the obstacles and what are the challenges? What other areas present challenges? Do we underestimate the risk when decontaminating non channeled scopes and ultrasound devices?

 

MAIN TOPICS

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The Flexible Endoscope,
an everlasting problem
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Hierarchy
of Risk
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Show me the
Evidence
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New Decomtamination
Systems
questions

QUESTIONS:

  • Decontamination of Uro-Genital endoscopes based upon risk. Are the required standards being achieved?
  • Does the interpretation agree with Spaulding when considering risks decontaminating Uro-Genital scopes prior to re-use?
  • Are Uro-Genital endoscopes a source of harm?
  • Should the true levels of contamination be determined?
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WEBINAR #5
Sustainability & Economic considerations behind MD reprocessing technologies
Victoria McCreanor MSc, PhD. photo

Victoria McCreanor MSc, PhD.

Associate Director Health Economics, Hunter Medical Research Institute

Newcastle, Australia.

SYNOPSIS:

When considering which sterilizer is right for a particular setting, there is more to think about than the up-front costs of the sterilizer system itself. A comprehensive evaluation should assess longer-term costs and benefits of different options, including environmental considerations, in different settings. This presentation will cover an overview of climate considerations and carbon emissions healthcare, an introduction to health economic evaluation concepts, factors related to the sterilizer system, the instruments/devices being sterilizer and wrap up with how to use these concepts to evaluate different products.

 

MAIN TOPICS

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Addressing the climate
impact of healthcare
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Introduction to health
economic evaluation
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Sterilizer
factors
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Instrument
factors
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How to evaluate
the economics in your context?
questions
  • How much do we know about the climate impact of healthcare?
  • How much do we know about health economics?
  • Which factors are most important when thinking about the costs of reprocessing medical devices?
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Register for the webinar to learn more
GENERAL ANNOUNCEMENT

Medical devices (MD) reprocessing is a set of activities essential for healthcare systems response, answering to the needs of millions of procedures that are daily worldwide performed and contributing to the prevention of surgical site infections (SSI) and other procedure-related infections, mainly endoscopy.1

The Sterile Processing Department (SPD), also known as the Central Sterile Services Department (CSSD), requires high operational standards in order to achieve quality, safety, responsiveness, efficiency and sustainability. Besides according to JCI’s “top 5 most challenging requirements for 2022,” a key focus was on implementing infection prevention protocols for disinfecting and sterilizing medical equipment, devices, and supplies to minimize the risk of healthcare-associated infections (HAIs).2,3

Every day, tones of healthcare waste are produced worldwide, contributing to approximately 4-5% of total gas emissions.4,5

A holistic approach that integrates sustainability principles into the entire lifecycle of medical devices is urgent to be implemented.6,7

The trend for single-use devices, due to concerns related to healthcare associated infections, is a dangerous path that increases healthcare waste production, causes environmental damage to the planet and requires new approaches.8,9

In this new ASP webinar series, Medical device reprocessing: Back to the Future, the focus will be on new trends in reprocessing that could solve some of the existing challenges, consolidating the future of procedures and processes, aiming higher standards of quality, safety and economic and environmental sustainability. Off-site facility reprocessing is increasingly seen as an option to overcome small scale operations using outsourcing to achieve high quality reprocessing capabilities. By outsourcing they can also avoid 80% of organization errors which are related with the adverse events.10,11

However, this process must address several challenges to be successful, namely investment in MD to guarantee the turnaround needed, monitoring, traceability, process quality, transportation, etc… to have the surgical sets available when needed.12

The use of hydrogen peroxide (H2O2) sterilization is a major advance in reprocessing reusable medical devices.
New ISO 22441standard have been recently published to improve its implementation and validate H2O2 sterilization processes on medical devices, in a proper way.13,14

The reprocessing of uro-genital and airway devices, such as endoscopes (cystoscopes, uretroscopes, broncoscopes and laryngosopes), has become increasingly demanding in terms of quality. Endoscopy is increasingly used as an alternative form of diagnosis and increasingly invasive treatment, which points to the need to reclassify endoscopes in the Spaulding classification.15,16

Several issues related to incomplete MD reprocessing have been identified that require process improvement in this area.17-20

Reprocessing technologies must also take into account economy and sustainability principles in order to support better decision-making. For example, efficient sterilization methods with reduced water and energy consumption mean cost savings and less damage to equipment and the environment, contributing to sustainable healthcare systems and a greener environment.4,5,21-23

By Dr. Carlos Palos

SCIENTIFIC DIRECTOR

References :

1. Global guidelines for the prevention of surgical site infection, second edition. Geneva: World Health Organization; 2018. Licence: CC BY-NC-SA 3.0 IGO
2. https://www.jointcommission.org/resources/news-and-multimedia/newsletters/newsletters/jointcommission-online/april-19-2023/top-5-most-challenging-requirements-for-2022/.
3. The Joint Commission Guide to reprocessing reusable medical devices. JC, 2023.
4. Pichler P, Jaccard IS, Weisz U, Weisz H. International comparison of health care carbon footprints. Environ Res Lett. 14(6):064004. 7.
5. Health Care Without Harm, Arup. Health care’s climate footprint. Health Care Without Harm; 2019. https://noharm-global.org/documents/health-care-climate-footprint-report.
6. Montesinos L, Checa Rifá P, Rifá Fabregat M, Maldonado-Romo J, Capacci S, Maccaro A, Piaggio D. Sustainability across the Medical Device Lifecycle: A Scoping Review. Sustainability. 2024; 16(4):1433. https://doi.org/10.3390/su16041433
7. Decontamination and Reprocessing of Medical Devices for Health-care Facilities, https://apps.who.int/iris/bitstream/handle/10665/250232/9789241549851-eng.pdf.
8. Keil M, Viere T, Helms K, Rogowski W. The impact of switching from single-use to reusable healthcare products: a transparency checklist and systematic review of life-cycle assessments. Eur J Public Health. 2023;33(1):56-63. doi:10.1093/eurpub/ckac174
9. Benedettini O. Green Servitization in the Single-Use Medical Device Industry: How Device OEMs Create Supply Chain Circularity through Reprocessing. Sustainability. 2022; 14(19):12670. https://doi.org/10.3390/su141912670
10. Relocating Sterile Processing Activities to an Off-Site Facility: Cost, Design, and Project Management Considerations April Cardone; Carolyn A. Grous,– AORN Journal, July 2020, Vol. 112, No. 1, pp 30-38.
11. Applying safety to quality: human error – https://ale.com/applying-safety-to-quality-human-error-traps.
12. Outsourcing or not outsourcing ? stérilisation magazine, page 10 111 # Été 2019 https://www.mobius.eu/app/uploads/Sourcing_STeMag111.pdf , October 2022.
13. Sterilization of healthcare products-low temperature vaporized hydrogen peroxide. Requirements for the development of a sterilization process for medical devices. ISO 22441:2022.
14. Rutala WA, Donskey CJ, Weber DJ. Disinfection and sterilization: New technologies. Am J Infect Control. 2023;51(11S):A13-A21. doi:10.1016/j.ajic.2023.01.004.
15. Rutala, W., Weber, D.. 2013. New Developments in Reprocessing Semicritical Items. American Journal of Infection Control. Elsevier Inc. pp. 560-566. https://doi.org/10.1016/j.ajic.2012.09.028.
16. Rational Approach _ Disinfection & Sterilization Guidelines_ CDC https://www.cdc.gov/infectioncontrol/guidelines/disinfection/rational-approach.html.
17. Pyrek, K. M. August 10, 2018. Device-Related Infections: Patient-Ready Bronchoscopes Found to be Contaminated Despite Cleaning and Disinfection. Infection Control Today. https://www.infectioncontroltoday.com/view/devicerelated-infections-patient-ready-bronchoscopesfoundbe-contaminated;
18. Ofstead, C. L., Heymann, O. L., Quick, M. R., Johnson, E. A., Eiland, J. E., & Wetzler, H. P. (2017). The effectiveness of sterilization for flexible ureteroscopes: A real-world study. American journal of infection control, 45(8), 888–895. https://doi.org/10.1016/j.ajic.2017.03.016.
19. Center for Devices and Radiological Health. (2022d). UPDATE: Change in reprocessing methods with certain Karl Storz Urological endoscopes – Letter to health care providers. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/letters-health-careproviders/update-change-reprocessing-methodscertain-karl-storz-urological-endoscopes-letter-health-care.
20. Food and Drug Administration (FDA). September 17, 2015. Infections Associated with Reprocessed Flexible Bronchoscopes: FDA Safety Communication. Retrieved June 8, 2023 from https://www.fdanews.com/ext/resources/files/09- 15/092115-safety-notice.pdf?1520852028
21. McCreanor, V., & Graves, N. (2017). An economic analysis of the benefits of sterilizing medical instruments in low-temperature systems instead of steam. American journal of infection control, 45(7), 756–760. https://doi.org/10.1016/j.ajic.2017.02.026.
22. Schafer B. Decreased number of repairs of rigid scopes as a result of low-temperature sterilization with H2O2 gas plasma. A field report form the Barmherzige Bruder Hospital in Trier, Germany. Central Serv 2009;17:194-6.
23. Skogas J, Marvik R. Measures taken to reduce damage and repair costs of rigid endoscopes during their handling and processing in surgical practice. Minim Invasive Ther Allied Technol 2003;12:76-81