Medical Devices Reprocessing: Back to the Future - ASP University

Dra. Elisabetta Anzanello

The Challenges behind Outsourcing your MD Reprocessing
Register for Webinar#1
  1. Home
  2. /
  3. ASP Web Summit
  4. /
  5. Webinars Series #5

ASP SUMMIT Webinars are back!

The reprocessing of medical devices answers the needs of millions of procedures and enhances the quality, safety of care, and sustainability. 1-5
​As high standards in Central Sterile Services Departments are essential for quality, safety, and sustainability 2,3, this has also made the healthcare waste produced worldwide rise. 8,9

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. 4,5, 6,7, 21-23​

​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.10-12​

​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. 15, 16; 17-20​


We invite you to take part in our​  5th Webinar Series 

Medical Device Reprocessing: ​The Back to the Future


Register for Webinar#1

Dra. Elisabetta Anzanello

The Challenges behind Outsourcing your MD Reprocessing


ISO 22441 - The new standard for H2O2 sterilization​


Airway Devices reprocessing (Laryngoscopes & Bronchoscopes)


Eirway Devices reprocessing (Laryngoscopes & Bronchoscopes)


Sustainability & Economic behind MD reprocessing technologies
The Challenges behind Outsourcing your MD Reprocessing

Dra. Elisabetta Anzanello

Experienced Consultant for Decontamination and Sterilisation projects, Protocols and Certifications

Saniservice, Italy


Offsite MD reprocessing has become a trend but no matter being appellative most of the times brings several challenges to both CSSD and OR departments
Would it be interesting to have an in-house sterilization service, inside the Hospital, not far from OR department and health care services, or to outsource this service to facilities far from the hospital?
The question is not new and in both solutions there are advantages and disadvantages. We must take into account economic aspects, the needs of each stakeholder but mainly we must continue to ensure safe and quality patient care
Keeping in mind the expected outcome, the questions are so many, from the place to do the process, the organization, the protocols, but most of all the aim is to meet the surgical and health care team expectations, paying attention to our environment as well.
Working in a circular economy perspective, we can do our best for the patient, for the health care system, and to our planet





What is Outsourcing
of the MDs Reprocessing?
Hospital Needs
Project and Service organization
through different steps
Procedures, Traceability
and Certifications
Integration between Outsourcer
and Healthcare Team
Register for Webinar#1

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

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
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.
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.
7. Decontamination and Reprocessing of Medical Devices for Health-care Facilities,
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.
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 –
12. Outsourcing or not outsourcing ? stérilisation magazine, page 10 111 # Été 2019 , 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.
16. Rational Approach _ Disinfection & Sterilization Guidelines_ CDC
17. Pyrek, K. M. August 10, 2018. Device-Related Infections: Patient-Ready Bronchoscopes Found to be Contaminated Despite Cleaning and Disinfection. Infection Control Today.;
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.
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.
20. Food and Drug Administration (FDA). September 17, 2015. Infections Associated with Reprocessed Flexible Bronchoscopes: FDA Safety Communication. Retrieved June 8, 2023 from 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.
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