Challenges of Medical Devices Reprocessing - ASP University
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Efficiency in Medical Devices reprocessing: the road ahead E-Modules

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Efficiency in healthcare refers to do more and better with less resources to provide health services who are cost-effective, safe and based on high standards of care.1

Efficiency can be achieved with the implementation of strategies that reduce the number of unnecessary resources, optimize workflows, and adopt innovation.2

Efficiency in healthcare has become a cornerstone, as technologic advances and greater coverage creates pressure on limited budgets, and ecologic aspects must also take into consideration.1

Increasing efficiency in healthcare contributes to their economic sustainability, competitiveness, while reducing environmental damage and lastly improving quality of care and quality of life.3,4

In each day, millions of invasive procedures take place and millions of reusable medical devices are reprocessed throughout the World. The appropriateness of reprocessing of medical devices is a pillar for quality and safety of care, reducing the incidence of Healthcare Associated Infections (HAI), namely Surgical Site Infections (SSI), which are responsible for 18% of all HAI in Europe.5-9

Without the reprocessing of reusable medical devices most procedures could not take place. Such reprocessing is also central for the adoption of a circular economy strategy, lowering the climate damage.10-12

Reprocessing is a complex process with several steps and different players that requires efficient technologies, proficient human resources and good health technology assessments.13-15

The Central Sterilization Services Department, where multiple strategies can be adopted in different moments, including the adoption of low temperature sterilization can contribute to maximize efficiency. 18-20

We will also cover the importance of good traceability and material handling systems to improve efficiency in this field.21

Taking as a point of departure the global concept of Efficiency in Healthcare, its applicability and implications for medical devices reprocessing, in this Webinar Series, Efficiency in Medical Devices reprocessing: the road ahead, we will dive into the different scenarios where medical devices are used and need to be reprocessed: the operating room and the applicability of the lean principles to increase efficiency in the global process of reprocessing.16,17

Prof. Francesco Venneri

Medical Device Reprocessing Efficiency impact in Healthcare: an overview

Mr. Manuel Valente

Applying Lean principles at the OR to improve MD reprocessing efficiency

Mr. Wouter Meert

ISO 13485 certification as a motor to improve MD Reprocessing Efficiency

Eng. Jonathan Hart

Health Technology Assessment role on MD Reprocessing efficiency
Medical Device Reprocessing Efficiency impact in Healthcare: an overview

Prof. Francesco Venneri

Clinical Risk Manager and Patient Safety Officer

Florence Healthcare System, Italy


General analysis of the impact of DM Reprocessing efficiency on healthcare systems (addressing the right reprocessing process according to  Spaulding classification, certification & accreditation processes,  value base healthcare, and healthcare professionals training)  that have contributed to reducing the SSI related to MD reprocessing, in the last decade.



Impact of HAI and SSI
in healthcare
The importance of MD reprocessing
in the prevention of SSI
Efficiency in healthcare definitions and perspectives:
affordability, sustainability and value based healthcare
Efficiency of MD reprocessing:
impact and optimization strategies
take home messages alert
  • Optimization of MD reprocessing through training and increase in awareness among all healthcare workers is the main goal of the upcoming future.
  • Strategies are to be supported and among these accreditation and quality certification surely may be an added value.
  • Outcomes are to be measured on a value-based healthcare basis.
  • Circular economy and its links to the fields of HTA, Medical Device reprocessing and economy in healthcare are key topics for future implementations
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Applying Lean principles at the OR to improve MD reprocessing efficiency

Mr. Manuel Valente

Department of Quality Nurse Director

Unidade Local de Saúde de Santo António, Porto - Portugal


All over the world, healthcare has an increasing financial burden because of aging population and evolving technologies, both of which drive an increasing cost trend.

In addition, the healthcare market is more competitive and patients are more informed and demanding. On the other hand, evidence demonstrates that in the healthcare area, 30-40% of costs are waste.

Improving the efficiency and effectiveness of medical device reprocessing is one component of the solution for providing more and better healthcare at a lower cost.

The operational response to this challenge must be to reduce the number of activities or tasks that do not add value to the process, in order to make them “fat-free”. This is the basis of the philosophy “Lean healthcare”



General LEAN
Quality and standardization
of procedures and processes
Reduction of waste associated with
the management of surgical MD
Process improvement and pre-processing
activities for MD reprocessing efficiency
Integration of management processes for
continuous improvement and efficiency
take home messages alert
  • Looking at reality with an alternative matrix leads us to a new reality, with a high potential for improvement​
  • Normalizing is not intended to constrain professionalism or a visionary streak, just to ensure that the expected result happens at first time​
  • The awareness of results enhancement, is the lever and the fulcrum of the continuous improvement​
  • The strategic simplicity of the LEAN philosophy cannot be confused with ease of implementation​
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ISO 13485 certification as a motor to improve MD Reprocessing Efficiency

Mr. Wouter Meert

Process-Project Manager CSSD, Head Instrument Management

Uz Leuven, Belgium

Manual labor is necessary for the daily operation of a CSSD. Many of the critical processes remain without automation. Additionally, customer requirements can increase workloads and define the process flow within our departments. How can we change this inefficient use of resources based on random customer demands? By introducing ISO 13485 quality system requirement standards in your department, you are able to strictly define your own processes and continuously improve them. ISO 13485 standards allow you to use various types of data to conduct process analyses and identify areas where improvements should be made. The fundamental idea is to “secure our qualitative sterile end-product in the most efficient way.”



Developing a data management system
to analyze your daily operations
Risk analyses
as the basis for improving efficiency
Policy plans and management review
to ensure top management support
Automation and robotization
how far can we go?
take home messages alert
  • Collecting and analyzing data is an essential part of identifying inefficient processes, detecting necessary changes to keep your efficiency, or pointing out possibilities to increase efficiency.
  • Risk analyses need to prevent possible bad outcomes but often give a base for improvement due to developed action plans.
  • Increasing efficiency sometimes is long-term work with the availability of extra resources. Policy plans and management reviews help to ensure the support of top management.
  • AI, automation, robots, RFID: new technologies are becoming more available for the CSSD processes. Reducing human error, increasing quality and efficiency. Make sure they are in balance with the economic reality
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Health Technology Assessment role on MD Reprocessing efficiency

Eng. Jonathan Hart

Head of Technological Innovation and Health Technology Assessment Policlinic Universitario Campus Bio-Medico

Rome, Italy

Effectiveness and efficiency of MD reprocessing are achieved through proper selection, use, maintenance, and technological updates of the equipment involved (decontaminators, washers/disinfectors, sterilizers, etc.) as well as adequate planning of workflows, procedures, staffing, and organization in general in order to meet throughput needs. Health Technology Assessment (HTA) takes all these aspects into account and therefore can play an important role in managing reprocessing efficiency.



Introduction to
Health Technology Assessment
HTA and its role in
the reprocessing of MDs
Efficiency in MD reprocessing
and HTA applications
MD reprocessing efficiency
examples and future ahead
take home messages alert
  • HTA is a valuable tool in addressing MD reprocessing​
  • Reprocessing efficiency depends on effective management of productive assets (staffing, planning, equipment, instruments)​
  • Productive efficiency: increasing the output by reducing costs, materials, and time.​
  • Economic efficiency: retaining inventory value​
  • Technological advances: can help in providing data and reducing human error
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References :

1. European Observatory on Health Systems and Policies, Cylus, Jonathan, Papanicolas, Irene & Smith, Peter C. (‎2017)‎. Identifying the causes of inefficiencies in health systems. Eurohealth, 23 (‎2)‎, 3 – 7. World Health Organization. Regional Office for Europe.
2. Efficiency: What It Means in Economics, the Formula To Measure It (, Accessed on the 10th January 2023
3. Mortimer, F., Isherwood, J., Wilkinson, A., & Vaux, E. (2018). Sustainability in quality improvement: redefining value. Future healthcare journal, 5(2), 88–93.
4. Zarulli V, Sopina E, Toffolutti V, Lenart A (2021) Health care system efficiency and life expectancy: A 140-country study. PLoS ONE 16(7): e0253450.
5. Prevalence of healthcare-associated infections, estimated incidence and composite antimicrobial resistance index in acute care hospitals and long-term care facilities: results from two European point prevalence surveys, 2016 to 2017 (Pag. 7, Table 3) 3.
6. Special Report Top 10 Patient Safety 2020 – Executive-Brief, ECRI, page 9, 5. Device Cleaning, Disinfection, and Sterilization.
7. Surgical site infections linked to contaminated surgical instruments. The Journal of hospital infection, 81(4), 231–238.
8. Infections and exposures: reported incidents associated with unsuccessful decontamination of reusable surgical instruments. The Journal of hospital infection, 88(3), 127–131.
9. Badia, J. M., Casey, A. L., Petrosillo, N., Hudson, P. M., Mitchell, S. A., & Crosby, C. (2017). Impact of surgical site infection on healthcare costs and patient outcomes: a systematic review in six European countries. The Journal of hospital infection, 96(1), 1–15.
10. Andrea J. MacNeill, et al. Transforming The Medical Device Industry: Road Map To A Circular Economy. Health Affairs,
11. WHO Europe. Circular Economy and Health: opportunities and risks. Geneva, 2018.
12. G.M. Kane, C.A. Bakker, A.R. Balkenende. Towards design strategies for circular medical products. Resources, Conservation and Recycling, Volume 135, 2018, Pages 38-47,
13. Emily A. Hildebrand, L. Bryant Foster, Russell J. Branaghan. Chapter 19 – The Human Factors of Reprocessing Reusable Medical Equipment,Editor(s): Mary Beth Privitera, Applied Human Factors in Medical Device Design, Academic Press,2019,Pages 303-314,ISBN 9780128161630,
14. Introduction to Health Technology Assessment.
15. ASP Webinar#5 Series 2 factsheet: Health Technology Assessment for medical devices reprocessing improvement. Jonathan Hart. Available on:
16. Dyas, A. R., Lovell, K. M., Balentine, C. J., Wang, T. N., Porterfield, J. R., Jr, Chen, H., & Lindeman, B. M. (2018). Reducing cost and improving operating room efficiency: examination of surgical instrument processing. The Journal of surgical research, 229, 15–19.
17. Rothstein, D. H., & Raval, M. V. (2018). Operating room efficiency. Seminars in pediatric surgery, 27(2), 79–85.
18. 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. 13.
19. Alfred, M., Catchpole, K., Huffer, E., Fredendall, L., & Taaffe, K. M. (2020). Work systems analysis of sterile processing: decontamination. BMJ quality & safety, 29(4), 320–328.
20. Alfred, M., Catchpole, K., Huffer, E., Fredendall, L., & Taaffe, K. M. (2021). Work systems analysis of sterile processing: assembly. BMJ quality & safety, 30(4), 271–282.
21. Martins, F., Ribeiro, M., Implementation and use of automated traceability system in the central sterile supply department. Rev. SOBECC, São Paulo. JAN./MAR. 2017; 22(1): 52-58. DOI: 10.5327/Z1414-4425201700010009.