Webinar 3# ISO 13485 certification as a motor to improve MD Reprocessing Efficiency​ - ASP University

During the third webinar, Mr Wouter Meert will explain how we can change this inefficient use of resources by introducing ISO 13485 quality system requirement standards in the CSSD/SPD, allowing to  strictly define your own processes and continuously improve them.

Developing a data management system
to analyze your daily operations

We all understand the principles of traceability and its importance in patient safety. However, is traceability within the CSSD sufficient to call it a data management system? To objectively assess your process performance, you need data. This data should not only come from your traceability system but also from other sources. Developing a data management system involves finding the right balance between measuring and obtaining the correct data and conducting analyses. What do you need to know to have an objective view of your process? Is it turnover times, the number of sets reprocessed per day, distribution of sets over operational working hours, etc.? We used all this data to make changes in our department’s policy and make it more efficient. One example of change we made is optimizing staff dispersion efficiently through the department. 

Risk analyses
as the basis for improving efficiency

Identifying the risks within your CSSD process is an important aspect of ensuring the daily operational activity is secure. We employ methods like FMEA (Failure Modes and Effects Analyses) or risk matrix to assess various aspects of our department and process, including energy, infrastructure, human resources, IT, and the CSSD process itself. These analyses trigger the drafting of action plans to control these risks and often result in increased efficiency as a side effect. For instance, digitalizing the control process to reduce the risk of releasing non-sterile loads not only enhanced safety but also brought about significant time and economic savings. 

Policy plans and management review
to ensure topto ensure top management support management support

Policy plans play a crucial role in the development of your CSSD department. Creating a 10-year plan focused on equipment, increasing capacity, and optimizing staff deployment is essential. Thinking and working on both short and long-term ideas are key to improving efficiency. As a confirmation of these ideas, a yearly management review is performed to provide an overview of the department’s present activities and ensure top management’s support. Both of these components share the same goal: ensuring top management is on board with the improvement efforts. 

Automation and robotization
to ensure top management support

CSSD has always been a department heavily reliant on manual handling, which demands a considerable workforce. Manual handling can be costly and not always efficient, as staff members are not robots. However, due to advancements in technology, CSSD can now embrace automation and robotization. By utilizing AI, RFID, and robots in the CSSD process, efficiency can be improved.  

What does this means and how far can we go? 

The question remains as to what impact automation and robotics can have on the daily workflow of a CSSD and what is possible as technologies advance. 

This is the third webinar dedicated to “ISO 13485 certification as a motor to improve MD Reprocessing Efficiency​”, presented by ASP Continuous Education.

27th SEPTEMBER 2023

  • Board member VSZ (Flemish sterilization Society)
  • Board member VVOV (Flemisch society of operating room nurses)
  • Member of the superior health council ministry of Healthcare, infection prevention, development Belgian guidelines
  • Teaching sterilization courses in various schools
  • Member Working group, ministry of Healthcare
  • Management training risk analyses, ISO 13485, MDR 2017-745, Internal auditor
  • Speaker at various congresses

Great to see such a good explanation from an experienced and ISO certified CSSD facility
After this webinar I really felt the importance to have a consistent data management process
Thank you, gained a lot of insights how to improve the efficiency in my CSSD!
Risk analyses need to prevent possible bad outcomes but often give a base for improvement due to developed action plans.
  • 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