Industry Collaboration: A pilot study for developing a competency framework for Radiation Sterilization Professionals Arthur Dumba The Society for Sterility Assurance Professionals Co-Authors: Removed the mailing list reference in footer. Adjust font of the Co-Authors Title/Heading- Capitalize all or none Nicola Bench Sterilization Program Manager, Corporate Quality - Global Sterility Assurance, Becton Dickinson  Tim Carlson Sterilization Program Manager, Corporate Quality - Global Sterility Assurance,  Becton Dickinson John R. Logar Chairman Committee E61 on Radiation Processing ASTM International Vu Le Mfg Engineering Manager, Divisional Engineering Services, Abbott Paul Wynne Chairman - International Irradiation Association

Medical Device Industry Challenges and Opportunities The MDR and FDA require industry to define the requirements by which they prove knowledge, experience and demonstrate competency in specific modalities of sterilization and sterilization microbiology. The International standards on validation and routine control of sterilization reference ISO 13485 in regards to competence. These requirements place a responsibility on conformity assessment bodies, FDA and National Competent Authorities who will assess compliance and the process used to demonstrate knowledge, experience and competency in Sterility Assurance. Opportunities There is an opportunity for interested parties to collaborate in defining a framework that outlines the content and process by which the competency of sterility assurance professionals can be demonstrated. There is an opportunity to provide a career development pathway that will enable individuals to develop and to maintenance their competency, knowledge and skills throughout their sterility assurance career. This opportunity fits perfectly with the Kilmer theme – Collaborate to Innovate Recommendation: Can we make this more visual- maybe add timed animations. Added “for” in the footer. The Society for Sterility Assurance Professionals

Competency Model for Terminal Sterilization This is the learning of theory for your associated sterilization modality and functional role within the organization   Build foundation of knowledge in scientific area associated with the sterilization modality Network with experience users of the science associated with the sterilization modality Know This involves understanding how the (knowledge) you have gained can be applied in your associated sterilization modality and functional role within the organization Laws and Regulations Standardized Methods and Protocols Historical Precedence Acceptance Criteria Understand This involves both your knowledge + Understanding, to demonstrate the skills you have acquired in the sterilization modality and functional role within the organization Comprehend the Science Equipment and Processes Qualification and Validation Calibration and Traceability Capability Limitations or Restrictions Examination of proficiency AAMI or ASTM Execute This involves the application of your (knowledge + understand + Execution) over a number of years to demonstrate understanding and gain experience in your associated sterilization modality and functional role within the organisation Continual execution of the science Training of others Demonstrate Acknowledged Competency Provide objective documented evidence of the following: Certification of Proficiency in Understanding the Requirements Certification of Proficiency in Understanding the Execution Portfolio Review of Execution of the Science Competency can be looked at like a puzzle. The different elements can be achieved in any order, and all the elements are required to demonstrate competency. It is left to the organizations or individual to determine how much time is required to achieve each element Recommendations: Use slide 3 to explain competency model (enlarge the visuals)- maybe add timed animations or pop-outs. It is acceptable to add 4th content slide for the Industry Curriculum. The Society for Sterility Assurance Professionals

Who are our industry collaborators? What has been achieved? July 18 Arthur Dumba led the initiative and has been supported by the International Irradiation Association (iia), Becton Dickinson, Abbott Medical and ASTM. The group is now widely based and well placed to engage with manufacturers and contract sterilization providers. Industry Associations - International Irradiation Association (iia) October 18 The group has identified the stages of competency and has begun to define the components that are required to demonstrate a knowledge, understand and experience in the application of sterility assurance using the modality of Ionizing Irradiation. Standards Development Organizations – AAMI and ASTM Contract Sterilizers – Sterigenics and Steris January 19 The participants have created a working group The Society for Sterility Assurance Professionals, have created a website www.sfsap.org and will share their work with participants and members of the Society. Sterility Assurance Competency Framework Medical Device Manufacturers – Abbott Medical, Becton, Dickinson, Boston Scientific, KCI and J&J Interest Groups – The Panel on Gamma & Electron Irradiation (The Panel). March 19 SfSAP group meeting was held at IMRP19 and the Irradiation committee formed which begins to define the components that are required to demonstrate knowledge, understanding and experience in the application of sterility assurance using the modality of Ionizing Irradiation Recommendation: Industry collaborators – tell this in a visual way. Add a timeline of what has been achieved with pop-up descriptions May 19 Created the curriculum for Medical Device customers who use irradiation as a sterilization modality The Society for Sterility Assurance Professionals

Type Of Training Method Medical Device Industry - Radiation Curriculum Using Know, Understand and Apply matrix, Organisation or Individual can identify what type of training they needed for each of the competency elements, related to each learning modules of the curriculum. Competency is achieved when the required combination of K,U or A is acquired for each module of the curriculum. Once Competency is acquired for all modules of the curriculum, Acknowledged Competency has been achieved for that curriculum. Each organization or individual can determine the time required for each of the competency elements. Each of the curriculum modules can be undertaken in any order. Examination of proficiency by AAMI (CISS) or ASTM is required as part of the Execution Element of the competency journey. Recommendations: Use slide 3 to explain competency model (enlarge the visuals)- maybe add timed animations or pop-outs. It is acceptable to add 4th content slide for the Industry Curriculum. The Society for Sterility Assurance Professionals