Proving that personnel involved in sterilisation are Qualified and Competent

1. Proving that personnel involved in sterilisation are Qualified and Competent

2. The MDR, ISO 13485:2016, FDA requires evidence regarding the qualification and competency of personnel in sterilization How is the Medical Device industry going to achieve this?

3. Annex VIIMDR Requirements to be met by Notified Bodies 3. Resources 3.2 Qualification criteria in relation to personnel 3.2. 1 The Notified Body shall establish and document qualification criteria and procedures for selection and authorization of persons involved in conformity assessment activities, including as regards knowledge, experience and other competency required and the required initial and ongoing training. The qualification criteria shall address the various areas within the conformity assessment process, such as auditing, product evaluation or testing, technical documentation review and decision making, as well as devices, technologies and areas, such as biocompatibility, sterilisation, tissues and cells of human and animal origin and clinical evaluation, covered by the scope of designation.

4. ISO 13485:2016 Clause 6.2Requirements to be met by Medical Device Manufacturers 6.2 Human resources • Personnel performing work affecting product quality shall becompetent on the basis of appropriate education, training, skills and experience. • The organization shall document the process(es) for establishing competence, providing needed training, and ensuring awareness of personnel. • The organization shall: • a) determine the necessary competence for personnel performing work affecting product quality; • b) provide training or take other actions to achieve or maintain the necessary competence; • c) evaluate the effectiveness of the actions taken; • d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives; • e) maintain appropriate records of education, training, skills and experience (see 4.2.5).

5. GUIDE TO FDA INTERNATIONAL INSPECTIONSFIELD MANAGEMENT DIRECTIVE No. 13 A “outlines the requirements and procedures to be followed for appointment to the International Inspection Cadre and the selection of cadre members in ORA (Office of Regulatory Affairs) international inspection programs.” SPECIFIC REQUIREMENTS FOR INVESTIGATORS: • Device Investigators: Successfully completed Basic Medical Device Training Course and Process Validation or Industrial Sterilization (or equivalent**). • Biologics Investigators: Blood Banks/Plasma Center: Completed Basic Blood Banking and Plasmapheresis Course and Advanced Blood Banking and Plasmapheresis Course (or equivalent**). Biologics Products: Drug Manufacturing and Quality Control and Industrial Sterilization (or equivalent**).

6. GUIDE TO FDA INTERNATIONAL INSPECTIONSFIELD MANAGEMENT DIRECTIVE No. 13 A  SPECIALIZED REQUIREMENTS FOR INVESTIGATORS AND ANALYSTS: (Not mandatory, except for certain program areas, as described under specific requirements, if the Investigator/Analyst can show alternate experience in lieu of FDA requirement) Courses in: • Process Validation • Industrial Sterilization • Computer System Validation

7. Notified Bodies Compliance Challenge With the focus on the sterilisation process, how do the Notified Bodies, Medical Device Manufacturers, Contract Sterilizers, Laboratories prove with objective evidence that personnel are • Appropriately qualified in the sterilization technology • Have two years professional experience in the appropriate sterilization technology • Have evidence to prove to the Competent National Authority that their personnel meet this requirement of the MDR, ISO, FDA etc.

8. The Society for Sterility Assurance Professionals • The initiative is being pioneered by Arthur Dumba and is being supported by iia. ASTM indicated a willingness to become involved at its meeting in San Diego. Abbott and J&J are also providing leadership and support. • Working with the sterilization industry in defining the requirements for proving competency in specific modalities of sterilization and microbiology. • Providing a pathway for those involved in the sterilization lifecycle, to follow for development and maintenance of competency, knowledge and skills • Support the ISO, MDR, FDA and Competent National Authorities requirements, for individuals to prove that they are a certified Sterility Assurance Professional. • Provide certification pathway for those Auditors that work for Certification Bodies, Notified Bodies and Competent National Authorities to develop and maintain their competency, knowledge and skills, in order to meet ISO, MDR and FDA requirements.