Dr Jörg Degen, Eurofins
Lothar Fruth, ATC
Jan Havel, TÜV Süd
Hana Hofman-Hüther, Eurofins
Peter Huonker, Zimmer Biomet
Tim Sandle, Bio Products Laboratory Limited
Walter Zwisler, Zwisler Laboratorium
This course will provide you with information about the current regulatory requirements for microbiological and toxicological quality of Medical Devices. Well-versed speakers from Notified Body, Manufacturer and Quality Laboratory will share their experiences with implementation and validation of suitable test methods, common pitfalls, and the expectations of auditors and customers.
They will share their knowledge in transfer the regulatory requirements in the daily business and how to manage the challenges in the fast developing field of Medical Devices
Since 1996, the requirements for the development, the manufacture and the distribution of Medical Devices in the USA have been laid down in the revised cGMP regulations for Medical Devices (21 CFR 820, QSR). In the USA, medical devices are regulated by the FDA’s Center for Devices and Radiological Health (CDRH). Inspections are primarily performed by the FDA.
In Europe, three EU directives (90/385/EWG, 93/42/EWG and 98/79/EG) and one amending directives regulate the medical devices industry. GMP regulations - strictly speaking - are not notified. Instead, harmonised standards, especially ISO 13485, revised in 2016, represent the state-of-the-art in the EU. Inspections are primarily performed by Notified Bodies („New Approach for Product Regulations and Conformity Assessment“).
Statistical data about deficiencies of medical devices do only exist in the USA because of the Freedom of Information Act. For years now, CAPA/Complaint Handling, insufficient Design Controls, Management Responsibility, Process Controls and Process Validation and Quality Audits have been among the Top 10 deviations.
An additional focus of authorities and notified bodies is the microbiological and toxicological safety. This means the requirements for hygienic production, sterilisation appropriate to ISO11137/11135 as well as a suitable method for bioburden sterility testing or endotoxin detection.
A new challenge relating to microbiological and sterilisation safety became the ISO 17664 and which Information must the MD Manufacturer provide now to the customer.
For toxicological and biocompatibility analysis, the ISO 10993 defines some requirements, but a current question will be: “How can I get the data I need” especially for the raw materials and intermediates whilst a medical grade is not really defined.
This course is designed for all people from
- Medical Device Manufacturing
- Medical Device Quality Control
- Contract Laboratories
- Regulatory Authorities
- Notified Bodies
who are involved in quality and safety issues of medical devices.
Regulatory Requirements on Medical Devices
Biological Safety of Medical Devices: general and agency expectations
- General requirements for Sterile Products and packaging
- Requirements for control of manufacturing and microbiological and biological safety
- General requirements on documentation for validation and biological safety
Short Introduction into Microbiology
- General biological safety requirements
Microbiological Quality Control during Production of Medical Devices
- What are Microorganisms
- Behaviour of Microorganisms
Consideration of different sterilization methods for medical devices, focusing on gamma radiation and ethylene oxide
- Essentials of ISO 11737-1 and USP <1229.3>Sampling, Extraction, Testing, Validation, Limits
- Regulatory Requirements concerning hygienic aspects
- Environmental Control of Production Processes
- Microbiological Quality Control Testing
- Bioburden and Validation
- Sterility including Suitability Testing
Validation of Sterilisation appropriate to ISO11137/11135 - New sterilization approach X-ray
- Methods of microbial inactivation and destruction
- Suitability of different methods for different materials
- Shelf-life testing
Current Requirements of ISO 17664 – Which Information must the MD Manufacturer provide for the processing of resterilizable medical devices
The (Re-)Processing cycle of MDs
Instruction for use – part (re-)processing: the need of a validated process
Microbial Identification with Maldi: A comparison with other methods (cons/pros)
- General introduction of ISO 11137 and some practical remarks
- General introduction of ISO 11135 and some practical remarks
- Different X Ray technologies and treatment approaches
Endotoxin Testing - Studies on BET Recovery rates with different Methods and Materials
- General overview about current identification methods: DNA, biochemical, and phenotypical identification methods
- Technical introduction of MALDI-TOF
- Financial aspects and for whom it could be an interesting investment
MAT and Medical Devices
- Endotoxin test with LAL
- Recovery efficiency with ultrasonic bathes
- Recovery efficiency with different materials, like polymer, ceramic and metal
- Combined methods
Requirements on ISO 10993 - current updates
- MAT overview
- Pyrogens in (MD-) Production
- MAT for MD
Toxicological evaluation - Risk Assessment and TTC approach
- General introduction of ISO 10993
- Update of ISO 10993-1
- ISO 10993-12 : is the extraction procedure sufficient for all tests?
Biocompatibility as challenge for the communication in the supply chain - how do I get the data I need?
- Prerequisites and elements of a successful risk assessment
- How to close typical data gaps
- TTC approach as a quick way out from the efforts of the traditional way in toxicology?
- Limitations of the TTC concept
Cleanliness/Validation of washing machines/chemical and microbiological aspects
- Typical situations in the daily communication
- Recommendations for the definition of the minimum requirements for the data from the suppliers
- How to accelerate the process
- Data plausibility check: Trust or control?
- Instruments: Basics about ISO 15883
- Implants: Chemical and biological cleaning validation and its aspects