Semi-Annual Medical Device Sterilization Conference

December 10-11, 2019 | San Diego, CA

Andaz San Diego Hotel

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DAY ONE | TUESDAY, DECEMBER 10

7:45 REGISTRATION & WELCOME COFFEE

8:30 CHAIRPERSON’S OPENING REMARKS
Beau Rollins, Director of Quality Services; Biocompatibility, Sterilization, and Corporate Auditing
CONVATEC

8:45 EVALUATING THE STATE OF ETHYLENE OXIDE STERILIZATION

  • Current concerns surrounding EO sterilization
  • Integration of ISO 10993-7 and 11135 in EO sterilization
  • Optimizing the use of EO in sterilization of medical products
  • Ensuring compliance under optimized validation approaches
  • Impact of reduced EO sterilization capacity on overall industry

MODERATOR: Ken Gordon, STERIS

PANELISTS:
Nancy Gonzalez, MICROVENTION-TERUMO

Aaron DeMent, STERIGENICS

Steven Douglas, BECTON DICKINSON

 

9:30 MITIGATING RISKS THROUGH ENHANCED EO STERILIZATION TECHNIQUES
As regulations are becoming more rigorous and EO residual acceptance rates are being lowered, industry experts are looking to novel EO sterilization optimization approaches focused on risk management and process maintenance. This short-form case study will explore and provide insight into the benefits accrued through the deployment of a manifold, novel approach to optimization while maintaining process integrity and sterility assurance outcomes equitable to traditional methods.

Ken Gordon, Principal Scientist, Innovation & Industry Representations, STERIS

 

10:15 COFFEE AND NETWORKING BREAK

 

10:45 SCIENTIFIC ISSUES IN THE REGULATORY ASSESSMENT OF EO CANCER RISK

  • Dose-response modeling issues
  • Endogenous & carcinogenic doses
  • Risk: Population & key worker estimates
  • Scientific weight-of-evidence

Joseph ‘Kip’ Haney, Toxicologist, TEXAS COMMISSION ON ENVIRONMENTAL QUALITY

 

11:30 RISK ASSESSMENT & BIOCOMPATIBILITY: ALIGNMENT UNDER ISO 10993
FDA’s January 2019 consensus on ISO 10933-1 specifies the requirement for a comprehensive biological evaluation of all devices pending 510(k) pre-market approval. This new guidance represents not only a heightened level of regulatory scrutiny, but also implies a technically intensive and refined multi-disciplinary approach to biocompatibility testing and comprehension thereof on a device-specific basis. As such, device manufacturers and sterilization professionals are moving to integrate interpretive tools and practices to best ensure compliance under a device-specific regulatory schema.

  • Successful device classification and risk assessment
    • ISO 10993-17 on leachable substances
    • ISO 10993-18 on chemical composition
  • Return of negative biocompatibility results
  • Interpreting and troubleshooting these results

Peter Seiler, Principal Biocompatibility Engineer, WRIGHT MEDICAL

 

12:15 LUNCHEON FOR ALL PARTICIPANTS

 

1:30 ISO 11737: IMPROVING BIOBURDEN CALCULATION VALIDITY
From routine monitoring of manufacturing processes and raw materials to endotoxin detection and radiation dosimetry audits, effective bioburden calculation informs and is necessary in almost every aspect of each sterilization method. Recent updates to the ISO 11737 standard governing bioburden calculation reflect this importance with revised guidance for inhibitor testing and elimination, setting appropriate limits of detection, and package testing requirements. This session will give focus to these updates while recommending practices for improving the validity of bioburden calculation in each instance.

  • Determining bioburden suitability
  • Inhibitor testing and selection
  • Weighing limit of detection parameters
  • Best practices in package testing

Matt Roybal, Senior Director, Microbiological Quality & Sterility Assurance, JOHNSON & JOHNSON

 

2:15 PRACTICAL DEVICE STERILIZATION WORKSHOP: PROCESS SELECTION, VALIDATION & OVERCOMING TECHNICAL OBSTACLES
The objective of this workshop is to utilize knowledge and insights gained throughout the conference program through the conduct of a dynamic group exercise incorporating real-life scenarios and decision making. Having been provided with a unique device, each group will work through the sterilization validation process stage by stage: device classification, modality selection, product sterilization risk assessment, biocompatibility test selection, and biological evaluation. In the course of testing, participants will be presented with challenges requiring them to negotiate common pitfalls associated with failing test results while formulating a plan of corrective action to overcome validation challenges.

Beau Rollins, Director of Quality Services; Biocompatibility, Sterilization, and Corporate Auditing
CONVATEC

 

3:15 COFFEE AND NETWORKING BREAK

 

3:45 INDUSTRY APPLICATION OF SUCCESSFUL DEVICE APPROVAL UTILIZING PARAMETRIC RELEASE

  • Processes supporting migration to parametric release
  • Challenges parametric release approval processes
  • Considerations in auxiliary validation in parametric release
  • Evidentiary requirements to support regulatory clearance

Fabiano Andreazza, BECTON DICKINSON

Steven Douglas, BECTON DICKINSON

 

4:30 NOTIFIED BODY PERSPECTIVE ON PARAMETRIC RELEASE STERILITY ASSURANCE
In order to obtain market clearance, medical device manufacturers must provide documentation validating the sterilization process and outcome of terminal sterilization, which has traditionally taken the form of a biological indicator sterility test. To streamline approval processes, FDA is now permitting the use of process records or parametric release in lieu of traditional tests, saving time and resources for medical device firms in the final stages of approval, for a number of sterilization modalities. Discussion surrounding current guidance and best practices for industry executives will provide insights for those considering this type of regulatory submission.

Chris Sarner, Sr. Technical Project Manager, Sterilization Expert, DEKRA

 

5:15 END OF DAY ONE CONFERENCE