Semi-Annual Medical Device Sterilization Conference

December 10-11, 2019 | San Diego, CA

Andaz San Diego Hotel

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DAY TWO | WEDNESDAY, OCTOBER 30

8:00 REGISTRATION & WELCOME COFFEE

8:25 CHAIRPERSON’S OPENING REMARKS
Tim Carlson, Sterilization Program Manager, Global Sterilization Assurance, BECTON DICKINSON

8:45 NAVIGATING STERILIZATION IN THE NEW MDR LANDSCAPE
The European Medical Device Regulation (MDR) released in 2017 has resulted in a paradigm shift for manufacturers accessing the European market, with new device classifications, requirements for enhanced evaluation, conformity assessment and recertification for many established products. Of core concern for sterilization executives are chemistry risk assessment and biocompatibility requirements surrounding chemical character and toxicology risks. Although aligned with ISO 10993-1, the MDR takes further the testing and validation regulation surrounding devices, in addition to new requirements on biological endpoints and device reprocessing.

  • Alignment of MDR sterilization with ISO 10993-1
  • Requirements for recertification and requalification
  • Chemistry risk assessment & biocompatibility in MDR

Carrie Long, Regulatory Affairs Specialist, ZIMMER BIOMET

 

9:30 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

Scott Weiss, Director of Industrial Microbiology, JOHNSON & JOHNSON STERILITY ASSURANCE

 

RADIATION MODULE: GAMMA RADIATION AND THE COMPETITIVE VIABILITY OF E-BEAM & X-RAY ALTERNATIVES
The National Nuclear Security Administration’s grant to Pacific Northwest National Laboratories comes in the wake of growing concerns related to the safe and secure transport of the Cobalt 60 isotope used in gamma radiation sterilization. Exploring device material compatibility with alternate sterilization modalities such as e-beam and x-ray, the grant and ensuing industry collaboration represents a nascent shift in interest away from the dominant mode of radiation sterilization, giving industry device sterilization experts cause to wonder both about the future of gamma radiation and the competitiveness of its alternatives.

 

10:45 RADIATION MASTERCLASS I: COBALT, E-BEAM, AND X-RAY EFFECTS FOR 6 PRODUCT POLYMERS

  • Description of DOE/NNSA program
  • Summary of first phase data results
  • Interpretation of application/benefit for industry

Leo Fifield, PACIFIC NORTHWEST NATIONAL LABORATORY

Tony Faucette, BECTON DICKINSON

 

11:15 RADIATION MASTERCLASS II: OPPORTUNITIES IN TRANSITIONING TO EO & GAMMA ALTERNATIVES

  • Weighing the alternatives to EO & GAMMA
  • Remaining data and education gaps
  • Practical guide to accomplishing transition
    • E-Beam
    • X-Ray
  • Interpretation of comparative results

Rod Parker, STRYKER

Mark Murphy, PACIFIC NORTHWEST NATIONAL LABORATORY

 

11:45 INDUSTRY PANEL: OPPORTUNITIES IN ALTERNATIVE RADIATION MODALITIES

  • Assessment of gamma’s market position
  • Trajectory of e-beam and x-ray scalability
  • Regulatory import of an industry shift

MODERATOR:
Aaron Starkey, IOTRON INDUSTRIES

Byron Lambert, ABBOTT VASCULAR

Stephani Volk, CONVATEC

Tim Kruger, STERIS CORPORATION

 

12:30 LUNCHEON FOR SPEAKERS, SPONSORS & ATTENDEES

 

1:30 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.

Stephanie Volk, Senior Corporate Sterilization and Biocompatibility Scientist, CONVATEC

 

2:30 EXPLORING INNOVATIVE AND DISRUPTIVE STERILIZATION MODALITIES
Amidst the continued market dominance of gamma radiation and ethylene oxide sterilization modalities, the production of increasingly complex, delicate, and temperature sensitive medical devices has driven significant innovation in modalities with robust competitive advantages. Though not currently scalable to industrial production, the promising designs of these modalities service device manufacturer material and chemical compatibility requirements where gamma and ethylene oxide fall short. Attendees will have an opportunity to engage with peers and industry experts on advantages and opportunities in upcoming sterilization technology.

BREAKOUT DISCUSSION GROUPS:

GROUP 1: Peracetic Acid
Tim Carlson, BECTON DICKINSON

GROUP 2: Nitrogen Dioxide
Tony Faucette, BECTON DICKINSON

GROUP 3: Vaporized Hydrogen Peroxide
Rod Parker, STRYKER CORPORATION

 

3:15 EFFECTIVE STERILIZATION OF COMPLEX COMBINATION PRODUCTS
As the market for combination products continues to expand, medical device sterilization executives, traditionally focused on terminal product sterilization, must increasingly consider complex methods of sterilization which maintain the integrity of multiple product mechanisms while at the same time mitigating risks of microbial contamination. Further complicating an already complex process are the unique attributes of each combination product, whether designed as a coated device, a pre-packaged or assembled kit, or a drug delivery mechanism which require thoughtful consideration related to sterilization process and modality.

  • Combination product sterilization method selection
  • Introduction of new risks in product sterilization
  • Radiation & EO impact on combination products
  • Successes in dual modality sterilization techniques
  • Opportunities in aseptic processing solutions

Byron Lambert, Sr. Fellow, Sterilization, ABBOTT VASCULAR

 

4:00 END OF CONFERENCE