Semi-Annual Medical Device Sterilization Conference

December 10-11, 2019 | San Diego, CA

Andaz San Diego Hotel

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DAY TWO | WEDNESDAY, DECEMBER 11

8:00 REGISTRATION & WELCOME COFFEE

8:25 CHAIRPERSON’S OPENING REMARKS
Beau Rollins, Director of Quality Services; Biocompatibility, Sterilization, and Corporate Auditing
CONVATEC

8:30 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

 

9:15 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

GROUP 2: Nitrogen Dioxide
Ken Gordon, STERIS

GROUP 3: Vaporized Hydrogen Peroxide
Horacio Ireta, MICROVENTION-TERUMO

 

10:00 COFFEE AND NETWORKING BREAK

 

REUSABLE MEDICAL DEVICE STERILIZATION MODULE
Throughout the healthcare industry, medical products used in the surgical and clinical setting are frequently sterilized in order to be reused, creating considerable concerns for OEMs surrounding the development of effective instructions for use, maintenance of product integrity, as well as validation of the sterilization process. From the development of comprehensive, validated instructions to the integration of end-user perspectives on current sterilization technologies and processes, device executives will gain insights into this rapidly evolving and important aspect of medical device sterilization.

 

10:30 DEVELOPMENT OF EFFECTIVE & VALIDATED CLEANING INSTRUCTIONS

  • Creation of clear device cleaning instructions
    • Guidance surrounding device disinfection
    • Consistency in cleaning processes
  • Human factors studies on reusable device cleaning
  • Reusable cleaning process validation practices
  • TIR30 report on validating reprocessing instructions

FACILITY PERSPECTIVE:
Gene Ricupito, Interim Director, Sterile Processing, UCSF MEDICAL CENTER

 

11:15 FACILITY PANEL: END-USER PERSPECTIVES ON STERILIZATION OF MEDICAL PRODUCTS

  • Interpretation of device sterilization instructions
  • Facility best practices in disinfection & sterilization
  • Current sterilization methods and future methodologies

Gene Ricupito, UCSF MEDICAL CENTER

Lee Haugen, EISENHOWER MEDICAL CENTER

Robert Dix, VALLEY PRESBYTERIAN HOSPITAL

 

12:00 LUNCHEON FOR ALL PARTICIPANTS

 

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.

 

1:00 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

 

1:30 RADIATION MASTERCLASS II: OPPORTUNITIES IN TRANSITIONING FROM ETHYLENE OXIDE AND GAMMA-RAY STERILIZATION

  • 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 CORPORATION

Mark Murphy, PACIFIC NORTHWEST NATIONAL LABORATORY

 

2:00 COFFEE & NETWORKING BREAK

 

2:30 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

Horacio Ireta, MICROVENTION-TERUMO

Beau Rollins, CONVATEC

Clint Olsen, STERIS

 

3:30 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

 

4:15 END OF CONFERENCE