Experience:

Gerry O’Dell Consulting

Owner/President, 1998 - present - Consult to companies in all phases of business development in the areas of sterilization (all major sterilization modalities and some novel sterilization methods), environmental monitoring, laboratory and other related compliance areas for single-use medical devices, reusable medical devices, biologics and pharmaceuticals.

Johnson & Johnson Medical

Manager Laboratory & Sterilization Services, 1994 -1998 - Manager of laboratory and sterilization group that included sterilization, microbiology, analytical, packaging, stability and physical testing for JJM and other J&J companies.

Critikon, Inc. (a Johnson & Johnson Company)

Manager Sterilization Services, 1990-1994 - Manager of sterilization and microbiology group that supported routine and new product development.


Supervisor Sterilization Services, 1988-1990 - Supervised the microbiology group. Instituted computerization that resulted in 25% reduction in errors.

Assistant Sterilization Scientist, 1985-1988 - Validated sterilization operations, conducted study to reduce BI testing time by 50% and set up in-house residual testing.

Microbiology Lab Technician, 1983-1985

 

Education:

M.S. in Microbiology, University of South Florida, 1985

B.A. in Microbiology, University of South Florida, 1980

Assessment to EN46000 and Medical Device Directive, 1995
GMP and ISO 9001 Requirements of Medical Devices, 1995
Signature of Quality Examiner Training, 1993
Quality Control in Manufacturing, 1990

Microbiological Aspects of Process Validation, 1988
EtO & Radiation Sterilization Techniques, 1986
Statistical Process Control, 1985

Affiliations and Accreditations:

Certified Industrial Sterilization Specialist (CISS) for ethylene oxide (EO), moist heat (MH), and radiation (RAD), ACI Certified January 1, 2018

Registered Microbiologist, 1983 -present

Member, American Society for Microbiology, 1984 - present
Member, Association for the Advancement of Medical Instrumentation, 1985 - present
J&J Medical Global Technical Service Team, 1996-1997
J&J Signature of Quality Examiner, 1993

Member, U.S. Sub-TAG for ISO/TC 198/WG 1 (Industrial Ethylene Oxide Sterilization)

Member, U.S. Sub-TAG for ISO/TC 198/WG 3 (Industrial Moist Heat Sterilization)

Member of the following AAMI Sterilization Standards Committee Working Groups

·       Industrial Ethylene Oxide Sterilization (AAMI/ST/WG 01), Co-chair 2006 – 2016

·       Radiation Sterilization (AAMI/ST/WG 02)

·       Industrial Moist Heat Sterilization (AAMI/ST/WG 03), Current Co-chair

·       Microbiological Methods (AAMI/ST/WG 08)

·       General Criteria for Sterilization Processes (AAMI/ST/WG 11)

·       Instructions for Reusable Device Reprocessing (AAMI/ST/WG 12)

·       Dry Heat Sterilization (AAMI/ST/WG 42)

·       Sterilization Residuals (AAMI/ST/WG 63)

·       Endoscope Reprocessing (AAMI/ST/WG 84)

·       Human Factors for Device Reprocessing (AAMI/ST/WG 85)

·       Sterility Assurance Level (SAL) (AAMI/ST/WG 90)

·       Cleaning of Reusable Medical Devices (AAMI/ST/WG 93)

·       Rigid Sterilization Container Systems (AAMI/ST/WG 94)

·       Compatibility of Materials Subject to Sterilization (AAMI/ST/WG 96)

 

Publications/Training Programs:

Current Lead Instructor – AAMI Course “Industrial Ethylene Oxide Sterilization for Medical Devices”

Current Instructor – AAMI Course “Radiation Sterilization for Medical Devices”

Instructor – AAMI Presentation & Webinar “Applying Novel Sterilization Processes to Healthcare Products”

Past Instructor as Subject Matter Expert in Sterilization, Biocompatibility, Controlled Environments and Laboratory Testing – ASQ CBA Review Course

Co-Instructor – AAMI Webinar – “EO Sterilization: Comparison of 1994 and 2007 versions of ANSI/AAMI/ISO 11135-1”

Co-Instructor – AAMI Webinar – “EO Sterilization: Guidance on the Application of ANSI/AAMI/ISO 11135-1”

Instructor for the following Compliance Online Webinars

·       “Basics of testing associated with sterilization validation and routine processing”

·       “Ethylene Oxide (EO) Sterilization Basics for R&D Engineers”

·       “How to investigate environmental monitoring excursions”

·       “You have a sterility failure or bioburden excursion – Now what?”

·       “Designing an effective cleaning validation for reusable medical devices in today's regulatory environment”

 

Author – “Sterilization Validation Principles” in The Medical Device Validation Handbook. 2015. Editor Max Sherman. Regulatory Affairs Professionals Society.

Author – “Sterilization by Ethylene Oxide” in Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices. 2011. Editors Madhu Raju Saghee, Tim Sandle, and Edward C. Tidswell.

Author - “How to Conduct and Document a Microbiological Failure Investigation”, July 1998 - The Validation Consultant.

Co-Author - “Industry Responds to Pyronema domesticum: HIMA Screening Studies”, September 1997 - Medical Device & Diagnostics Industry.