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FDA CDRH General Hospital and Personal Use Devices Panel Advisory Committee Meeting November 6 – 7, 2019 DoubleTree by Hilton Grand Ballroom Washington DC North/Gaithersburg 620 Perry Pkwy. Gaithersburg, MD 20877 The Food and Drug Administration (FDA) is convening the General Hospital and Personal Use Devices Panel (the Panel) for the purposes of obtaining recommendations about strategies to reduce or eliminate environmental ethylene oxide (EtO) emissions secondary to medical device sterilization. EtO emissions are an environmental health concern and emissions greater than EPA allowable limits may trigger EtO sterilization facility closure limiting sterilization processing capacity for medical devices. This could potentially lead to medical device shortages. FDA is holding this panel meeting to obtain input on how to reduce EtO environmental emissions without compromising assurance of sterility of medical devices. AGENDA Day 1 – Reduction or Elimination of Ethylene Oxide Emissions for Medical Device Sterilization 8:00 a.m. Call to Order, Opening Remarks, and Introduction of the Committee Frank Lewis, M.D., FACS Panel Chair 8:10 a.m. Conflict of Interest Statement CDR Patricio Garcia, M.P.H. Designated Federal Officer Introduction and International Perspective Ryan Ortega, Ph.D. Center for Devices and Radiological 8:15 a.m. FDA/CDRH Opening Remarks Health (CDRH) Food and Drug Administration (FDA) Mike Koerber Deputy Director, Office of Air Quality Planning and Standards 8:25 a.m. EPA/OAQPS Opening Remarks (OAQPS) Environmental Protection Agency (EPA) Chris Reh, Ph.D. Associate Director, Agency for Toxic Substances and Disease Registry 8:35 a.m. CDC/ATSDR Opening Remarks (ATSDR) Centers for Disease Control and Prevention (CDC) Page 1 of 8

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Page 1: & Z,' v o , } ] o v W } v o h À ] W v o À ] } Ç } u u ] D

FDA CDRH General Hospital and Personal Use Devices Panel Advisory Committee Meeting

November 6 – 7, 2019 DoubleTree by Hilton Grand Ballroom Washington DC North/Gaithersburg

620 Perry Pkwy. Gaithersburg, MD 20877

The Food and Drug Administration (FDA) is convening the General Hospital and Personal Use Devices Panel (the Panel) for the purposes of obtaining recommendations about strategies to reduce or eliminate environmental ethylene oxide (EtO) emissions secondary to medical device sterilization. EtO emissions are an environmental health concern and emissions greater than EPA allowable limits may trigger EtO sterilization facility closure limiting sterilization processing capacity for medical devices. This could potentially lead to medical device shortages. FDA is holding this panel meeting to obtain input on how to reduce EtO environmental emissions without compromising assurance of sterility of medical devices.

AGENDA Day 1 – Reduction or Elimination of Ethylene Oxide Emissions for Medical Device Sterilization

8:00 a.m. Call to Order, Opening Remarks, and Introduction of the Committee

Frank Lewis, M.D., FACS Panel Chair

8:10 a.m. Conflict of Interest Statement CDR Patricio Garcia, M.P.H. Designated Federal Officer

Introduction and International Perspective

Ryan Ortega, Ph.D. Center for Devices and Radiological

8:15 a.m. FDA/CDRH Opening Remarks Health (CDRH) Food and Drug Administration (FDA)

Mike Koerber Deputy Director, Office of Air Quality Planning and Standards

8:25 a.m. EPA/OAQPS Opening Remarks (OAQPS) Environmental Protection Agency (EPA)

Chris Reh, Ph.D. Associate Director, Agency for Toxic Substances and Disease Registry

8:35 a.m. CDC/ATSDR Opening Remarks (ATSDR) Centers for Disease Control and Prevention (CDC)

Page 1 of 8

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FDA CDRH General Hospital and Personal Use Devices Advisory Committee Meeting

November 6 – 7, 2019

AGENDA Day 1 – Reduction or Elimination of Ethylene Oxide Emissions for Medical Device Sterilization

Andrew Bent BEng (Hons), CSci, MTOPRA

8:45 a.m. UK perspective on industrial EtO medical device sterilization Devices Division Medicines & Healthcare products Regulatory Agency (MHRA)

FDA’s Oversight of Medical Devices and their Sterility

Shortage of Ethylene Oxide Sterilized Medical Devices: CDRH’s 8:55 a.m. U

Adam Saltman, M.D., Ph.D. S FDA/CDRH Role

Karoll Cortez, M.D. Shortage of Industrial Ethylene Oxide Sterilized Medical Devices: 9:05 a.m. US FDA/CDRH Clinical Impact

Steven Elliott, M.S. 9:15 a.m. Overview of Industrial Ethylene Oxide Sterilization US FDA/CDRH

Christopher Dugard, M.S. How FDA reviews sterilization information in premarket

9:25 a.m. US FDA/CDRH regulatory submissions for medical devices

9:35 a.m. Clarifying questions from the Panel

9:55 a.m. Break

Impact of contract sterilization on medical device supply chains

Mark Leahy, J.D. Manufacturer perspective of medical device supply chains and Medical Device Manufacturers 10:10 a.m. device sterilization Association (MDMA)

David Gillian Group purchasing organization perspective of medical device 10:20 a.m. Vizient supply chains and shortages due to loss of sterilization capacity

Page 2 of 8

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FDA CDRH General Hospital and Personal Use Devices Advisory Committee Meeting

November 6 – 7, 2019

AGENDA Day 1 – Reduction or Elimination of Ethylene Oxide Emissions for Medical Device Sterilization

Healthcare delivery organization perspective of potential impact Kara Mascitti, M.D. 10:30 a.m. on patients due to loss of medical device sterilization capacity St. Luke's University Health Network

Reducing Ethylene Oxide Emissions for Medical Device Sterilization

10:40 a.m. Overview of EtO sterilization process and engineering to optimize EtO use

Phil Cogdill Medtronic

Brian McEvoy B.Sc., MBA and

11:00 a.m. Reduction of EtO emissions by changing cycle design and validation methods

William Brodbeck, Ph.D. STERIS Applied Sterilization Technologies

11:20 a.m. Reducing EtO use in sterilization cycles by changing sterilization load configuration

Denny Christensen

SVC Inc.

A. E. Ted May

Andersen Sterilizers, Inc. and

11:40 a.m. Flexible chamber EtO sterilization William Andersen, M.D., FAAOS Andersen Products, Inc.

12:00 a.m. Clarifying questions from the Panel

12:30 p.m. Lunch

Open Public Hearing

1:30 p.m. Open Public Hearing

2:00 p.m. Clarifying questions from the Panel

Page 3 of 8

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FDA CDRH General Hospital and Personal Use Devices Advisory Committee Meeting

November 6 – 7, 2019

AGENDA Day 1 – Reduction or Elimination of Ethylene Oxide Emissions for Medical Device Sterilization

Elimination of Ethylene Oxide Emissions for Medical Device Sterilization: Modalities with Existing Industrial Infrastructure

Emily Craven 2:10 p.m. Gamma sterilization of medical devices Mevex

Thomas Kroc, Ph.D. 2:30 p.m. X-ray and e-beam based industrial sterilization methods Fermilab

Jonathan Wilder, Ph.D.

2:50 p.m. Moist and dry heat sterilization of medical devices Quality Processing Resource Group, LLC

3:10 p.m. Clarifying questions from the Panel

3:40 p.m. Break

Open Public Hearing

3:50 p.m. Open Public Hearing

4:20 p.m. Clarifying questions from the Panel

FDA questions regarding impact to the medical device ecosystem and optimization of EtO (reducing emissions), followed by panel deliberation

4:30 p.m. Panel Deliberation

4:35 p.m. FDA Questions 1 - 6

6:00 p.m. Adjourn Day 1

Page 4 of 8

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FDA CDRH General Hospital and Personal Use Devices Advisory Committee Meeting

November 6 – 7, 2019

AGENDA Day 2 – Reduction or Elimination of Ethylene Oxide Emissions for Medical Device Sterilization

Frank Lewis, M.D., FACS 8:00 a.m. Call to Order and Opening Remarks Panel Chair

CDR Patricio Garcia, M.P.H. 8:05 a.m. Conflict of Interest Statement Designated Federal Officer

8:15 a.m. Day 1 Summary and Overview of Day 2 Clarence Murray, III, Ph.D. US FDA/CDRH

Elimination of Ethylene Oxide Sterilization Emissions for Medical Device Sterilization: Modalities with Unknown Industrial Infrastructure

Sylvie Dufresne, Ph.D. Partner, IM3 Consulting 8:20 a.m. Hydrogen Peroxide Group

David Opie, Ph.D. 8:40 a.m. Nitrogen Dioxide Noxilizer

Paul Lorcheim, P.E. 9:00 a.m. Chlorine Dioxide ClorDiSys Solutions Inc

Joe McDonald, Ph.D. Life Sciences Division

9:20 a.m. Vaporized Peracetic Acid and Other Chemicals Cantel Medical

Sue Klacik

International Association of 9:40 a.m. Healthcare sterilization of medical devices Healthcare Central Service Materiel Management

10:00 a.m. Clarifying questions from the Panel

10:20 a.m. Break

Page 5 of 8

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FDA CDRH General Hospital and Personal Use Devices Advisory Committee Meeting

November 6 – 7, 2019

AGENDA Day 2 – Reduction or Elimination of Ethylene Oxide Emissions for Medical Device Sterilization

10:30 a.m. Panel Deliberation/FDA Questions 7 - 10

11:35 p.m. Lunch

Page 6 of 8

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FDA CDRH General Hospital and Personal Use Devices Advisory Committee Meeting

November 6 – 7, 2019

Agenda Day 2 - Reducing the Risk of Infections from Reprocessed Duodenoscopes

12:30 pm FDA Presentation Shani Haugen, PhD

1:10 pm Clarifying Questions from the Panel

1:20 pm Open Public Hearing

Combined Nursing Professional Societies – Erin Kyle, DNP, RN, CNOR, Association of perioperative Registered Nurses (AORN); Society of NEA-BC and Catherine Bauer, Gastroenterology Nurses and Associates (SGNA) MSN, MBA, RN, CGRN, CFER

Jahan Azizi, Mary Ann Healthmark Industries Drosnock, and John Whelan,

BSN, RN

Rebecca Bartles, MPH, CIC, Providence St. Joseph Health System FAPIC and Jack Brandabur,

MD

Sylvia Garcia-Houchins, MBA, The Joint Commission RN, CIC

Guest Speaker Presentation – Endoscopes: Reprocessing Challenges 1:50 pm Michelle Alfa, PhD, FCCM and Quality Assurance

2:05 pm Guest Speaker Presentation – Human Factors and Quality Assurance Cori L. Ofstead, MSPH

2:20 pm Clarifying Questions from the Panel

2:30 pm Break

2:40 pm Perspectives from Stakeholder Professional Societies

Combined Physician Gastrointestinal Professional Societies – American College of Gastroenterology (ACG); American Michael L. Kochman, MD, Gastroenterological Association (AGA); American Society for and Bret T. Petersen, MD Gastrointestinal Endoscopy (ASGE); Society of American Gastrointestinal and Endoscopic Surgeons (SAGES)

International Association of Healthcare Central Service Materiel Susan Klacik Management (IAHSCMM)

Combined Infection Management Professional Societies – Association for Professionals in Infection Control and Michael Anne Preas, MS, RN, Epidemiology (APIC); Infectious Diseases Society of America CIC, FAPIC (IDSA); Society for Healthcare Epidemiology of America (SHEA)

Page 7 of 8

Page 8: & Z,' v o , } ] o v W } v o h À ] W v o À ] } Ç } u u ] D

FDA CDRH General Hospital and Personal Use Devices Advisory Committee Meeting

November 6 – 7, 2019

Agenda Day 2 - Reducing the Risk of Infections from Reprocessed Duodenoscopes

3:10 pm Perspectives from Device Manufacturers

FUJIFILM Medical Systems U.S.A., Inc. Randy Vader

Olympus Corporation of the Americas Ross Segan, MD, MBA, FACS

J. Hudson Garrett Jr., PhD, PENTAX Medical MSN, MPH, FNAP

Ambu Inc. Patrick Hurley, PhD

Boston Scientific Corporation Brian J. Dunkin, MD

3:50 pm Clarifying Questions from the Panel

4:00 pm Panel Deliberation/FDA Questions

5:30 pm Adjourn

Page 8 of 8


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