The Food and Drug Administration (FDA) is announcing a public Workshop entitled “Physiological Closed-Loop Controlled (PCLC) Devices.” The topic to be discussed is challenges related to the design, development, and evaluation of critical care PCLC devices. FDA considers PCLC devices an emerging technology and aims to hold a workshop focusing on design, development and performance evaluation of PCLC systems intended for use in critical care environments. Such devices include closed-loop anesthetic delivery, closed-loop vasoactive drug and fluid delivery, and closed-loop mechanical ventilation.
(CORRECTION: The docket will remain open and accept comments until November 13, 2015. The link for submitting comments is http://www.regulations.gov and docket # is: FDA-2015-N-2734.)
- Discussion Paper
- Date, Time and Location
- Federal Register Notice
- Registration
- Contact Us
Date, Time and Location:
This 2-day workshop will be held October 13-14, 2015, beginning at 8:00 a.m. – 5:00 p.m. at the following location:
FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993
FDA Campus Information (Airports, Directions, Lodging Accommodations, Public Transportation, etc.)
The meeting will be webcast.
Agenda
Day 1- October 13, 2015
Overview Background, Expectations, and Design of PCLC Medical Devices
Day 1 – Morning
Time
Topic
Speaker
Affiliation
7:30
Registration
8:00
Welcoming Remarks – Objectives of the workshop
Bahram Parvinian M.S
Allison Kumar
PCLC Working Group Leader-Office Of Device Evaluation, CDRH
EMCM Senior Project Manager-Office of Center Director, CDRH
8:10
FDA vision
Jonette Foy, Ph.D
Deputy Director for Engineering Science, Office of Device Evaluation, CDRH
8:25
Keynote Presentation:
Autonomy in Healthcare
Mary Cummings, Ph.D
Director of Humans and Autonomy Laboratory Duke University
8:55
QA for Keynote Speaker
9:05
Control system history/advances in physiological control and future challenges
Boris Kovatchev PhD
Professor, University of Virginia School of Medicine Director, UVA Center for Diabetes Technology
9:25
Potential benefits/challenges
Tim Bentley Ph.D
Deputy, Force Health Protection
Office of Naval Research
9:45
Potential benefits/challenges (Anesthesia and Hemodynamic stability)
Robert Loeb M.D
Professor of Anesthesiology, University of Arizona
American Society of Anesthesiologists
10:05
Potential benefits/challenges (Hemodynamic Stability)
Maxime Cannesson M.D, Ph.D
Professor, University California Los Angeles
10:25
Break
10:35
Potential benefits/challenges of Mechanical Ventilation)
Robert Chatburn, MHHS, RRT
Clinical Research Manager Cleveland Clinic,
American Association of Respiratory Care
10:55
Roles of Clinician and Engineer in design and evaluation. Knowledge Gaps
LesterSchultheis, M.D Ph.D
Director UMD Regulatory Science and Innovation Initiative
11:15
Importance of Standards and standardization
Julian Goldman, M.D
Director MDPnP program
MGH Harvard University
11:35
Panel Discussion (Drs. Loeb, Schultheis, Goldman, Chatburn, Kovatchev, Cannesson, Bentley)
Moderator: TBD
12:15
Lunch
Day 1 – Afternoon
Breakout Sessions: Design and Implementation Strategies/Considerations
Engineering (Room 1)
Speaker
Clinical (Room 2)
Speaker
1:15
Physiological system modeling and control system design
Jin-Oh Han, Ph.D
Professor, Mechanical Engineering University of Maryland
PCLC user interfaces Design/ Design for better reporting and operational transparency
Larry Fennigkoh Ph.D
Milwaukee School of Engineering
1:30
Software Implementation of controller / Hardware considerations Sensors and actuators (i.e. pumps
David Arney Ph.D Lead Engineer, MD PnP Program, Massachusetts General Hospital
Enroute care closed-loop systems: clinician expectation
Lt. Col. Jennifer Hatzfeld, Ph.D, RN
Combat Casualty Care Research Program
1:45
procedures for safe design and verification of physiological closed-loop controlled medical devices
Rahul Mangharam Ph.D Professor of Electrical Engineering, University of Pennsylvania
PCLCs design for ICU: clinician perspective
Jeremy Pamplin, M.D
US Army Institute of Surgical Research
2:00
Fall back and system fail safe design Risk mitigations for Infusion pumps
Alan Stevens, Infusion Pump Team Leader, FDA
Human in the Loop Modeling for anesthesia delivery
Jeff Mandel, M.D University of Pennsylvania
2:15
Model-Based Design and Verification of Medical Device Software
David, Hoadley, Ph.D Principle Technical Consultant MathWorks Inc
Clinical Expectations for EndTidal anesthetic gas delivery
Jim Philips M.D MGH/Harvard
2:30
Model-Driven Safety Analysis of Closed-Loop Medical Cyber-Physical Systems
Insup Lee, Ph.D Professor of Electrical Engineering University of Pennsylvania
Big Data and System ID for PCLC modeling
Joseph Frassica, M.D Chief Technology Officer Philips Healthcare
2:45
Panel Discussion
Moderator: Sandy Weininger, Ph. D
Panel Discussion
Moderator: Allison Kumar
3:45
Break
4:00
Sandy Weininger and Allison Kumar to summarize answers to clinical and engineering questions
4:15
Conclusion of Day 1 (Bahram Parvinian)
Day 2-October 14, 2015
Evaluation of PCLCS and Focused Device Area sessions
Day 2 – Morning
Time
Topic
Speaker
Affiliation
7:30
Registration
8:00
Day 2 overview
Bahram Parvinian M.S
PCLC Working Group Leader-Office Of Device Evaluation, CDRH
8:05
PCLC devices and Drug Labeling Conformance
James Bertram Ph.D
Senior Policy Analyst, Office of Device Evaluation, FDA
8:20
Open-loop vs Closed-loop anesthesia control-OUS Evidence from Target controlled infusion
Steve Shafer M.D
Professor of Anesthesiology Stanford University
8:40
Regulatory challenges for PCLC critical care devices
Lex Schultheis M.D Ph.D
Director UMD Regulatory Science and Innovation Initiative
9:00
PK/PD models used for closed-loop drug delivery devices
Joga Gobburu Ph.D
UMD School of Pharmacy
9:20
Panel Discussion (Drs. Shafer, Schultheis, Gobburu, and Bertram)
Moderator: Patricia Beaston M.D Ph.D ODEFDA
10:00
Break
Evaluation Studies Breakout Sessions
Day 2 – Morning Cont.
Pre-clinical Session (Room 1)
Speaker
Clinical Usability(Room 2)
Speaker
10:15
Toward robust and safe closed-loop control of anesthesia
Klaske van Heusden, Ph.D University of British Columbia
Usability of PCLC: A clinician perspective
Richard Branson, RRT, FAARC University of Cincinnati
10:30
Simulation studies – sensitivity analysis/patient variability
Boris Kovatchev Ph.D / University of Virginia
Human factors studies to address automation bias
Debbie McConnell Ph.D Battelle Inc.
10:45
Use of animal testing for evaluation of PCLCs: Fluid resuscitation
Mike Kinsky M.D University of Texas Medical Branch
Clinician Training and Clinician expertise: use of simulator based training
Katherine Berry Michael Sawyer Ph.D
11:00
Stability robustness evaluation for PCLC mechanical ventilation/Hardware In the Loop testing.
Nicolas Chbat Ph.D Philips Healthcare
Human Factors Consideration for Devices used in emergency care
Colin Mackenzie, M.B Ch.B University of Maryland Medical School
Evaluation Closed-Loop Fluid Resuscitation
Jose Salinas Ph.D U.S Army Institute of Surgical Research
11:15
Panel Discussion
Moderator: Christopher Scully Ph.D
Panel Discussion
Moderator: CDR Nikhil Thakur
12:15
Lunch
Product Specific Break Out Sessions
Day 2 – Afternoon
Drug/fluid infusion
Anesthetic/fluid resuscitation (Room 1)
Speaker
Mechanical ventilation (Room 2)
Speaker
1:15
Closed-loop delivery of anesthesia for medical induced Coma
Patrick Purdon Ph.D Brandon Westover M.D Ph.D Mass General Hospital
FDA perspective: Closed-Loop Mechanical Ventilation
James Lee, Ph.D Office of Device Evaluation FDA
1:30
Use of single sensor (BP, SVV) for fluid resuscitation
Jin-Oh Hahn, Ph.D University of Maryland
Closed-loop Neonatal oxygenation
Nelson Claure, Ph.D University of Miami
1:45
HIL testing for Closed-Loop Anesthetic Delivery
Stephan Bibian, Ph.D Neurowave Medical
Integrative cardiopulmonary mathematical modeling short term regulation
Nicolas Chbat Ph.D, Philips Healthcare
2:00
Clinical outcomes for closed-loop anesthesia
Steve Parker M.D, Georgetown University
Benefit Risk consideration for fully closed-loop mechanical ventilation
Jean-Michel Arnal M.D Hamilton Medical
2:15
Closed-Loop Fluid management
Mike Kinsky M.D University of Texas Medical Branch
Clinical Validation for SmartCare Pressure Support
Daniel Wolansky M.D Draeger Medical
2:30
Panel Discussion
Moderator: Ryan McGowan
Panel Discussion
Moderator: Bahram Parvinian M.S
3:30
Break
3:45
4 Moderators to summarize discussions
4:15
Concluding Remarks (Bahram Parvinian)
Registration to Attend the Workshop
There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.
If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, [email protected].
Contact Us
For questions regarding workshop content please contact:
Bahram Parvinian, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Rm 2534, Silver Spring, MD 20993-0002, 301-796-6445, email: [email protected].
Allison Kumar, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Rm 5402, Silver Spring, MD 20993-0002, 301-796-6369, email: [email protected]