Medical Devices

Public Workshop - Physiological Closed-Loop Controlled Devices, October 13-14, 2015

The Food and Drug Administration (FDA) announced a public Workshop entitled "Physiological Closed-Loop Controlled (PCLC) Devices." The topic discussed was challenges related to the design, development, and evaluation of critical care PCLC devices. FDA considers PCLC devices an emerging technology and held a workshop focusing on design, development and performance evaluation of PCLC systems intended for use in critical care environments. Such devices included closed-loop anesthetic delivery, closed-loop vasoactive drug and fluid delivery, and closed-loop mechanical ventilation.

(CORRECTION: The docket remained open and accepted comments until November 13, 2015. The link for submitting comments is http://www.regulations.gov and docket # is: FDA-2015-N-2734.)


Date, Time and Location:

This 2-day workshop was 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.)

Webcast

10/13 - Main Session and 1st Breakout

10/13 - 2nd Breakout

10/14 - Main Session and 1st Breakout

10/14 - 2nd Breakout

Agenda

Day 1- October 13, 2015
Overview & Background, Expectations, and Design of PCLC Medical Devices

Day 1 - Morning - Plenary Session

Time Topic Speaker Affiliation
  Day 1 Plenary Questions    
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: The Promises and Pitfalls of Autonomous Systems Mary Cummings, Ph.D Director of Humans and Autonomy Laboratory Duke University
8:55 Q&A for Keynote Speaker
9:05 Advances in physiological autonomous control devices: unique challenges and lessons learned from artificial pancreas studies. Boris Kovatchev PhD Professor, University of Virginia School of Medicine.
Director, UVA Center for Diabetes Technology
9:25 Potential benefits/challenges Timothy Bentley Ph.D Deputy, Force Health Protection
Office of Naval Research
9:45 Potential benefits/challenges (Anesthesia and Hemodynamic stability) Robert Loeb M.D Associate Professor, 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 Clinician and Engineer Knowledge Gaps in Closed-loop 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 Lester Schultheis, M.D Ph.D Director, University of Maryland Regulatory Science and Innovation Initiative
11:15 Importance of  Standards  and standardization Julian Goldman, M.D Director, MD PnP program
MGH \ Harvard  University, Chair ISO TC 121
11:35 Panel Discussion  (Drs. Loeb, Schultheis, Goldman, Chatburn, Kovatchev, Cannesson, Bentley)
Moderator: Dr. Tejashri Purohit-Sheth/Dr. Leila Bahadori
12:15 Lunch

Day 1 - Afternoon

   Breakout Sessions: Design & Implementation Strategies/Considerations
  Engineering (Room 1) Speaker   Clinical (Room 2) Speaker
  Engineering Design Breakout Questions     Clinical Considerations Questions  
1:15 Modeling and Model-Based Control Design / Testing Jin-Oh Han, Ph.D
University of Maryland College Park
  The Complexities of the Patient-Machine Interface: Human Factors Challenges for Autonomous Medical Devices 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 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, University of Pennsylvania PCLCs design for ICU: Clinician Perspective Jeremy Pamplin, M.D 
US Army Institute of Surgical Research
2:00 Infusion Devices Design and Risk Assessment Considerations Alan Stevens, Infusion Pump Team Leader, FDA Human in the Loop Modeling for Anesthesia Delivery Jeff Mandel, M.D M.S University of Pennsylvania
2:15 Model-Based Design of Medical Devices David, Hoadley, Ph.D Principle Technical Consultant MathWorks Inc Clinical Expectations for Closed-Loop Control of inhalation anesthetics and oxygen James Philip M.D M.E Brigham and Women’s Hospital/Harvard Medical School
2:30 Model-Driven Safety Analysis of Closed-Loop Medical Cyber-Physical Systems Insup Lee, Ph.D University of Pennsylvania Big Data and System ID for PCLC modeling Joseph Frassica, M.D Philips Healthcare
2:45 Panel Discussion+ Q&A (Tina Morrison Ph.D+ Catherine Li M.S.)
Moderator: Sandy Weininger, Ph. D
  Panel Discussion+ Q&A (Linda Ricci)
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 - Plenary Session

Time Topic Speaker Affiliation
  Day 2 Plenary Questions    
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 Steven Shafer M.D Professor of Anesthesiology Stanford University
8:40 Regulatory challenges for PCLC critical care devices Lester Schultheis M.D  Ph.D Director University of Maryland Regulatory Science and Innovation Initiative
9:00 PK/PD models used for closed-loop drug delivery devices Joga Gobburu Ph.D Professor, University of Maryland School of Pharmacy
9:20

Panel Discussion (Drs. Shafer, Schultheis, Gobburu, and Bertram)
Moderator: Patricia Beaston M.D Ph.D   ODE\FDA

10:00

Break

Evaluation Studies Breakout Sessions

Day 2 - Morning Cont.

  Pre-clinical Session (Room 1) Speaker     Clinical Usability(Room 2) Speaker
  Pre-clinical Questions     Clinical Usability Questions  
10:15 Evaluation Closed-Loop Fluid Resuscitation Jose Salinas Ph.D U.S Army Institute of Surgical Research   Usability of PCLC: A Clinician Perspective Richard Branson, RRT, FAARC University of Cincinnati
10:30 Metabolic modeling, simulated populations, and in silico pre-clinical trials Boris Kovatchev Ph.D / University of Virginia   Considerations for use error analysis for PCLC systems. 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, Fort Hill Group Inc
11:00 Toward Robust and Safe Closed-Loop Control of Anesthesia Klaske van Heusden, Ph.D University of British Columbia   Human Factors Consideration for Devices Used in Emergency Care Colin Mackenzie, M.B Ch.B University of Maryland Medical School
Stability Robustness Evaluation for PCLC Mechanical Ventilation/Hardware In the Loop Testing Nicolas Chbat Ph.D Philips Healthcare

 

 

11:15

Panel Discussion+Q&A (Bahram Parvinian M.S)
Moderator: Christopher Scully Ph.D

 

Panel Discussion+Q&A (Hanniebey Wiyor Ph.D)
Moderator: CDR Nikhil Thakur

12:15

Lunch

Product Specific Break Out Sessions

Day 2 - Afternoon

  Anesthetic/fluid resuscitation (Room 1) Speaker     Mechanical ventilation (Room 2) Speaker
  Anesthesia and Hemo Stability - Session Moderation Slides
Discussion Questions
    Mechanical ventilation Panel Questions  
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 RPDB Branch Chief / Office of Device Evaluation FDA
1:30 Model-Based Fluid/Vasopressor 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 Inc   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+Q&A+( Bahram Parvinian M.S)
Moderator: Ryan McGowan

 

Panel Discussion+Q&A (Richard Branson+Leila Bahadori M.D)
Moderator: James Lee Ph.D

3:30

Break

3:45

4 Moderators to summarize discussions

4:15

Concluding Remarks (Bahram Parvinian M.S)

Registration to Attend the Workshop

Online registration is closed. On-site Registration will be available the morning of the workshop and for registration requests, please email Susan Monahan.

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: Bahram.Parvinian@fda.hhs.gov.

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: Allison.Kumar@fda.hhs.gov

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