Medical Devices

Public Workshop – Hemostatic Medical Devices for Trauma Use, September 3-4, 2014

The Food and Drug Administration (FDA) announced a public Workshop entitled: “Hemostatic Medical Devices for Trauma Use”. The purpose of the workshop was to obtain information on the current challenges and opportunities related to Hemostatic Medical Devices for use in emergency situations. Workshop participants discussed factors that contribute to hemostatic medical device performance, reliability, and the types of studies that could potentially be used to evaluate appropriate bench testing, animal testing, bleeding severity, human factors, and clinical data collection for these products.

In advance of the workshop, CDRH invited interested stakeholders to submit protocols which describe procedures to evaluate issues (e.g., design, validation, conduct, and analysis) related to the adequacy of the above mentioned studies. Of particular interest are methods for assessing high-risk products used in non-compressible wound hemorrhage. These protocols were reviewed by CDRH in order to determine viable solutions and paradigms for assessing the safety and effectiveness of hemostatic devices based on scientifically supported expert stakeholder opinions. Results of the review were incorporated into the workshop for in-depth discussion and consensus, potentially leading to guidance from the Agency.


Date, Time and Location:

This meeting was held September 3-4, 2014, beginning at 8:00 a.m. (EDT) at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503A (Section A of the Great Room)
Silver Spring, MD, 20993

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Agenda

Wednesday, September 3, 2014

7:30am - 8:00amOnsite Registration

Day 1: Landscape and Challenges

8am - 8:10amWelcome Remark - Binita Ashar, MD (FDA)
8:10am - 8:30amKeynote Address - COL Todd Rasmussen

Session I - Landscape

Objective:  Gain an understanding of the regulatory pathways for hemostatic medical devices with indications for trauma use, and their current operational environments.

8:30am - 9:10amFDA Landscape and Regulatory Paths
Speakers: David Krause, PhD (Surgical Devices, CDRH) , Kenneth Cavanaugh, PhD (Cardiovascular Devices, CDRH), Nisha Jain, MD (CBER), Nicole Verdun, MD (CDER)
9:10am - 9:55amEnd User Perspectives of Currently Marketed Products
Speakers: LTC David King (Military Perspective), Rick Alcorta, MD (First Responder Perspective), John Holcomb, MD (Civilian Trauma Perspective)
9:55am - 10:10amPanel Discussion - Moderator: Howard Champion, MD
10:10am - 10:25amBreak

Session II - Unmet Trauma Care Needs

Objective:  Gain an understanding of the unmet needs in the military and civilian communities in terms of types of injuries, operational challenges, translational research, use of existing data, and clinical data collection hurdles.

10:25am - 11:10amMilitary Unmet Needs
Speakers: Tony Pusateri, PhD (MRMC), David Marcozzi, MD (USARMY), LTC David King (USARMY)
11:10am - 12:00pmCivilian Unmet Needs
Speakers: Tim Emhoff, MD (Surgery - Trauma), Rick Alcorta, MD (EMS), Tom Scalea, MD (Shock Trauma), Jason Sperry, MD (Prehospital studies)
12:00pm - 1:00pmLunch
1:00pm - 2:00pmHow can we get more data?
Speakers: Kevin Prohaska, MD (FDA), John Holcomb, MD (Civilian Trauma Studies), COL Todd Rasmussen (DoDTR), Ben Eloff, PhD (FDA and Data Registries)
2:00pm - 2:30pmPanel Discussion - Binita Ashar, MD (FDA)
2:30pm - 2:45pmBREAK

Session III - Assessing Safety and Effectiveness

Objective: Gain an understanding of the types of novel products being developing and their challenges with target patient populations, regulatory strategies and human factors consideration.

2:45pm - 3:45pmIndustry Perspectives
Speakers: Lance Hopman, MS (SAM Medical), David Spencer, BS (Pryor Medical), George Falus, PhD and Grant Bochicchio, MD (Biomedica), Upma Sharma, PhD (Arsenal),
3:45pm - 3:55pmHuman Factors Considerations - Ron Kaye, MA (FDA)
3:55pm - 4:20pmPanel Discussion – Moderator: Andrew Barofsky, JD (RevMedX)
Additional Panel Participants: T.S. Sudarshan, PhD (Materials Modification), Maynard Ramsey, MD PhD (CardioCommand), Allison Kumar, BS (FDA), David Krause, PhD (FDA), Rick Alcorta, MD (EMS), and Military Representative
4:20pm - 4:30pmDay 1 Recap, Set Stage for Day 2, Adjourn

Thursday, September 4, 2014

7:30am - 8:00amOnsite Registration
8:00am - 8:05amWelcome Remark - Binita Ashar, MD (FDA)
8:05am - 8:50amKeynote Address - Bijan Kheirabadi, PhD (USAISR)

Session IV - Challenges in Evaluation and Validation

Objective:  Gain an understanding of the advances in pre-clinical bench testing, the various translational animal models and other novel studies.

8:50am – 10:15amThinking Outside the Box: Pre-clinical Testing
Speakers:  LTC David King (USARMY), Maynard Ramsey, MD PhD (CardioCommand), T.S. Sudarshan, PhD (Materials Modification), Adam Rago, BS (Arsenal), Peter Kofinas, PhD (University of Maryland-Academia), Charles Durfor, PhD (FDA)
10:15am - 10:45amPanel Discussion - Moderator:  Joshua Crist, MSE (FDA)
Additional Panel Participants: Bijan Kheirabadi, PhD (USAISR), Adam Rago, BS (Biomedica), Keith Hoots, MD (NHLBI), Karen Manhart-Byrnes, VMD (FDA)
10:45am – 11:00amBREAK

Session V - Case Study: XSTAT's Regulatory Journey

11:00am - 11:35amAndrew Barofsky, JD (RevMedX), Military Representative, Joshua Crist, MSE (FDA) and FDA Representative discuss the regulatory pathway and challenges met along the way
11:35am - 11:45amQ&A
Additional Participant: David Krause, PhD (FDA)

Session VI - Interactive Solutions

11:45am - 12:30pmWorkshop participants will work in focus groups to collaboratively propose answers to key questions raised during the course of the workshop and suggest next steps and prioritization to FDA.
Moderator: Allison Kumar, Sr. Program Manager / Military Liaison (FDA)
12:30pmWorkshop Adjourns

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Webcast Archive

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Contact

For questions regarding workshop content please contact:

Maegen Colehour
Center for Devices and Radiological Health, Food and Drug Administration
10903 New Hampshire Ave., Bldg. 66 Rm. G423
Tel: 301-796-6970, Email: Maegen.Colehour@fda.hhs.gov

Or

Allison Kumar
Center for Devices and Radiological Health, Food and Drug Administration
0903 New Hampshire Ave., Bldg. 66
Tel: 301-796-6369, Email: Allison.Kumar@fda.hhs.gov

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Page Last Updated: 09/18/2014
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