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U.S. Department of Health and Human Services

Medical Devices

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Medical Device Use in the Home Environment Workshop: Implications for the Safe and Effective Use of Medical Device Technology Migrating Into the Home, May 24, 2010


Overview

Workshop Objective and Format:

The purpose of this workshop is to solicit information from primary and secondary health care providers, academia, human factors experts, industry, medical device distributors, manufacturers, professional societies, patient advocate groups and patients on the challenges surrounding medical device technology in the home environment.

The format for the meeting will include a general session in the morning. The presentations in this session will provide topics for the breakout groups centered around 1.) risks in the home environment 2.) end users in the home environment, and 3.) postmarket tracking of medical devices in the home that will meet in the afternoon. Each breakout session will begin with an invited presentation to describe the issues of concern in the specific specialty, which will be followed by a question and comment session. Breakout group participation will be limited by space and will be available on a first-come, first-served basis. At the conclusion of the day’s breakout group discussions, the general session will reconvene to report to the general session the results of the discussions related to the general topics discussed in each group.

This workshop was organized to discuss the following objectives:

Our current working definition of “home use” as a medical device intended for users in a non-clinical or transitory environment, is managed partly or wholly by the user, requires adequate labeling for use, and may require training by a licensed health care provider in order to be used safely and effectively

The unique risks in the home environment that need to be factored into device design

The unique characteristics of end users in the home environment that need to be factored into device design

The challenges, limitations, and solutions to tracking medical devices in the home for purposes of safety notices and recalls

What users want to see in labeling to help them understand and use their device safely in the home

Date, Time and Location

The meeting was held on May 24, 2010 (7:30 a.m. to 5:00 p.m.) at the following location:

Hilton in Silver Spring
8727 Colesville Road
Silver Spring, MD 20910

Agenda and Presentations

7:30 - 8:00am Registration and badges (Sandy Berman CDRH/OMO, Janette Collins-Mitchell CDRH/OC, Ian Chan CDRH/OSB, Jao LaCorte CDRH/OC, Joyce Raines CDRH/OCER)
8:00 - 8:20am Our Charge (Mary Brady CDRH/OSB)
8:20 - 8:30am Overview of CDRH Premarket and Postmarket Process (Mary Brooks CDRH/OSB)
8:30 - 9:00am Discussion of the HHC definition and feedback (Sonna Patel CDRH/ODE)
PRE MARKET Introduce Speakers (Janette Collins-Mitchell)
9:00 - 9:20am Human Factors and the Unique Characteristics of the User (Suzanne Mintz, National Family Caregivers Association)
9:20 - 9:40am Unique Characteristics of the Environment (Dave Osborn, Philips Healthcare)
9:40 - 10:00am Labeling and Training for Home Use - Focus on User Performance (Pat Patterson, Agilis Consulting)
10:00 - 10:20am Wireless Issues for Home Care Medical Devices (Don Witters, CDRH/OSEL)
10:20 - 10:45am Questions and Comments (Janette Collins-Mitchell)
10:45 - 11:00am BREAK
POST MARKET Introduce Speakers (Terri Garvin CDRH/OCER)
11:00 - 11:20am Surveillance of Marketed Products: Home Use (Susan Gardner, Director, CDRH/OSB) voluntary reporting, mandatory reporting, MedSun, postmarket studies, tracking, and Unique Device Identifiers
11:20 - 11:50am Questions and Comments (Terri Garvin)
11:50 - 12:00 PM Plan for the afternoon (Terri Garvin)
12:00 - 12:50 PM Lunch (on your own)
12:50 - 1:00 PM Breakout Session Locations (Sandy Berman)
1:00 - 2:15 PM Concurrent breakout sessions to address:
  • human factors and the user (Facilitator: Lisa Winstel NFCA, Scribe: Jao LaCorte
  • the environment (Facilitator: Dave Osborn Phillips Medical, Scribe: Sandy Berman)
  • patient labeling (Facilitator: Pat Patterson Agilis Consulting, Scribe: Sonna Patel)
  • wireless (Facilitator: Don Witters, Scribe: Terri Garvin)
  • postmarket (Facilitator: Susan Gardner, Scribe: Janette Collins-Mitchell)
2:15 - 2:30 PM BREAK
2:30 - 3:30 PM Reconvene with reports by the breakout groups (Mary Brooks)
3:30 - 3:45 PM Any additional questions and comments (Mary Brady)
3:45 - 4:15 PM FDA summary, action items, future work
4:15 - 4:30 PM Questions/wrap up

Attendee List

Name Affiliation Organization
Mr. Pradip Akolkar FDA FDA
Mr. Adil Alaoui Academia Georgetown
Mr. Prabhu Ambatipudi Industry SJM
Ms. Cynthia Andersen Industry SP Corp
Mr. Eric Assaraf Other WRGDC
Ms. Cara Bachenheimer Industry Invacare
Ms. Luann Battersby Other Averture
Mr. James Beck Industry MS Distributors
Mr. Anatoly Belkin Industry Hospira
Ms. Alexandra Bennewith Industry AA Homecare
Ms. Sandy Berman FDA FDA
Ms. Beth Bierman Other Morgan Lewis
Ms. Karen Sjaarda Bland Industry Baxter
Carolyn Bloch Other Cbloch
Mr. Mike Blomquist Industry Smiths Medical
Mr. Paul Blowers Industry Medtronic
Mrs. Terri Bonadio Industry FMC NA
Nicole Boramanand Non-Profit GMWHI
Ms. Mary Brooks FDA FDA
Mr. Thomas Brown Medical Jefferson Hospital
Mr. Gert Bruning Industry Philips
Mr. Jay Burkholder Industry Deka Research
Mr. Jason Bush Industry Roche
Mr. James Callaghan FDA FDA
Elizabeth Callaghan FDA FDA
Mr. William Carroll Industry Meagan Medical
Mr. William Carroll Industry RS Medical
Mr. Ian Chan FDA FDA
Mr. James Chapman Industry Smiths Medical
Ms. Lori Chow Industry SJM
Mrs. Patricia Christian Industry CR Bard
Mr. Anthony Ciccarello Industry Philips
Mr. David Collins Industry Deka Research
Janette Collins-Mitchell FDA FDA
Mr. Richard Conroy Government NIH
Mr. Dennis Cook Other Ohio Medical
Richard Courtney Industry JNJ
Ms. Desiree Crisolo Industry Gene
Mr. David Cumin Industry FPH Care
Mr. David D'Cruz Industry Resmed
Mr. Siddharth Desai Industry IFLO
Ms. Meredith DeZutter Industry XI Medical
Mr. Robert Di Tullio Industry Invmed
Ms. Loretta Dorn (RN) Industry Baxter
Mr. David Eilers Other Blue Highway
Ms. Ruth Ann Ellison Industry Apria
Ms. Tara Federici Industry Advamed
Ms. Mary Lou Fleming Industry Achc
Mr. Michael Flessner Academia UMC
Beverly Gallauresi FDA FDA
Ms. Terri Garvin FDA FDA
Mr. Laurent Giovangrandi Industry Physiowave
Mrs. Melissa Gonzales Industry Medela
Mr. Erin Grossi Non-Profit US UL
Mr. Ramji Gupta Industry Moog
Mrs. Arava Hacohen Medical Medingo
Ms. Judith Harbour Industry ITINPWT
Mr. Charles Ho FDA FDA
Mrs. Hilary Hoffman FDA FDA
Mrs. Shannon Hoste Industry Intel
Mr. Thierry Houdayer Non-Profit Kennedy Kreiger
Mr. David Hruda Industry Water Mark Medical
Mrs. Campbell Hutton Non-Profit JDRF
Mrs. Shirley Hyink Industry Moog
Mr. Richard Isenberg Industry Regenesis Bio
Mr. Amir Jafri Non-Profit GMWHI
Ms. Dianna Johannson Industry Medtronic
Mr. Gary Johnson Industry unknown
Mr. Jeremy Jones Industry Atmosmed
Mr. Dulip Kaluarachchi Industry SJM
Mr. Peri Kasthuri Industry unknown
Mr. Ryan Kaufman Industry unknown
Mrs. Masako Kaufman Other unknown
Mr. Janet Kay Industry FMC NA
Josephine Kelly Medical Walgreens
Mr. Moazzam Khan Industry Abbott
Mr. Satoshi Konishi Industry Namiki
Mr. Lester "Jao" Lacorte FDA FDA
Ms. Yvonne Leonard Industry Nonin
Mr. Mitchell Levinson Industry Zeltiq
Mrs. Maureen Lyden-Green Industry FMA NA
Janet Mas Industry Merck Research Labs
Mr. Luis Maseda Industry NP Medical
Ms. Nancy Mathewson Industry OFWLAW
Mr. Robert Mazzaferro Industry unknown
Ms. Michele McDonald Industry Abbott
Mr. Rod Mell Industry Baxter
Ms. Laurie Mendelson FDA FDA
Mr. Claude Miller Industry FMA NA
Mr. James Milostan Industry MS Distributors
Ms. Suzanne Mintz Non-Profit The Family Caregiver
Ms. Krys Modrzejewski Industry EMD Serono
Mr. Aaron Moskowitz Non-Profit Bref Net
Mr. Joseph Murnane Non-Profit US UL
Ms. marcia nusgart Industry Nusgart Consulting
Mr. David Osborn Industry Philips
Mr. Daniel G. Papadopoulos Industry CC Policy Group
Mr. Brodie Pedersen Industry Nonin
Mr. Bill Phillips Industry Neo Sync
Mr. David Platt Industry Ohio Medical
Mr. Ernest Posey Medical Posey
Joseph Purpura Industry Baxter
Ms. Kristine Joy Quinones Industry Philips
Ms. Joyce Raines FDA FDA
Ms. Melinda Ramsey Industry unknown
Mr. Jeffrey Ravel Industry West Pharma
Ms. Deborah Reuter Non-Profit AAMI
Mrs. Mary Lacey Reuther Other BGRDC
Ms. Laura Reynolds Industry Smith Nephew
Mr. Mason Robbins Industry Smith Nephew
Karen Roberts Industry Roche
Mary Rodgers Government NIH
Ms. Dana Rodriguez Industry NMITKB
Ms. Susan Rolih Industry Meridian Bioscience
Ms. Lori Roth Industry Nonin
Mrs. Lisa Runci Industry Philips
Mr. Charles Ryan Industry Convatec
Ms. Patt Ryder Industry FMC NA
Mr. Robert Samec Industry Care Fusion
Mr. Les Schnoll Industry Posey
Mrs. Lisa Skeens Industry Baxter
Ms. Agata Smieja Industry GE
Ms. Amy Smith Industry JNJ
Mr. Karen St. Onge Industry NX Stage
Ms. Lauren Starck Non-Profit US UL
Molly Story Other Nas
Mr. Kevin Tanis Industry Smith Nephew
Mr. Marc Taub Industry Abbott
Mr. Kokeb Tefera Industry IFLO
Mr. Deborah Thomas Industry West Pharma
Ms. Beth Thompson Industry Medline
Mr. Joan Todd FDA FDA
Mr. David Tumey Industry ITINPWT
Mrs. Rhoda Valera Industry Hospira
Ms. Roxanne Venard Industry Care Fusion
Mr. Philip Vierling Industry Kalyto Medical
Mr. Henry Vierling Consumer Hughes
Mr. Howard Wactlar Academia CMU
Mr. Sandy Weininger FDA FDA
Mr. Nathaniel Weixel Other BNA
Mr. Jim Welsh Industry Covidien
Mr. Stephen Wilcox Industry Dscience
Lisa Winstel Non-Profit The Family Caregiver
Mr. Don Witters FDA FDA
Mr. Brian Young Industry KCI
Mr. Jianchao Zeng FDA FDA
Mrs. Jacqueline Zimovan Industry JNJ
Mrs. Elizabeth Zola Industry Abbott
Mr. Paul Smedberg Industry American Society of Nephrology

Transcripts and Notes

Contact Us

The workshop organizer may be contacted at:

Ian Chan
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue WO-66-3313
Silver Spring, MD 20993
Email: ian.chan@fda.hhs.gov (preferable)
Phone: 301-796-6658