[Federal Register Volume 75, Number 76 (Wednesday, April 21, 2010)]
[Notices]
[Pages 20854-20856]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-9287]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0202]
Medical Device Use in the Home Environment: Implications for the
Safe and Effective Use of Medical Device Technology Migrating Into the
Home; Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
workshop entitled Medical Device Use in the Home Environment:
Implications for the Safe and Effective Use of Medical Device
Technology Migrating Into the Home. The purpose of the workshop is to
solicit information from healthcare providers, academics, human factors
experts, medical device manufacturers and distributors, professional
societies, patient advocacy groups, patients, and caregivers, on the
challenges surrounding medical device technology in the home
environment. FDA seeks input and comments on a number of identified
topics related to medical device home use.
Dates and Times: The public workshop will be held on May 24, 2010,
from 7:30 a.m. to 5 p.m. Persons interested in attending and/or
participating in the workshop must register by 5 p.m. on May 17, 2010.
Submit written or electronic comments by June 30, 2010.
Location: The public workshop will be held at the Hilton Hotel,
8727 Colesville Rd., Silver Spring, MD 20910. The hotel's front desk
telephone number is 301-589-5200.
Contact Person: Mary Brady, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 2320, Silver Spring, MD 20993-0002, e-mail:
[email protected] (preferable), 301-796-6089.
Registration and Requests for Oral Comments: If you wish to attend
the public meeting, you must register online at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select the
appropriate meeting from the list). Please provide complete contact
information for each attendee, including name, title, organization or
company, address, e-mail, and telephone number. Registrations must be
submitted by May 17, 2010.
If you wish to make an oral comment during general sessions of the
public workshop (see section III of this document), you must indicate
this in your registration. Please also identify which topics you wish
to address in your oral comment. Topics for discussion are listed in
section II of this document. FDA will do its best to accommodate all
persons who wish to make oral comments during the general sessions.
However, FDA strongly recommends that you provide written or electronic
comments as instructed in this document to ensure that your comments
are captured. Please refer to the section entitled Comments for
instructions on submitting written or electronic comments.
Registration is free and will be on a first-come, first-served
basis. Early registration is encouraged because seating is limited.
There will be no onsite registration.
[[Page 20855]]
If you need special accommodations due to a disability (such as
wheelchair access or a sign language interpreter), please notify Ian
Chan, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 3313, Silver
Spring, MD 20993-0002, e-mail: [email protected] (preferable); 301-
796-6658 at least 7 days before the public workshop (no later than May
17, 2010).
Comments: The goal of this public workshop is to gain a greater
understanding of medical device use in the home and to solicit feedback
from the public regarding how the Center for Devices and Radiological
Health (CDRH) should be reviewing and monitoring these devices. The
deadline for submitting comments related to this public workshop is
June 30, 2010.
Regardless of attendance at the public workshop, interested persons
may submit written or electronic comments on the topics listed in
section II of this document. If you wish to comment in writing on a
particular topic, please identify the topic that you are addressing
before providing your response to the question. For example, your
comment could take the following format:
``Topic 1--[Quote the topic].''
``Response--[Insert your response].''
You do not have to address every topic. For those topics pertaining
to the prevalence of a particular need, problem, or scientific
question, please provide data and/or references so that FDA can
understand the basis for your comment, figures, and any assumptions
that you used.
Written comments should be submitted to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Electronic comments should be submitted
to http://www.regulations.gov. Comments should be identified with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
SUPPLEMENTARY INFORMATION:
I. Background
Assuring the safety and safe use of medical devices in the home is
becoming an increasingly important public health issue. The aging of
the U.S. population and shifts toward shorter hospital stays continue
to make home healthcare more common. With these trends, a significant
number of medical devices, including infusion pumps, ventilators, and
wound care therapies, are now being used in the home.
Home healthcare can provide significant benefits to patients, in
terms of both quality of life and cost of care. However, because the
home environment is fundamentally different from the clinical
environment, home use of medical devices presents unique challenges,
many of which have the potential to impact patient safety. Home medical
care is often provided by lay caregivers, who may not have received
proper training in the operation of the medical devices on which their
loved ones rely. Moreover, many medical devices that are currently used
in the home were not designed for use by lay caregivers or outside of a
controlled clinical environment.
FDA's CDRH has announced its Medical Device Home Use Initiative, a
multi-pronged effort to support the safety and safe use of medical
devices in the home. The goal of the initiative is to support safe,
high-quality home healthcare and facilitate the development of medical
devices that are capable of meeting patients' needs in the home. This
public workshop is one of several steps CDRH is taking to provide
greater assurance of the safety and safe use of medical device
technology used in the home setting. Additional information on the
benefits and challenges associated with the use of devices in the home,
other actions FDA is taking as a part of its home use device
initiative, as well as an agency white paper is available at
www.fda.gov/homeusedevices.
II. Why Are We Holding This Public Workshop?
The purpose of the public workshop is to solicit expert input on
topics related to the safe and effective use of medical device
technology in the home environment. The workshop will highlight steps
that can be taken to assure that medical devices are safe and effective
when used by lay people in the home. The information gathered in the
workshop will help guide future efforts by FDA's CDRH to address the
growing use of medical devices in the home environment. Some of this
information may be incorporated a into guidance document or other
agency actions. Accordingly, FDA looks forward to participation and
written or electronic comments from manufacturers and distributors,
innovators, and organizations that either market or have in development
technologies that could be used in the home environment.
FDA will solicit feedback on:
1. The agency's current working definition of ``home use'' as a
medical device that: Is 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 healthcare provider in order to be used safely and
effectively;
2. The unique risks in the home environment that need to be
factored into device design;
3. The unique characteristics of end users in the home environment
that need to be factored into device design;
4. The challenges and limitations associated with tracking medical
devices in the home for purposes of safety notices and recalls, as well
as potential solutions to these challenges; and
5. What elements, from the user perspective, should be incorporated
into device labeling to help lay users understand and use a medical
device safely in the home.
FDA intends to discuss and expand on these topics during the
breakout group discussions at the workshop.
III. What Will Be the Format for the Workshop?
The workshop will begin with a general session. The presentations
during this session will provide topics for a set of breakout groups
that will meet in the afternoon. Each of the breakout group discussion
sessions will be led and moderated by an expert panel. Each breakout
session will begin with a presentation by an invited speaker,
describing the issues of concern in the specific topic area. This will
be followed by a moderated question and comment session, including both
pre-specified questions posed to the assembled group and any questions
that arise during the workshop discussions. 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. When the general
session reconvenes, each breakout group will report to the general
session the results of its discussion.
IV. Where Can I Find Out More About FDA's Medical Device Home Use
Initiative?
Information on the public workshop, registration information, the
agenda, lodging, and other relevant information will be posted, as it
becomes available, on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select the
appropriate meeting from the list). Background information regarding
[[Page 20856]]
FDA's Medical Device Home Use Initiative can be found at www.fda.gov/homeusedevices.
V. Additional Information
Following the meeting, a report of the workshop and the information
presented will be available on the meeting Web page which can be found
at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select the appropriate meeting from the list).
Dated: April 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-9287 Filed 4-20-10; 8:45 am]
BILLING CODE 4160-01-S