[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]


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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.

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    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.

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    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

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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