Food and Drug Administration, HHS.
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: Mary.Brady@fda.hhs.gov (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. Start Printed 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: Ian.Chan@fda.hhs.gov (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.End Preamble Start Supplemental Information
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 Start Printed Page 20856FDA'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).Start Signature
Dated: April 16, 2010.
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-9287 Filed 4-20-10; 8:45 am]
BILLING CODE 4160-01-S