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September 12-13, 2002 Public Meeting on Home Health Care and Medical Devices: Opening Remarks

Welcoming Remarks to the Public Conference on
Medical Devices Use in the Home Health Care Community

Joseph S. Arcarese, Facilitator

Welcome to this two day public meeting on Home Health Care and Medical Devices, sponsored by the Food and Drug Administration’s Center for Devices and Radiological Health. Thank you for making the effort to attend this meeting; I hope you will find your attendance worthwhile for what you will learn and for what you can contribute.

My name is Joe Arcarese, and I will be the moderator for these two days of discussion on this important subject. I am representing the Food and Drug Law Institute, a non-profit, non-partisan educational organization.

As you all know well, the use of sophisticated medical devices in the home as greatly increased over the past few decades. As health care delivery has become more sophisticated, it has become considerably more expensive especially since the 1970’s. Changes in health care economics, as well as demographic changes, have stimulated a significant evolution of the “hospital” model, with more and more patients being cared for at home or at other non-clinical places for their convalescence, after the patient’s acute medical status has been stabilized. And inevitably, their care has been performed or maintained more and more by patients’ parents, spouses, or other non-clinical personnel. As patients have been moved to the home and other non-medical facilities for their recuperation or long term care, the medical devices needed for their care have followed them. But many such medical devices were given FDA approval for marketing under the expectation that they would be used by trained health care practitioners in controlled health care delivery facilities. Thus sophisticated medical devices are being used under conditions that neither their manufacturers nor the regulatory system had necessarily contemplated or intended. This in turn has had consequences for the safe and effective operation of these medical devices, especially those with sophisticated requirements for proper operation, maintenance, calibration, electrical power, etc.

The focus of this meeting is on the programs, actions, and positions of government agencies that have responsibilities that relate directly or indirectly to the delivery of health care and the use of medical devices in the home or other non-controlled environments. This meeting is an outgrowth of two smaller meetings held at the Food and Drug Law Institute 3 months ago on June 6-7, where a small number of invited participants from government, manufacturers, health care and patient advocacy organizations, and academia were convened to discuss their concerns regarding the use of medical devices in the home environment. They made many important points, especially emphasizing the need for human factors design of devices and their instructional materials, so that they can be effectively and safely used by non-clinical personnel, and that the health care reimbursement system needs to provide adequate incentives for the evaluation of the adequacy of the home environment and of lay caregivers for long term care of patients in the home. They also urged that government agencies need to collaborate in order to share information and develop a coordinated strategy to improve the safety and effectiveness of the use of medical devices in the home. This meeting is an initial response to that sentiment. We are very aware that what government agencies do and do not do directly impacts manufacturers, distributors, home health care agencies, health professionals, lay caregivers, and patients, and we fully expect that those points will be elucidated here. By the way, the report of those June meetings is available on the CDRH web site and there are a few copies at the registration table.

Before we begin the business of this meeting, I want to make a few observations.

First, regarding logistics, the bathrooms are located on either side of the foyer to this conference room. We will be having coffee breaks in the morning and afternoon, each day, and there is a cafeteria in this building for lunch.

Second, I have an important request to make of you. We are pleased to have representatives of several manufacturers of medical devices here, and we are very anxious to have your participation. However, as a government sponsored meeting, this is not a forum to advertise individual products or services. I ask manufacturers to avoid any solicitation of individual products or services, and I will use my prerogatives as the meeting moderator to limit the participation of anyone who does not abide by this request. I sincerely thank you in advance for your cooperation in this respect.

Third, the two days of this meeting will be formatted in the following way: we will have several sessions, each featuring a guest speaker making a brief presentation, followed by a panel discussion, and then audience participation. During that time, you will have the opportunity to ask questions and make comments. To facilitate your participation, we have microphones located in each aisle, and when the time comes, I’ll invite you to move to one of the mikes. Or if you prefer, you can write your questions on small question cards that the staff will distribute and collect. We will also have one roving microphone for use by anyone who has difficulty moving about in the aisle.

Fourth, I will be summarizing this meeting in a written report with the help of notes being taken by staff, and that report once completed will be made available on the CDRH web site. Meanwhile, if you have additional questions or comments to make after this meeting, you are invited to use the following e-mail address: cdrhhhc@cdrh.fda.gov.

Finally, I have the honor to introduce to you the panelists on stage, who represent a number of agencies. I apologize for not having the time to read you their distinguished bios, but they are available as a handout. In alphabetical order, our panelists are:

• Arthur Ciarkowski, member of the Home Health Care Committee, Center for Devices and Radiological Health.
• Gilbert Devey, Program Director, Biomedical Engineering, National Science Foundation.
• Robert J. Floro, Associate Director, Home Care Accreditation Service, Joint Commission for Accreditation of Healthcare Organizations
• Margaret Giannini, Director, Office on Disability, Department of Health and Human Services
• Kerm Henriksen, Center for Quality Improvement and Patient Safety, Agency for Healthcare Research and Quality
• Robert Jaeger, Interagency and International Affairs, National Institute on Disability and Rehabilitation Research
• Michael Keane, Health Insurance Specialist, Centers for Medicare and Medicaid Services
• Bob Ochsman, Director, Human Factors Division, U.S. Consumer Product Safety Commission
• Dena Puskin, Director, Office for the Advancement of Telehealth & Chair of the Joint Working Group on Telehealth, Health Resources and Services Administration
• Janine Purcelle, Cognitive Engineer, Veterans Administration’s National Center for Patient Safety
• Robin Remsburg, Chief, Long-term Care Statistics Branch, Division of Health Care Statistics, National Center for Health Statistics
• Judy Sangl, Center for Quality Improvement and Patient Safety, Agency for Health Research and Quality
• Kathleen Walch, Nurse Consultant, Centers for Medicare and Medicaid Services

I want to express our sincere appreciation to all these panelists and our speakers for their time and effort to help us make this meeting a success. And thanks are also due:

• to Dr. Ellen Feigal at NCI for being the NIH sponsor for our meeting;
• to Dr. David Feigal, Director of CDRH, for his support of the home care committee initiatives;
• to Mr. Phil Frappaolo at CDRH for being the Center champion for the committee;
• and to the CDRH Home Care Committee, and to Shirley Meeks, and Frances Benedict for their hard work to make this meeting a reality.

And now, without further delay, it is my pleasure to introduce our keynote speaker. He is David Feigal, Director, FDA’s Center for Devices and Radiological Health.

Updated 9/19/2002

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