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(See Related Information)Medical Devices in the Home Healthcare Community

Report of a Public Conference Held September 12-13, 2002 at the Natcher Auditorium, National Institutes of Health

by Joseph S. Arcarese1
Conference Facilitator

Report Date: November 1, 2002

On Thursday and Friday, September 12-13, 2002, an open public conference was held in the Natcher Auditorium on the campus of the National Institutes of Health, under the aegis of the Center for Devices and Radiological Health (CDRH), which is the Food and Drug Administration’s component responsible for assuring the safety and effectiveness of medical devices. Previously announced in the Federal Register, the conference was convened for the purpose of discussing the programs, policies, and plans of several government agencies regarding the issue of the safety and effectiveness of medical devices used in the home environment, and for soliciting the comments and opinions of members of the public who attended. This report summarizes the results of that conference.

I. Background
CDRH constituted a Health Care Committee, as a part of CDRH’s strategic planning process, to understand the impediments to the safe and effective operation of medical devices used in the home environment and to recommend appropriate Center actions within its legislative mandates and public health responsibility. The committee also wanted to see how the home environment influenced the use, functioning, and safety of devices that were not necessarily intended for use outside of clinical facilities by trained health care practitioners.

As part of its study of how the safety and effectiveness of medical devices used in the home environment can be improved, CDRH asked the Food and Drug Law Institute (FDLI) to convene two meetings earlier this year. On June 6 and 7, two meetings were held by the FDLI at the request of CDRH, involving invited participants from government, academia, manufacturers, health care and patient advocacy organizations, in order to discuss the issue2. The report of those two meetings (“Report on Home Use Medical Device Meetings”) is available on the CDRH web site at: http://www.fda.gov/cdrh/cdrhhhc/. The participants at those two meetings made many important points, especially emphasizing: (1) medical devices and their associated instructional materials need to be designed according to human factors principles, which would greatly improve the likelihood that they can be used effectively and safely not only by non-clinical personnel but also by clinical personnel as well; 2), 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; and (3), 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.

II. Development of the Conference
The September 12-13 conference was convened as an initial response to the strong sentiment expressed at these meetings that the relevant government agencies need to be communicating and collaborating on the home use issue. CDRH planners readily acknowledged that what government agencies do and do not do directly impacts manufacturers, distributors, home health care agencies, health professionals, lay caregivers, and patients, and they intended that those points would be elucidated more fully in a conference in which the policies and programs of relevant government agencies would be highlighted.

Based upon the outcome of the June 6 and 7 meetings, the CDRH Home Care Committee decided to convene an open public conference featuring representatives of government agencies and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) to discuss their programs and policies regarding home care. After making preparations to hold the conference at the Natcher Auditorium on the campus of the National Institutes of Health, CDRH published information and an invitation for the public to attend on its website3 (see Attachment I) and an announcement in the Federal Register4. Informal invitations were also sent by e-mail and phone to help spread the word about the conference. The Committee contacted a number of Federal agencies about the conference, and many of those agencies agreed to participate as speakers and/or as members of an on-stage panel of experts.

The Conference was organized to consist of a series of formal presentations, each followed by a discussion by the panel and by questions and comments from the audience. The agenda for the meeting, listing sessions and speakers, is attached (see Attachment II). Also attached is a complete list of all the panelists and speakers with their contact information (see Attachment III). During the conference, notes were taken by several CDRH staff attending in attendance, and the following summary was prepared based upon those notes.

III. Summary of Conference

Note: Most of the speakers presented projected slides, and the texts of their slides are available for viewing at the CDRH web site http://www.fda.gov/cdrh/cdrhhhc/. This report, however, will not summarize individual presentations, but will highlight major points.

The use of sophisticated medical devices in the home environment has evolved as significant changes in medical care delivery have occurred over the past few decades. Prior to World War II, medical care was primarily a home affair, with doctors and nurses visiting the patient in the home, and hospital-based care reserved primarily for the severely ill. However, after World War II, as medical diagnosis and therapy became more sophisticated and intensive, of necessity it was delivered primarily in medical care facilities, such as hospitals, medical offices, and clinics. However, as health care delivery has become more sophisticated, it has also 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 sites 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.

The use of medical devices is an intrinsic part of the delivery of diagnostic and therapeutic medical care. In addition to being used in controlled clinical care environments, such as hospitals, clinics, and the offices of doctors, dentists, and other health care practitioners, medical devices are also widely used in the home, in the workplace, and indeed, in every place where people go. Not only are there a wide variety of medical devices available over the counter, there are increasing numbers available for use by lay people under prescription from health care practitioners. Thus millions of people in the United States now use devices of a bewildering variety. Millions go about their lives with implanted medical devices, including dental implants, orthopedic implants such as hips and knees, cardiovascular stents, electronic pacemakers, cochlear implants, etc. Many people with impaired mobility use mobility aids, including crutches, braces, walkers, wheelchairs, scooters, etc., and many people use a variety of sensory and cognitive aids. Many people convalescing at home use hospital beds, intravenous fluid delivery devices, inhalation therapy devices, etc. And many people use diagnostic kits and electronic devices, such as pregnancy test kits, occult blood detection kits, glucose monitoring devices, etc.

But many medical devices currently being used by lay people under prescription were originally given CDRH 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 benefits of all these kinds of devices to improve diagnosis and treatment of ailments or conditions in the home environment are impressive and necessary to our evolving health care system, but their use comes with a disadvantage--the risk that the diagnostic information may be inaccurate or misinterpreted, or that the therapeutic treatment may be faulty in a number of ways.

Through a variety of information-gathering mechanisms, FDA is aware that deaths and serious injuries are sometimes associated with the use of medical devices, and there are device malfunctions that can and do occur which could lead to death and serious injury if they recur. Despite efforts by manufacturers and FDA to mitigate these problems whenever possible, the risk of unintended side effects from the use of medical devices is an ever-present reality. These sorts of problems occur even with the use of medical devices by trained health practitioners in controlled health care delivery environments, but FDA believes that the use of sophisticated medical devices in the home environment adds an additional level of risk of unintended adverse events. This is not to imply that the use of these devices should be prohibited in the home environment, in order to reduce this additional risk; indeed such a strategy would be practically impossible given the way that health care has evolved. But it is FDA’s intention to seek ways of improving the safety and effectiveness of these devices used by patients and lay caregivers.

The safe and effective use of medical devices by lay persons is a multi-faceted issue, involving the design and manufacture of devices; the design and implementation of training users; systems for prescription of suitable devices and for their delivery and setup; the patient’s medical condition; the evaluation of patients and lay caregivers for their capability to use the devices properly; the evaluation of the environment in which the devices will be used; systems for maintenance, calibration, repair, and waste disposal; communication between patient/lay caregivers and health professionals; systems for responding to and handling emergencies; and financial considerations. The conference, “Medical Devices in the Home Healthcare Community,” September 12-13, 2002, Natcher Auditorium, National Institutes of Health, was convened by FDA’s CDRH to explore the involvement in this particular set of issues of several Federal agencies and the JCAHO having various responsibilities in health care. Representatives of these organizations were invited to speak and/or to sit on a panel to discuss the issues presented. The following are issues discussed at the conference.

Scope of the Problem
No one organization is monitoring or tracking the use of many medical devices in the home that were not designed for such use, and that do not have the necessary support system, e.g., installation and set up, training, monitoring, assistance. Nor has any organization obtained a good understanding of the problems occurring with these devices prior to the occurrence of serious adverse events. FDA’s CDRH, for example, implements a regulation requiring manufacturers to report deaths, serious injuries, or serious malfunctions in medical devices, but manufacturers can only know about what is reported to them, and the home user is a notoriously poor reporter. And even when these adverse events are reported, the manufacturer has limited ability to recover faulty devices from the home for analysis, and finds it difficult to ascertain the circumstances surrounding alleged failure from untrained individuals. Regardless what might happen in the home, since the devices are often approved only for use in controlled clinical environments, the manufacturer may disavow responsibility for the home situation. Furthermore, there is no present way of tracking the use of equipment in the home that was not prescribed by health care practitioners and installed by responsible and appropriate third parties, so that outdated or poorly performing or malfunctioning equipment may migrate to the home from somewhere else without any knowledgeable authorities knowing it. Finally, some consumer products (i.e., non-medical) are being used for medical applications (e.g., personal digital assistants used for cognitive assistance). Consequently, the magnitude and scope of the problem of home use equipment remains vague and unclear, with responsible agencies having to rely largely on anecdotal information.

Device Design
One important facet of any device is the interface between equipment and human user. When a device works according to its design, but is applied or controlled improperly by a human user, any adverse outcomes are often referred to as “user error.” This term is inherently misleading. The implication of the term is that the fault for errors lies solely with the user when the device performs predictably according to its design and intended purpose. In fact, many avoidable errors occur because of inadequate or even faulty design that does not accommodate for known human limitations. Many occasions of misuse can be avoided by careful design of the device/user interface. There is growing appreciation of the importance of human factors design principles in the development of equipment that can be used with less risk of error. Broader application of human factors principles in the design of devices is needed to improve the interface between the device, the person, and the environment.

Manufacturers need to be educated and encouraged to consult experts in principles of good device design at an early stage in the product development cycle. The National Center for Patient Safety of the Department of Veterans Affairs has an initiative to actively mentor the manufacturer in developing products. Furthermore, it was emphasized that the use of human factors principles is compatible with the design control requirements in FDA’s Quality Systems Regulation for medical devices.

Furthermore, devices intended for use in the home (i.e., outside of controlled clinical environments) need to be designed with an appreciation that not all that goes on in the home is “medical” in nature. For example, pets and little children running around the house and knocking into devices or pulling cords can have an adverse impact on some devices. Thus there needs to be a greater appreciation for the realities of the environment.

Manufacturers need to be encouraged to understand and take into account the environment in which the devices will be used. One approach involves so-called smart homes. Georgia Tech has sponsored the Aware Home Research Initiative (AHRI)5, is an interdisciplinary research endeavor at Georgia Tech aimed at addressing the fundamental technical, design, and social challenges presented by the following questions: Is it possible to create a home environment that is aware of its occupants whereabouts and activities? If we build such a home, how can it provide services to its residents that enhance their quality of life or help them to maintain independence as they age?

A related concern is the location where the devices are intended to be used. We should not restrict our outlook literally to the home, since there are other places besides a person’s home where so-called “home use” devices may be used routinely, such as the workplace, the school, the automobile, and indeed any locale which is part of normal daily life. The Americans with Disabilities Act recognizes that there should be “reasonable accommodation in the workplace.” Ideas for improving the safety and effectiveness of medical devices used outside of controlled medical environments ought to consider their use in all the locales where the users of these devices normally may go.

There are guidelines available regarding the design of specific device categories. For example, the National Institute on Disability and Rehabilitation Research has information available on the design of products for disabled people. It is important for the manufacturer to meet with patients, lay caregivers, and consumers when designing a device in order to ascertain all the facets and nuances in the needs of these users for achieving a particular medical purpose and for operating the device safely and effectively in the real environment in which the device will be used.

Device Risk Assessment
There is a considerable range in types of medical devices according to the level of risk that they present, especially for patients and lay caregivers. Obviously, the degree of concern for safety and effectiveness depends in large measure on the level of risk that particular devices present, and there is a need for a realistic and sensible approach to rating and categorizing these risks. Much work has been done in developing hazard and risk assessment models, and this work may help facilitate the development of appropriate guidelines and/or requirements. Speakers suggested that a type of stratified approach to risk may be most appropriate for this purpose. In this regard, the Department of Veterans Affairs has developed a comprehensive risk assessment tool (Healthcare FMEA) for determining the severity and probability of each potential cause of risk.

Certification of Home Care Products
Many medical devices, especially FDA Class II and III devices, have not been specifically evaluated for the suitability of their use outside of regulated clinical care environments. The suggestion was made that a process of certifying the suitability of devices for home use would facilitate the effort to improve the safety and effectiveness of patient and lay caregiver use of these devices, and many participants supported the suggestion. Home users or device prescribers could deliberately choose particular models and types of devices certified for home use (this potential benefit would require the availability of some kind of “Consumer Reports” type of database, so that competing products could be evaluated, and manufacturers’ claims could be compared). There are many factors that determine the amount of control necessary to ensure safe use of a product in the home. A “one size fits all” approach to the problems is neither possible nor even desirable. Various groups have developed risk models which might be a starting point.

This suggestion immediately calls to mind several key issues among others:

Training and Competency Assessment of Users
Although many medical devices, especially those available over-the-counter, can be used easily and intuitively by many people with little or no difficulty, some devices used in the home are complex and sophisticated, and their proper operation depends on the competency and capabilities of the home user. The needs, capabilities, and competency of the home user and the suitability of the home environment should be assessed with regards the use of more sophisticated devices, such as respiratory therapy and intravenous infusion devices. This is especially true for those devices that require higher levels of cognition, memory, and decision-making and/or physical tasks for their proper operation.

The competency of user should be assessed with regards the unique characteristics of a particular device, with appreciation of the fact that not all users can do all things. For example, not all individuals can operate computers or complicated electronic devices, or can adequately see or hear in order to respond to equipment signals. But not all devices require specialized or sophisticated capabilities on the part of the user, in order for satisfactory results to be achieved. Thus, there needs to be a reasonable relationship between the benefits of projecting the necessity of high levels of user competency for a particular device and the costs and disadvantages of doing so; of course, this raises difficult questions about what is good enough. Many factors need to be considered in the determination. Appropriate outcome studies are needed, but there needs to be agreement by all the stakeholders on what are good indicators to measure.

Among the questions that need to be answered in order to develop a good system for assessing user competency and capabilities are the following:

It is difficult to write a one size fits all recommendation for training, since users are different and devices are different, and understanding the particular characteristics of the home environment is critical to assessing the needs of individual users.

Accreditation of Home Healthcare Providers
JCAHO accredits over 17,000 healthcare organizations, including writing applicable standards and evaluating adherence to them. The accreditation is voluntary, and the organization seeking accreditation pays for this service. Currently over 4,300 home care agencies are accredited, but this is only 25% of home care providers. JCAHO is currently collecting outcomes data to demonstrate the effects of having or not having accreditation. Allegedly, some organizations are doing quality work without accreditation, but without some other standardized system of evaluating their work, there really is no way to evaluate such organizations unless they seek accreditation. Some have asked if it might be possible for providers to self-certify, but this raises the same question of how would the compliance of such an organization be evaluated and verified.

Costs and resources for accreditation by home healthcare providers are important deterrents to organizations getting accredited. The costs for an accreditation for three years are dependent on size, i.e., the number of patients being cared for by the facility:

JCAHO does not offer limited accreditation, so that an agency seeking accreditation will be evaluated on the basis of all applicable standards. Thus an agency cannot get accredited for just a particular set of devices. The accreditation process involves on-site visits at least once every three years, and JCAHO may put a facility on probation or remove an accreditation for violation of pertinent standards.

In addition to the disincentive of cost, there are few incentives for suppliers to seek accreditation by JCAHO, since accreditation is not made mandatory by the Centers for Medicare and Medicaid Services (CMS) or by third party payers. JCAHO currently does not have agreements with states to supplant state licensing. Additionally, organizations that contract with providers do not all require accreditation.

Telemedicine
Telemedicine offers intriguing new ways of linking home care patients and their professional caregivers in cost effective ways. Various technologies, from simple telephone communications to Internet-based approaches, offer ways that patients can be monitored at a distance, all at considerable savings of professional time and expense. Many of these approaches do not require very specialized or expensive equipment in order to be effective.

The Office for the Advancement of Telehealth in the Health Resources and Services Administration (HRSA) and the Veterans Administration currently fund research projects to demonstrate and evaluate new techniques for linking patients and health professionals using communications technologies. HRSA staff discussed a program they sponsor at the University of Tennessee where a telemedicine program connects cardiac patients with health professionals by means of computers and the Internet. The program demonstrated a significant reduction in healthcare cost in terms of reduction of hospitalizations. The study investigators have estimated that if this technique were used across the United States with all such patients, the savings in health care maintenance of these patients could be as much as $4 billion a year. The Veteran’s Administration’s Homebase Primary Care Program has also done a study to demonstrate the positive outcomes and savings from keeping ailing veterans out of the hospital and at home by means of remote monitoring. Hospital admissions, length of stay in the hospital, and clinic visits were reduced. A member of the audience discussed the success of a telemedicine program at Georgetown University with diabetic patients in improving their care and reducing their overall health care costs. These studies demonstrate that telemedicine could be very important, especially so for patients in rural areas or those at great distances from major medical centers, where they have great difficulty in obtaining routine health care monitoring under any other circumstances.

Unfortunately, telemedicine devices are not reimbursed by CMS, and this serves as a disincentive for manufacturers to investigate and produce new products.

In addition to providing direct communication via remote hookup between patients and healthcare providers, another remote communication tool was mentioned. Monitors on equipment could be programmed to contact service providers and alert them to service needs, equipment performance characteristics, and even inform them if patients are using the equipment as prescribed. In addition to remote communications between equipment and provider, it was pointed out that microprocessor monitors on medical devices could be used to detect certain malfunctions, and either fix them automatically, guide the consumer to fix the problem, or instruct the user to discontinue use.

Speakers offered three suggestions regarding the future development of telemedicine equipment and services:

It was noted that patients are influenced indirectly by the Hawthorne effect, i.e., when they know someone is monitoring, their behavior improves. For example, quality of life and improved care were demonstrated when patients needed to appear in front of a TV camera to communicate with their health care provider. The patients typically got up out of bed, got cleaned up, and got dressed, so that the act of communicating itself actually provided them with a strong psychological incentive to lead a more normal life. Caregivers could also see when their patients didn’t look quite right, even when a patient was reluctant or unable to articulate a sense of being unwell.

Despite these positive outcomes, telemedicine is not a universal panacea; although telemedicine makes some patients feel empowered, others feel intimidated by homecare technologies and require the kind of hands-on care provided by caregivers in direct physical contact. Nevertheless, telemedicine offers intriguing new ways of delivering communication, a sense of caring, and effective diagnostic and therapeutic care to patients who are at considerable distances from their healthcare providers.

Coordination of Responsibilities Among Government Agencies
It is apparent that there are resources available, including expertise and funding, among several involved Federal agencies which, if coordinated properly, could address many or all of the issues of concern about the use of home care devices. But this raises the question how can they be best coordinated. No single agency is presently addressing all the issues because none has the responsibility, ability, or authority to develop a totally comprehensive program. A broader approach involving multiple agencies is needed to search out and fill the loopholes. In addition to Federal agencies, there is also the question of whether and how can state and local governments be involved in addressing the problems. And of course, beyond governments, it is apparent that all stakeholders must play a part, including manufacturers and home health agencies, in order to address all aspects of the problems. Speakers suggested that all the problems and issues involved with home care medical devices, and indeed many problems in the world of health care, cannot be solved by one government agency, and that there needs to be a coalition of involved agencies to deal with this issue.

It was suggested that all the relevant Federal Agencies should agree to participate in a Federal Advisory Committee constituted to address all the issues of home care. They should agree to communicate and coordinate their efforts. In addition to Federal agency representatives, advisory participation on the committee should also be offered to representatives of private sector stakeholders. The role of such a committee could be to help determine what training and control (regulation) is needed or appropriate, what research is needed, and what incentives ought to be developed for manufacturers, health care providers, and other private sector stakeholders of this issue.

An alternative approach suggested was to see if the home care initiative could be added to the agenda of the Quality Interagency Coordination Task Force (QuIC)6, led by the Agency for Healthcare Research and Quality (AHRQ). This intergovernmental group was established in 1998 in accordance with a Presidential directive. The purpose of the QuIC is to ensure that all Federal agencies involved in purchasing, providing, studying, or regulating health care services are working in a coordinated manner toward the common goal of improving quality care.

Congress has given the Agency for Healthcare Research and Quality (AHRQ) a mandate to report annually to the Nation about health care quality7 as part of Public Law 106-129, and this report could include information about home care and medical devices. This National Healthcare Quality Report (NHQR) will include a broad set of performance measures that will be used to monitor the Nation’s progress toward improved health care quality. The NHQR is intended to serve a number of purposes, such as:

• Demonstrating the validity (or lack thereof ) of concerns about quality.
• Documenting whether health care quality is stable, improving, or declining over time.
• Providing national benchmarks against which specific States, health plans, and providers can compare their performance.

The first report is due to Congress in fiscal year 2003, and subsequent reports will be delivered annually thereafter. The project is being led by AHRQ with collaboration from the National Center for Health Statistics. An interagency work group will develop the final content and design of the report. Other members of the work group include the Office of the Assistant Secretary for Planning and Evaluation, the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services, the National Institutes of Health, and the Substance Abuse and Mental Health Services Administration. AHRQ is currently in the design phase of the initiative. CDRH and AHRQ staff have agreed to collaborate about the possibility of incorporating information about home use in the report.

AHRQ is also responsible for the implementation of the Medical Expenditure Panel Survey (MEPS)8. The survey provides a new and extensive data set on the use of health services and health care in the United States. Survey data may include information about the use of medical devices in the home, and CDRH and AHRQ staff have agreed to collaborate on this possibility.

MEPS is conducted to provide nationally representative estimates of health care use, expenditures, sources of payment, and insurance coverage for the U.S. civilian noninstitutionalized population. MEPS also includes a nationally representative survey of nursing homes and their residents. MEPS is cosponsored by the AHRQ and the National Center for Health Statistics (NCHS).

MEPS comprises three component surveys: the Household Component (HC), the Medical Provider Component (MPC), and the Insurance Component (IC). The HC is the core survey, and it forms the basis for the MPC sample and part of the IC sample. The separate NHC sample supplements the other MEPS components. Together these surveys yield comprehensive data that provide national estimates of the level and distribution of health care use and expenditures, support health services research, and can be used to assess health care policy implications.

Reimbursement
Ultimately, discussion of any home use issue brings up the question of reimbursement. Reimbursement or the lack of it drives development and availability of home use devices and drives the direction in which implementation systems go. It was recognized that outdated or unreasonable CMS reimbursement regulations need to be changed, but there was considerable confusion about how appropriate regulatory change at CMS can be achieved. CMS needs to be more instructive on how that can be done. Current reimbursement regulations under Title 18 of the Social Security Act consider only whether a given healthcare treatment modality meets a benefit category and whether it is medically necessary. Equipment can be reimbursed only if it is considered durable; expendable items are not covered for reimbursement. Furthermore, devices must be used primarily for medical purposes, and cannot be used in the absence of injury in order to qualify for reimbursement. If there are alternatives to traditional reimbursement schemes for both products and services, the case needs to be demonstrated to CMS with positive outcomes data. It will be challenging to develop policies that will keep pace with fast changing technology, but there are a number of Agencies that can assist in the development of outcomes study designs. It was noted that there is a Memorandum of Understanding between FDA and CMS regarding the reimbursable use of so-called investigational devices that are not experimental. Finally, it was suggested that other third party payers need to be involved in any attempts to change the reimbursement policies.

Privacy
All homecare performed with the involvement of those outside the family bring up issues of privacy and how is patient’s information is handled? Whose responsibility is it to ensure privacy is maintained? What is the role of HIPAA in this respect?

Telemedicine brings up special issues that need to be considered, such as the privacy concerns occasioned by the storage of data bases, and the quality and the integrity of the data. Speakers mentioned that firewalls are needed to protect information that goes through the internet.

Orphan products
Orphan devices for use in the home need special attention. There is not enough incentive for manufacturers to develop products for use by smaller disabled populations.

Public Awareness
The public needs to be educated concerning the most common problems with or misuse of medical equipment. It was suggested that public awareness of these issues might be heightened if a “Home Medical Device Safety” week was recognized and promoted. For example, disposing of sharps is an area of public interest. Funding for public education projects is a need, but grantors may not themselves be aware of home health issues. In addition to the general public, speakers felt that manufacturers need to be informed about the needs in this area.

IV. NEXT STEPS
At the conclusion of the conference, CDRH staff made some concluding remarks concerning current activities and the possibility of future actions. CDRH is in the process of conducting focus group meetings with consumers regarding the use of medical devices in the home, and will make that information available. CDRH recognizes the importance of partnering and collaborating with other governmental agencies to deal with the full scope of medical devices in the home, a problem well beyond the authority and resources of CDRH alone. In this regard, CDRH is considering developing an independent advisory committee composed of representatives of the government agencies relevant to the issue of home use medical devices, as a means of developing a long term strategic plan for improving the safety and effectiveness of the use of home use devices.

  1. Mr. Arcarese can be contacted either through the Food and Drug Law Institute at: Jerome A. Halperin, President, FDLI, 1000 Vermont Ave. NW, Washington, DC 20005, Tel: 202-371-1420, E-Mail: jah@fdli.org; or directly at: 12005 Suffolk Terrace, Gaithersburg, MD 20878, Tel: 301-977-4655, E-Mail: arcarese@erols.com.
  2. The meetings were facilitated by Mr. Joseph S. Arcarese, under an agreement with FDLI. Mr. Arcarese, FDLI’s former Executive Vice President, currently is a private consultant. Prior to his seven years employment with FDLI, Mr. Arcarese worked for 26 years with CDRH and its progenitor organizations.
  3. The website with information about the Conference appeared at http://www.fda.gov/cdrh/meetings/meddevhome.html. A copy of the announcement is included in this document as Attachment I.
  4. “Notice of Public Meeting”, Federal Register, Volume 67, Number 161, August 20, 2002, pp. 53954-53955.
  5. Information about the Aware Home Research Initiative is available on the web at http://www.cc.gatech.edu/fce/ahri/
  6. Information about QuIC is available on the web at http://www.quic.gov/
  7. Information about National Healthcare Quality Report is available on the web at http://www.ahcpr.gov/qual/nhqrfact.htm
  8. Information about MEPS is available on the web at http://www.meps.ahcpr.gov/Pubdoc/HC026H/H26HDoc.htm

Updated 11/1/2002

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