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Report on Home Use Medical Device Meetings |
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June 6 & 7, 2002
The Food and Drug Law Institute
1000 Vermont Avenue NW
Washington, DC 20005
by Joseph S. Arcarese
Meetings Facilitator
Table of Contents
I. Background
II. Process
III. Summary of Meetings
Report on Home Use Medical Device MeetingsA. General Comments
B. Home Care Device Definition
C. Challenges/Problems to Safe and Effective Use in the Home Environment
D. Where Should CDRH Start?
E. Maintenance and Repair
F. Future Medical Technologies
G. Safe Migration of Devices from Hospitals to Home
by Joseph S. Arcarese1
Meetings Facilitator
Report Date: July 24, 2002
On Thursday, June 6 and Friday, June 7, 2002, two separate meetings were conducted at the office of the Food and Drug Law Institute (FDLI) for the purpose of discussing the issue of the safety and effectiveness of medical devices used in the home environment. The participants were invited from relevant government agencies, non-profit organizations, health practitioners, patient caretakers, academia, and industry. The meetings were held at the request of 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. This report summarizes the results of those meetings.
For several years, CDRH has had an intensive program to review and revise many of its policies and procedures, and it has done so through the use of teams composed of CDRH and other FDA staff. One such team, The Home Health Care Committee, is studying how medical devices used in the home environment by patients and lay caregivers can be made more safe and effective. The Home Health Care Committee was formed as part of CDRH’s strategic planning 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.
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 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 (e.g., respiratory and intravenous therapy devices) have followed them. But many such medical devices were 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.. Anecdotal reports of patient deaths or injuries as a result of problems with these factors are increasing.
1 Mr. Arcarese can be contacted either through FDLI, or directly at: 12005 Suffolk Terrace, Gaithersburg, MD 20878, Tel: 301-977-4655, E-Mail: arcarese@erols.com.
As part of its study of how the safety and effectiveness of medical devices used in the home environment can be improved, CDRH desires the input of individuals, companies, and organizations that are familiar with this use. To help obtain this input, CDRH asked FDLI to convene and facilitate a small meeting 2 of invited participants on Thursday, June 6, 2002, and a similar meeting on Friday, June 7, 2002, at FDLI’s office in Washington DC. Invited organizations and individuals were asked to select which meeting they would like to attend.
Holding these meetings is consistent with Section 406(b) of the Food and Drug Administration Modernization Act, which charges FDA with consulting with “appropriate scientific and academic experts, health care professionals, representatives of patient and advocacy groups and the regulatory industry” when developing its plans for statutory compliance with the law. CDRH does not seek advice or consensus at such meetings, but the staff looks for opinions from invited individuals on an ad hoc, one-time basis. Once CDRH develops its specific plans regarding the home use of medical devices, it will conduct other activities in order to obtain broad public input on this issue.
2This work was conducted under the auspices of FDA/CDRH Service Order No. C45917-00-02-SE-00 with FDLI. Mr. Arcarese’s participation in the project was under the auspices of a separate agreement between him and FDLI.
The idea for the two June meetings derived from the success of previous meetings conducted by FDLI for other CDRH topics, in which a relatively small number of invited experts were convened at FDLI for facilitated discussions. The conversations between invited experts and CDRH staff proved remarkably fruitful in identifying issues and ideas which CDRH staff could use in formulating new program initiatives. In every case, CDRH followed up with public meetings, Federal Register publications, or other means of assuring broad public input prior to mounting a formal program to deal with the issues about which it had sought opinions.
These facilitated conversations are unlike typical conferences. Typical conferences are usually characterized by speakers at a podium addressing a listening audience, with little provision for debate and interaction between speakers and audience other than a few questions and answers. Thus conferences primarily consist of a process of one-way communication from speaker to audience, and the audience for the most part does not actively interact with the speaker or with each other, except for what might incidentally occur informally between individuals during breaks. Unlike conferences, there are no “speakers at a podium” in these facilitated conversational meetings. All the participants are invited specifically for the purpose of actively discussing and interacting with each other, probing each other’s experiences, questioning claims and preconceived notions, and positing and debating suggested alternatives, under the general guidance of a facilitator. In this kind of environment, where the total number of participants is small enough to allow all participants to have sufficient “air time” to discuss their points of view, the accumulated wisdom and experience of all the participants is tapped. This process honors the contribution of the participants, who donate their valuable time and incur expenses to attend the meeting without recompense from FDA or FDLI, by giving them a sufficient opportunity to express themselves and to interact with other participants. This produces a very intellectually enriching experience for all. Unlike typical so-called “focus-group testing,” these facilitated meetings are not recorded, nor is there a one-way wall separating participants from silent and unseen observers. Consequently, participants feel free to express themselves candidly. Notes taken by FDA participants are used for the purpose of compiling a report which makes no individual attributions.
CDRH staff familiar with those previous meetings felt that the same approach would be helpful at this stage in the home use program, and they contacted FDLI about the idea of holding similar meetings for the home care issue. Specific planning for the meetings was conducted between members of the CDRH Home Use Committee and Mr. Joseph S. Arcarese, who would be the facilitator of the planned meetings. Although now retired from full time employment with FDLI, Mr. Arcarese continues to facilitate meetings under an agreement with FDLI. He facilitated a large number of FDLI/CDRH meetings during his seven year tenure in FDLI, and facilitated many similar meetings during his 26 year tenure in FDA’s CDRH. Planning was conducted over a series of meetings, phone calls, and e-mail communications, starting with a meeting on Friday, December 7 between Mr. Arcarese and members of the Committee. Committee members expressed their desire for information and comment from relevant communities (including government agencies dealing with health care, and non-government entities and individuals with experience relevant to the home care topic).
It was agreed that Mr. Arcarese would draft an invitation letter to be sent to a variety of organizations and individuals known to be involved with the home use issue. Between March 28 and April 19, the language and format of an invitation letter was drafted, reviewed by the Home Use Committee, and revised accordingly (final copy attached). Individually addressed invitation letters were mailed to 82 recipients. In many instances, invitation letters initially addressed to particular people were passed on to others who subsequently contacted Mr. Arcarese. The list of initial addressees and those who subsequently received copies is attached. In addition, on May 5, reminder e-mail invitations were sent to 52 recipients who had not responded to the mailed invitations. The invitation letters offered recipients the choice of attending either the June 6 or June 7 meeting. Positive responses were ultimately received from 29 individuals. Of the positive respondents, 26 actually attended and three did not. The lists of attendees at each meeting are attached.
The invitation letters included a request that the respondent fill out a brief survey form, consisting of six questions, and send their answers to Mr. Arcarese. A number of participants did so, and he compiled their responses (copy attached).
The six questions were:
1. How would you define “home care devices”?
2. What, in general, do you see as “challenges” or problems to the
safe and effective use of medical devices in the home?
3. What challenges to successful maintenance and repair of home care medical
devices are you aware of?
4. How can communication between the user and the manufacturer be improved?
5. What future technology do you anticipate having an impact on home care?
6. What process would you like to see for safely managing the migration of professional
use devices into the home?
Copies of the anonymous responses submitted by the respondents were provided to all attendees, and the discussions at the meetings were organized around the six questions.
During the meetings, notes were taken by several CDRH staff attending in attendance, and the following summary was prepared based upon those notes. Subsequently, all attendees were asked to review a draft of this summary, and the final version reflects the comments received.
(Note: This section summarizes comments from both the June 6 and the June 7 meetings)
The use of medical devices for home care is widespread and increasing. Most care is going on outside of the control or supervision of regulated agencies.
Although the early years of regulation of medical devices by FDA was characterized by a more rigorous approach with a great many devices classified so that health care practitioners were needed to prescribe their use, this last decade has been characterized by many devices being reclassified, so that prescriptions are not necessary for the general public to have access to them. Consequently, a growing number of medical devices are available for the general public to purchase over the counter. Although Class II and Class III devices are prescription devices, and thus are not directly available over the counter for use by the general public, prescriptions for their use in the home are now more readily provided by licensed health care practitioners.
Although manufacturers are required to provide labeling and other information to give health care practitioners sufficient information in order for them to use the devices safely and effectively, devices that are not labeled for “over-the-counter” use are not required to be accompanied by training and education for use by non-clinical users. There has been the assumption that the prescribing health care practitioners will assure that such necessary education will be provided to lay caregivers, but in fact, a major problem with the current system is that the education and training of homecare users is woefully deficient. The use of some sophisticated devices places unrealistic expectations on the capabilities of lay caregivers. Furthermore, the home environment is devoid of the safety and support systems found in hospitals.
Thus, training and education of the lay user is a major issue. Current labeling and instructional materials are inadequate for use by lay persons, and may be quite difficult to understand. Although some home healthcare organizations do instruct the lay caregivers, it frequently happens that the devices are delivered for use with little or no instruction or supervision by trained professionals.
The current system of health care in this country leaves much to be desired. Due to reimbursement limitations, the hospital may order the attending physician to discharge a patient for home care. The physician signs an order for the use of a particular device type. However, the distributor ordinarily chooses the specific brand and model. The attending physician may receive little or no feedback about the specific circumstances at home into which the patient is released. Three quarters of the home healthcare industry is not accredited by the Joint Commission for the Accreditation for Healthcare Organizations (JCAHO) for assessment of patients/home caregivers regarding their capability for use of medical devices in the home. The current reimbursement system does not provide adequate funding to assure that such assessments occur.
Device design is also a major issue. Design of the same generic kinds of products are inconsistent from manufacturer to manufacturer. Included in the design issue is the related issue of standardization of user interfaces. There are no regulatory requirements for the application of human factors principles in the design of medical devices.
B. Home Care Device Definition
CDRH operationally defines home use medical devices as: “medical devices used in the home environment by persons who are ill or disabled and need, or whose providers of care need, education and/or other related health care services to use and maintain the devices safely and effectively”.
However, there are several problems with this definition. First, it may be incompatible with telemedicine and telemetry. Second, it doesn’t take into account those people who are recovering (i.e., not presently “ill” per se) and who may need to be monitored during their recuperation. One person thought that adding the term “at risk” might also help characterize that not all home care users are presently ill. Third, the word “home” is too limiting and “home use” is an inaccurate characterization, because there are other non-clinical venues besides the home where medical devices are used (e.g., car or other transport). Some monitoring or therapeutic devices are used on the person wherever he/she might go, inside or outside. To deal with this, it was suggested that the definition be changed to speak about the use of devices outside of controlled environments (or outside of “traditional health care settings”), where the concept of controlled environments is understood to mean those venues under relevant regulatory and professional control.
It was emphasized that neither the home health agency nor a visiting health professional actually controls the “home” environment where medical devices may be installed, at least not to the extent that a hospital’s environment is controlled (for example, with reference to the consistency and suitability of electrical power, minimizing the existence of extraneous electric and magnetic fields, preventing children or animals from having physical access to devices, circumventing any stairs, narrow doorways, and other barriers impeding movement, having quick and ready access to professional maintenance and repair, etc.). Although many homes are modern and have adequate electrical power, plumbing, and other modern physical characteristics, not all homes are so well endowed. Some homes have very old wiring and inadequate electrical power, or no power at all. Some homes even have dirt floors and lack indoor plumbing. Some homes are in rural areas with very limited access. Thus, the range of “homes” is extremely broad with respect to their suitability for some medical devices.
C. Challenges/Problems to Safe and Effective Use in the Home Environment
There are a number of categories of issues that need to be examined with regards the suitability of certain devices for home use, including:
With regards the characteristics of the home user population, it was pointed out that it is essentially unbounded. The age of home device users ranges from newborns to the very aged. Especially with regards the home care of very aged patients, the caregivers are frequently aged themselves. In addition to a range of ages, there is a broad range of capabilities and limitations in the population of potential medical device users. Limitations are both cognitive and physical.
It was readily acknowledged that the type and number of medical devices used in the home is increasing. There is a growing pressure for the use of devices in the home, due to the changes in health care delivery that have occurred in this country as a result of the extraordinary expense of hospital-based care. This causes a strong incentive to move patients out of the hospital as soon as possible, thus necessitating convalescence and recuperation at home or at locations costing less than hospitals, with the help and monitoring of family or of people who are less well trained (and thus less expensive). These patients are now often “sicker” or more medically demanding than in the past, due to their shorter hospital stays. Also, as the American public has become more educated and sophisticated, consumers have demanded having access to certain devices in the home, because they would rather convalesce in their home than stay in the hospital. People are aware that staying in hospitals longer than absolutely necessary puts them at increased risk of infections, they are aware of the inconvenience and discomfort for their families, and they are aware that hospitals are simply not the most comfortable places for their own convalescence. Furthermore, people want to take more responsibility for their own care or for the care of their loved ones out of their own sense of autonomy and responsibility.
However, some participants questioned the current process whereby decisions about releasing patients from hospitals to home care are frequently made without adequate assessment of the capability of the home caregivers or the suitability of the home environment for this purpose. Moreover, the quality and quantity of training and education provided to lay caregivers is highly variable, dependent on the level of reimbursement, and on the capabilities and motivation of the person providing the education (e.g., whether the information is being transmitted by a delivery truck driver or by a registered homecare nurse). One person felt that the cost of needed education needs to be incorporated into the cost of the device.
The changes in healthcare delivery have put increasing pressure on the regulatory agencies to adapt their policies and procedures. For example, the Center for Medicare and Medicaid Services (CMS) impacts the use of medical devices in the home through its reimbursement policies. But this inevitably raises questions about the safety of the use of these devices in new surroundings. This places pressure on the manufacturers of such devices to decide what is needed at home to operate their devices safely. There is increasing pressure on manufacturers to spell out the circumstances for safe use in the home directly on the device labeling. There is also pressure on the manufacturer to design devices to the least common denominator. But the previously mentioned range of cognitive and physical capabilities in the population of patients/lay caregivers makes such strategies extremely difficult and even risky propositions for the manufacturer.
Manufacturers are ambivalent about the use of their devices in the home. Although presumably the migration of devices into the home increases their markets, it also has significant implications on the safe and effective use of their products. They point to the fact that they are regulated in multiple ways (e.g., by U.S. and foreign regulatory agencies) and they assert that this level of regulatory control provides a large measure of assurance against badly designed devices. But the proper functioning of the device is dependent on the competency of its user. In the past, doctors, nurses, and other highly trained health professionals were the users. Now, the world of users is expanding to include lay people, where there is no real assurance about the competency of the user or the suitability of the home environment for the proper functioning of the device. It is true that some devices are designed by the manufacturer to be used safely by patient or family; such devices, for example, might be designed to have no or few external function buttons, working automatically with little or no human intervention. However, the natural incentive of manufacturers to build in features that differentiate their product from their competition militates against the idea of simplicity or standardization.
But manufacturers are aware that many complicated devices designed for the hospital have been sold into homecare, and they often do not have control over this process of migration out of controlled facilities into uncontrolled facilities. These devices don’t meet the manufacturer’s requirements for use in the home (e.g., power requirements, alarms, safety mechanisms). At least one manufacturer purchases back its devices intended for the clinical environment that have wended their way into the home. However, this does not appear to be a general practice in the industry.
There was much discussion about ways of addressing the fact that risks of medical device use in the home are greater than those in the clinical environment. Human factors professionals suggest that, as a solution strategy, the first priority ought to be to design out problems in the first place (i.e., obviate the problem from occurring at all). If a potential problem cannot be designed out, then the next priority ought to be to guard against the error (e.g., have an automatic shut off). Only as a last alternative, when the first two priorities cannot be fulfilled, should reliance be placed on warnings about a problem.
One human factors professional objected to the seemingly implicit assumption that manufacturers who design their devices for use in controlled clinical environments, but know that they are being used in the home environment, are nonetheless apparently absolved of the responsibility to make needed design changes to improve use in the home. This person emphasized that the best solutions to user problems are designed into the product. Reliance on instructions, training, and administrative controls are poor substitutes for good design, and are generally not nearly as effective.
There is universal dissatisfaction with the quality of instructional materials accompanying medical devices. And there is also skepticism about how many people actually read instructions. The human factors community does have statistics available on the use and understanding of labeling instructions, and this information might be quite useful in the design of informative materials that the lay public would be more likely to heed. One benefit of equipment designed specifically with lay users and the home environment in mind using human factors principles will be that instructional materials may not need to be complicated, since simpler, more usable systems ought to be easier to explain.
Instructions for how to use devices ought to be clear and easy to understand, and operating the devices themselves ought to be intuitive. In the world of consumer devices, there is general familiarity with the fact that instructional materials are often poor and/or the controls are not intuitive, and these inadequacies consequently limit the ability of consumers to take full advantage of the capabilities of these devices (e.g., the blinking “12:00” on the VCR). Given the fact that the consequences of error with medical devices are much higher than with consumer devices, since errors with some devices might even result in a patient’s death, the stakes are much higher for the development of informative materials and human factors designs to help avoid such dire consequences.
Labeling medical devices for consumers presents some very challenging problems. First, people often don’t often pay attention to instructions until they are in trouble. Also, the ways people learn are different from individual to individual. Some are visual, some auditory, and some are kinesthetic learners, so a “one size fits all” approach to instructional materials may be unsatisfactory. In addition, some older adults have problems with cognitive processing, and people with certain kinds of disabilities may be unable physically to carry out certain functions. So, if a product is intended for use by older adults or the disabled, then it needs to be tested with these limitations in mind.
From the manufacturer’s perspective, writing instructions for device use is extremely difficult, because so many different expectations need to be met. In addition to their own internal requirements, the manufacturer has to meet FDA requirements, end user needs, and the requirements necessitated by the legal tort system. Consequently, it is not unusual for instructional manuals to weigh more than the device. This is hardly conducive for patients or lay caregivers to read and understand them. Furthermore, training materials and instructions prepared to satisfy multiple and sometimes conflicting incentives is not the kind of situation envisioned by human factors professionals when they call for a human factors approach to the development of instructional materials for the health professional as well as for the home lay caregiver. They believe that manufacturers ought to be engaging human factors expertise (e.g., having human factors professionals on staff) in developing instructional materials.
Instructions for home caregivers need to be presented in plain language, with care that jargon is not used, and that the caregiver can understand. Also instructions for home use need to be presented in a sensitive manner that keeps in mind that the caregivers and the patient may be under great stress and may have difficulty in focusing on important device use matters.
There is a company called Simulis (www.simulis.com/home.html) that develops online simulations of medical devices and provides simulation-based device training programs. Presumably this sort of resource might enable manufacturers to perform some kinds of premarket assessments of their devices with suitability for lay users in mind.
Everyone concurs that the competency of the individual using the device is critical to its safe and effective operation. The Joint Commission for the Accreditation of Healthcare Organizations (JCAHO) insists that healthcare organizations must follow guidelines and evaluate the competency of lay caregivers who will be vested with the responsibility of using certain kinds of medical devices. But it is not clear who evaluates the competency of lay caregivers when JCAHO accredited organizations are not involved. Outside of the involvement of JCAHO accredited organizations3 , there appears to be no systematized way of enforcing compliance with appropriate standards of competency for lay caregivers. If consumers can obtain medical devices for use in the home, they probably do not have to demonstrate their own competency or the competency of their home environments in order to do so.
There need to be standards for home use, including criteria for prescriptions for home use, that take into account the hazards and unique situations in the home. Home audits may be necessary to evaluate these situations, such as whether there are young children around, whether the caregivers are older adults, whether the electrical power in the home is suitable, etc. Devices for home use need to be designed with these kinds of situations in mind.
3It should be noted that there are some other accrediting bodies for home medical equipment providers, but JCAHO is the largest and most widely recognized.
Some participants advocated the development of an FDA hotline so that home caregivers can get support and unbiased information. Some others felt that a hotline ought to be run by different organizations, rather than FDA, under the presumption that people would not want to talk to a government agency when they are in crisis. One thought that the need for information during a crisis ought to be fulfilled by a process involving telemedicine. One person pointed out that internal diagnostics in the device itself would be useful in monitoring how the device is being used, and might be helpful in some remote expert in ascertaining the cause and solution of a problem being reported by a home caregiver.
There is no such thing as zero defects. Unintentional situations will always occur, even under the best of circumstances, and with the best processes of design, manufacture, and implementation. Thus, there will always be risks involved with the use of medical devices, whether in the home or in the hospital. The existence of risks should not, by itself, obviate the use of a device in the home.
It is also necessary to take into account the kind of harm that could be done if a particular device was not available for use in the home. There is a need for compassion and creativity as medical devices are evaluated for use in non-clinical environments like the home. There is always a benefit/risk tradeoff that ought to be taken into account. The question needs to be asked, what would be the alternative if a particular device were not allowed to be used in the home. Sometimes the alternative is unacceptable, such that, despite the risk, the device ought to be used in the home.
It is also important to take into account whether the device will be used on a temporary basis in the home, or whether it will be used permanently. A greater risk (i.e. from the seriousness of a potential adverse event, and/or from the likelihood of its occurrence) might be tolerable for a device to be used in the home for a short period of time, as opposed to devices that will be used on a permanent basis.
One participant pointed out that some medical devices are handed down from one lay caregiver to another, without the intervention of some supervising health care assessing organization. And this transfer of devices is accompanied by a transfer of information and experience, but there is no guarantee that the information will be accurate and complete. It is also possible that the transferred device itself may not be appropriate for the intended user.
“Rough Crossing” is a report written by the United Hospital Fund of New York (www.uhgnyc.org) which contains quotes from caregivers regarding equipment. The report emphasizes the problem of lack of coordination in the process of releasing patients to home care.
The National Science Foundation and FDA have a working partnership, developing an undergraduate design program as one means of training the future designers of medical devices.
There need to be priorities for action to improve medical devices for home use, as a means of organizing a sensible process to examine and redesign them. One approach is to stratify medical devices by the risk involved in using them, and then proceed to examine those devices presenting the highest risk, rather than considering that all devices for the home reside in one risk category. In this regard, it was suggested to begin a deliberate process of examining devices by focusing on several characteristics, such as prescription devices vs. OTC, Internal vs. external use, and therapeutic vs. diagnostic. One suggestion was for focusing first on prescription devices used for external therapeutic purposes. By suggesting these characteristics to focus on, it was not intended that medical devices with other characteristics (e.g., diagnostic devices) do not present inherent risks. This approach was suggested merely to get a sensible process started.
There was also the suggestion that devices need to be investigated in terms of the level of risk (i.e., the seriousness of the consequences of device malfunction or failure) and the expected frequency of such problems. It is possible to conceive of a risky situation arising from the use of even the most innocuous of devices. But it is apparent that not all devices present the same level of risk nor the same frequency of occurrence of serious problems. There was no disagreement that such a means of stratifying devices by risk and frequency was necessary in order to have a sensible approach to evaluating devices for home use.
In this regard, it should be noted that the VA National Center for Patient Safety has developed a patient safety matrix in their patient safety handbook. It is available at this website: http://www.patientsafety.gov/NCPShb.pdf. The VA National Center for Patient Safety has the same sort of matrix in the Healthcare Failure Modes and Effects Analysis (HFMEA, trademarked), available at this website: http://www.patientsafety.gov/HFMEAIntro.pdf . The HFMEA format is applicable for doing proactive risk assessment.
There is a question about what constitutes “safe”? The concept of safety is complex and is relative to the circumstances. This in turn raises the question about the data available alleging risks and problems for particular devices. Assessing risk based on anecdotal information always raises the question about whether this represents the exception or the rule. Is it possible that risks may be anticipated that never really happen?
One way to prioritize medical devices in this respect is to first focus on a category of devices, such as therapeutic, permanent, external devices, and stratify these by risk. It might also be useful to stratify by electrical or mechanical devices, under the presumption that electrically operated devices present greater risk than mechanical devices.
Monitoring needs to be built into devices, so that their operation can be easily monitored and problems diagnosed.
The quality of risk stratification is dependent on acquiring realistic data about the performance of devices in non-clinical environments. There are some sources of information that can be applied. For example, some information might be gathered during the premarket review process. Participants felt that a process for postmarket surveillance in the home environment is needed, in order to ascertain how these devices are used in the home. Data gathered on the rates of success and failure of devices in the home, collected for a suitable period of time, could serve as basis for categorizing devices by risk level. Data on problems might also be obtained from biomedical engineers and technologists working in hospital settings.
It was suggested that two categories of medical device products are responsible for the vast majority of problems in the home environment, and that intensive analysis ought to be focused on these device categories first: 1) Respiratory Therapy, 2) Infusion Therapy. There was a suggestion that a third category, Rehabilitation Therapy, is also responsible for problems in the home. Human factors professionals claim that some device problems can be extrapolated to other similar devices in the same general category, so that it may not be necessary to individually examine every device in the category.
With reference to postmarket surveillance, it was pointed out that CDRH collects adverse event information from manufacturers and from hospitals, clinics, and nursing homes. However, the Center only started capturing the location where an event took place in 1996, so this data is limited. This data is also largely anecdotal, so it suffers from not being able to be statistically compiled. Other agencies have data on device use. For example, the Veterans Administration has a good reporting system regarding adverse events. The JCAHO will check to see what information it collects can be shared with CDRH.
CDRH needs to ascertain what other government agencies are doing. In this respect, these meetings are useful because representatives of other agencies that use medical devices are in attendance, and CDRH staff can make appropriate linkages with other agencies for the purpose of sharing information.
There was a suggestion that there should be a process of assessing patient (or family) capabilities before they should be relied upon to use prescribed medical devices in the home. JCAHO accredits 25% of home health care agencies and home suppliers, and they do conduct assessments. JCAHO standards require that patients/caregivers are asked to demonstrate their ability to use the equipment. JCAHO has a definition of home use medical devices (not necessarily prescription devices).
Reimbursement policies affect whether patient assessments and reassessments can be or are performed. It is important that manufacturers realize that marketing devices that qualify for reimbursement is not necessarily the same as responding to what the consumer wants.
The performance of routine maintenance and repair of medical devices in the home is acknowledged to be a serious problem affecting the safety and effectiveness of medical devices. Lay caregivers and patients do not necessarily have the knowledge and capability to perform these functions, so the question of who ought to do this is an unresolved issue. There is a sense that durable medical equipment suppliers who install the equipment bear certain responsibilities for maintenance and repair, but it is not clear who would pay for this service. Manufacturers are concerned that, if they were required to perform maintenance and repair of their equipment in the home or other non-clinical locations, this would present them with insurmountable difficulties and expense.
Calibration needs to be included in routine maintenance, and it needs to be part of quality systems. Low maintenance devices would probably gain market favor in the home use environment over devices that require higher levels of maintenance. There is some sentiment that FDA ought to require that devices be either self-calibrating or disposable to be used in the home, thus obviating the need for the home user to perform calibrations.
However, there is also a serious concern that regulations may add hurdles to the development of devices suitable for the home, ultimately acting as a disincentive for manufacturers to design devices specifically for home use.
Finally, the major hurdle regarding maintenance and repair is the issue of reimbursement. Ultimately, any service needs to be paid for, and maintenance and repair are not unique in this regard. Ideally, the design of devices that need no routine maintenance and repair would get around this issue of funding.
F. Future Medical Technologies
There is a general sentiment that robotics and interactive technologies will provide solutions to some of the problems currently plaguing the world of medical devices and also the provision of medical care in the home. Interactive technologies include telemedicine (e.g., teleradiology, teledermatology, etc.). There is also the assumption that “smart house” technologies in the future will help provide capabilities for assisted living. There are also new speech technologies to help those with certain disabilities. Also the growing use of home wireless computing will certainly have applicability.
There is an awareness that markets and manufacturers move faster than the development of regulations, so that regulations might be 3-4 years behind the leading edge of new technologies. Regulatory agencies need to be concerned that, as they try to control certain kinds of problems, they don’t act to stifle the development of new technologies, to the net detriment of society.
G. Safe Migration of Devices from Hospitals to Home
There is a general consensus that the use of medical devices in the home ought to be officially recognized, and that it ought not to occur simply by default. Manufacturers ought to acknowledge the possible or probable use of their devices in the home, and the regulatory process ought to do so as well.
There should be criteria/guidelines about what should and what should not be used in the home, and under what circumstances.. There should also be an effective system of discharge planning, that includes an effective system of patient/caregiver assessment, suitable and effective training, and effective means of assuring equipment maintenance and repair. The discharge process ought to include appropriate consideration for the particular equipment to be used in the home, as well as evaluation of the environment into which it will be placed.
One person suggested that devices ought to be classified by whether they are (or could be): (1) OTC; (2) approved for use by lay persons with suitable assessment; and (3) approved for use only under the direct supervision of a health care professional. Another person thought that there ought to be criteria for the approval of devices that might go into the home, and that assessment of competency ought to be linked to these criteria. Others felt that human factors professionals should play a strong role in the evaluation of devices proposed for home use, as well as in the development of instruments for the assessment of competency. They also felt that there should definitely be involvement of users, especially the aged and the disabled, in the effort to develop criteria and competency assessment instruments. Finally, they felt that potential home use issues should be investigated from three perspectives:
Although there was agreement or sympathy over the need for some system of reporting adverse events occurring in the home, there was also some skepticism whether any home reporting system could ever work due to the reluctance of people to admit that they were involved with a problem. It is interesting to note that this reluctance for self-reporting is not unlike the reluctance in the healthcare system in general, where there is concern for the potential legal liability and consequent ramifications from reporting problems. There is also the concern that the decision to gather adverse event data ought to be premised on having a plan for mining the data and for proposing corrective actions.
(Note: Before the close of each meeting, participants were asked to identify their key concerns and questions).
There was a question about how the European Union controls the movement of prescription medical devices in the home. It was acknowledged that the way it happens in the U.S. may not be the norm.
There is concern about how medical devices can be properly maintained in the home.
One participant noted that the issue of children’s use of medical devices did not get mentioned, nor the issue of parent/child interaction.
A manufacturer mentioned the concern that ill-considered regulations, however well-intentioned, might serve to stifle progress in the development of new medical devices for the home. The manufacturer also commented that there needs to be a greater participation of manufacturers in this process, in order to ensure that their legitimate concerns as well as their proposals for solution strategies are taken into account. In this regard, he emphasized obtaining input from manufacturers of respiratory therapy and infusion therapy devices4 . He mentioned that two of the general concerns expressed by CDRH and the meeting participants, device design and the operating instructions provided to the user, are issues that need to be addressed by manufacturers. Certain manufacturers are already involved in serious efforts to improve the design of their home use devices, provide better training materials to the home patient, monitor patient compliance in the home, and improve the follow-up systems available to DME dealers who deliver the equipment to the home. He also thought that the manufacturers can also provide valuable insight regarding the DME distribution system in the US. He urged CDRH to recall that home use devices are usually delivered to the home by DME dealers, not by an employee of the manufacturer. It is the DME supplier that has direct contact with the patient and their caregivers in the home. He felt that CDRH would be well advised to gain a better understanding of how manufacturers best efforts could be enhanced or thwarted by the DME supplier that delivers the equipment to the home patient.
4This manufacturer representative mentioned Respironics, ResMed, AirSep, Puritan-Bennett (Mallinckrodt), Invacare, DeVilbis, as some of the biggest manufacturers of respiratory and infusion therapy devices
One participant urged a multifaceted approach to the solution of problems affecting the safety and effectiveness of medical devices used in the home, including education programs, focus groups to determine actual failure modes and rates, and the development of standards to deal with problems. Other participants urged that regulation ought not to be the only strategy.
One urged that FDA needs to investigate information and data that already exists in other Federal agencies and private organizations prior to making its own decisions. Its decisions ought to be based on solid data.
JCAHO has already addressed many problems in their healthcare organization accreditation process. It has data that can be used to help quantify the problems. However, this might not yield representative data on home care problems.
Assessing the competency of patients and lay caregivers was acknowledged to be a serious need in the equation about the safety and effectiveness of medical devices used in the home.
Stratification of device risks was acknowledged to be an important strategy in prioritizing the examination of the suitability of devices for home use.
There was a general recognition of the importance of real data needed to make a valid assessment of the kinds of problems that are likely to occur in the home environment, and to quantify their frequency.
There was also general agreement that devices need to designed better to avoid subsequent problems, including human factors design to help avoid user errors, and that informational materials and educational programs need to be much better than they presently are.
There was the suggestion that potential home use issues should be investigated from three perspectives:
One participant reminded everyone about the necessity of taking into account the risks of NOT having a medical device in the home, when risks are assessed and solution strategies are devised.
Participants urged that the CDRH operational definition of Home Use Devices be modified to include the following concepts: broaden “home” to direct or indirect “place of residence”, outside of traditional care settings, recuperation, at risk, robotics, virtual diagnosis and therapy, non-controlled or non-clinical settings.
Updated on August 29, 2002
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