Post on 18-Aug-2020
1448 Technobgy and Assessment and Support of LJfe-sustainlng De�nces in Home Care (Allen I. Goklbeip)
Technology Assessment and Supportof Life-sustaining Devices in HomeCare*The Home Care Physician Perspective
Allen I. Goldberg, M.D., M.M., F.C.C.P.
Practicing physicians are increasingly using life-
sustaining devices in the home setting for patientswith long4erm needs due to chronic conditions. Atthe same time, public policy focus on technology assess�ment has broadened from narrow medical concernsabout safety and efficacy to considerations of effec-tiveness, quality of life, patient preferences, andcost/benefit. Around the world high-technology home
care (HTHC) features a number of ways to evaluateoutcomes. One category of HTHC that requiresinitial and on-going technology assessment is homemechanical ventilation (HMV). Home MV has devel-oped in nations with a variety of healthcare financesystems: England (national health system), France(national health insurance), and the United States
(regulated/market-economy). Approaches to tech-nology assessment differ among nations accordingto organizational design and evolution. Physicianbehavior is a major determinant in the applicationof medical technologies. There are new physicianroles that can influence what, when, and how tech-nology is appropriately used in the home-initially
and over time. For this reason, it is crucial toconsider the role of the practicing physician inhome care technology assessment.
(Chest 1994; 105:1448-58)
FDAFood and Drug Administration; HMVhomemechanical ventilation; HTHChigh-technology home
care
5 nations battle the rising burden of expendi-
tumes for heaithcame and social services, they
face new demands from growing numbers of people
with chronic conditions.’ This population sector in-
ciudes survivors of life-threatening illness of all ages
who have benefited from modern medical progress
in acute cane, some of whom depend on the pro-
longed use of life-sustaining technologies. More
efforts are needed to determine the size of the
segment requiring long-term cane.2 The transfer of
these patients from institutions to community alter-
native came settings may result in cost savings and
improved health outcomes.
The assessment of medical technology and its
relation to cost and quality management concerns
many groups: heaithcare professionals, engineers,
physical and social scientists, public policy analysts,
government officials, business coalitions, and con-
sumem organizations. These groups have broadened
the scope of technology assessment from concerns
about safety and efficacy to considerations of effec-
tiveness, quality of life, patient preference, and
cost/benefit. The application of new technologies
and overuse of existing ones account for up to 50
percent of the rise in healthcare costs.3’4
*From the Loyola University Medical Center, Stritch School ofMedicine, Loyola University of Chicago, Maywood, Illinois.
Manuscript received June 14, 1993; revision accepted Septem-ber 29.Reprint requests: Dr. Goldberg, Department of Pediatrics, Loy-ola University Medical Center, 2160 South First Avenue, May-wood, IL 60153
Many technologies are now applicable in the
home.5 Although home healthcare is not a new
concept,6 the use of life-sustaining technologies in
the home has a more recent history.7’8 It is essential
that groups concerned about technology assessment
have a better understanding of the home use of life-
sustaining devices. High-technology designed for
home use must be assessed before introduction and
reassessed with experience for efficacy and safety as
well as outcome and appropriateness.
The following observations review several na-
tions’ approaches to high-technology home care
(HTHC) in the form of home mechanical ventiia-
tion (HMV). They will consider the evolution of
programs from the poliomyelitis era to modern day
and focus on how each country has on has not
evaluated performance of devices used in the home.
They will attempt to determine if a systems ap-
proach is feasible, necessary, and whether it makes
a difference. They will describe technology assess-
ment for home came physicians-physicians who
consider the home as an appropriate setting for
care.
HISTORY OF HOME MECHANICAL VENTILATION
The poliomyelitis pandemic of the 1950s repme-
sented a global healthcare crisis affecting the lives
of countless children and young adults. The most
remembered achievement of that period was the
successful application of research leading to the
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CHEST/105/5/MAY,1994 1449
polio vaccine. The medical community, however,
also made major advances in life-supportive medical
technologies. For example, the prototype of the
modern positive pressure ventilator9 and its applica-
tion via tracheostomy reduced mortality due to
acute respiratory failure from 90 percent to 20
percent.10 A less-recognized technological advance
was the adaptation of mechanical ventilatons for
home use by physicians working with engineers and
polio survivors. These survivors with residual respi-
matory impairment required prolonged mechanical
assistance and desired to leave the institution and
return to their families. According to Gini Laurie,
Continuing home care was an integral part of the whole
system. . . . The centers and home care resulted intremendous financial savings and a greater degree ofindependence and self-sufficiency than was ever dreamed
possible for people so severely disabled. . . . The averagehospital time was cut from more than a year to sevenmonths. The home care costs were one-tenth to one-
fourth hospital costs.11
The poiiomyelitis experience represented the first
generation of ventilator-assisted individuals to use
HTHC. An international network of designated
polio respiratory centers arose, making technologi-
cal progress possible.’2 Physicians, engineers, and
manufacturers met and directly communicated their
needs and perspectives.13 Physicians played a vital
role with others in establishing a well-defined mecha-
nism for designing equipment, evaluating expeni-
ence, and tracking device performance.
After the poiiomyelitis era, the new technical
capabilities of long-term mechanical ventilation via
tnacheostomy provided the life-sustaining means to
maintain and improve the lives of patients with
other categories of chronic respiratory insufficiency.
Some physicians who had participated in interdisci-
plinary teams established to meet the complex needs
of polio patients became the first leaders of neona-
toiogy, critical care, and rehabilitation medicine. As
a result of advances in these modern interdiscipli-
nary practices, patients were saved with many van-
eties of previously fatal life-threatening medical and
surgical conditions. A few survivors who benefited
from this progress, however, still maintained a de-
gree of respiratory impairment that required pro-
longed support of medical technology.
The option of mechanical ventilation at home
currently exists in several nations.�16 In England,
France, and the United States, special centers omigi-
nally designated for polio provided the models for a
second experience in HMV. Critical cane and nespi-
matony rehabilitation units developed home cane
programs to permit the option of life in the commu-
nity for a new generation of ventilator-assisted
individuals. The organizational structure in each
nation reflected political, economic, social, and cul-
tural realities as determined by national, regional,
and local influences.’7’9 Each nation’s technological
achievements, product support, and device surveil-
lance mechanisms stemmed from the experiences,
perspectives, and backgrounds of the physicians
who helped design the home cane programs. The
architects of the original programs included physi-
cians from a variety of professional disciplines (le,neonatology, anesthesiology, critical care, pulmo-
nology, cardiology, surgery, rehabilitation medicine)
and other healthcare professionals (ie, nursing, mes-
piratony cane, social work, physical therapy).
Ventilator-assisted individuals do not always have
the same HMV option. Where they do, the quality
of their program and safety at home varies greatly by
location. Current life-sustaining technology used at
home also varies in terms of availability and penfon-
mance evaluation. In many situations where HMV
has been available for several decades, the original
technology initially designed for home or hospital
application is still in use. This technology has been
used for prolonged periods with or without assess-
ment oven time. Although the equipment may have
originally met patient needs, most early technolo-
gies predate the rigors of current device standards
and pnemarketing/clinical application approval pro-
cesses.
In general, devices are used either on an mdi-vidual or collective basis with variable tracking of
location, use record, repair experiences, and main-
tenance history. Older technologies are used inter-
changeably and/or modified. More modern prod-
ucts specifically designed and manufactured for
home use may have been subject to an initial
technology assessment. There have been few at-
tempts at reassessment, however, since there is no
formal system in place to make involved actors
aware of device failure or inadequacies during a
product life-cycle.5
Patient safety, quality determination, medical
necessity, cost control, and risk management de-
mand technology assessment to evaluate the medi-
cal appropriateness and performance of technology
after prolonged application in the home. The foi-
lowing remarks will show this need and update
previous communications about approaches to these
concerns in three nations where HMV has evolved
in different heaithcare finance systems: England
(national health system), France (national health
insurance), and the United States (market-on-
ented).’�2#{176}
MULTINATIONAL COMPARISON OF HOME
MECHANICAL VENTILATION
England
The “Responaut Program,” England’s unique hos-
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1450 Technokgy and Assessment and Suppoil of Ufe-sustaining Devices in Home Care (Allen I. Goldberg)
pital-based HMV program, has served over 500
patients for more than 20 years.’5 As with most
regional HMV programs of this magnitude, it began
with the need to send home polio survivors with
chronic respiratory insufficiency. When these pa-
tients were incorporated into the first !CU in Eng-
land at St. Thomas Hospital, they considered them-
selves “Responauts,” risking to enter the “unknown”-
their community-despite prolonged need for me-
chanical ventilation. This program, based now in the
Baroness Lane Fox unit, continues to actively serve
about 250 persons at home. The majority of
Responauts have neuromuscular diseases and reside
with their families all over the United Kimgdom.
Those Responauts with complex medical needs and
no family members can benefit from HMV with cane
from personal attendants as a nsuit of recommen-
dations of the Responaut Study.2’
The devices used at home by the Responaut
Program include positive pressure “respirators” fea-
turing simple “bicycle technology” and “alligator”
iron lungs, which open to provide ready access and
permit notation for physical therapy. This innovative
technology, specially designed for the original polio
survivors, has a history of simplicity for instruction,
adaptability for use, proven reliability, and ease of
maintenance and repair.
Hospital-based technicians track the performance
of all original equipment. These experts make
monthly/bimonthly visits to the homes for routine
maintenance and surveillance of the well-being of
the Responauts, as well as emergency repair calls at
any time of day on night. They replace original
equipment with a loaner when they must perform
more extensive repair in the hospital-based work-
shop. In the past when modern devices were im-
ported, they were proven to be costlier to purchase
and maintain. Manufacturers of imported technol-
ogy had not established repair facilities in England,
and returning them abroad required one-third to
one-fourth the cost of the original machine and up
to 4 months (C. Spencer, personal communication,
1990)! Modern portable ventilators for home cane are
now manufactured in England. Examples include
The Nippy portable positive pressure ventilator
(Thomas Respiratory Systems, London, England)
and the Brompton PAC assiston-controiled ventilator
(Pneumo Pac, Luton Beds, England).
The Responaut Program is directed by an expert
home cane physician, who remains personally in-
volved in technology assessment for each patient.
All Responauts at home have direct telephone ac-
cess to the hospital base-unit and this physician.
Professional team members representing multiple
disciplines (ie, nursing, physical/respiratory therapy,
social work) schedule regular home visits to each
ventilator-user and their equipment. The physician
and team members always remain immediately avail-
able to support technical, medical, social, and finan-
cial needs. The physician communicates with manu-
factunems providing direct feedback regarding
equipment performance and design modification.
France
France has a system of 32 regional associations
and one national organization that serves over 20,000
ventilator-assisted and/on oxygen-dependent per-
sons. Its origin dates back to the 1960s when polio
patients were discharged from respiratory centers,
which had subsequently evolved into !CUs, to des-
ignated home care organizations in the commu-
nity.8’16 At the end of the 1970s, the French govern-
ment authorized a study evaluating the initial me-
gional experiences with home mechanical ventila-
tion?’�’� The study recommended a uniform national
approach for both home mechanical ventilation and
the growing demand for home oxygen. This resulted in
the establishment of associations for chronic respira-
tony insufficiency in all regions of France and the
creation of a national organization (Association Na-
tional pour la Tm#{225}itment aDomicile de l’insuffisance
Respiratoine, ANTAD!R).’82#{176}
Currently, HMV is available in every part of
France from designated, not-for-profit regional as-
sociations that provide equipment, supplies, clinical
oversight, and technological surveillance. The
patient’s physician must prescribe devices for home
use by a uniform national mechanism that guaran-
tees full reimbursement for the technology and its
essential support. After physicians from the regional
association and social security review each initial
prescription ANTAD!R orders the appropriate
equipment, which receives its own identification
number. These prescriptions and a computerized
database permit the system to track and evaluate the
application of technology at home and the penfom-
mance of devices from initial manufacture and
delivery through all clinical use until obsolescence.
Regional associations do not provide primary
caregivens; ventilator-assisted persons in France
require care from a highly committed family. When
events at home require supplemental caregivers,
professionals and personal attendants are available
on a limited basis from other organizations.’�’7
Home care physicians, along with nurses, respina-
tony/physical therapists, and technician specialists
from regional associations do make intermittent
home visits to ensure that equipment matches the
need of each user and to evaluate technology per-
fonmance. In most regional associations, clinical and
technical information immediately enters a comput-
enized database that permits national pooling of
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CHEST I 105 I 5 I MAY, 1994 1451
information for review, analysis, and feedback to
users and manufacturers. The information network
provides physicians with access to instant notifica-
tion by all regional associations of technological
problems as discovered. An “info-alert” and/or tn-
monthly bulletin disseminate news about relevant
experiences and unusual occurrences. Additionally,
expert physicians and technicians from regional
associations shame this information and conduct
essential field trials and device me-evaluations at the
Medical-Technology Commission of ANTADIR24
United States
In the United States, technology assessment is
impeded by our complex system that has many gaps.
It is true that the Food and Drug Administration
(FDA) evaluates new respiratory came products be-
fore distribution. By FDA regulation, manufactur-
ems must test new devices to establish safe and
effective performance before release to consumers.
However, market channels among manufacturers,
distributors, professionals, and consumers break-
down thereafter. Theme is no established mecha-
nism for multidirectional flow of safety information
or use experience. Although the home cane physi-
cian may have access to device reporting processes
for life-threatening events,�’26 the fragmentation of
our complex system hampers dissemination of iso-
lated experiences of inadequate product penfom-
mance. This leaves the physician, the HMV team
members, and the ventilator user without a pmede-
termined way to shame their device experiences and
inform both manufacturers and distributors. For the
physician, this translates into isolation; the only way
to learn about shared device performance expeni-
ences is through informal and irregular networking.
The home care physician depends heavily on com-
munication from the ventilator user, family mem-
bems, and professionals in the home for information
about technology performance. Personal attendants
who may serve as acceptable alternate caregivers for
ventilator-assisted individuals may be another source
of observations for the physician.27’�
The means of promoting product improvement
through technology assessment and information ex-
change in our free market has been limited. In the
past, funding for home care technology and its
support has been discretionary and dependent on
fragmented heaithcame funding policies. Managed
care organizations, commercial insurers, public pay-
ens, and self-insured employers have differed in
their willingness to pay for such coverage. A grow-
ing number of patients have had either insufficient
on nonexistent means to pay for technology sumveil-
lance. Only recently (1993) have Health Came Fi-
nancing Administration rulings defined comprehen-
sive home care requirements for health maintenance
organizations and managed came organizations based
on medical necessity without regard to cost or
duration. As a result of past funding inadequacies,
HTHC in the United States has featured inequities
of access and allocation of resources. Without suffi-
cient funding for technology and its support, the
physician and management team cannot adequately
address quality improvement, risk management, and
cost control.
Recent initiatives have begun to raise conscious-
ness about the need to disseminate information
about home care technology. In 1986, the American
College of Chest Physicians created guidelines for
physicians about mechanical ventilation in the home
or alternative community settings.28 In 1988, con-
sensus conferences sponsored by The American
Thonacic Society, The Food and Drug Administra-
tion, The American Association of Respiratory Came,
and The Health Resources and Services Administra-
tion addressed HMV and equipment-related prob-
lems.293#{176} Several committees of the American Soci-
ety for Testing and Materials developed voluntary
consensus standards,3’ and the Joint Commission of
Accreditation of Healthcare Organizations estab-
lished quality management accreditation for home
cane organizations providing support services me-
lated to medical technology.32 Consumer organiza-
tions have begun to formalize their networks to
share information,33 and manufacturers have estab-
lished networks among professionals to describe
product-related experiences.34 The National Center
for Home Mechanical Ventilation, an independent
nonprofit research organization supported by manu-
facturems, suppliers, healthcame professional associa-
tions and consumer organizations, encourages de-
vice performance tracking and information exchange
among representatives of its constituency.33 These
recent attempts, however, have not completely solved
the systemic fragmentation of technology assess-
ment and information dissemination.
DiscUssIoN AND RECOMMENDATIONS
Home care technology use and assessment in
England, France, and the United States show what
can (or cannot) be accomplished in different nations
because of (or despite) certain healthcare financial
and delivery systems in place. In each country,
healthcare professionals, consumers, and organiza-
tional leaders have achieved some awareness of the
universal importance of a mechanism to evaluate
and improve technology performance with use over
time.
In England, The Responaut Program represents a
unique model approach; it does not reflect a uni-
form national experience.36 Rather, it functions as a
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1452 TechnolOgy and Assessment and Support of Life-sustaining Devices in Home Care (Alien I. Goldberg)
regional program with a national outreach. This
achieves technology assessment on a program level
without a formal system and despite healthcane
finance not necessarily geared for this purpose.
The French system shows a formal mechanism
established to track and reassess home technology
performance. Prior to application, a rigorous
premanket evaluation process with strict device stan-
dards and protocols determines acceptability of
technology for home use. The French system then
determines whether continuous home use is appro-
pniate, safe, and medically necessary. This mecha-
nism conforms to healthcare financing and political,
social, and cultural realities in France.19
The current inadequacy of technology tracking in
the United States results from absence of a defined
health policy and lack of success establishing an
organized way to effectively link all involved actors.
This is partly explained by our political history and
market based approach to the economy which en-
courages individual freedom, pluralism, and diver-
sity as an acceptable way we approach issues.20
Rather than working together for a common pun-
pose, professionals, service providers, manufactun-
ems, suppliers, and consumers have pursued and
lobbied their own interests. Our nation, however,
also has a tradition of unity of purpose and action in
times of crisis as shown during the poliomyelitis era.
Now is such a crisis due to the impact of technology
costs on overall heaithcare spending. Technology
assessment should involve all potential stakeholdens
of a system; they should also define the coordinated
way to accomplish it.14 The absence of an effective
systems approach will result in continued opera-
tional inefficiencies and requirements for additional
costly safeguards (second ventilatons, professional
surveillance). Consequently, HTHC may become
prohibitive for financial and risk concerns.
In the United States, there is a growing general
interest in technology assessment to accomplish
quality healthcane and cost containment.37 Evaiua-
tions of the Office of Technology Assessment found
that only a minority (15 to 20 percent) of existing
healthcare practices in 1978 were considered ben-
eficial based on well-controlled trials.38 Theme is a
strong case for regular reassessment of existing
technology in use as well as the assessment of newer
technology before introduction into the clinical
setting and heaithcane marketplace.5 Reassessment
is especially important in view of high economic
costs, burdens to patients and families, and risk of
adverse outcomes to users of technology that may
be inappropriately prescribed or continually used.
The scope of future technology assessment must
be broad. Devices and procedures should be cniti-
cally tested before routine clinical use, with the
focus going beyond the biomedical perspective of
safety and efficacy.39 The “new technology assess-
ment” has to include a wide scope of perspectives
representing multiple disciplines with an emphasis
on outcome, efficiency, and medical appropriate-
ness.L�� The interplay of forces that determine the
diffusion of technology in the marketplace is poorly
understood.5 Physician attitude and behavior, how-
even, determine to a large extent when and how
technology will be applied in the clinical setting.5
Unfortunately, not much is known about the influ-
ences on physicians regarding how they obtain and
apply practice-related information about use of tech-
noiogies.”#{176}
In the United States, HTHC may evolve without
input of physicians due to the lack of incentives for
physician participation.4’ Nevertheless, pediatric
home care physicians surveyed unanimously agree
that a physician must be directly involved.42 These
physicians stated a need for access to information
about home came technology to assume their respon-
sibilities. Physicians also want mechanisms to report
experiences as users of technology in the home.
These experiences would provide invaluable infor-
mation for technology reassessment.
A system that encourages physician participation
in home cane technology assessment should focus on
what physicians value: quality cane. Continuous
quality improvement activities of practicing physi-
cians should incorporate technology assessment. A
system also ought to reflect how physicians work; a
technology tracking mechanism should relate physi-
cians to physicians and to other healthcame profes-
sional experts. Physicians who use home cane tech-
nology have insights that might then be transmitted
to others involved in technology assessment and
technology tracking systems could integrate their
experiences.
The United States can look to other nations that
have created successful mechanisms for home care
technology assessment. The experiences of these
nations show that methods of technology evaluation
exist regardless of the healthcane finance system in
place. Each nation’s particular approach reflects
their own culture, which determines what and how
things are done. Physicians in each country recog-
nize that technology assessment represents a com-
ponent of quality, risk, and cost management that
impacts patient care and safety. Technology assess-
ment should incorporate physician experience as
technology users in the home environment.
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