New Medical Devices Invention, Development, and Use (1988) / Chapter Skim
Currently Skimming:
Perspectives of Industry, the Physician, and Government
Perspectives of Industry, the Physician, and Government
Pages 138-163
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From page 138... ...
Unfortunately, because tort law is concerned only with segments of the health care system that fail, our attention has been inappropriately diverted from the much more important objective of achieving success. The overall quality of medical care and biomedical products has not decreased; significant advances in the pharmaceutical, medical device, and health care arenas continue to occur.
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From page 139... ...
Although risk/benefit assessment has been used extensively in the evaluation of drugs and medical devices, much remains to be done to ensure a better public understanding of the delicate balance between risks and benefits (Carpenter, 1983~. For example, if manufacturers more readily acknowledged the possibility of failure of a medical device, then all parties would be better informed and less likely to be surprised when a failure occurs.
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From page 140... ...
Although manufacturers face strict reporting requirements, they must depend on voluntary reports from doctors to alert them or the FDA to problems that patients experience with biomedical products. The United Kingdom's more formalized yellow-card program facilitates adverse reaction reporting by physicians.
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From page 141... ...
There is a strong tradition in clinical trials and for many surgical procedures of making sure that the participants or patients are well informed about the risks and benefits of the planned medical intervention, and that the participant has freely elected to accept these risks. For some reason this tradition has, in general, not carried over to the postapproval use of most biomedical products.
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From page 142... ...
We must pursue innovation in order to improve medical treatment inventing new devices, developing new drugs, and seeking new uses for and forms of delivery of old drugs. Yet, the threat of product liability hangs over any innovation.
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59~596) modeled on the informed consent used for clinical trials.
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From page 144... ...
At ALZA, once we determine that a medical product is safe and effective in controlled clinical trials, we ask how we can support its safe and appropriate postapproval use with the proper software. Throughout the medical device industry, such biomedical product software deserves much more attention.
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From page 145... ...
SAMUEL, JR. TEN STAGES IN THE INNOVATION OF MEDICAL DEVICES There are ten stages through which medical innovation should flow if we are going to have the highest degree of patient care.
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The development of a replicable medical device and the conduct of a clinical trial may go hand in hand, and it is important to remember that much interactive development of new devices takes place. The seventh stage in the innovation process is obtaining FDA approval based on the results of the clinical trial and other relevant information.
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From page 147... ...
FACTORS INFLUENCING THE TEN STAGES IN MEDICAL DEVICE INNOVATION An issue that cuts across several of these stages is professional and patient acceptance of new medical technologies. Professional accep
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From page 148... ...
A regulatory agency should be staffed with professionals who are cognizant of the state of the art of medical technologies. Both the public and the medical devices industry will rely on decisions made by such an agency, but we are not at that point.
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From page 149... ...
Instead, we should concentrate on ensuring that the products are used the way they were intended to be used. Whether health care providers follow reasonable standards in reuse of disposable products or acceptable procedures for calibrating anesthesiology equipment, the single greatest opportunity for shortterm improvements in patient care remains greater education for the users of medical devices.
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From page 150... ...
FINEBERG What is, perhaps, most important about the Prospective Payment System is that prospective payment represents a more centrally controllable pattern of payment for health care services than did costbased reimbursement. As we consider moving from the Prospective Payment System, which is payment based on episode of illness, to payment systems
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From page 151... ...
The answer depends on how much money we put into the Prospective Payment System and how it is directed to be spent. In the future, physicians increasingly will be subject to the incentives of prospective payment.
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From page 152... ...
BIOMEDICAL INNOVATION Several individuals have suggested that the United States needs to have an explicit strategy to promote biomedical innovation in research, in the field, and in industry; that we do need to think about biomedical innovation systematically; and that we should be seeking ways to encourage the kind of creativity, inventiveness, and independence that seem to be at the heart of successful innovation in the past. Several approaches have been suggested: various industry/university associations, the kind of small business investment program that the National Institutes of Health has started, the possibility of consortia funded or convened under government auspices, and various proposals for coordinating and integrating interagency activities within the government.
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From page 153... ...
Susan Foote discussed the risks of allowing judgments about the appropriateness of medical devices to be made in court, and I agree that it is unlikely to be effective. But we should recognize that if those judgments are to be made by physicians and evaluators in an informed way, they must also be made relative to the alternatives.
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How Trends Will Interact: The Perspective of the Government LOUISE B RUSSELL The government has at least four major perspectives on new medical devices in health care.
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From page 155... ...
I will review the changes in the government's roles in medical device innovation during the last 35 years; this will provide the background for projecting changes in the government's roles in the future. THE GOVERNMENT'S ROLE IN RESEARCH The 1950s and 1960s were halcyon days for medical research.
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From page 156... ...
In the beginning, the government was primarily an observer; many federal programs were debated, but few were passed. Meanwhile, private insurance payments rose from less than 10 percent of total expenditures for personal health care in 1950 to nearly 25 percent in 1965.
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From page 157... ...
Government regulation of medical devices expanded under the Medical Device Amendments of 1976. The Food and Drug Administration's responsibility for drugs has been widened "to include efficacy as well as safety.
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From page 158... ...
I project that this situation will continue for some time, unlike earlier periods when health spending leveled off for a couple of years before increasing again. This means that, while the market for medical devices is large and will remain large, it will not grow faster than the GNP.
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From page 159... ...
It has sampled this new role in the last few years with the implementation of policies like the Prospective Payment System, which were implemented to help slow increases in government expenditures for health care. For these reasons, I agree with Anthony Romeo's conclusion (this volume)
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From page 160... ...
From 1981 to 1983 the number of days of intensive care used by Medicare beneficiaries increased every year. Between 1983 and 1984, the first year of prospective payment, the number of days used declined 14 percent.
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I cite two examples of what ~ see as an increasing appetite for information. The first is the release of hospital mortality data by the Health Care Financing Administration.
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From page 162... ...
Many of them have undertaken studies. But, except for the Health Care Financing Administration, which for obvious reasons should not be counted on to provide complete and objective information, none of them is in a position to produce more than a series of small, rather specialized studies.
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From page 163... ...
1986. Medicare Past Overuse of Intensive Care Services Inflates Hospital Payments.
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