Medical devices therapy

The cardiovascular health care marketplace is highly competitive. This works to the advantage of medical device companies. Hospitals are engaged in intense competition for those who might be candidates for cardiovascular therapies. Therefore, hospitals are anxious to offer the best treatment possible, having the newest devices. Medical specialties are also competing for their share of the same patient population. 

Heart transplantation represents the final option for refractory, end-stage HF patients who have exhausted medical and device therapies. Heart transplantation is not a cure, but should be considered a trade between a life-threatening syndrome and the risks associated with the operation and long-term immunosuppression. Assessment of appropriate candidates includes comorbid illnesses, psychosocial behavior, available financial and social support, and patient willingness to adhere to lifelong therapy and close medical follow-up.1 Overall, the transplant recipient s quality of life may be improved, but not all patients receive this benefit. Posttransplant survival continues to improve due to advances in immunosuppression, treatment and prevention of infection, and optimal management of patient comorbidities. 

More generally, the presence or absence of good clinical data imposes limits on the economic evaluations that can be conducted. It is usually easier to undertake economic evaluations of drug therapies, where there are usually some reasonable clinical data, as compared with medical devices or procedures. However, even for drugs, the data from standard Phase 3 clinical trials are far from ideal. These trials are usually conducted under conditions that are atypical of normal practice. In addition, they are often of short duration and often fail to compare the most relevant alternatives for economic evaluation. This means that decision-analytic modeling is usually required as a supplement to, or alternative to, economic analysis alongside trials. 

Clinical trials, also known as clinical studies, test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. A treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy. Potential treatments, however, must be studied in laboratory animals first to determine potential toxicity before they can be tried in people. Treatments having acceptable safety profiles and showing the most promise are then moved into clinical trials. 

Dalby, R. N., Hickey, A. J., and Tiano, S. L. Medical devices for the delivery of therapeutic aerosols to the lungs, in Inhalation Aerosols Physical and Biological Basis for Therapy (Lung Biology in Health and Disease, Vol. 94). New York Marcel Dekker, 1996. 

Pharmaceutical Care includes the supply, preparation, control, storage and dispensation of medicinal products and medical devices, providing information and consultation for the patient and following the therapy. The licence for pharmaceutical care can only be granted to the natural person with the pharmaceutical qualification. 

Ocular irritation tests are significantly different from the other local tissue irritation tests on a number of grounds. For the pharmaceutical industry, eye irritation testing is performed when the material is intended to be put into the eye as a means or route of application for ocular therapy. There are a number of special tests applicable to pharmaceuticals or medical devices that are beyond the scope of this discussion since they are not intended to assess potential acute effects or irritation. In general, however, it is desired that an eye irritation test be both sensitive and accurate in predicting the potential to cause irritation in humans. Failing to identify human ocular irritants (lack of sensitivity) is to be avoided, but of equal concern is the occurrence of false positives. 

We should note here that there are some special cases for which the use of healthy participants is not justified in early studies. For particularly invasive therapies (for example, implantation of a medical device) or therapies with known toxicity (for example, oncologies) it is not ethical to study healthy participants. The use of healthy participants in early studies may also provide a misleading result for future studies of participants with disease. For example, the maximum tolerated dose of new antidepressants or anxiolytics may differ quite markedly between healthy participants and those with the disease. 

The Food and Drug Administration (FDA) develops standards for radioactive material concentrations in food (FDA 1998), and medical devices used in radiation therapy (FDA 1997). The FDA recently updated its guidance document that presents recommended action levels for radionuclides in foods, both domestic and imported (FDA 1998). These derived intervention levels (DILs) are estimated levels in food that could lead to individuals receiving a radiation equivalent dose equal to the FDA protection action guide (PAG) that is set as the more limiting of either 0.5 rem (5 mSv) for committed effective dose or 5 rem (50 mSv) committed dose equivalent to any individual tissue or organ. Table 8-2 presents the most restrictive DILs for strontium. 

Novel APIs, medical devices and gene therapy vectors/systems are increasingly being discovered and designed based on tlieii interaction with genetic and biological networks. Tlie similarity of tlie genomes of many different species and the conservation of protein stmc-tnre and fnnction necessitates consideration of the effects on the environment and tlie biosphere. 

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