Medications and devices

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. 

Kessler, D. (1993). Introducing MedWatch A new approach to reporting medication and device adverse effects and product problems. Journal of the American Medical Association, 269, 2765—2768. 

Kessler, D.A. Introducing Medwatch new approach to reporting medication and device adverse effects and product problems. J.A.M.A. 1993, 269, 2765-2768. Hartzema, A.G., Porta, M.S., Tilson, H.H., Eds. Pharmacoepidemiology An Introduction, 2nd Ed., Harvey Whitney Books Cincinnati, 1991. 

The sponsor/CRO must go through a formal assessment procedure before placement of a study. Some of the most important areas requiring assessment are described in Table 12.2. All studies involving research of investigational medications and devices require qualified investigators, and the internationally accepted standard for qualified usually encompasses three main criteria medically qualified, that is legally licensed to practise medicine as a physician experienced in the relevant therapeutic specialty and experienced in clinical research. 

Management of clinical study medications and devices is a complicated activity, and many clinical researchers report that they are not particularly interested in this aspect of clinical studies they assume that it is all handled by other personnel in the manufacturing facility. Meanwhile, personnel in the manufacturing facility usually report that they assume no further responsibility once the supplies are released ... 

Kessler, D.A. Introducing MEDWatch New Approach to Reporting Medication and Device Adverse Effects and Product Problems. J.A.M.A. 1993, 269, 2765-2768. 

Improvement in Management Skills. Patients and families should be shown the various types of medications and devices, and the patients should be tested to determine their preferences and ability to use them correctly. The appropriate selection of devices for specific patients cannot be overemphasised. Once the device is selected, patients and families must learn how to use them correctly. On repeat visits, patient ability and competence is checked and re-checked. Peak flow measurement with home monitoring is generally prescribed for those with moderate-to-severe asthma. Self-management is made as simple as possible. 

Figure 9.1 provides a conceptual framework for risk identification. There are various sources of risk of medical products that can result in injury or death, including known side effects, medication and device errors, product defects, and other remaining uncertainties. These risks are influenced by many factors, including patient characteristics (such as demographics, comorbidities, concomitant medications, and health service utilization), health system factors (such as utilization practice and provider behavior). 

FDA Form 3500A, MedWatch Mandatory Reporting Medication and Device Experience... 

The advantages of miniaturization are now being exploited in areas beyond microelectronics. Adaptation of materials and processes originally devised for semiconductor manufacture has allowed fabrication of sensors (for example, pressure meters and accelerometers used in the automotive industry) (6,7), complex optical (8) and micromechanical (6,7,9) assembHes, and devices for medical diagnostics (6,7,10) using Hthographic resists. 

Composite Devices. Composites made of active-phase PZT and polymer-matrix phase are used for the hydrophone and medical imaging devices (see Composite materials, polymer-matrix Imaging technology). A usehil figure of merit for hydrophone materials is the product of hydrostatic strain coefficient dj and hydrostatic voltage coefficient gj where gj is related to the dj coefficient by (74)... 

The American Society for Testing and Materials (ASTM) F4 Committee on Medical Materials and Devices has developed specifications for chemical composition, mechanical properties, and other factors. Standard test methods also are available from ASTM, 1916 Race Street, Philadelphia. The quaHty of castings is important for dental implants, and standards to define this would be useful. 

Assembly of medical and veterinary devices made of polypropylene. 

Table 7-15(a) Guide to relative radiation stabilization of medical plastic devices where dose (kilogray) in ambient air and room temperature at which elongation changes by 25%... 

In the case of IVDs that require the involvement of a Notified Body, data on performance characteristics, the results of performance evaluation and device certificates issued by the Notified Body must be included in the submission. The Competent Authorities are responsible for entering the following information in a European medical device databank, EUDAMED ... 

A major progress in the field is the availability of epinephrine autoinjectors which can be used by the patient him-/herself as a self-medication. Different devices are available which either trigger the injection needle just by pressure on the thigh or which have to be triggered by pressing on a button (like a pencil). The handling of these devices has to be explained and practiced with the patients (see Management, Education) [37-40]. 

In silico models will aid both the standardisation and individualisation of medical care. Standardisation of diagnoses, drug and device descriptions, procedures, etc. will make relevant information more readily and more widely available. On the other hand, advanced models will allow development of patient-specific procedures for diagnosis and treatment. This will move the focus from the treatment of diseases to the curing of patients. 

Walker, J. L. Single Cell Measurement with Ion-Selective Electrodes, in Medical and Biological Applications of Electrochemical Devices (Koryta, J., ed.) New York, Wiley, 1980, p. 109... 

Patients must understand the role of long-term control and quick relief medications in their asthma treatment plan. The importance of understanding asthma as a chronic disease and the need for daily treatment with long-term control medications should be stressed. Additionally, the importance of proper use of medication delivery devices should be continually reinforced. Basic education should be provided over several visits with the health care provider. 

Because prostheses are the most invasive treatment available, they are only considered in patients who do not respond to medications or external devices, or those who have significant adverse effects from other therapies. Patient satisfaction rates can be as high as 80% to 90% with partner satisfaction rates just slightly lower.9 The primary risks of insertion of prostheses are infection and device failure, although these only happen in 2% to 3% and 2% to 14% of patients, respectively. Higher infection rates have been reported in uncontrolled diabetic patients, paraplegics, and patients undergoing reimplantation or penile reconstruction.14,15 Most prostheses can be expected to last from 7 to 10 years.16... 

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