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Although the experience of the Hospital for Joint Diseases is unique in terms of size of market controlled, the cost-containment techniques described above are applicable to almost any hospital. A crucial factor in any such process is enlisting the active participation of the surgical staff at every stage. On the basis of the success, this cost-containment procedure is being applied to other components of the medical device purchases.

In order to analyse the ratio of costs to clinical benefit of the implantation of a neurostimulator (type Medtronic SE-4) we examined a group of 14 patients who required treatment for chronic lumboischialgia after repeated surgery for herniated discs. Over a period of two years we evaluated the pre- and postimplantation costs. The implantation of a DC-Stimulator resulted in a striking decrease in drug requirements, in the total time of clinical treatment, and in the degree of disability. The DCS provides a satisfying method of treatment for chronic lumboischialgia after repeated surgery for herniated discs. Despite relatively high primary costs, treatment with a DCS results in a significant decrease in the accumulated expenses in comparison to other methods of medical treatment in similar cases.

Technology assessment is attracting new attention and funding as concern about costs and effectiveness of health care grows. This article provides a general overview of technology assessment and relates recent trends and future prospects specifically to the use and evaluation of implanted medical devices. In the next decade we may expect to see renewed interest in technology assessment as pressure to control health care costs continues and as a different focus of evaluation emerges that emphasizes patient preferences and quality of life in addition to traditional measures of safety, efficacy, and cost-effectiveness. These pressures and forces will act to increase the visibility and importance of proper assessment of medical technology, and the field may more nearly achieve its early promise as a tool to make medical care more rational.

The evaluation of survivors of sudden cardiac death with serial electrophysiologic studies involves a lengthy and expensive hospitalization, especially when an automatic implantable cardioverter-defibrillator is ultimately necessary. The cost efficacy of this conventional approach was therefore compared with direct implantation of a cardioverter-defibrillator after the first electrophysiologic study. Thirty-two survivors of sudden death who had inducible ventricular tachycardia during their initial electrophysiologic study underwent serial drug trials. At discharge 12 (37%) were taking an antiarrhythmic drug found to prevent induction of ventricular tachycardia and 20 underwent cardioverter-defibrillator implantation after serial drug trials proved ineffective. The average length of hospitalization for this group that had undergone serial drug testing was 20.2 +/- 9.3 days at an average cost of $48,900 +/- $31,600. Seven survivors of sudden death had no inducible ventricular tachycardia during their initial electrophysiologic study and underwent direct cardioverter-defibrillator implantation. Their average length of hospitalization was 12.6 +/- 6.2 days at an average cost of $40,400 +/- $8,300. It is concluded that automatic implantable cardioverter-defibrillator implantation as an early intervention is not more costly and indeed may be cost-effective compared with therapy guided by serial electrophysiologic testing. As antitachycardia devices become more versatile, long lived and easier to implant, earlier implantation is likely to compare even more favorably with drug therapy.

The automatic implantable defibrillator has been shown to decrease the mortality of patients who have survived cardiac arrest due to ventricular tachycardia or fibrillation and are at high risk for recurrence. We performed a cost-effectiveness analysis of this seemingly expensive new technology with data obtained from the 1984 Medicare data base, the medical literature, Medicare carriers, individual pharmacies and hospitals, and expert opinion. Analyzing combinations of principal and secondary discharge diagnoses across 18 diagnosis-related groups, we estimated the cost of hospitalization for a comparison group of patients. Hospitalization costs for the defibrillator group were obtained from reported empirical data. Rehospitalization rates and other health-care use estimates were solicited from an expert panel of physicians, and mortality rates for both groups were obtained from the literature. Using a decision-analytic model, we estimated that the net cost effectiveness of the defibrillator, when used in the high-risk patient, is approximately $17,100 per life-year saved, with sensitivity analyses suggesting that the true value lies between $15,000 and $25,000. This estimate is well within the range that is currently accepted by the US medical care system for other life-saving interventions. We also estimated the cost effectiveness of the defibrillator in a 1991 scenario to be $7,400 per life-year saved, when the device would have greater longevity, would be programmable, and would not require a thoracotomy. Sensitivity analyses suggest that the true value lies between a value that is cost saving (less expensive than pharmacologic therapy) and $19,600 per life-year saved.

A case is presented of a young woman implanted with a programmable implantable medication system (PIMS). Implanted insulin pumps have been the subject of research for over a decade but have encountered a series of obstacles ranging from design problems to insulin aggregation to catheter blocking from omental tissue. Many of these problems, but not all, have been overcome. Implanted insulin pumps are still in a developmental phase. Glucose sensing is not yet available. Nevertheless, PIMS has demonstrated in this case that it can safely and effectively control insulin-dependent diabetes for over 1.5 years.

Since 1974, 900 patients with erectile dysfunction from various causes underwent implantation of a semi-flexible prosthesis, generally of the Small-Carrion type. The largest group had arteriosclerotic or hypertensive cardiovascular disease. The second largest group was composed of patients with diabetes mellitus. Those in the third group had undergone prostatectomy, cystectomy, or abdominal-perineal resection. For a large number of patients a diagnosis of psychogenic impotence was reached, mainly from the results of the history questionnaire and the Minnesota Multiphasic Personality Inventory. Complications were rare (8.1%). Preoperative, intraoperative, and postoperative considerations include correct selection of prosthesis, rigorous antibiotic coverage, prevention or care of perforation, and possible need for reoperation. The results were almost uniformly successful. Psychogenic cases and instances of infertility related to the impotence are reviewed.

Experience of myoelectric prostheses for unilateral below-elbow amputees in a large region of Great Britain is presented. Of the cases considered, 14 were adults and 29 were 16 years of age or less. The rejection rate was 25% overall but it was lower in adults, at 17%. Comparisons with published data and other aspects of myoelectric prostheses are discussed. Just over half the 37 amputees interviewed were independent in activities of daily living; independence was more common in the adults, at 77%. A very large proportion of myoelectric prosthesis users also used body-powered prostheses, demonstrating a need for both types of prosthesis for optimum rehabilitation. It is recommended that myoelectric prosthetic programmes should be carried out from specialized centres with comprehensive facilities for this expensive rehabilitation aid.

The author presents the view that there is a real need to diagnose impotence in more detail as demand for physiologic solutions to erectile dysfunction make inroads into the simplistic solution offered by penile implantation. Penile blood pressure measurements are diagnostic of vascular insufficiency only when values are low, since it is possible to demonstrate obstructive disease of the internal pudendal artery and its branches with selective arteriography of the presence of normal penile blood pressure. A rational approach to the workup of impotence is called for and practitioners are asked to weigh the ultimate usefulness of each test in the context of the individual patient's needs.

Once the concept of strict liability was extended to cover defective product design, negligence was no longer truly an issue in a products liability case. The manufacturer must now design his product so that it will be "safe" when used for its intended purpose and must foresee any possible misuse that may be made of the product. As the doctrine of strict liability became prevalent throughout the United States, the cost of insuring against the potential of huge verdicts associated with products rose dramatically. The resultant increased costs borne by a manufacturer may eventually lead to fewer and fewer implantable devices being developed and placed on the market.