Development of a specialized bioengineering service-based organization to augment the clinical application of artificial organ technology

Summary form only given. The emergence of artificial organ (AO) technologies as a conventional therapy for end stage failure and alternative to organ replacement has produced a need for dedicated clinical personnel to manage patients supported by them. These focused individuals provide clinical, educational and technical support in the hospital surroundings, and because a principal goal of AO device application is to enhance quality of life, they also serve as a resource for patients living outside the hospital or at home. Furthermore, AO specialists furnish post-marketing feedback to manufacturers and clinicians yielding superior products that should enhance patient outcomes. Currently, more than 1000 patients receive mechanical cardiac support (MCS) devices each year. Recent estimates indicate that this number could surpass 20,000 within in the next five years. With the impending manifestation of other AO technologies, e.g., the bio-artificial liver and chronic artificial lung, many thousands of patients and several clinical sites worldwide can be expected to utilize sophisticated mechanical devices. To accommodate the widespread application of AO technologies, new "best practice" models for patient care, training, and follow up will need to be fashioned and refined. In addition, clinical centers may be required to have experts on site to supervise the utilization of AO devices. We propose an innovative model support system that utilizes professional biomedical engineers, with both clinical and technical expertise, to interface with these technologies, in the structure of a service-based company. Our center has developed such a model program in which a cadre of biomedical engineers undertakes both AO technical support and patient care responsibilities. This group has participated in the support and care of more than 220 MCS patients over a 15-year period; of the MCS patients, more than 50 have been managed following discharge home. In addition, the biomedical engineers have trained literally thousands of medical specialists to care for patients and AO systems in their own hospital and home settings. We believe that a biomedical engineering-based program model enhances the capacity of medical centers to utilize state-of-the art AO technologies, and c- ould ultimately yield augmented AO devices and better outcomes for those patients who require these products.