Obstacles to implement machine perfusion technology in routine clinical practice of transplantation: Why are we not there yet?

Abstract

Machine perfusion of solid human organs is an old technique, and the basic principles were presented as early as 1855 by Claude Barnard. More than 50 years ago, the first perfusion system was used in clinical kidney transplantation. Despite the well-known benefits of dynamic organ preservation and significant medical and technical development in the last decades, perfusion devices are still not in routine use. This article describes the various challenges to implement this technology in practice, critically analyzing the role of all involved stakeholders, including clinicians, hospitals, regulatory, and industry, on the background of regional differences worldwide. The clinical need for this technology is discussed first, followed by the current status of research and the impact of costs and regulations.Considering the need for strong collaborations between clinical users, regulatory bodies, and industry, integrated road maps and pathways required to achieve a wider implementation are presented. The role of research development, clear regulatory pathways, and the need for more

Establishing a HOPE Program in a Real-life Setting: A Brazilian Case Series

“…27 Secondly, hurdles regarding regulations and registration of perfusion devices for clinical use are ongoing worldwide. 28 Therefore, thus far, to cope with these difficulties, MP programs frequently start with the research pathway. This path may provide a funding opportunity and facilitate the introduction of the technology in the country before the time-consuming final regulatory body authorization for clinical use and avoid the enormous tax rates for device internalization.…”

“…For example, in Brazil, the tax rates for biomedical devices increase their prices 2-3 times compared with other countries. 28 Additionally, setting the program demands multidisciplinary team training and hospital administrative authorizations. For example, clinical engineering must revise and approve the equipment before clinical use, even in a research project.…”

Challenges With the Implementation of Machine Perfusion in Clinical Liver Transplantation

“…To successfully expand the use of MP and to transform scientific knowledge into a surgeon's daily practice, it is important to develop new practice guidelines, evidence summaries, and materials to educate staff and patients and to report on uniform risk and outcome measures. 10 Studies on MP have focused on their clinical impact regarding safety and feasibility, early liver function, complications, graft survival, and organ utilization so far. The effect of MP strategies on economic aspects should also be considered more often in the future.…”

“…59 An additional challenge is to include costs related to device amortization, staffing, and savings with the treatment of end-stage liver disease while being listed with more expedited transplantation and less long-term complications. 10 Novel technologies in healthcare impact patients' quality of life, a "soft factor" not easy to objectively measure, which requires cost-utility analyses to consider the value of an intervention, going beyond the "simple price. "…”

“…Regulations vary between countries not only regarding organ donation and allocation but also for device approval and registration. 10 Despite the recent progress with equipment development, testing in clinical studies, and implementation in different regions worldwide, clear guidelines for regulatory approvals, staff training, and required clinical trials are lacking. This article discusses the various challenges with the implementation of MP in clinical LT on the background of 2 recent international webinars organized and supported by the Special Interest Group for DCD LT and MP at the International Liver Transplant Society.…”