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The role of clinical engineers in dialysis therapy in Japan

The role of clinical engineers in dialysis therapy in Japan Traditionally in Japan, dialysis treatment has been performed primarily by physicians and nurses. However, with the advancement of related medical equipment, such as the development of dialyzers and dialysis monitor- ing equipment, technical support by technicians has become necessary. Therefore, in 1988, the “Clinical Engineers Act” was enacted and recognized as an official national qualification for technicians to operate these devices, in light of the actual status of these technicians and the fact that further advancement and diversification of medical devices will require their expertise in the future. This is a professional qualification unparalleled anywhere in the world. In dialy- sis treatment, purification of dialysate and efficient removal of uremic substances are fundamental principles. Clinical engineers have contributed significantly to the elimination of biological and chemical contaminants in the process of production of dialysis water, to the development of high-performance membranes, and to the development and advancement of online HDF, a high-volume fluid replacement method. Furthermore, clinical engineers have been involved in the proposal and development of safe devices to prevent medical accidents that occur during continuous dialysis treatment for many patients. Clinical engineers will continue to contribute to the provision of the best treat- ment methods, not only in the development and deployment of equipment, but also in remote medicine and the uti- lization of large-scale data, as they are medical professionals with knowledge of both medicine and engineering. Furthermore, the scope of the profession, which started in the field of hemodialysis, has the potential to expand to include peritoneal dialysis and other modalities of renal replacement therapy. Keywords Automatic priming function, Back-filtrated dialysis fluid, Purified dialysis fluid Introduction Japanese government enacted the Clinical Engineers Act Dialysis therapy spread rapidly across Japan with the to recognize the expertise required of clinical engineers, introduction of equipment such as dialysis monitor- based on the realities of these technicians’ work and ing systems. In response to this increase in demand, anticipating the increasing sophistication and diversity unlicensed technicians in charge of such equipment of medical equipment to come. Indeed, clinical engineers began participating in patient care alongside physicians are tasked with operating and maintaining increasingly and nurses, at the physician’s discretion. This was how sophisticated medical equipment under direction from a the role of the clinical engineer was born. In 1988, the physician. Before the Clinical Engineers Act went into effect, clinical engineers were unlicensed and were primarily *Correspondence: responsible for preparing equipment for dialysis and pro- Takashi Honma takashi.honma@grp.zenjinkai.or.jp viding technical support to physicians and nurses. How- Japan Association for Clinical Engineers, KT Ochanomizu-Hijiribashi-Bldg ever, the new law clarified the unique responsibilities of 5F, 1-3-4, Yushima, Bunkyo-ku, Tokyo 113-0034, Japan clinical engineers as medical professionals, and expecta- Department of Blood Purification, Tokyo Women’s Medical University, Shinjuku-ku, Japan tions of clinical engineers in these areas have grown even © The Author(s) 2024. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecom- mons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Honma et al. Renal Replacement Therapy (2024) 10:1 Page 2 of 7 greater due to increasing reliance on all kinds of medi- which had become a problematic complication in patients cal equipment. This is due in part to newly arising issues on long-term dialysis. Dialysis-related amyloidosis with medical accidents involving medical equipment causes various symptoms including itching, restless legs and because the conventional team medicine approach syndrome, and bone and joint pain, as well as organic of physicians, nurses, and clinical engineers working in diseases such as bone destruction and carpal tunnel a fragmented fashion under a physician’s discretion has syndrome, and it came to be considered a typical com- failed to ensure sufficient safety. Quality and safety assur - plication of long-term dialysis [3]. In recent years, the fre- ance will improve if team medicine can mature into an quency of its occurrence has reportedly decreased, and independent and collaborative model in which team the cause is believed to be related to improved β2-MG members work independently but share information with clearance on hemodialysis [4]. β2-MG later became an each other based on a clear understanding of their own index for membrane performance evaluation based on responsibilities and abilities. This article discusses how its clearance and sieving coefficient, and it remains so the work and role of clinical engineers has evolved since in the current functional classification of dialysis mem - the dawn of dialysis therapy, as well as future possibilities branes [5]. This development also made the removal of for the profession. solutes (uremic substances) that are not cleared from the body an important proposition for dialysis [6]. Dialy- sis membranes now use synthetic polymer membranes The dawn of dialysis therapy and the birth of the clinical rather than regenerated cellulose membranes and target engineer role medium-sized molecules and protein-bound solutes for In the 1960s, flat-plate dialyzers (also known as Kiil dia - removal rather than small molecules. High-performance lyzers) began to be widely used. Kiil dialyzers are labori- membrane (HPM) dialyzers were introduced to clini- ous to assemble and use, making it difficult for physicians cal practice and modifications were devised to promote and nurses to manage them alone, and this led to the internal filtration and increase removal capacity through emergence of specialized facilities with staff dedicated to HPM. The modality of online hemodiafiltration (HDF) those tasks. The introduction of disposable dialyzers in was also introduced, which allows for large replace- the 1970s made dialysis much less labor-intensive. This ment volumes. The evaluation of HD membranes is also led to greatly increased numbers of dialysis facilities, at discussed in the ISO. The ISO 8637-1:2017 describes which dialysis technicians were hired. During this era, dialysis modality, including evaluation methods for ultra- dialysis technicians mostly worked behind-the-scenes filtration coefficient, ultrafiltration rate, and sieve coef - and faced barriers to involvement in clinical work. These ficient, establishing standards parallel to those in Japan problems were resolved with the passage and enactment [5]. Clinical engineers were essential to the research and of the Clinical Engineers Act in 1987. After a five-year development that led to these dialysis methods, and they transitional period, clinical engineers began engaging in collaborated with physicians on many studies whose clinical work as qualified professionals [1]. results were applied back to clinical practice. Early dialysis systems consisted of a combination of individual devices, instruments, and other equipment with the necessary functions. Later, integrated dialy- Role of clinical engineers in dialysate purification sis systems containing all the essential equipment and The importance of clean dialysate, which is the site of instruments for safe dialysis came onto the market. The solute diffusion and ultrafiltration through the dialy - blood circulation system used for extracorporeal circula- sis membrane, has been pointed out from the begin- tion of blood consisted of devices such as an air bubble ning. In  vitro studies have reported that mediator detector to prevent air from entering the patient’s blood- products pass through the dialysis membrane [7]. It was stream and a venous pressure manometer. The dialysate also reported that the use of clean dialysate reduced circulation system used to deliver and remove dialysate inflammatory reactions, inflammatory cytokines, and was equipped with devices such as a blood leak sensor to improved nutritional status [8]. It was already analogized monitor blood leakage in the blood purifier, a concentra - that the quality of dialysate was involved in the compli- tion sensor to properly control concentration, a dialysate cations of chronic dialysis such as chronic inflammation, pressure manometer, and a fluid removal controller to emaciation, and anemia. Particularly in Japan, the use of ensure accurate removal of fluid from the dialysate. high-performance, high-flux dialysis membranes and the inevitable back-diffusion and back-diafiltration inevi - Developments in dialysis therapy, enabling long‑term tably led to the demand for clean dialysate. Under such dialysis circumstances, if the dialysate is contaminated, pyro- Gejyo et  al. [2] identified beta-2 microglobulin (β2-MG) gens such as endotoxin will inevitably enter the human as the causative agent of dialysis-related amyloidosis, Honma  et al. Renal Replacement Therapy (2024) 10:1 Page 3 of 7 body through reverse filtration and diffusion, and clean introduced in 2005 [11] proposed the bacterial culture dialysate became an essential condition [9]. method to monitor purity by measuring viable bacte- Biological contamination of dialysate was rarely a prob- ria, which are the root cause of contamination, rather lem with conventional dialyzers, but it began to attract than measuring endotoxin activity. Its classification of attention once HPM became popular. To eliminate con- dialysate types into standard, ultrapure, and replace- tamination, clinical engineers devised and implemented ment dialysate, with corresponding viable count limits of −6 a technique called dialysate purification. Dialysis water is 100 CUF/mL, 0.1 CFU/mL and 10  CFU/mL, had a par- produced by a dialysis water preparation system. Essen- ticularly major impact. tially, purification requires the removal of chemical and In 2008, the Japanese Society for Dialysis Therapy biological contaminants. Chemical contaminants are set water quality standards for biological contamina- removed by two types of equipment, an activated carbon tion of dialysate solutions [12]. These standards are the filtration system and reverse osmosis (RO) filters. Bio - strictest in the world for standard dialysate. In 2007, a logical contaminants are removed by equipment such as one-year prognostic study on dialysate cleanliness and an endotoxin-retentive filter, ultraviolet germicidal lamp, mortality risk by the JSDT confirmed a 22.8% increased and ultrafiltration module [10]. Efforts to promote purifi - risk of mortality at dialysate endotoxin levels of 0.1  EU/ cation were particularly bolstered by health care provider mL or higher, validating the appropriateness of setting reimbursements through the Japanese National Health the standard at 0.05 EU/mL or lower [13]. Insurance system, beginning with the introduction of Since 2005, clinical engineers have joined industry reimbursement for water treatment in 1988. The popu - representatives at ISO meetings to continuously investi- larity of RO in Japan dramatically increased when the gate current practices and provide input. In addition, the reimbursement for RO was introduced in1988, prompt- Japan Association for Clinical Engineering (JACE, estab- ing medical facilities to begin removing chemical con- lished in 1990) conducted surveys on viable count control taminants from dialysis water. Figure 1 shows the history at dialysis facilities in 2005 and 2006 and used the results of water quality control and the related reimbursements. to propose clinically realistic guidelines for dialysate After this point, dialysate purification efforts in Japan purification and promote the practice of purification [14]. paralleled those in the rest of the world. Standards are The guidelines are updated as appropriate (Ver. 1.06 in issued by the International Organization for Standardi- 2009, Ver. 1.07 in 2010, Ver. 2.00 in 2011, and Ver. 2.01 zation (ISO; a non-governmental organization head- in 2014) and aim to improve the accuracy of purification quartered in Geneva, Switzerland). ISO/CD 23500 was techniques. 1985 1990 2000 2005 2010 2015 2020 Monitoring of dialysate purification Measurement of EMT Measurement of activity value Chemical pollutant viable bacterial count Treatment & Payment for medical service Bundle of EPO Use of EPO Addition of water Reimbursement approval for on line HDF 2012.4 Use of HPM quality assurance Addition of water treatment Addition of water quality assurance 1,2 2012.4 2018.4 (RO) 1988.4 1994.3 Approval of on line HDF machine 2010.1 Addition of water quality assurance 2010.4 ISO criterion ISO/CD 23500 (2005) ISO 13959 (2009) ANSI/AAMIRD52 Proposal of criteria (2004) ISO 23500 (2011) 2016 Standard of fluids JSDT Water quality criterion for hemodialysis JSDT Revision of standards (2008) 2011 Endotoxin capture filter (ETRF) JSDT criterion (1995) management standards JSDT Revision of standards (2005) JACE Purification guideline Purification GL Purification GL Ver 2.00 (2011) Ver 2.01 (2014) Purification GL Ver 1.07 (2010) 2016 Procedure for achieving Purification GL Ver 1.06 (2009) dialysate fluid quality standards Purification GL Ver 1.05 (2006) (2017) ET: endotoxin, EPO: erythropoietin, HPM: High performance membrane,HDF: hemodiafiltration, HF: hemofiltration, ISO: International Organization for Standardization, ANSI/AAMI: American National Standards Institute/Association for the Advancement of Medical Instrumentation, JSDT: Japanese Society for Dialysis Therapy, JACE: Japanese Society for Clinical Engineering Fig. 1 Changes in purification of dialysate solution, reimbursement, and water quality standards Water quality criterion Honma et al. Renal Replacement Therapy (2024) 10:1 Page 4 of 7 Later, three organizations, JACE, the Japan Society for continuously installed in multiple stages. In chronic Dialysis Therapy (JSDT), and ISO, issued guidelines for dialysis, dialysate management must be carried out rou- dialysate quality, but no standardized clinical target was tinely and permanently, and the work never stops. Many established. Therefore, when JSDT published an update maintenance dialysis patients today need to repeat this to their standard for fluids for hemodialysis and related process to perform dialysis without problems, and a clini- therapies in 2016 (Table  1) [15] that addressed these cal engineer is essential to carry out, manage, and vali- three guidelines, at JACE we adapted our proposed cri- date this process. Currently, each facility is required to teria to the JSDT standard and presented them as the verify the management of dialysate and search for prob- 2016 Procedures for Achieving the Standard of Fluids for lems monthly, and those in charge of management are Hemodialysis and Related Therapies. From the above, it required to attend a course at the JSDT annual meeting is clear that clinical engineers have played a major role in to renew their qualifications. dialysate purification and supporting the advancement of hemodialysis to where it is today [16]. Development of dialysis systems On the other hand, as well as the cleanliness of the Clinical use of HPM dialyzers began after the causative dialysate itself, its management is important, and the agent of dialysis amyloidosis was discovered in 1985. management of water treatment equipment, endotoxin- HPMs are now collectively referred to as membranes retentive filters (ETRFs), and cleaning and disinfec - with added value, such as albumin leakage rate, in addi- tion after each dialysis session are key points. It is also tion to the conventional features of dialyzers with high essential to check whether the cleaning and disinfection ultrafiltration rate. Clinical engineers have played an is being carried out properly and whether the dialysate important role in the actual operation of HPMs, in deter- preparation process is in operation, and to establish mining their efficacy and in monitoring their cleanliness, water quality testing guidelines at each point. In par- a situation that continues to the present day [19–21]. ticular, many dialysis centers in Japan have adopted the Because the fractionation properties of HPMs allow CDDS (central dialysis fluid delivery system), where the them to remove β2-MG, it became essential to use a dial- dialysate preparation process is established by installing ysis system with higher permeability and better control multi-stage equipment in a sequential manner [17, 18]. of fluid removal than a conventional dialyzer. Therefore, Each dialysis center selects and installs its own equip- as HPMs became popular, systems with more advanced ment. The introduction of the validation concept is fluid removal control functions were developed, and necessary for process control and product quality assur- clinical engineers worked on the development and main- ance in manufacturing processes where equipment is tenance of these systems to ensure their safe use. One Table 1 2016 Update Japanese Society for Dialysis Therapy Standard of fluids for hemodialysis and related therapies Chapter 1: water quality standard for biological contaminants 1.1 Ultimate goals of the standard established for biological contamination 1.2 Test for compliance 1.3 Sampling points 1.4 Day of sampling 1.5 Frequency of monitoring (ET and viable bacteria 1.6 Conditions of dialysis to which the respective dialysis fluid standards are applicable 1.7 Endotoxin-retentive filter (ETRF) management standard 1.8 Safety measures Chapter 2: water quality standard for chemical contaminants 2.1 Chemical contaminants and relevant standards 2.2 Control of chemical contaminants: at installation of a water treatment equipment 2.3 Control of chemical contaminants: daily management 2.4 Control of chemical contaminants: in the event of disasters or in case of emergencies Chapter 3: measurement of the residual chlorine Chapter 4: proposal of a “management standard for water treatment equipment” Chapter 5: supplement and management standard for water treatment equipment Honma  et al. Renal Replacement Therapy (2024) 10:1 Page 5 of 7 Future possibilities for clinical engineers in dialysis care of the major challenges in this area was to balance the As the population ages, demographics shift, and medi- goal of eliminating medical accidents against the cost of cine continues to advance, health care providers must modifications, which decreases as the number of patients duly consider patients’ psychosocial backgrounds and increases. In 2007, fully automated machines that substi- lifestyles. This will require further promotion of team tuted dialysate for normal saline were clinically investi- medicine involving physicians, nurses, clinical engi- gated as a means of solving this problem and were shown neers, and other health care professionals. In addition, to be safe and economical. Later, in 2010, an online HDF/ as Japan’s working-age population shrinks due to the HF system was approved through a partial change appli- declining birthrate and aging population, work styles cation and began to be used in clinical practice. This sys - and needs are becoming more diverse. Japanese compa- tem had built-in online priming, blood return, and fluid nies, particularly large ones, have been slowly adopting replacement functions, and it marked the advent of auto- work style reforms since April 2019 [24] and overtime mated systems in clinical practice [22]. Clinical engineers hours are starting to decrease as well. Physicians, who were heavily involved in the development and modifica - are responsible for patient care, tend to work longer tion of these so-called fully automated machines. Clinical hours than many other professions because they are engineers have also significantly contributed to safety, the required to treat patients day and night. In the past, most important aspect of medical care, by not only main- clinicians believed these long hours were for their taining and managing equipment but also operating the patients’ sake and that they improved care quality, but equipment [23]. the state of health care in Japan was unsustainable and needed to be changed. This led to task shifting and Establishment of safety measures sharing being promoted, which refers to redistribution As professionals who handle medical equipment, clini- of less specialized tasks from physicians to other health cal engineers are also tasked with safety management for care professionals. that equipment. Since 2006, Japanese law has mandated On October 23, 2019, the Ministry of Health, Labour that all medical facilities assign a Medical Equipment and Welfare (MHLW) established a task force on task Safety Manager (MESM) to ensure safe management shifting and sharing to promote reforms to physician of medical equipment. The MESM has the following work styles. On January 22, 2021, the MHLW proposed duties: (1) plan and properly execute maintenance and the Act to Amend the Part of Medical Care Act to Ensure inspection of medical equipment, (2) collect information the Establishment of a System to Provide Quality Medical regarding safe use of medical equipment and implement Care (https:// www. mhlw. go. jp/ engli sh/ wp/ wp- hw7/ dl/ of measures to improve safe use, and (3) train others on 02e. pdf ). The law was passed on May 21, 2021, and went the safe use of medical equipment. into effect on May 28, 2021. Legislation concerning clini - The 2006 revisions to the Medical Care Act mandated cal engineers was developed in conjunction with this new that medical facilities ensure medical safety, and they law, and the amended Clinical Engineers Act went into clearly defined requirements to enhance and strengthen effect on October 1, 2021 [25]. The amended law legally safety management systems, enhance nosocomial infec- defines a new scope of work for clinical engineers. The tion control systems, and establish safety management original Clinical Engineers Act allowed clinical engineers systems for pharmaceuticals and medical devices. When to participate in various dialysis care tasks, including the new law was enacted in 2007, JACE published guide- “setting and changing dosages of blood, replacement flu - lines for the maintenance/inspection and operation of ids, and drugs through operation of a blood purifier” and medical equipment, including dialysis equipment, and “using ultrasound equipment to check parameters nec- we have been periodically revising these guidelines ever essary for safe and proper connection of the blood puri- since. To address the legal requirement for training, we fier to the vascular access, such as vessel diameter and issued guidelines for proper use training in 2014, and flow rate at the vascular access,” whereas the amended to address infection prevention, we issued guidelines to law allows clinical engineers to “operate a blood purifier, prevent spread of infection through medical equipment change dosages, and check the connection to the vas- in 2016. In response to the COVID-19 pandemic that cular access.” In the revised law, the scope of work now started at the end of 2019, we published a compilation of includes, “the act of puncturing a superficial artery or these guidelines and shared them publicly, including with vein, including connection/removal of the tip of a punc- government agencies, incorporating findings pertaining ture needle or other blood purifier component to/from to COVID-19. We will continue to formulate guidelines a superficial artery or vein.” Puncturing a superficialized on safety measures for medical equipment, including artery (usually a subcutaneously elevated brachial artery) dialysis equipment, as measures to ensure the safety of does not include direct puncture of the artery. quality medical care and to prevent infection. Honma et al. Renal Replacement Therapy (2024) 10:1 Page 6 of 7 Task shifting and sharing in dialysis care will hope- already authorized clinical engineers to assist with some fully continue to progress. Because medical care involves care tasks, and the recent revision of the Clinical Engi- multiple professions working together as a team, each neers Act will enable further progress in dialysis-related profession must further the practice of team medicine tasks in general, including these new tasks. Clinical engi- to improve quality through attentive patient care and neers will need to take the lead. improve efficiency by reducing workload. As experts involved in various hemodialysis modalities, clinical engi- neers must lead efforts to improve treatment efficiency Conclusion and safety management, including troubleshooting. In The field of dialysis care has joined the movement to the future, it must be determined how clinical engineers actively address the sustainable development goals involved in blood purification can actively participate in unanimously adopted at the 2015 United Nations sum- clinical tasks, including home care, as part of a patient- mit. Dialysis treatment requires disposable products and centered team medicine approach. relies on large amounts of electricity to power medical equipment, which has resulted in continuous consump- tion of large amounts of energy to sustain human life. In New areas and new certifications conventional dialysis systems, excess water and dialysate One major characteristic of the dialysis care landscape are discharged as effluent during the process of mak - in Japan is that the average age of patients on dialysis is ing dialysis water in an RO machine [28]. A system was increasing and these patients have comorbidities, which recently tested clinically that recovers thermal energy means that many patients have reduced activities of daily by heating this dialysis effluent to around body tem - living and quality of life. Another is that hemodialysis is perature and temporarily storing it after it contacts the by far the most commonly selected renal replacement blood, and it was found to be effective. Clinical engineers therapy (RRT) in Japan, used by approximately 97% of oversee entire dialysis systems, and their role is critical to patients on chronic dialysis, and other options such as the operation of such equipment. Cybersecurity meas- peritoneal dialysis and renal transplantation are only ures are also important for operating medical databases, rarely selected [26]. A team medicine approach is essen- which are indispensable to modern health care. Clinical tial to improving activities of daily living and quality of engineers are the health care professionals most qualified life and to promoting appropriate selection of varied RRT for this task, due to their knowledge of engineering. modalities, which is why the Renal Replacement Therapy In summary, (1) the clinical engineer is a nationally Professional Instructor Association was established to licensed position, rare in the world, that was created in certify specialists in the field of RRT [27]. Peritoneal dial - Japan as a leader in the field of engineering in medicine. ysis is also becoming increasingly important as a home- (2) In basic medical engineering, the clinical engineer based option. Widespread use of automated peritoneal is involved in the theoretical construction and develop- dialysis systems has increased the specialized knowledge ment of new devices, and in actual clinical practice, the required for tasks such as patient counseling, equipment clinical engineer is involved in the operation of medical management, and remote monitoring, which in turn has devices in the medical field and in the management of increased demand from physicians and nurses for clini- medical devices from the aspect of medical safety. (3) The cal engineers to participate in these tasks. For this reason, clinical engineer plays a particularly important role in the the Japanese Society for Peritoneal Dialysis established a fields of renal replacement therapy, especially in hemo - peritoneal dialysis certification program for clinical engi - dialysis. He has managed the long-term treatment of so neers. JACE has decided to actively participate in these many patients in Japan with good results. Replacement new specialty areas and certification programs. of kidney function by dialysis requires long-term stable According to statistics from JSDT, the number of management, operation, and maintenance of equipment, clinical engineers engaged in dialysis care (includ- which could not be achieved without the work of clinical ing both full-time and part-time) has tripled over the engineers. (4) In the future, with the development of new past 20  years, from 9346 in 2001 to 16,580 in 2010 and medical devices, the evolution of remote medicine, and 26,263 in 2020. According to JACE membership data the use of AI (artificial intelligence) for the accumulation from 2022, 60% of members are between the ages of 20 and analysis of large-scale data, the role of clinical engi- and 39 and 26% are female. Assuming that the age distri- neers will become more important and indispensable in bution is similar for clinical engineers involved in dialy- medical engineering. sis care, their relatively young age should ensure enough manpower to continue meeting the demand for dialysis- Acknowledgements The authors would like to thank all dialysis staffs who gave us the chance to related tasks in the future. A partial amendment to the write this review. Act on Public Health Nurses, Midwives, and Nurses has Honma  et al. Renal Replacement Therapy (2024) 10:1 Page 7 of 7 Author contributions 14. Kawasaki T, Uchino J, Shinoda T, Kawanishi H. Guidance of technical HT planned the review, searched the literature, and prepared the article. TM management of dialysis water and dialysis fluid for the Japan Association and UJ searched the literature and assisted in writing the article. KT planned for Clinical Engineering Technologists. Blood Purif. 2009;2(Suppl 1):41–9. the context of this article and assisted in writing the article. All authors read 15. 2016 Update Japanese Society for Dialysis Therapy Standard of fluids for and approved the final manuscript. hemodialysis and related therapies. Renal Replacement Therapy 2018; 4:15. Funding 16. Naramura T. The role of clinical engineers in dialysis therapy in Japan. None. Blood Purif. 2018;46:134–5. 17. Tomo T, Shinoda T. Standardization of water purification in the central Availability of data and materials dialysis fluid delivery system: validation and parametric method. Blood Not applicable. Purif. 2009;27(Suppl 1):36–40. 18. Uchino J, Kawasaki T. Purification of dialysis water in the central dialysis fluid delivery system in Japan: a prospective observation study. Blood Declarations Purif. 2009;27(Suppl 1):64–9. 19. Nakai S, Iseki K, Tabei K, Kubo K, Masakane I, Fushimi K, et al. Outcomes Ethics approval and consent to participate of hemodiafiltration based on Japanese dialysis patient registry. Am J Not applicable. Kidney Dis. 2001;38(4 Suppl 1):S212-216. 20. Yamashita AC, Sakurai K. Clinical effect of pre-dilution hemodiafiltra- Consent for publication tion based on the permeation of the hemodiafilter. Contrib Nephrol. Not applicable. 2015;185:1–7. 21. Masakane I, Kikuchi K, Kawanishi H. Evidence for the clinical advantages Competing interests of predilution on-line hemodiafiltration. Contrib Nephrol. 2017;189:17–23. The authors declare that they have no competing interests. Prof. Ken Tsuchiya 22. Kawanishi H, Moriishi M, Sato T, Taoka M. Fully automated dialysis is working as a guest editor in this “Renal Replacement Therapy” journal. system based on the central dialysis fluid delivery system. Blood Purif. 2009;27(Suppl 1):56–3. 23. Shibata M. Safety management of dialysis fluid in Japan: important duties Received: 19 March 2023 Accepted: 10 November 2023 and responsibilities of clinical engineers. Blood Purif: JACE Focus Section, 2021: 1–6. 24. Act on the Arrangement of Related Acts to Promote Work Style Reform (Act No. 71 of 2018) 25. The revised Clinical Engineers Act: Act No. 60 of 1987 (Revised by Act No. References 49 of 2021) 1. Kawasaki T. Developments in the role of clinical engineers in blood purifi- 26. Percentage of each type of renal replacement therapy selected by coun- cation therapy. Blood Purif. 2018;46:136–42. try or region source: International Society of Nephrology, Global Kidney 2. Gejyo F, Yamada T, Odani S, Nakagawa Y, Arakawa M, Kunitomo T, et al. Health Atlas, 2nd ed. 2019; https:// www. theisn. org/ initi atives/ global- A new form of amyloid protein associated with chronic hemodialysis kidney- health- atlas. Accessed 2022 Jan 31 was identified as β2-microglobulin. Biochem Biophys Res Commun. 27. 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The role of clinical engineers in dialysis therapy in Japan

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Abstract

Traditionally in Japan, dialysis treatment has been performed primarily by physicians and nurses. However, with the advancement of related medical equipment, such as the development of dialyzers and dialysis monitor- ing equipment, technical support by technicians has become necessary. Therefore, in 1988, the “Clinical Engineers Act” was enacted and recognized as an official national qualification for technicians to operate these devices, in light of the actual status of these technicians and the fact that further advancement and diversification of medical devices will require their expertise in the future. This is a professional qualification unparalleled anywhere in the world. In dialy- sis treatment, purification of dialysate and efficient removal of uremic substances are fundamental principles. Clinical engineers have contributed significantly to the elimination of biological and chemical contaminants in the process of production of dialysis water, to the development of high-performance membranes, and to the development and advancement of online HDF, a high-volume fluid replacement method. Furthermore, clinical engineers have been involved in the proposal and development of safe devices to prevent medical accidents that occur during continuous dialysis treatment for many patients. Clinical engineers will continue to contribute to the provision of the best treat- ment methods, not only in the development and deployment of equipment, but also in remote medicine and the uti- lization of large-scale data, as they are medical professionals with knowledge of both medicine and engineering. Furthermore, the scope of the profession, which started in the field of hemodialysis, has the potential to expand to include peritoneal dialysis and other modalities of renal replacement therapy. Keywords Automatic priming function, Back-filtrated dialysis fluid, Purified dialysis fluid Introduction Japanese government enacted the Clinical Engineers Act Dialysis therapy spread rapidly across Japan with the to recognize the expertise required of clinical engineers, introduction of equipment such as dialysis monitor- based on the realities of these technicians’ work and ing systems. In response to this increase in demand, anticipating the increasing sophistication and diversity unlicensed technicians in charge of such equipment of medical equipment to come. Indeed, clinical engineers began participating in patient care alongside physicians are tasked with operating and maintaining increasingly and nurses, at the physician’s discretion. This was how sophisticated medical equipment under direction from a the role of the clinical engineer was born. In 1988, the physician. Before the Clinical Engineers Act went into effect, clinical engineers were unlicensed and were primarily *Correspondence: responsible for preparing equipment for dialysis and pro- Takashi Honma takashi.honma@grp.zenjinkai.or.jp viding technical support to physicians and nurses. How- Japan Association for Clinical Engineers, KT Ochanomizu-Hijiribashi-Bldg ever, the new law clarified the unique responsibilities of 5F, 1-3-4, Yushima, Bunkyo-ku, Tokyo 113-0034, Japan clinical engineers as medical professionals, and expecta- Department of Blood Purification, Tokyo Women’s Medical University, Shinjuku-ku, Japan tions of clinical engineers in these areas have grown even © The Author(s) 2024. 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The Creative Commons Public Domain Dedication waiver (http://creativecom- mons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Honma et al. Renal Replacement Therapy (2024) 10:1 Page 2 of 7 greater due to increasing reliance on all kinds of medi- which had become a problematic complication in patients cal equipment. This is due in part to newly arising issues on long-term dialysis. Dialysis-related amyloidosis with medical accidents involving medical equipment causes various symptoms including itching, restless legs and because the conventional team medicine approach syndrome, and bone and joint pain, as well as organic of physicians, nurses, and clinical engineers working in diseases such as bone destruction and carpal tunnel a fragmented fashion under a physician’s discretion has syndrome, and it came to be considered a typical com- failed to ensure sufficient safety. Quality and safety assur - plication of long-term dialysis [3]. In recent years, the fre- ance will improve if team medicine can mature into an quency of its occurrence has reportedly decreased, and independent and collaborative model in which team the cause is believed to be related to improved β2-MG members work independently but share information with clearance on hemodialysis [4]. β2-MG later became an each other based on a clear understanding of their own index for membrane performance evaluation based on responsibilities and abilities. This article discusses how its clearance and sieving coefficient, and it remains so the work and role of clinical engineers has evolved since in the current functional classification of dialysis mem - the dawn of dialysis therapy, as well as future possibilities branes [5]. This development also made the removal of for the profession. solutes (uremic substances) that are not cleared from the body an important proposition for dialysis [6]. Dialy- sis membranes now use synthetic polymer membranes The dawn of dialysis therapy and the birth of the clinical rather than regenerated cellulose membranes and target engineer role medium-sized molecules and protein-bound solutes for In the 1960s, flat-plate dialyzers (also known as Kiil dia - removal rather than small molecules. High-performance lyzers) began to be widely used. Kiil dialyzers are labori- membrane (HPM) dialyzers were introduced to clini- ous to assemble and use, making it difficult for physicians cal practice and modifications were devised to promote and nurses to manage them alone, and this led to the internal filtration and increase removal capacity through emergence of specialized facilities with staff dedicated to HPM. The modality of online hemodiafiltration (HDF) those tasks. The introduction of disposable dialyzers in was also introduced, which allows for large replace- the 1970s made dialysis much less labor-intensive. This ment volumes. The evaluation of HD membranes is also led to greatly increased numbers of dialysis facilities, at discussed in the ISO. The ISO 8637-1:2017 describes which dialysis technicians were hired. During this era, dialysis modality, including evaluation methods for ultra- dialysis technicians mostly worked behind-the-scenes filtration coefficient, ultrafiltration rate, and sieve coef - and faced barriers to involvement in clinical work. These ficient, establishing standards parallel to those in Japan problems were resolved with the passage and enactment [5]. Clinical engineers were essential to the research and of the Clinical Engineers Act in 1987. After a five-year development that led to these dialysis methods, and they transitional period, clinical engineers began engaging in collaborated with physicians on many studies whose clinical work as qualified professionals [1]. results were applied back to clinical practice. Early dialysis systems consisted of a combination of individual devices, instruments, and other equipment with the necessary functions. Later, integrated dialy- Role of clinical engineers in dialysate purification sis systems containing all the essential equipment and The importance of clean dialysate, which is the site of instruments for safe dialysis came onto the market. The solute diffusion and ultrafiltration through the dialy - blood circulation system used for extracorporeal circula- sis membrane, has been pointed out from the begin- tion of blood consisted of devices such as an air bubble ning. In  vitro studies have reported that mediator detector to prevent air from entering the patient’s blood- products pass through the dialysis membrane [7]. It was stream and a venous pressure manometer. The dialysate also reported that the use of clean dialysate reduced circulation system used to deliver and remove dialysate inflammatory reactions, inflammatory cytokines, and was equipped with devices such as a blood leak sensor to improved nutritional status [8]. It was already analogized monitor blood leakage in the blood purifier, a concentra - that the quality of dialysate was involved in the compli- tion sensor to properly control concentration, a dialysate cations of chronic dialysis such as chronic inflammation, pressure manometer, and a fluid removal controller to emaciation, and anemia. Particularly in Japan, the use of ensure accurate removal of fluid from the dialysate. high-performance, high-flux dialysis membranes and the inevitable back-diffusion and back-diafiltration inevi - Developments in dialysis therapy, enabling long‑term tably led to the demand for clean dialysate. Under such dialysis circumstances, if the dialysate is contaminated, pyro- Gejyo et  al. [2] identified beta-2 microglobulin (β2-MG) gens such as endotoxin will inevitably enter the human as the causative agent of dialysis-related amyloidosis, Honma  et al. Renal Replacement Therapy (2024) 10:1 Page 3 of 7 body through reverse filtration and diffusion, and clean introduced in 2005 [11] proposed the bacterial culture dialysate became an essential condition [9]. method to monitor purity by measuring viable bacte- Biological contamination of dialysate was rarely a prob- ria, which are the root cause of contamination, rather lem with conventional dialyzers, but it began to attract than measuring endotoxin activity. Its classification of attention once HPM became popular. To eliminate con- dialysate types into standard, ultrapure, and replace- tamination, clinical engineers devised and implemented ment dialysate, with corresponding viable count limits of −6 a technique called dialysate purification. Dialysis water is 100 CUF/mL, 0.1 CFU/mL and 10  CFU/mL, had a par- produced by a dialysis water preparation system. Essen- ticularly major impact. tially, purification requires the removal of chemical and In 2008, the Japanese Society for Dialysis Therapy biological contaminants. Chemical contaminants are set water quality standards for biological contamina- removed by two types of equipment, an activated carbon tion of dialysate solutions [12]. These standards are the filtration system and reverse osmosis (RO) filters. Bio - strictest in the world for standard dialysate. In 2007, a logical contaminants are removed by equipment such as one-year prognostic study on dialysate cleanliness and an endotoxin-retentive filter, ultraviolet germicidal lamp, mortality risk by the JSDT confirmed a 22.8% increased and ultrafiltration module [10]. Efforts to promote purifi - risk of mortality at dialysate endotoxin levels of 0.1  EU/ cation were particularly bolstered by health care provider mL or higher, validating the appropriateness of setting reimbursements through the Japanese National Health the standard at 0.05 EU/mL or lower [13]. Insurance system, beginning with the introduction of Since 2005, clinical engineers have joined industry reimbursement for water treatment in 1988. The popu - representatives at ISO meetings to continuously investi- larity of RO in Japan dramatically increased when the gate current practices and provide input. In addition, the reimbursement for RO was introduced in1988, prompt- Japan Association for Clinical Engineering (JACE, estab- ing medical facilities to begin removing chemical con- lished in 1990) conducted surveys on viable count control taminants from dialysis water. Figure 1 shows the history at dialysis facilities in 2005 and 2006 and used the results of water quality control and the related reimbursements. to propose clinically realistic guidelines for dialysate After this point, dialysate purification efforts in Japan purification and promote the practice of purification [14]. paralleled those in the rest of the world. Standards are The guidelines are updated as appropriate (Ver. 1.06 in issued by the International Organization for Standardi- 2009, Ver. 1.07 in 2010, Ver. 2.00 in 2011, and Ver. 2.01 zation (ISO; a non-governmental organization head- in 2014) and aim to improve the accuracy of purification quartered in Geneva, Switzerland). ISO/CD 23500 was techniques. 1985 1990 2000 2005 2010 2015 2020 Monitoring of dialysate purification Measurement of EMT Measurement of activity value Chemical pollutant viable bacterial count Treatment & Payment for medical service Bundle of EPO Use of EPO Addition of water Reimbursement approval for on line HDF 2012.4 Use of HPM quality assurance Addition of water treatment Addition of water quality assurance 1,2 2012.4 2018.4 (RO) 1988.4 1994.3 Approval of on line HDF machine 2010.1 Addition of water quality assurance 2010.4 ISO criterion ISO/CD 23500 (2005) ISO 13959 (2009) ANSI/AAMIRD52 Proposal of criteria (2004) ISO 23500 (2011) 2016 Standard of fluids JSDT Water quality criterion for hemodialysis JSDT Revision of standards (2008) 2011 Endotoxin capture filter (ETRF) JSDT criterion (1995) management standards JSDT Revision of standards (2005) JACE Purification guideline Purification GL Purification GL Ver 2.00 (2011) Ver 2.01 (2014) Purification GL Ver 1.07 (2010) 2016 Procedure for achieving Purification GL Ver 1.06 (2009) dialysate fluid quality standards Purification GL Ver 1.05 (2006) (2017) ET: endotoxin, EPO: erythropoietin, HPM: High performance membrane,HDF: hemodiafiltration, HF: hemofiltration, ISO: International Organization for Standardization, ANSI/AAMI: American National Standards Institute/Association for the Advancement of Medical Instrumentation, JSDT: Japanese Society for Dialysis Therapy, JACE: Japanese Society for Clinical Engineering Fig. 1 Changes in purification of dialysate solution, reimbursement, and water quality standards Water quality criterion Honma et al. Renal Replacement Therapy (2024) 10:1 Page 4 of 7 Later, three organizations, JACE, the Japan Society for continuously installed in multiple stages. In chronic Dialysis Therapy (JSDT), and ISO, issued guidelines for dialysis, dialysate management must be carried out rou- dialysate quality, but no standardized clinical target was tinely and permanently, and the work never stops. Many established. Therefore, when JSDT published an update maintenance dialysis patients today need to repeat this to their standard for fluids for hemodialysis and related process to perform dialysis without problems, and a clini- therapies in 2016 (Table  1) [15] that addressed these cal engineer is essential to carry out, manage, and vali- three guidelines, at JACE we adapted our proposed cri- date this process. Currently, each facility is required to teria to the JSDT standard and presented them as the verify the management of dialysate and search for prob- 2016 Procedures for Achieving the Standard of Fluids for lems monthly, and those in charge of management are Hemodialysis and Related Therapies. From the above, it required to attend a course at the JSDT annual meeting is clear that clinical engineers have played a major role in to renew their qualifications. dialysate purification and supporting the advancement of hemodialysis to where it is today [16]. Development of dialysis systems On the other hand, as well as the cleanliness of the Clinical use of HPM dialyzers began after the causative dialysate itself, its management is important, and the agent of dialysis amyloidosis was discovered in 1985. management of water treatment equipment, endotoxin- HPMs are now collectively referred to as membranes retentive filters (ETRFs), and cleaning and disinfec - with added value, such as albumin leakage rate, in addi- tion after each dialysis session are key points. It is also tion to the conventional features of dialyzers with high essential to check whether the cleaning and disinfection ultrafiltration rate. Clinical engineers have played an is being carried out properly and whether the dialysate important role in the actual operation of HPMs, in deter- preparation process is in operation, and to establish mining their efficacy and in monitoring their cleanliness, water quality testing guidelines at each point. In par- a situation that continues to the present day [19–21]. ticular, many dialysis centers in Japan have adopted the Because the fractionation properties of HPMs allow CDDS (central dialysis fluid delivery system), where the them to remove β2-MG, it became essential to use a dial- dialysate preparation process is established by installing ysis system with higher permeability and better control multi-stage equipment in a sequential manner [17, 18]. of fluid removal than a conventional dialyzer. Therefore, Each dialysis center selects and installs its own equip- as HPMs became popular, systems with more advanced ment. The introduction of the validation concept is fluid removal control functions were developed, and necessary for process control and product quality assur- clinical engineers worked on the development and main- ance in manufacturing processes where equipment is tenance of these systems to ensure their safe use. One Table 1 2016 Update Japanese Society for Dialysis Therapy Standard of fluids for hemodialysis and related therapies Chapter 1: water quality standard for biological contaminants 1.1 Ultimate goals of the standard established for biological contamination 1.2 Test for compliance 1.3 Sampling points 1.4 Day of sampling 1.5 Frequency of monitoring (ET and viable bacteria 1.6 Conditions of dialysis to which the respective dialysis fluid standards are applicable 1.7 Endotoxin-retentive filter (ETRF) management standard 1.8 Safety measures Chapter 2: water quality standard for chemical contaminants 2.1 Chemical contaminants and relevant standards 2.2 Control of chemical contaminants: at installation of a water treatment equipment 2.3 Control of chemical contaminants: daily management 2.4 Control of chemical contaminants: in the event of disasters or in case of emergencies Chapter 3: measurement of the residual chlorine Chapter 4: proposal of a “management standard for water treatment equipment” Chapter 5: supplement and management standard for water treatment equipment Honma  et al. Renal Replacement Therapy (2024) 10:1 Page 5 of 7 Future possibilities for clinical engineers in dialysis care of the major challenges in this area was to balance the As the population ages, demographics shift, and medi- goal of eliminating medical accidents against the cost of cine continues to advance, health care providers must modifications, which decreases as the number of patients duly consider patients’ psychosocial backgrounds and increases. In 2007, fully automated machines that substi- lifestyles. This will require further promotion of team tuted dialysate for normal saline were clinically investi- medicine involving physicians, nurses, clinical engi- gated as a means of solving this problem and were shown neers, and other health care professionals. In addition, to be safe and economical. Later, in 2010, an online HDF/ as Japan’s working-age population shrinks due to the HF system was approved through a partial change appli- declining birthrate and aging population, work styles cation and began to be used in clinical practice. This sys - and needs are becoming more diverse. Japanese compa- tem had built-in online priming, blood return, and fluid nies, particularly large ones, have been slowly adopting replacement functions, and it marked the advent of auto- work style reforms since April 2019 [24] and overtime mated systems in clinical practice [22]. Clinical engineers hours are starting to decrease as well. Physicians, who were heavily involved in the development and modifica - are responsible for patient care, tend to work longer tion of these so-called fully automated machines. Clinical hours than many other professions because they are engineers have also significantly contributed to safety, the required to treat patients day and night. In the past, most important aspect of medical care, by not only main- clinicians believed these long hours were for their taining and managing equipment but also operating the patients’ sake and that they improved care quality, but equipment [23]. the state of health care in Japan was unsustainable and needed to be changed. This led to task shifting and Establishment of safety measures sharing being promoted, which refers to redistribution As professionals who handle medical equipment, clini- of less specialized tasks from physicians to other health cal engineers are also tasked with safety management for care professionals. that equipment. Since 2006, Japanese law has mandated On October 23, 2019, the Ministry of Health, Labour that all medical facilities assign a Medical Equipment and Welfare (MHLW) established a task force on task Safety Manager (MESM) to ensure safe management shifting and sharing to promote reforms to physician of medical equipment. The MESM has the following work styles. On January 22, 2021, the MHLW proposed duties: (1) plan and properly execute maintenance and the Act to Amend the Part of Medical Care Act to Ensure inspection of medical equipment, (2) collect information the Establishment of a System to Provide Quality Medical regarding safe use of medical equipment and implement Care (https:// www. mhlw. go. jp/ engli sh/ wp/ wp- hw7/ dl/ of measures to improve safe use, and (3) train others on 02e. pdf ). The law was passed on May 21, 2021, and went the safe use of medical equipment. into effect on May 28, 2021. Legislation concerning clini - The 2006 revisions to the Medical Care Act mandated cal engineers was developed in conjunction with this new that medical facilities ensure medical safety, and they law, and the amended Clinical Engineers Act went into clearly defined requirements to enhance and strengthen effect on October 1, 2021 [25]. The amended law legally safety management systems, enhance nosocomial infec- defines a new scope of work for clinical engineers. The tion control systems, and establish safety management original Clinical Engineers Act allowed clinical engineers systems for pharmaceuticals and medical devices. When to participate in various dialysis care tasks, including the new law was enacted in 2007, JACE published guide- “setting and changing dosages of blood, replacement flu - lines for the maintenance/inspection and operation of ids, and drugs through operation of a blood purifier” and medical equipment, including dialysis equipment, and “using ultrasound equipment to check parameters nec- we have been periodically revising these guidelines ever essary for safe and proper connection of the blood puri- since. To address the legal requirement for training, we fier to the vascular access, such as vessel diameter and issued guidelines for proper use training in 2014, and flow rate at the vascular access,” whereas the amended to address infection prevention, we issued guidelines to law allows clinical engineers to “operate a blood purifier, prevent spread of infection through medical equipment change dosages, and check the connection to the vas- in 2016. In response to the COVID-19 pandemic that cular access.” In the revised law, the scope of work now started at the end of 2019, we published a compilation of includes, “the act of puncturing a superficial artery or these guidelines and shared them publicly, including with vein, including connection/removal of the tip of a punc- government agencies, incorporating findings pertaining ture needle or other blood purifier component to/from to COVID-19. We will continue to formulate guidelines a superficial artery or vein.” Puncturing a superficialized on safety measures for medical equipment, including artery (usually a subcutaneously elevated brachial artery) dialysis equipment, as measures to ensure the safety of does not include direct puncture of the artery. quality medical care and to prevent infection. Honma et al. Renal Replacement Therapy (2024) 10:1 Page 6 of 7 Task shifting and sharing in dialysis care will hope- already authorized clinical engineers to assist with some fully continue to progress. Because medical care involves care tasks, and the recent revision of the Clinical Engi- multiple professions working together as a team, each neers Act will enable further progress in dialysis-related profession must further the practice of team medicine tasks in general, including these new tasks. Clinical engi- to improve quality through attentive patient care and neers will need to take the lead. improve efficiency by reducing workload. As experts involved in various hemodialysis modalities, clinical engi- neers must lead efforts to improve treatment efficiency Conclusion and safety management, including troubleshooting. In The field of dialysis care has joined the movement to the future, it must be determined how clinical engineers actively address the sustainable development goals involved in blood purification can actively participate in unanimously adopted at the 2015 United Nations sum- clinical tasks, including home care, as part of a patient- mit. Dialysis treatment requires disposable products and centered team medicine approach. relies on large amounts of electricity to power medical equipment, which has resulted in continuous consump- tion of large amounts of energy to sustain human life. In New areas and new certifications conventional dialysis systems, excess water and dialysate One major characteristic of the dialysis care landscape are discharged as effluent during the process of mak - in Japan is that the average age of patients on dialysis is ing dialysis water in an RO machine [28]. A system was increasing and these patients have comorbidities, which recently tested clinically that recovers thermal energy means that many patients have reduced activities of daily by heating this dialysis effluent to around body tem - living and quality of life. Another is that hemodialysis is perature and temporarily storing it after it contacts the by far the most commonly selected renal replacement blood, and it was found to be effective. Clinical engineers therapy (RRT) in Japan, used by approximately 97% of oversee entire dialysis systems, and their role is critical to patients on chronic dialysis, and other options such as the operation of such equipment. Cybersecurity meas- peritoneal dialysis and renal transplantation are only ures are also important for operating medical databases, rarely selected [26]. A team medicine approach is essen- which are indispensable to modern health care. Clinical tial to improving activities of daily living and quality of engineers are the health care professionals most qualified life and to promoting appropriate selection of varied RRT for this task, due to their knowledge of engineering. modalities, which is why the Renal Replacement Therapy In summary, (1) the clinical engineer is a nationally Professional Instructor Association was established to licensed position, rare in the world, that was created in certify specialists in the field of RRT [27]. Peritoneal dial - Japan as a leader in the field of engineering in medicine. ysis is also becoming increasingly important as a home- (2) In basic medical engineering, the clinical engineer based option. Widespread use of automated peritoneal is involved in the theoretical construction and develop- dialysis systems has increased the specialized knowledge ment of new devices, and in actual clinical practice, the required for tasks such as patient counseling, equipment clinical engineer is involved in the operation of medical management, and remote monitoring, which in turn has devices in the medical field and in the management of increased demand from physicians and nurses for clini- medical devices from the aspect of medical safety. (3) The cal engineers to participate in these tasks. For this reason, clinical engineer plays a particularly important role in the the Japanese Society for Peritoneal Dialysis established a fields of renal replacement therapy, especially in hemo - peritoneal dialysis certification program for clinical engi - dialysis. He has managed the long-term treatment of so neers. JACE has decided to actively participate in these many patients in Japan with good results. Replacement new specialty areas and certification programs. of kidney function by dialysis requires long-term stable According to statistics from JSDT, the number of management, operation, and maintenance of equipment, clinical engineers engaged in dialysis care (includ- which could not be achieved without the work of clinical ing both full-time and part-time) has tripled over the engineers. (4) In the future, with the development of new past 20  years, from 9346 in 2001 to 16,580 in 2010 and medical devices, the evolution of remote medicine, and 26,263 in 2020. According to JACE membership data the use of AI (artificial intelligence) for the accumulation from 2022, 60% of members are between the ages of 20 and analysis of large-scale data, the role of clinical engi- and 39 and 26% are female. Assuming that the age distri- neers will become more important and indispensable in bution is similar for clinical engineers involved in dialy- medical engineering. sis care, their relatively young age should ensure enough manpower to continue meeting the demand for dialysis- Acknowledgements The authors would like to thank all dialysis staffs who gave us the chance to related tasks in the future. A partial amendment to the write this review. Act on Public Health Nurses, Midwives, and Nurses has Honma  et al. Renal Replacement Therapy (2024) 10:1 Page 7 of 7 Author contributions 14. Kawasaki T, Uchino J, Shinoda T, Kawanishi H. Guidance of technical HT planned the review, searched the literature, and prepared the article. TM management of dialysis water and dialysis fluid for the Japan Association and UJ searched the literature and assisted in writing the article. KT planned for Clinical Engineering Technologists. Blood Purif. 2009;2(Suppl 1):41–9. the context of this article and assisted in writing the article. All authors read 15. 2016 Update Japanese Society for Dialysis Therapy Standard of fluids for and approved the final manuscript. hemodialysis and related therapies. Renal Replacement Therapy 2018; 4:15. Funding 16. Naramura T. The role of clinical engineers in dialysis therapy in Japan. None. Blood Purif. 2018;46:134–5. 17. Tomo T, Shinoda T. Standardization of water purification in the central Availability of data and materials dialysis fluid delivery system: validation and parametric method. Blood Not applicable. Purif. 2009;27(Suppl 1):36–40. 18. Uchino J, Kawasaki T. Purification of dialysis water in the central dialysis fluid delivery system in Japan: a prospective observation study. Blood Declarations Purif. 2009;27(Suppl 1):64–9. 19. Nakai S, Iseki K, Tabei K, Kubo K, Masakane I, Fushimi K, et al. Outcomes Ethics approval and consent to participate of hemodiafiltration based on Japanese dialysis patient registry. Am J Not applicable. Kidney Dis. 2001;38(4 Suppl 1):S212-216. 20. Yamashita AC, Sakurai K. Clinical effect of pre-dilution hemodiafiltra- Consent for publication tion based on the permeation of the hemodiafilter. Contrib Nephrol. Not applicable. 2015;185:1–7. 21. Masakane I, Kikuchi K, Kawanishi H. Evidence for the clinical advantages Competing interests of predilution on-line hemodiafiltration. Contrib Nephrol. 2017;189:17–23. The authors declare that they have no competing interests. Prof. Ken Tsuchiya 22. Kawanishi H, Moriishi M, Sato T, Taoka M. Fully automated dialysis is working as a guest editor in this “Renal Replacement Therapy” journal. system based on the central dialysis fluid delivery system. Blood Purif. 2009;27(Suppl 1):56–3. 23. Shibata M. 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Journal

Renal Replacement TherapySpringer Journals

Published: Jan 17, 2024

Keywords: Automatic priming function; Back-filtrated dialysis fluid; Purified dialysis fluid

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