Introduction
Medical units based mostly on cutting-edge applied sciences areas important for human well being and are promising high-value-added industries with anticipated steady progress. East Asia stays one of many technologically most superior areas on this sense whereas Japan and China internet hosting the second and third largest medical gadget markets.1–4 Korea possesses costly medical units, reminiscent of Computed Tomography (CT), Positron Emission Tomography (P.E.T)/CT scanner Magnetic Resonance Imaging (MRI), Surgical Robots, Proton Beam Radiotherapy Techniques, INUMAC MRI Scanner and so forth., most of them, in density considerably exceeding the typical of people who Group for Financial Co-operation and Improvement (OECD) nations have.5 In line with OECD Well being 2023 report and different sources South Korea surpassed the OECD common for medical imaging assessments, with 229.5 CT scans and 167.8 MRI scans per 1000 folks.6 But, roughly one in 4 units superannuated by greater than ten years. Because of this alternative doesn’t happen promptly throughout medical gadget analysis. Accordingly, to handle the lifecycle of medical units, It’s needed to ascertain a system by which the standing of a tool can be recognized and evaluated periodically to find out its alternative at an acceptable time.
Preventive inspections should be carried out for medical units used for sufferers in hospitals to establish and handle the dangers to affected person security. Danger administration throughout the life cycle is crucial for sustaining the standard of medical units and managing their efficiency.7,8 The key objectives of danger administration of medical units are to regulate, forestall, or scale back affected person sicknesses, accidents, lack of life, property injury, oblique losses, and environmental impacts. To this finish, the ISO 14971 customary, a world customary for medical gadget danger administration, was developed, which covers the general danger administration procedures utilized to the life cycles of medical units.9,10 To forestall efficiency degradation owing to growing old, in keeping with medical gadget danger administration procedures, medical units require steady alternative to make sure operation, upkeep, and stability, and right now, financial issues happen.11 The alternative of medical units is an issue confronted by all medical establishments; nonetheless, the alternative time and prices are inclined to differ relying on the rise in upkeep prices and technological developments in medical units.12,13 Related challenges had been largely noticed even amongst wealthiest South-East Asia ASEAN nations whose home manufacturing processes stay extremely dependent of overseas imports.14
Taylor Ok. and Jackson (2005) proposed the medical tools alternative rating (MERS) to establish and prioritize medical units eligible for alternative.15 Faisal M. and Sharawi (2015) recommended that the precedence of medical gadget alternative could be decided utilizing a multi-criteria decision-making mannequin (MCDM).16 Web optimization et al (2022) developed a life cycle of high-risk medical units by deriving analysis standards and gadgets for medical gadget alternative from main medical establishments in Korea, the USA, and others.13 Nonetheless, current researches primarily take into account solely the efficiency of the gadget in figuring out priorities for its alternative, whereas the components, reminiscent of cost-benefit to medical establishments, scientific effectiveness, and so forth., are ignored. Specifically, there’s a severe scarcity of research analyzing the priorities of medical gadget alternative from the consumer perspective. Subsequently, it’s needed to contemplate the constraints to the efficiency of medical units, the traits of medical establishments, and the priorities of medical gadget alternative from the consumer perspective.
Environment friendly administration of medical units is crucial to keep up the conventional operation of healthcare establishments and improve their competitiveness. Repeated overuse of medical units can place an invisible burden on sufferers, whereas faulty units could cause operational shutdowns, resulting in severe accidents or accidents for sufferers. In healthcare establishments, there’s a tendency for medical gadget alternative to focus extra on fastened upkeep relatively than preventive administration, leading to 5–80% of kit being nonfunctional. Moreover, it’s essential to implement acceptable analysis strategies and set priorities for medical gadget alternative to foster scientific improvement in healthcare establishments. If tools alternative shouldn’t be carried out in a well timed method or is delayed, it could hinder scientific progress inside the establishment and finally have a unfavorable impression on affected person expertise and security.17–19
The life cycle of a medical gadget typically follows the form of a tub curve. Initially, the failure fee will increase, regularly decreases after a stabilization interval, after which will increase owing to put on. Medical units straight associated to a affected person’s life and with excessive alternative prices require preventive administration. Nonetheless, at the moment, medical units are changed primarily when their efficiency deteriorates, which could be seen as follow-up administration.20 Accordingly, on this examine, we current priorities for medical gadget alternative by evaluating the obsolescence analysis index of medical units and the components affecting alternative choices in a user-centered method. Via this, we are able to perceive consumer views on changing medical units to allow proactive administration and put together medical gadget alternative plans relevant in precise medical establishments. Any such long-term alternative methods refering to medical imaging diagnostics units, oncology radiotherapy cupboards, invasive vascular radiology cupboards and robotics assisted orthopedic and laparoscopic surgical procedure units, nonetheless need to be included into the nationwide and provincial tools acquisition plans.21 For such a goal sustainable and dependable lengthy – time period budgeting is critical not just for the preliminary acquisition however as properly for the aim of upkeep.22 As already witnessed the standard of such upkeep largely displays to the radiation leakage within the radiology imaging cupboards with doubtlessly important well being penalties for the sufferers and radiology specialty physicians and radiology technicians alike.23 These details have already led to a sure diploma {of professional} medical employees shortages in Korea and wider East Asia.24
Literature Evaluate
Danger Administration of Medical Gadgets
The danger administration of medical units was talked about in 1997 when the European Committee for Standardization (CEN) developed EN 1441 because the “Medical Machine-Danger Evaluation”. ISO 14971–1, the primary customary, was printed in 1998 and revised to ISO 14971:2000 (1st version) in 2000. In 2007, the second revision of ISO 14971:2007 (2nd Version) was printed.25,26 In 2012, CEN launched EN ISO 14971:2012, the European model, in concord with the healthcare sectors of 93/42/EEC, 98/79/EC, and 90/385/EEC. In 2019, it was revised to ISO 14971:2019 (3rd Version), the newest model.27–29
ISO 14971 stipulates the rules and processes for managing dangers in medical units (together with software program and IVD(In Vitro Diagnostic) merchandise as medical units) and is a crucial customary for producers and suppliers of medical units. The danger administration technique of medical units outlined in ISO 14971 has a complete of six steps, together with a danger administration plan, danger analysis, danger management, analysis of total residual danger, danger administration overview, and manufacturing and post-production actions.30 The primary part, the chance administration plan, identifies medical gadget safety-related properties and hazard sources and predicts the chance for every hazard supply. The second part, the chance analysis, determines whether or not danger discount is required for the recognized conditions. The third part, danger management, entails performing danger discount actions at an appropriate degree. Within the fourth part, the analysis of the general residual danger should assess whether or not there’s an unacceptable degree of residual danger to find out how residual dangers will likely be dealt with and disclosed. The fifth part, danger administration overview, entails reviewing the chance administration course of to document and retailer the outcomes as a danger administration report. Lastly, the sixth part, manufacturing and post-production actions, establishes and maintains a system for gathering details about medical units (Determine 1). 25,31
 |
Determine 1 ISO 14971 danger administration course of overview.32
|
As well as, ISO 14971 is intently associated to ISO 13485, a world high quality administration customary for medical units. ISO 13485 was standardized based mostly on ISO 9001 by including associated key components to swimsuit the traits of medical units. It specifies the necessities for the standard administration system of medical units, together with their set up and sterilization, administration overview, buyer satisfaction, design and improvement, and manufacturing and enchancment actions for medical units.33–35 This customary defines the necessities that producers should meet, starting from the design of medical units to manufacturing and enchancment actions. Corporations can set up high quality administration methods to cut back defects by steady product enchancment actions. ISO 13485 supplies the necessities for high quality administration methods for organizations to design, develop, manufacture, and supply medical units that adjust to the laws and requirements laid out in ISO 13485.36 Danger evaluation and document maintaining laid out in ISO 13485 are required for all medical device-related dangers. Thus, all processes associated to danger identification, danger analysis, and danger evaluation required by ISO 14971 are offered, and the general content material of danger administration is managed.35,37
Life Cycle of Medical Gadgets
Sturdiness refers back to the life expectancy of a product or because the interval throughout which the product is beneficial in its authentic situation.38 Kotler (1979) seen the product life cycle as the method by which a product is made, launched available in the market, will increase its gross sales, after which decreases its demand. Fabiano and McCarthy (1981) outlined it because the stage between the product launch and disappearance.37,39 Each product has a life cycle, and medical units have distinctive life cycles. Medical units used to diagnose or deal with sufferers straight or not directly have an effect on human life and well being. Subsequently, in contrast to basic industrial merchandise, medical units are managed by legal guidelines and laws throughout manufacturing, distribution, and gross sales processes.40
In Korea, laws on medical gadget sturdiness are beneath Article 16–2 of the Commodity Administration Act and No. 2018–14 of the Public Procurement Service Notification. The Public Procurement Service determines the elemental issues concerning the acquisition, storage, utilization, and disposal of nationwide commodities and stipulates the sturdiness life to handle nationwide commodities effectively and appropriately. Sturdiness life is outlined for steadily used gadgets with a big stock, and the sturdiness life of those commodities is stipulated to be relevant to related commodities with an undetermined sturdiness life.41 Within the case of medical units, the necessities for efficiency, security, and inspection cycles are specified just for 16 forms of particular medical tools. Other than this, no particular sturdiness laws exist for the alternative occasions of different medical units. Medical units have to be changed periodically in keeping with established requirements and procedures to supply optimum medical providers to sufferers. Since just some units have stipulated sturdiness, laws are required to plan and handle the use, upkeep, and alternative of medical units. Lately, the Inexperienced Agenda and Sustainable Improvement necessities, largely led by the specialised UN businesses, have led to standardization of potential environmental injury originating from a disposable medical units and assessments after the expiration of their due date.42,43 Such necessities at the moment are more and more embedded into associated medical gadget laws, advertising and marketing and reimbursement approval pathways and finally into the decision-making course of on analysis and innovation funding throughout East Asia, Europe and North America.44,45
In distinction, in the USA, the American Hospital Affiliation (AHA) suggests estimated figures of the sturdy lifetime of medical units for the accounting functions of medical establishments.46 As well as, the American Society for Well being Care Engineering has developed a calculation methodology to estimate the sturdiness of medical units to help alternative plans for medical units.13 In Canada, the Diagnostic Imaging Gear Substitute and Improve has developed life cycle tips for medical imaging tools to find out the upgradation or alternative time of current units.47 In line with these tips, radiology units, together with fluoroscopic units, have to be utilized for five–10 years, angiography units for 7 years, computed tomographic units for 7 years, magnetic resonance imaging units and ultrasound units for 7 years, mammography units for five–7 years, and single photon computed tomography units for 10 years.48
Indicators for Evaluating the Life Cycle of Medical Gadgets
Inspecting current research associated on medical gadget alternative components, Fennigkoh (1992) developed a easy mannequin to establish and prioritize the alternative of medical units.49 Subsequently, Taylor Ok. and Jackson (2005) proposed an automatic MERS system that thought-about know-how, security, and vital guidelines.15 He analyzed the potential dangers of utilizing medical units in medical establishments and utilized a pairwise comparability method based mostly on six standards: operate, mission criticality, age, danger, recall and hazard alerts, and upkeep necessities. Determine 2 presents the decision-making hierarchy for prioritizing medical gadget alternative utilizing the pairwise comparability methodology. This hierarchical framework is structured to outline analysis standards for alternative prioritization and to systematically allocate them to acceptable ranges inside the hierarchy. The analysis standards are positioned on the second degree, with their respective weights decided by pairwise comparisons. On this course of, the relative significance of every criterion is assessed to derive the required weights for establishing alternative priorities. Particularly, the system assigns weights to every criterion; thus, units with increased ultimate scores are prioritized for alternative.50
 |
Determine 2 Hierarchy to find out priorities.
|
Rajasekaran (2005) developed a program that might routinely generate relative alternative numbers (RRNs) in keeping with security, technical elements, and monetary standing for units requiring alternative.51 Mummolo et al (2007) utilized a mannequin to find out medical gadget alternative priorities based mostly on indicators reminiscent of restore fee, failure fee, sturdy years, and so forth.52 Taghipour, Banjevic, and Jardine (2011) emphasised the need of alternative prioritization to reduce malfunctions and preserve the steady operation of medical units.50 Faisal M. and Sharawi (2015) labeled help, availability, efficiency, upkeep price, age, tools operate, operational impression, and scientific acceptability as dominant components in figuring out alternative precedence and proposing decision-making processes.16
Supplies and Strategies
AHP Evaluation
On this examine, an analytic hierarchy course of (AHP) evaluation was carried out to find out the significance of alternative analysis gadgets in medical units. The AHP MCDM was developed by Saaty (1977) in 1971. The AHP has been often known as a decision-making method that systematically combines details about tangible and intangible requirements and alternate options within the decision-making course of.53,54 The first and eminent part within the AHP entails stratifying the gadgets associated to decision-making, by which key components are decided by a pairwise comparability between the weather that compose the decision-making hierarchy.55 The hierarchy of AHPs entails structuring the elements of decision-making issues with varied components, and the decision-making analyst stratifies varied interrelated decision-making gadgets.56 On the high of the hierarchy is the aim of decision-making, and the underside layer consists of things that may affect the decision-making course of. These components turn into extra particular at decrease ranges, and every component inside a layer have to be comparable.
Analysis Framework and Indicators Choice
For the evaluation, earlier research had been reviewed to pick the most important components that have to be thought-about in medical gadget alternative analysis. The frequency of every issue is proven in Desk 1.
 |
Desk 1 Key Elements for Evaluating Medical Machine Substitute
|
A survey was carried out amongst 86 medical device-related specialists (docs, nurses, medical technicians, pharmacists, and medical engineering employees) based mostly on 21 variables derived to pick indicators of degradation. The survey interval was from October 6 to 14, 2020, and 71 survey outcomes had been analyzed, excluding 15 inappropriate questionnaires amongst these returned through electronic mail. Based mostly on the survey outcomes, 16 variables had been chosen from the 21 variables: discontinuation of components, age, variety of failures, life-support tools, potential danger, every day inspection, upkeep price, gadget standing, name response, serviceability, gadget reliability, frequency of use, main units, mannequin discontinuation, availability of backup units, and technological developments Subsequently, 5 variables – know-how, security, price, help, and scientific – had been chosen by brainstorming as the ultimate analysis indicators. The discount course of was carried out by group discussions involving specialists from varied scientific and technical fields. This course of targeted on figuring out the important thing components influencing the prioritization of medical gadget alternative. Specialists systematically reviewed the variables and underwent an iterative classification and issue extraction course of to pick probably the most crucial and broadly relevant components. The discount course of was carried out in a stepwise method, with the outcomes of every assembly summarized and re-evaluated in subsequent discussions. The brainstorming and consensus course of was carried out in two rounds, finally resulting in the number of 5 key analysis standards. The chosen 5 components characterize basic concerns which might be broadly relevant throughout various medical tools classes. The burden of every issue could be adjusted based mostly on particular scientific settings, guaranteeing flexibility in prioritization with out compromising the robustness of the mannequin.
The examine framework was established by making use of the MERS system to conduct the AHP evaluation. The MERS system served as the inspiration for structuring the decision-making hierarchy and deriving precedence weights for medical gadget alternative. Via this method, the examine built-in each methodologies to reinforce the robustness of the prioritization mannequin. Determine 3 presents the analysis mannequin that determines the precedence of medical gadget alternative by making use of the MERS system. It illustrates the method by which relative significance is assessed by pairwise comparisons, with the ultimate scores figuring out the alternative precedence. Because of this the gadget with the best ultimate rating is given precedence for alternative by making use of weights to 5 components: know-how, security, price, help, and scientific utility.
 |
Determine 3 Analysis mannequin for choosing alternative priorities.
|
The definitions of the important thing components used on this examine are listed in Desk 2. Expertise consists of the entire interval of use after set up and the variety of annual failures, referring to the truth that no repairs had been potential as a result of the required components had been discontinued by the producer. Security consists of every day inspections earlier than use and potential dangers to the human physique, which means that the chance to the human physique will increase in instances of malfunction. Value, having the identical which means as upkeep prices, refers back to the whole price used to keep up the gadget. Assist consists of the general deterioration diploma of the gadget, the response time from the request for restore till the restore, and so forth., referring to the time to revive the gadget after breakdown. Scientific refers back to the units that play a key function in a division, together with gadget reliability, frequency of use, mannequin discontinuation, units with new know-how utilized, and the supply of substitute units that can be utilized in case of failure.
 |
Desk 2 Definition of Analysis Elements
|
Evaluation Strategies
Frequency evaluation was carried out utilizing SPSS 22.0 to substantiate the final traits of the examine topics. As well as, AHP evaluation was carried out to pick priorities for every issue by using RStudio’s AHP package deal. First, for the pairwise comparability of AHPs, the 9-point scale proposed by Aczél J. and Saaty (1983) was used.62 On this scale, the respondent’s selection doesn’t considerably have an effect on the matrix calculation in quantitative judgment by pairwise comparability, and accordingly, respondents can scale back the psychological burden of selecting correct values, thus resulting in outcomes closest to the precise quantity.63 The 9-point scale was outlined by 1 (related), 3 (barely vital), 5 (vital), 7 (essential), and 9 (extraordinarily vital) in keeping with their relative significance. The Consistency Indicator (C.I) was measured and divided by the Random Index (R.I), acquiring the Consistency Ratio (C.R), calculated to make sure the consistency of the relative comparability outcomes between elements. This was meant to extend the reliability of the decision-making course of. The C.R will need to have a price lower than 0.1 to make sure the consistency of the pairwise comparability matrix.64 The C.R worth on this examine was lower than 0.1, guaranteeing consistency. Subsequently, the relative significance was calculated utilizing the geometric imply, obtained by multiplying the relative significance from the analysis perspective and the relative significance of the important thing efficiency indicators.
In AHP evaluation, you will need to establish probably the most prioritized components amongst quite a few variables utilizing an skilled group. Nonetheless, for the reason that judgments might differ relying on the non-public preferences of the individuals, consistency ratios are calculated to evaluate the reliability of the evaluation outcomes. The aim is to derive constant judgments from people with specialised data or expertise within the related subject. Subsequently, there is no such thing as a clear customary for the optimum pattern dimension, however it’s typically thought-about {that a} pattern of not less than seven individuals can present enough consistency.54 On this examine, to make sure the reliability and validity of the analysis, specialists with intensive expertise in medical gadget analysis had been chosen to establish the components, and consistency ratios had been calculated to substantiate the logical consistency of their responses. Moreover, the outcomes had been cross-verified by evaluating them with current literature. This method minimized subjective bias and ensured the validity of the analysis outcomes.
Desk 3 exhibits the consistency verification outcomes of the evaluation components and the rating of every issue. All C.R values had been lower than 0.1, guaranteeing the reliability of the AHP evaluation outcomes. The burden and rating of every issue had been as follows: scientific (0.3405), security (0.2651), know-how (0.1739), help (0.1568), and value (0.0636).
 |
Desk 3 Weight and Significance of Every Issue
|
Outcomes
Common Traits of Analysis Topics
This examine included 71 topics: 46 males (66.2%) and 25 females (33.8%). There have been 24 medical technicians (33.8%), 20 medical engineering employees (28.2%), 16 docs (22.5%), 8 nurses (11.3%), and three pharmacists (4.2%). As well as, 31 (43.7%) of the analysis topics had been in cost (see Desk 4).
 |
Desk 4 Traits of Analysis Topics
|
Variations in Priorities for Occupations
The outcomes of the evaluation of medical gadget alternative priorities in keeping with occupation are introduced in Desk 5. Medical technicians appeared within the order of scientific (0.33), security (0.29), help (0.16), know-how (0.15), and value (0.07); medical engineering employees within the order of security (0.32), scientific (0.30), know-how (0.18), help (0.14), and value (0.06); docs within the order of scientific (0.38), security (0.20), know-how (0.18), help (0.18), and value (0.06); and nurses within the order of scientific (0.33), security (0.25), know-how (0.19), help (0.13), and value (0.10). For pharmacists, these had been within the following order: scientific (0.33), security (0.31), help (0.16), know-how (0.15), and value (0.05). Scientific was the precedence issue for medical technicians, docs, nurses, and pharmacists, whereas, for medical engineering employees, security was the precedence issue for changing medical units. Moreover, price was the bottom precedence for all occupations.
 |
Desk 5 Issue Weight Outcomes by Occupation
|
Variations in Priorities for Skilled Expertise
Desk 6 exhibits the outcomes of the comparative evaluation of medical gadget alternative priorities in keeping with skilled expertise. The precedence components for changing the medical units for many who had 1–3 years of expertise appeared within the order of scientific (0.35), security (0.24), help (0.18), know-how (0.17), and value (0.06); for these with 4–6 years of expertise, the order was scientific expertise (0.32), security (0.29), know-how (0.18), help (0.15), and value (0.06); for these with 6–10 years of expertise, the order was scientific expertise (0.35), security (0.26), know-how (0.18), help (0.14), and value (0.07). Moreover, for these with greater than 10 years of expertise, it was within the following order: scientific (0.34), security (0.28), know-how (0.15), help (0.15), and value (0.08). Because of the evaluation, the important thing issue for changing medical units in all topics was scientific, adopted by security, know-how, and help so as.
 |
Desk 6 Issue Weight Outcomes by Skilled Expertise
|
Variations in Priorities for Instructional Background
The outcomes of the comparative evaluation of precedence components for medical gadget alternative in keeping with academic background are introduced in Desk 7. For Junior faculty graduates the precedence components had been within the following order: scientific (0.33), security (0.32), know-how (0.17), help (0.12), and value (0.06); for College graduates: scientific (0.34), security (0.26), know-how (0.18), help (0.16), and value (0.06); for postgraduates: scientific (0.33), security (0.25), know-how (0.17), help (0.17), and value (0.18). In alternative precedence components based mostly on academic background, scientific setting confirmed the best weight, adopted by security, know-how, help, and prices.
 |
Desk 7 Issue Weight Outcomes by Instructional Background
|
Dialogue
Security administration of medical units and their goal efficiency upkeep by common inspections are important as a result of superannuated medical units have a excessive potential for malfunction or errors throughout remedy. To this finish, related medical device-related dangers are at the moment recognized, calculated, and evaluated beneath ISO 14971 and ISO 13485. Nonetheless, these are laws that medical gadget producers should observe, and thus, there are limitations to their utility in medical establishments. Moreover, no particular alternative tips are at the moment accessible for calculating sturdiness to handle the life cycle of medical units, aside from specific units. It’s needed to pick alternative priorities from the consumer perspective by which medical establishments can proactively handle medical units to make sure affected person security.
Subsequently, on this examine, we composed medical gadget obsolescence analysis indexes from the attitude of medical employees who use medical units and analyzed the priorities of medical gadget alternative components by AHP evaluation. Moreover, a comparative evaluation of the significance of alternative components was carried out, classifying the respondents by occupation, expertise, and academic degree, which was not applied in earlier research. In earlier research on medical gadget alternative priorities, help availability was discovered to be crucial issue, adopted by efficiency, upkeep price, age, operate, operational impression, and scientific acceptability so as.16 Nonetheless, the outcomes of this examine confirmed that scientific components had the best weight among the many medical gadget alternative components. This implies that scientific elements have to be thought-about when changing medical units, ie, when a medical gadget turns into superannuated, it can’t be repaired, and the gadget has extra precedence for alternative. These outcomes are totally different from earlier research due to the totally different classes of medical units used within the analyses. On this examine, the priorities of the alternative components had been analyzed for all medical units; nonetheless, earlier research have primarily analyzed medical units in intensive care items. The intensive care unit consists of threerd or 4th-grade medical units with hazardous properties. Thus, within the occasion of a malfunction, the longer it takes to revive, the higher the chance to the affected person’s life. Subsequently, help seems to be an vital issue amongst medical gadget alternative components.
Because of conducting a comparative evaluation of the priorities of medical gadget alternative components in keeping with occupation, scientific is crucial issue for medical technicians, docs, nurses, and pharmacists. Nonetheless, for medical engineering employees, security was crucial issue. Medical engineering employees should straight examine medical units to handle them and are accountable for their security. Attributable to their roles and duties, security is a high precedence. In different phrases, when changing medical units, the significance of things might differ relying on the occupation. Thus, acceptable choices have to be made contemplating the place of every occupation.65 For the medical gadget alternative precedence components based mostly on occupational expertise and training ranges scientific was crucial issue. That is just like current analysis findings that you will need to guarantee the supply of backup tools to mitigate potential dangers to sufferers and medical employees whereas sustaining and managing medical units.66 Medical units used extra steadily by sufferers have to be produced extra constantly, and within the case of a breakdown, a alternative gadget have to be accessible. When the medical gadget turns into superannuated, the unavailability of an relevant new know-how, or a backup, will scale back the reliability of the gadget, limiting its utility to sufferers. With the rise in requirements of profession or training, the tendency to prioritize scientific components turns into stronger. Thus, it’s anticipated that medical units with low scientific components will likely be prioritized when changing medical units.
In the meantime, the price issue, which is the entire price of sustaining medical units, was not discovered to be an vital consider changing medical units. This seems to be considerably totally different from current analysis outcomes, which present that medical units geared up with new medical applied sciences are wanted owing to the rise in sufferers and that upkeep prices will enhance as medical establishments introduce new medical units and substitute the medical units which have reached the tip of their life cycle.67 Improper upkeep of medical units can have an effect on their efficiency and affected person security, considerably impacting the bills of medical establishments. Specifically, if a medical establishment is unable to safe manpower to handle medical units, its failure to watch the efficiency and security ranges of medical units might scale back the supply of the medical units, which may enhance upkeep prices. As a result of this examine was carried out in tertiary hospitals in Korea, manpower and sources had been secured for the upkeep of medical units; due to this fact, price components didn’t look like a significant factor in medical gadget alternative. Such reality is basically resulting from prioritization of huge college tertiary hospitals towards prefectoral and municipal hospitals positioned a lot decrease inside the nationwide well being system hierarchy.68 That is clearly seen when it comes to prioritization of technical, monetary and human useful resource allocation.69 Total, the dearth of upkeep of medical units might scale back their reliability. Subsequently, it’s needed to ascertain a medical gadget upkeep plan that focuses on scientific components to finally handle affected person security and the working prices of medical establishments. On this examine, we derived vital indicators that can be utilized as a reference in choices associated to changing medical units, and a extra environment friendly and systematic plan to interchange medical units, by contemplating the components prioritized by the occupation of medical employees, will likely be ready sooner or later.
As a way to higher perceive penalties of the worldwide medical gadget alternative panorama additionally it is notably vital to know huge scale demand and provide of medical units imposed by the main BRICs Rising Markets.70 Given the truth that these economies are driving world’s actual GDP progress for nearly three a long time, they do form medical gadget manufacturing and provide routes all through Asia.71,72 The identical case though with sure lag in improvement stage is seen amongst different huge Rising Markets reminiscent of Indonesia, Pakistan, Mexico, Nigeria.73 Their means to extend funding in healthcare is substantial, in contrast to relatively steady well being and pharmaceutical expenditures in rich OECD markets.74 Such regional and international disparities additionally drive rising demand for medical imaging, robotics assisted surgical procedure, oncology associated radiotherapy due to the actual fact of fast progress of the center citizen class in these LMICs nations.75 These layers of inhabitants depend in lots of of thousands and thousands and expertise sudden rise in total buying energy which inevitably transfers to rising demand for technologically superior medical care. One other extra uncared for driver of quickly rising demand can be accelerated inhabitants growing old with Korean, Chinese language and Japanese societies all discovering themselves in superior stage of third demographic transition.76,77 The “Silver Cunami” displays to the gradual extinction of conventional Asian household caregiving which was very a lot possible within the excessive fertility period preceeding two world wars.78 These days in single youngster households, and widespread burden of dementia, the demand for home-born robotics and synthetic intelligence assisted medical care is more likely to exponentially develop additional.79 Some well being expenditure forecasts and ongoing AI projections implicate the need to arrange for a profound transformation of up to date societies in a long time to return.76
Conclusion
The constraints of this examine had been as follows. First, medical units weren’t divided by class to find out the explanations for medical gadget alternative. This examine analyzed all medical units utilized in medical establishments. Medical units, labeled from 1st–4th grades based mostly on potential dangers, might have totally different priorities for alternative relying on the aim of use and the diploma of danger to the human physique. Future research ought to derive alternative priorities based mostly on the classification of medical units as a way to set up priorities in keeping with the forms of medical units. Second, the classification of the individuals as medical gadget customers, suppliers, sufferers, and others was not thought-about. Medical gadget ecosystems could be broadly divided into medical establishments, medical gadget corporations, and sufferers. The priorities for medical gadget alternative might differ in keeping with the traits of the teams, together with medical gadget corporations that present medical units, medical establishments that use medical units, and sufferers. Third, there’s a want for an evaluation in keeping with the kind of medical establishment. The medical units used, variety of sufferers, and manpower of medical employees differ relying on the classification of medical establishments into 1st, 2nd, and threerd establishments, due to this fact, components that have to be thought-about when changing medical units might differ. Moreover, this examine was restricted to knowledge from Korean medical establishments, which can pose limitations in generalizing the findings to different areas. Together with worldwide knowledge would assist assess the applicability of medical gadget alternative priorities in varied regional contexts. Specifically, making use of alternative precedence strategies tailor-made to regional traits might present optimized alternative methods for medical establishments in every area. A extra systematic alternative plan could be developed by an in depth evaluation of things reminiscent of medical gadget grades, medical gadget customers, and forms of medical establishments.
There are numerous causes for changing medical units, however a alternative should be based mostly on an acceptable analysis plan by every medical establishment. Subsequently, it’s potential to ascertain a sensible alternative program by using totally different alternative components for every occupation, specializing in scientific components. Finally, integrating a user-centered method when figuring out the precedence for medical gadget alternative is essential. This examine identifies scientific components as crucial component in figuring out alternative priorities and emphasizes the direct impression on affected person security when a tool is now not useful or turns into out of date. This method means that healthcare establishments ought to prioritize changing clinically vital units, no matter price or technical specs. Particularly, this examine derives a variety of medical gadget alternative priorities inside healthcare establishments, enabling the administration of the gadget lifecycle from a scientific perspective. Subsequently, by establishing acceptable restore and alternative insurance policies for not solely at the moment used medical units but additionally digital well being and IoT-based medical units, healthcare establishments can decrease operational prices and contribute to extending the lifespan of units. Moreover, making use of this alternative technique to healthcare establishments in nations with a healthcare ecosystem just like that of Korea might enhance the effectivity of medical gadget alternative.
Abbreviations
CT, Computed Tomography; P.E.T, Positron Emission Tomography; MRI, Magnetic Resonance Imaging; OECD, Group for Financial Co-operation and Improvement; AHA, American Hospital Affiliation; AHP, Analytic hierarchy course of; C.I, Consistency Indicator; C.R, Consistency Ratio; MCDM, Multi-criteria decision-making mannequin; MERS, Medical tools alternative rating; R.I, Random Index.
Acknowledgments
Sewon Park and Gihong Web optimization are co-first authors for this examine. Haengjun Lee and Munjae Lee are co-correspondence authors for this examine. This work was supported by the Ministry of Schooling of the Republic of Korea and the Nationwide Analysis Basis of Korea (NRF-2023S1A3A2A05095298), and by the Bio-convergence Expertise Schooling Programme by the Korea Institute for Development of Expertise (KIAT), funded by the Ministry of Commerce, Business and Power (No. P0017805).
Disclosure
The authors declare no conflicts of curiosity on this work.
References
1. Park S, Kim H-Ok, Lee H-J, Choi M, Lee M, Jakovljevic M. Strategic administration and organizational tradition of medical gadget corporations in relation to company efficiency. J Med Economics. 2023;26(1):781–792. doi:10.1080/13696998.2023.2224168
2. Jakovljevic M, Chang H, Pan J, et al. Successes and challenges of China’s well being care reform: a four-decade perspective spanning 1985—2023. Value Eff Resour Allocation. 2023;21(1):59. doi:10.1186/s12962-023-00461-9
3. Sapkota B, Palaian S, Shrestha S, Ozaki A, Mohamed Ibrahim MI, Jakovljevic M. Hole evaluation in manufacturing, innovation and advertising and marketing of medical units within the Asia-Pacific area. Professional Rev Pharmacoecon Outcomes Res. 2022;22(7):1043–1050. doi:10.1080/14737167.2022.2086122
4. Jakovljevic M, Wu W, Merrick J, Cerda A, Varjacic M, Sugahara T. Asian innovation in pharmaceutical and medical gadget trade–past tomorrow. J Med Economics. 2021;24(sup1):42–50. doi:10.1080/13696998.2021.2013675
5. Martella M, Lenzi J, Gianino MM. Diagnostic know-how: traits of use and availability in a 10-year interval (2011–2020) amongst sixteen OECD nations. MDPI. 2023;11:2078.
6. An in-depth examine of South Koreas diagnostic imaging tools market panorama.
7. Sittig DF, Wright A, Coiera E, et al. Present challenges in well being data know-how–associated affected person security. Well being Informatics J. 2020;26(1):181–189. doi:10.1177/1460458218814893
8. Singh Ok, Selvam P. Medical gadget danger administration. Developments Improvement Med Gadgets. 2020;65–76.
9. Security MoFaD. Tips for danger administration and preparation of danger evaluation and administration abstract in worldwide standardization paperwork for medical units. Med Machine Eval Division Korea Meals Drug Administration. 2014.
10. Park H-J. Enhancement of Danger Administration Traceability of Medical Gadgets and Their Administration. Ajou College Graduate College; 2019.
11. Verheyen P. Financial interpretation of fashions for the alternative of machines. Eur J Oper Res. 1979;3(2):150–156. doi:10.1016/0377-2217(79)90101-2
12. Kronenfeld M, Stephenson PL, Nail-Chiwetalu B, et al. Evaluate for librarians of evidence-based follow in nursing and the allied well being professions in the USA. J Med Lib Assoc. 2007;95(4):394. doi:10.3163/1536-5050.95.4.394
13. Web optimization G, Park S, Lee M. Find out how to calculate the life cycle of high-risk medical units for affected person security. Entrance Public Well being. 2022;10:989320. doi:10.3389/fpubh.2022.989320
14. Jakovljevic M, Liu Y, Cerda A, et al. The World South political economic system of well being financing and spending panorama–historical past and presence. J Med Economics. 2021;24(sup1):25–33. doi:10.1080/13696998.2021.2007691
15. Taylor Ok, Jackson S. A medical tools alternative rating system. J Clin Engineering. 2005;30(1):37–41. doi:10.1097/00004669-200501000-00046
16. Faisal M, Sharawi A. Prioritize medical tools alternative utilizing analytical hierarchy course of. IOSR J Electrical Electronics Engineering. 2015;10(3):55–63.
17. Liao H-Y, Cade W, Behdad S. Markov chain optimization of restore and alternative choices of medical tools. Resour Conserv Recycl. 2021;171:105609. doi:10.1016/j.resconrec.2021.105609
18. Abd Rahman NH, Ibrahim AK, Hasikin Ok, Abd Razak NA. Essential gadget reliability evaluation in healthcare providers. J Healthcare Engineering. 2023;2023(1):3136511. doi:10.1155/2023/3136511
19. Huang L, Lv W, Huang Q, et al. Reworking medical tools administration in digital public well being: a decision-making mannequin for medical tools alternative. Entrance Med. 2024;10:1239795. doi:10.3389/fmed.2023.1239795
20. Vokinger KN, Hwang TJ, Kesselheim AS, et al. Lifecycle regulation and analysis of synthetic intelligence and machine learning-based medical units. 2022.
21. Petrou S, Jakovljevic M. Reimagining the connection between economics and well being–WHO ‘Well being for all’provisions. Value Eff Resour Allocation. 2024;22(1):5. doi:10.1186/s12962-024-00512-9
22. Wang J, Xu DR, Zhang Y, et al. Improvement of the China’s checklist of ambulatory care delicate situations (ACSCs): a examine protocol. World Well being Res Coverage. 2024;9(1):11. doi:10.1186/s41256-024-00350-5
23. Lee WJ, Choi Y, Ko S, et al. Projected lifetime most cancers dangers from occupational radiation publicity amongst diagnostic medical radiation employees in South Korea. BMC Most cancers. 2018;18(1):1–10. doi:10.1186/s12885-018-5107-x
24. Oh Y. Potential provide and demand of medical technologists in Korea by 2030. Korean J Clin Laboratory Sci. 2018;50(4):511–524. doi:10.15324/kjcls.2018.50.4.511
25. Jung YA, Kim YJ. Comparative examine of ISO requirements for an efficient implementation of the home medical gadget GMP system. J Korean Soc High quality Manag. 2018;46(2):211–224.
26. Riess A, Lepmets M, McKechnie S, Walker A. Verification of the Effectiveness of Danger Administration within the Medical Machine Business. Springer; 2018:380–386.
27. Chan T, Tong RK. ISO 14971: utility of danger administration to medical units. Med Regulatory Affairs. 2022;191.
28. Luthra G, Sharma A. Significance of danger communication and danger evaluation in medical gadget trade. J Pharm Res Int. 2021;33(31A):32–41.
29. Orleoglo A, Ciobanu N. Danger administration in medicinal merchandise and medical gadget manufacturing. 2020.
30. Sharma A, Luthra G. A complete overview of danger administration within the medical gadget trade. J Pharm Res Int. 2023;35(6):14–23. doi:10.9734/jpri/2023/v35i67330
31. Knag IK. ISO14971:2019 detailed evaluation and put up market surveillance utility methodology – specializing in IVDR necessities. J Biomed Engineering Res. 2022;43(4):199–213.
32. Odaibo SG. Danger administration of AI/ML software program as a medical gadget (SaMD): on ISO 14971 and associated requirements and guidances. arXiv preprint arXiv:210907905. 2021.
33. Payments E, Mastrangelo S, Wu F. Documenting medical gadget danger administration by the chance traceability abstract. Biomed Instrumentation Technol. 2015;49(s1):26–33. doi:10.2345/0899-8205-49.s1.26
34. Geremia F. High quality elements for medical units, high quality system and certification course of. Microchem J. 2018;136:300–306. doi:10.1016/j.microc.2017.04.018
35. Wehde M. System design method to medical gadget improvement. IEEE. 2020;1–3.
36. Das M, Vogt-Ardatjew R, van den Berg B, Leferink F. Danger administration plan for the hospital atmosphere. IEEE. 2022;828–833.
37. Schaffarczyk D. Regulatory Affairs in gadget improvement–how you can design medical units succesful to enter the market. Ideas Biomed Sci Business. 2022;203–223.
38. Han kwang-hee KH-S, Juyoung L, Seung-ki R. Estimating a lifetime of ITS units. Estimating a lifetime of ITS units. The Korea Institute Clever Transport Techniques. 2009;2009(1):423–426.
39. Kotler P, Turner RE. Advertising and marketing Administration: Evaluation, Planning, and Management. Prentice-Corridor Canada; 1979.
40. Web optimization Gi-hong PE-Ok, Dong-il C. Improvement of easy analysis methodology for figuring out the precedence of medical gadget alternative in hospitals. J Biomed Engineering Res. 2020;41(6):256–263.
41. Kim D. A examine on public procurement legislation in response to COVID-19. Public Regulation. 2021;49(3):295–323. doi:10.38176/PublicLaw.2021.02.49.3.295
42. Unger SR, Hottle TA, Hobbs SR, et al. Do single-use medical units containing biopolymers scale back the environmental impacts of surgical procedures in contrast with their plastic equivalents? J Well being Companies Res Coverage. 2017;22(4):218–225. doi:10.1177/1355819617705683
43. Wu W, Zhang P, Zhu D, Jiang X, Jakovljevic M. Environmental air pollution legal responsibility insurance coverage of well being danger and company environmental efficiency: proof from China. Entrance Public Well being. 2022;10:897386. doi:10.3389/fpubh.2022.897386
44. MacNeill AJ, Hopf H, Khanuja A, et al. Reworking the medical gadget trade: highway map to a round economic system: examine examines a medical gadget trade transformation. Well being Affairs. 2020;39(12):2088–2097. doi:10.1377/hlthaff.2020.01118
45. Shao M, Jin H, Tsai F-S, Jakovljevic M. How briskly are the Asian nations progressing towards inexperienced economic system? Implications for public well being. Entrance Public Well being. 2022;9:753338. doi:10.3389/fpubh.2021.753338
46. Affiliation AH. Estimated helpful lives of depreciable hospital belongings, revised 2013 version. 2004.
47. Topfer L, Leseleuc L. Diagnostic imaging tools alternative and improve in Canada. Ottawa. 2016;56:1–32.
48. Healy GM, Ahrari A, Alkhalifah F, et al. Typology, severity, and outcomes of adversarial occasions associated to angiographic tools—a ten-year evaluation of the FDA MAUDE database. Canad Associat Radiolog Jl. 2023;08465371231167990.
49. Fennigkoh L. A medical tools alternative mannequin. J Clin Engineering. 1992;17(1):43–47. doi:10.1097/00004669-199201000-00019
50. Taghipour S, Banjevic D, Jardine AK. Prioritization of medical tools for upkeep choices. J Oper Res Soc. 2011;62(9):1666–1687. doi:10.1057/jors.2010.106
51. Rajasekaran D. Improvement of an automatic medical tools alternative planning system in hospitals. IEEE. 2005;52–53.
52. Mummolo G, Ranieri L, Bevilacqua V, Galli P, Menolascina F, Padovano G. A fuzzy method for medical tools alternative planning. 2007;229–235.
53. Kim SY. Improvement of a high quality competitiveness analysis index for Korean medical gadget corporations. Division of Medical Machine Business Graduate College of Dongguk College. 2018.
54. Park S, Kim H-Ok, Lee M. An analytic hierarchy course of evaluation for reinforcing physician–affected person communication. BMC Major Care. 2023;24(1):24. doi:10.1186/s12875-023-01972-3
55. Saaty TL. A scaling methodology for priorities in hierarchical buildings. J math psychol. 1977;15(3):234–281. doi:10.1016/0022-2496(77)90033-5
56. Saaty TL. The analytic hierarchy course of Mcgraw Hill, New York. Agricultural Economics Rev. 1980;70.
57. Amromanoh OA. How properly are tools alternative prioritization scores adopted? WRHA as a case examine. CMBES Proceedings. 2017;40.
58. Capuano M. Prioritizing tools for alternative: a plan based mostly on knowledge not notion. Biomed Instrumentation Technol. 2010;44(2):100–109. doi:10.2345/0899-8205-44.2.100
59. Dondelinger RM. A posh methodology of kit alternative planning: a complicated plan for the alternative of medical tools. Biomed Instrumentation Technol. 2004;38(1):26–31. doi:10.2345/0899-8205(2004)38[26:ACMOER]2.0.CO;2
60. Carleton KL, Enderle J, Jensen Ok, Zhu Q. Improvement of an tools alternative planning software for the veterans administration. IEEE. 2007;275–276.
61. Ouda BK, Mohamed AS, Saleh NS. A easy quantitative mannequin for alternative of medical tools proposed to growing nations. IEEE. 2010;188–191.
62. Aczél J, Saaty TL. Procedures for synthesizing ratio judgements. J Math Psychol. 1983;27(1):93–102. doi:10.1016/0022-2496(83)90028-7
63. Jeong Y-H, Chae I-S, Yang I-S, Kim H-Y, Lee H-Y. Evaluation of relative significance of key efficiency indicators for middle for child-care foodservice administration by analytic hierarchy course of (AHP). Korean J Neighborhood Diet. 2013;18(2):154–164. doi:10.5720/kjcn.2013.18.2.154
64. Saaty TL. The analytic hierarchy course of for resolution making. 1999.
65. Aljamali NM, Almuhana WHY. Evaluate on biomedical engineering and engineering know-how in bio-medical units. J Adv Electrical Gadgets. 2021;6(2):18–24.
66. Zamzam AH, Abdul Wahab AK, Azizan MM, Satapathy SC, Lai KW, Hasikin Ok. A scientific overview of medical tools reliability evaluation in enhancing the standard of healthcare providers. Entrance Public Well being. 2021;9:753951. doi:10.3389/fpubh.2021.753951
67. Ciklacandir S, Isler Y. Precedence evaluation of procuring medical tools in Turkish hospitals utilizing input-weighted fuzzy logic structure. Professional Syst Appl. 2023;213:119195. doi:10.1016/j.eswa.2022.119195
68. Jakovljevic MB. The important thing function of the main rising BRIC markets in the way forward for international well being care. Experimental Utilized Biomed Res. 2014;15(3):139–143.
69. Semenova Y, Lim L, Salpynov Z, Gaipov A, Jakovljevic M. Historic evolution of healthcare methods of post-soviet Russia, Belarus, Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, Uzbekistan, Armenia, and Azerbaijan: a scoping overview. Heliyon. 2024;10(8):e29550. doi:10.1016/j.heliyon.2024.e29550
70. Jakovljevic M, Lamnisos D, Westerman R, Chattu VK, Cerda A. Future well being spending forecast in main rising BRICS markets in 2030: well being coverage implications. Well being Res Coverage Techniques. 2022;20(1):23. doi:10.1186/s12961-022-00822-5
71. Jakovljevic M, Sugahara T, Timofeyev Y, Rancic N. Predictors of (in) efficiencies of healthcare expenditure among the many main asian economies–comparability of OECD and non-OECD nations. Danger Manag Healthcare Coverage. 2020;Quantity 13:2261–2280. doi:10.2147/RMHP.S266386
72. Stiglitz JE. An agenda for sustainable and inclusive progress for rising markets. J Coverage Modeling. 2016;38(4):693–710. doi:10.1016/j.jpolmod.2016.05.012
73. Zhou D, Ahuru RR, Yan M, Osabohien R, Jakovljevic M. Influences of girls empowerment indices on demand for childcare providers: proof from the Nigeria demographic and well being surveys. Afr J Reproduct Well being. 2023;27(10):65–80. doi:10.29063/ajrh2023/v27i10.6
74. Ollivaud P, Guillemette Y, Turner D. Hyperlinks between weak funding and the slowdown in productiveness and potential output progress throughout the OECD. OECD Financial Division Working Papers. 2016;(1304):
75. Jakovljevic M, Vukovic M, Chen CC, et al. Do well being reforms impression price consciousness of Well being care professionals? Outcomes from a nation-wide survey within the Balkans. Balkan Med J. 2016;33(1):8–17. doi:10.5152/balkanmedj.2015.15869
76. Jakovljevic MM, Netz Y, Buttigieg SC, Adany R, Laaser U, Varjacic M. Inhabitants growing old and migration–historical past and UN forecasts within the EU-28 and its east and south close to neighborhood–one century perspective 1950–2050. Globalization Well being. 2018;14(1):1–6. doi:10.1186/s12992-018-0348-7
77. Hyun KR, Kang S, Lee S. Inhabitants growing old and healthcare expenditure in Korea. Well being Economics. 2016;25(10):1239–1251. doi:10.1002/hec.3209
78. Chan SW-C. Household caregiving in dementia: the Asian perspective of a world downside. Dementia Geriatric Cognit Disord. 2011;30(6):469–478. doi:10.1159/000322086
79. Qi J, Wu C, Yang L, Ni C, Liu Y. Synthetic intelligence (AI) for dwelling help interventions in dementia: a scoping overview protocol. BMJ open. 2022;12(9):e062604. doi:10.1136/bmjopen-2022-062604
