Healthcare 4.0: Opportunities and barriers in the implementation of medical equipment

Caregiving is an inherently difficult role, replete with the emotional strains of watching a loved one deteriorate physically or mentally while trying to balance work and home responsibilities, and finding needed services with little or no guidance. These challenges are compounded by extreme stress, emotional overload, and a sense of isolation. Family caregiving is a lifespan issue, encompassing those with chronic conditions, disabilities, disease or the frailties of old age. Caregiving embraces a wide spectrum, ranging from the families of children with special needs to adult children caring for parents with Alzheimer's disease. Many family caregivers interact with medical devices in home settings.Advances in medical technology have allowed care recipients to remain ambulatory and independent. Because care recipients expect to be able to stay independent, mobile or active, the term “home use” extends beyond the home to encompass all environments in which a person plans to use his or her medical device to continue or enhance the quality of daily life.1For medical equipment designed for longterm use in the home, labeling will often not be with the device. In such cases, the home healthcare provider must develop his or her own basic instructions for use, maintenance, and cleaning. Through the MedWatch adverse event reporting system, the Food and Drug Administration (FDA) receives medical device reports of problems that stem from missing, absent or inadequate labeling, or misinterpretations of the information in labeling and instructions for use (IFU).The FDA also receives anecdotal information from consumers, healthcare practitioners (HCPs), healthcare organizations and device manufacturers suggesting interest in enhancing medical device equipment labeling content and format. Consumers and HCPs are particularly interested in having a searchable website containing medical device labeling and instructions for products intended for home use.This study was conducted to help the FDA better understand device labeling-related challenges that family caregivers face when care is provided in the home environment. Study respondents are members of the Caregiver Action Network (CAN), formerly the National Family Caregivers Association (NFCA), which educates, supports, empowers, and advocates for the more than 65 million Americans who care for loved ones with a chronic illness or disability or the frailties of old age,2 advocating for the needs of family caregivers, including their desires and need for instruction in the safe and effective use of medical devices in the home. These findings will assist in guiding the FDA's future efforts to characterize information pertinent to medical device labeling and provide online access in order to facilitate safe medical device use at home.A web-based survey contained multiple choice questions with pre-coded responses offering CAN respondents the opportunity to provide free-text responses and comments. The questionnaires were developed collaboratively by CAN, FDA/CDRH, and contractor to the FDA Social and Scientific Systems (SSS). Questions for both methods were based around the following topics:The survey questionnaire was administered via e-mail to a random sample of CAN members who met selection criteria (n=557; See Appendix 1 in online version of this article). The email provided background information about the FDA and the purpose of the study.The web-based survey was conducted October 5, 2011 through January 6, 2012. Reminders were sent four times over the course of the study, in October, November, and two in December. After the survey closed, results were collated and de-identified to maintain respondent confidentiality and then analyzed by the authors.One hundred twenty-seven respondents completed the web-based survey, a 22% response rate. Ninety-five percent of all respondents care for adult family members (over 21 years old). Forty-nine percent and 45% of these respondents care for a family member 65 years or over (n=63) or a family member between the ages 21–64 years (n=58), respectively.Of these 127 respondents, 77% care for their family member in their own home (n=99) and 59% of all respondents have cared for their family member more than five years (n=76). Forty-four percent of all respondents care for their spouse/partner (n=56).The majority of respondents indicated that they have been using their medical equipment for two or more years for chronic conditions, including heart disease, lung disease, and diabetes, or conditions related to stroke and cancer. Free text responses also included conditions, such as dementia and Alzheimer's disease.The survey determined that the home medical equipment respondents most commonly used in the care of family members included wheelchairs, specialty hospital beds, blood glucose monitors, patient lifts, nebulizers, and assistive equipment, such as canes, walkers, and bathroom handrails. Survey questions allowed respondents to share their experiences using the aforementioned medical products, specifically their experiences with the labeling and instructions that accompany the products they use.Respondents indicated that their medical equipment is most often delivered to their homes from the manufacturer or received from a pharmacy or drug store. From the free-text responses, respondents indicated that their equipment was handed down from friends or family after previous use. Respondents specified that it was ‘somewhat easy to very easy' to learn how to use their medical equipment, and most received training prior to use. Equipment use training was most often provided from the medical supply company representative.Other responses indicated that no training was received; or that training had been provided by the home health provider, rehabilitation staff, or hospital staff. Other methods besides training that helped respondents learn how to use their medical equipment included trial and error, following written (paper) instructions from the manufacturer, Internet instructions, verbal instruction, or observation and return demonstration.* Respondents noted that the best time to receive written instructions was upon delivery of equipment at home and the worst time was at the hospital.When manufacturer instructions came with their medical equipment, respondents indicated that it was ‘somewhat easy' to follow. Instructions were typically provided in a manual, booklet, or information sheet format. Respondents specify that the table of contents was most helpful in finding the information they need to use their equipment. When seeking information to troubleshoot their product, respondents believed they could ‘quickly and easily' find the information in the manufacturer's instructions.In free-text responses, respondents indicated that they would make use of the 1-800 helpline, or ask a nurse or company representative when they need information about using their product in general or for information about troubleshooting. Free-text comments indicated that a DVD would be helpful for these purposes.In addition to manufacturer's instructions, respondents indicated that they obtained information from medical supply companies, home health agencies, and hospitals, in the same format as the manufacturer's instructions. Interestingly, even when manufacturer's instructions are provided, information from additional sources is obtained in order to simplify and clarify the manufacturer's instructions.Respondents did not always use the instructions, because they felt the training they received was enough. The survey results indicated that most respondents commonly used their instructions when they were first learning to use their equipment; until they felt comfortable using it; and for information about cleaning.Respondents often referred back to their instructions when there was a problem, to find a phone number, or to refresh their memory and ensure they were using their equipment correctly. When respondents referred back to their instructions, they found what they needed to know. However, respondents specified that the information they needed was not always contained in the manufacturer's instructions. Instead, this information could come from other sources, such as from friends.Respondents who keep their instructions often file them with other medical information for as long as they own the equipment, which allows for easy access if needed. However, not all respondents have the instructions for their equipment. Whether this is because they never received it, or because they lost it requires further exploration.Most instructions include pictures and diagrams; however, whether respondents find them helpful is unclear. Interestingly, free-text responses indicated that pictures, diagrams, and other visuals are indeed useful and suggest that these be included in the instructions. Respondents report that the information they need to have to use their medical equipment, in the order of importance, includes the following:Respondents indicate that they most prefer to find information via paper instructions, such as a manual, brochure, or quick-start guide affixed to the equipment itself. In addition, respondents will also seek information online and find it helpful to obtain instructional information by phone with a company representative or home health nurse. To that end, respondents commonly turn to these sources, in addition to seeking advice from friends or others with the same condition or equipment.Respondents specify that a short version or quick-start guide would be helpful, especially if it includes the following:Sixty-five percent of all respondents are very comfortable with using computers (n=83), and 70% of respondents indicate they would welcome and make use of an FDA ‘searchable website that contained instructions for medical equipment used in the home' (n=90). Respondents noted that if the FDA created a searchable website, it should include videos to supplement the written instructions, diagrams, and pictures, all of which should be easy to print, and parallel the instruction preferences discussed above.Individuals likely to use medical products in the home setting may be elderly, chronically ill patients of any age, pregnant women, high-risk infants, and rehabilitation patients. These individuals vary significantly in their ability to operate and maintain devices. Complex instructions with multiple steps could confuse the user's ability to understand or adequately operate the device. To that end, instructions and information written in simple language should accompany any home use device product. Photographs, diagrams or other graphical representations may be used to provide clarity, as evidenced by respondent preferences.Survey results about medical equipment training portray an interesting situation: More complex devices used in the home environment are designed to be used by trained healthcare professionals in an acute care facility, rather than in a nonclinical setting. Furthermore, care recipients may not be able to choose the devices that they will ultimately use, as the device may be pre-selected by their insurance, for example.For these reasons, care recipients may not receive devices that are optimal for their comprehension level or that of a family caregiver. Therefore, it is imperative that home care recipients are properly trained on how to use their device as well as provided with instructional information that is readily accessible, easily understood and in a format that meets the users' needs.While this study generated important feedback on medical device labeling and use instructions, not all respondents (n=127) answered every question. Toward the end of the survey, there was attrition, evidenced by the dwindling number of responses to all remaining questions. This is likely due to the fact that respondents were requested to answer questions related to three pieces of medical equipment, which, in hindsight, is a large time commitment. While the free-text responses presented respondents with an opportunity to elaborate on their responses, many free-text reactions include ‘gripes' about the specific equipment(s) they use. Future studies like this one should consider responses of this nature during survey question development.Social desirability respondent bias was also present in this study. When comparing responses to questions with pre-coded selections with responses to questions that offered free text, there was a tendency for respondents to select favorable pre-coded responses to downplay the difficulties they experience, especially with regard to learning, following instructions, and using medical equipment.The pre-coded responses do not always match free-text feedback, which many times express frustration and confusion with regard to following medical device labeling and instructions. Furthermore, many free-text responses indicate that respondents do not recall receiving or did not receive instructions upon receipt of their medical equipment, which may also skew the results.Many study respondents are comfortable using computers, and often refer to information sources online and using a website that contains instructions for medical equipment used in the home. This finding, however, cannot be generalized to the entire population. Clearly there is selection bias at play: Respondents taking a web-based survey are likely to be more comfortable with computers, which could impact their ability to accurately respond to these questions.Another limitation to this study is that CAN respondent educational levels were not captured, nor were they included as part of the selection criteria eligibility. Authors suggest that in future studies of this nature, a question to obtain respondents' educational levels be included to determine whether there are relationships between education and labeling comprehension ease.

A hospital that wants to participate in Medicare must meet its standards—Medicare Conditions of Participation for Hospitals, 42 CFR §482—and receive accreditation from an organization that the U.S. Centers for Medicare & Medicaid Services (CMS) approves as a “deeming authority.”In September 2008, CMS approved DNV Healthcare for that role, and it is now the third accrediting organization for hospitals that want to be reimbursed by Medicare and most other third-party players. The other two such groups are The Joint Commission and the American Osteopathic Association.Here's a look at the DNV program and how it compares to that of The Joint Commission.DNV Healthcare is a subsidiary of Det Norske Veritas, a private, non-profit, Norwegian-based foundation. More than 100 years old, Det Norske Veritas says its purpose is to “protect life, property, and the environment” by advising and setting standards for many industries. It uses or incorporates International Organization for Standardization (ISO) standards as the basis for most of its work. While it has been involved with healthcare for about 20 years, DNV only got started in hospital accreditation with its acquisition of TUV Healthcare Specialists in 2007.To date, more than 120 U.S. hospitals have either achieved DNV accreditation, are awaiting their first survey, or are in the process of contracting with DNV. Recently, DNV has started expanding their hospital accreditation program to other countries.DNV's accreditation program is called National Integrated Accreditation for Healthcare Organizations (NIAHO). For now, its standards are applicable to hospitals only, although it is planning to develop accreditation programs for other healthcare specialties. Perhaps the most unique feature of NIAHO accreditation is that it incorporates the ISO 9001 Quality Management System Standards, one component of the ISO 9000 standards family. Getting an ISO 9001 certificate is an extra-cost option, but it's a major reason some hospitals choose to obtain DNV accreditation.Another unique feature of NIAHO accreditation is that the accreditation surveys, which are unannounced, are annual. The length of a survey and the number of surveyors are determined by the size and complexity of the organization being surveyed. All survey teams include at least two members—a nurse or physician, and a physical environment specialist. Another unique feature of NIAHO accreditation is that the standards and related literature are available free at: http://www.dnv.com/industry/healthcare.The DNV's accreditation standards for hospitals are published in National Integration Accreditation for Healthcare Organizations Accreditation Requirements (AR). The current version, only 53 pages, was published in September 2009. The standards were developed by specialists in each subject area in the AR. Since the standards are tied to the CMS Conditions of Participation and to ISO 9001, they are subject to change only when the Conditions of Participation or ISO 9001 change.The DNV's AR contains only their standards, unlike The Joint Commission's Comprehensive Accreditation Manual for Hospitals (CAMH), which includes standards plus explanatory materials. Separately, DNV does publish NIAHO Interpretive Guidelines and Surveyor Guidance (IGSG), which is also available free online. Educational programs are available, with the schedule posted on the DNV website.The AR has 25 chapters, including one entitled “Physical Environment,” which is analogous to the “Environment of Care” chapter in The Joint Commission's accreditation manuals. The “Physical Environment” chapter includes a section called Medical Equipment Management System.There are seven standards for medical equipment management in the AR. They are:Overall, the DNV standards for clinical engineering are very similar to the JC standards (Figure 1). The JC CAMH has 15 elements of performance that are specific to clinical engineering; the AR has seven requirements for clinical engineering. The AR doesn't have a written requirement for an equipment inventory or for equipment repairs. The CAMH doesn't have a requirement for equipment user training in its equipment standards. (It used to be there, but is now covered in the more general education and training standard in the “Human Resources” chapter.)In DNV's IGSG, the difference from JC standards becomes more distinct. In the interpretive guidelines section, it specifies that inspections and maintenance must be in accordance with the manufacturer's recommendations, along with federal and state laws and regulations. It requires that the medical equipment plan address the use and training for demonstration and rental equipment. Information on equipment repairs and periodic maintenance is included in the surveyor guidance section. This section states that “all medical devices and equipments are routinely checked by a clinical or biomedical engineer.” This section also contains a number of requirements for supplies—for both operational and emergency needs—even though there is no mention of supplies in the AR itself.Good standards should be well written, justifiable, and complete. I can find fault with all three aspects of the DNV standards for clinical engineering.The standards are not written clearly. Perhaps the best (worst?) example of a poorly written standard is SR.2. Besides being a poorly worded sentence, this standard appears to apply only to “issues related to” rental or physician owned equipment. Nowhere else in the standards is there any requirement for incoming inspections or for user training of all other medical equipment. I asked for clarification on the intent of this requirement from DNV staff. They explained that the intent of the requirement is that when equipment is purchased, there is an initial service inspection and orientation. In addition, if the equipment is rented or physician owned, there must be a demonstration. I believe that the wording of the requirement is too easily misinterpreted.I also have an issue with the fact that there is no mention of biomedical equipment technicians. The interpretive guidelines state that “a clinical or biomedical engineer or other qualified maintenance person” must maintain equipment. As stated in the surveyor guidance, all medical equipment must be routinely checked by a clinical or biomedical engineer. BMETs are better qualified by education, training, and experience to do all medical equipment maintenance—scheduled or unscheduled. There is no group more qualified to maintain medical equipment than BMETs, and they outnumber clinical and biomedical engineers in hospitals more than 100 to 1.As stated in the interpretive guidelines, manufacturers' testing and maintenance recommendations must be followed. But I believe manufacturers' recommendations are often a waste of time (e.g., when they require too frequent or too detailed inspections). Experience shows that all medical equipment does not need routine inspections, and evidence-based inspection procedures are more effective and economical.The DNV's AR standards are not complete. They do not explicitly require an equipment inventory or equipment repairs. One could probably argue that these are implicit in other standards, but requirements shouldn't be implied. An equipment inventory and equipment repairs are among the more important aspects of a clinical engineering function, and should be explicitly required. It isn't until you read the surveyor guidance section that you find out that the surveyors will be looking for a repair program. The surveyor guidance also requires “maintenance logs for significant medical equipment.” This suggests an inventory, but only for “significant” equipment. It includes some examples of significant equipment, but no definition, so this would obviously be open to interpretation. Do they want hospitals to develop their own list of significant equipment? If so, would this amount to something similar to the JC's inventory based upon risk categorization? We shouldn't have to guess.Randall Snelling is the chief physical environment officer at DNV Healthcare. He interprets the standards and trains surveyors pertaining to the “Physical Environment” chapter. I had a lengthy discussion about the medical equipment standards with Snelling. He explained that all NIAHO standards were written to comply with the CMS conditions of participation requirements and ISO 9001 standards. He emphasized that their physical environment standards, including for medical equipment, are collaborative, not prescriptive. Hospitals can establish their own medical equipment management programs if adequately described, explained, and justified. He believes that clinical engineers and BMETs know what needs to be done. He said that, during surveys, they always interview the clinical engineering manager. Their most common findings are that BMET training is not documented and that non-hospital owned equipment is not inspected.It was very interesting that we agreed on the fundamentals of medical equipment management programs: There should be a plan, the plan should be implemented, performance should be measured, and there should be continuous improvement. He reiterated that this is what surveyors looked for. However, I argued that their standards and their guidelines were not written that way. I believe that both the standards and the guidelines are prescriptive, and leave no room for alternatives. He said that this was not the intention, and that he would review them in light of my comments. He feels that SR.1, which requires a medical equipment management system, requires hospitals to develop a comprehensive program while allowing them to develop one that meets their unique needs. He said that anyone with questions or comments about the medical equipment management standards could contact him at Randall.Snelling@dnv.com.The people with whom I discussed the DNV standards clearly believe that it is appropriate for hospitals to develop their own programs that meet their unique needs and that are based on their expert experience. Unfortunately, CMS conditions of participation require hospitals to follow manufacturer recommendations for maintaining medical equipment. So, DNV would appear to be caught between a rock and a hard place. They have written their standards to comply with CMS's prescriptive requirements, but claim to interpret them more flexibly.

In recent years, high-precision medical equipment, especially large-scale medical imaging equipment, is usually composed of circuit, water, light, and other structures. Its structure is cumbersome and complex, so it is difficult to detect and diagnose the health status of medical imaging equipment. Based on the vibration signal of mechanical equipment, a PLSR-DNN hybrid network model for health prediction of medical equipment is proposed by using partial least squares regression (PLSR) algorithm and deep neural networks (DNNs). At the same time, in the diagnosis of medical imaging equipment fault, the paper proposes to use rough set to screen the fault factors and then use BP neural network to classify and identify the fault and analyzes the practical application effect of the two technologies. The results show that the PLSR-DNN hybrid network model for health prediction of medical imaging equipment is basically consistent with the actual health value of medical equipment; medical imaging equipment fault diagnosis technology is based on rough set and BP neural network. In the test set, the sensitivity, specificity, and accuracy of medical imaging equipment fault identification are 75.0%, 83.3%, and 85.0%. The above results show that the proposed health prediction method and fault diagnosis method of medical imaging equipment have good performance in health prediction and fault diagnosis of medical equipment.

Partnering With Families of Medically Complex Children Transitioning From the Hospital to Home.

Is ‘Old School’ Equipment Testing the Way to Go in Developing Countries?

Medical services, medical insurance institutions, medical administrations, pharmaceutical and medical device manufacturers, pharmaceutical and medical device research institutes, and health-related service providers produce large amounts of data in the operation, which constitute medical and healthcare big data. Medical and healthcare big data is the important basic strategic resource of a country. The construction of the national big data platform for medical and healthcare management is of great significance to the development of healthcare in China, and will bring new development and change. Medical devices and equipments are essential to the provision of quality services, the lack of safe and effective and functional medical equipments will affect the quality of healthcare services, affect the diagnosis and treatment of patients, and even threaten the healthy development of the entire health system. Application of IoT technology and big data technology, and with the help of the national big data platform for medical and healthcare management, can solve many problems existing in the supervision and evaluation of medical devices, medical device adverse event control, hospital medical equipment maintenance (such as maintenance, condition monitoring, accident retrospective, evaluation and scrap) and medical device acquisition process, so as to improve the management efficiency and management level of medical devices and improve the efficiency of medical equipment production enterprises in product registration, after-sale service and adverse events protection. This process has a realistic driving significance and long-term strategic significance to our medical system. In this paper, the problems in the management of medical equipment in China were analyzed, and the function of the national big data platform for medical and healthcare management in medical equipment management were introduced and analyzed. Key words: Healthcare big data; Medical equipment management; Medical equipment registration; Medical equipment supervision

Medical equipment is the main important part of the healthcare services system. Efficiently purchasing such a critical issue is a challenge. Time, effort, and expenses are spent to select the most appropriate required medical equipment. Also, this selection may not do in the best way. Therefore, planning for a public tender is essential to select the most appropriate required medical equipment. In this paper, an automated evaluation system based on standardization to select the most appropriate medical equipment from presented offers is presented. The Technique for Order Preference by Similarity to Ideal Solution (TOPSIS) method is used to evaluate the offers of medical equipment considering its resultant scores. Further, a software program is designed and implemented to evaluate the offers in terms of general, technical, and financial criteria. Each criterion has a set of evaluation points. A score index is generated for each criterion separately. The Emergency Care Research Institute (ECRI) is selected to be the technical reference for medical equipment specifications. In application, a set of medical imaging equipment such as X-Ray, Computed Tomography (CT), MRI, and ultrasound are used to test the software program. The results demonstrate a convenient utilization of the program considering the goal of this study. To improve the healthcare services in hospitals, the automated evaluation system based on standardization presents an automated platform to introduce, evaluate, and rank the offers of medical equipment.

Objectives: Many medical devices and equipment have been reserved in hospital wards and outpatient departments. Among these items, >80% are not often used but are being reserved for emergency situations. We aimed to reduce the number of unnecessarily reserved medical devices and to reduce the cost of unnecessary resterilization of devices and equipment. Methods: The central sterile supply department (CSSD), in coordination with other 13 wards within the Thammasat University Hospital, established a standard action plan for improving the efficiency of medical supply stocking and storage. Medical equipment and/or devices were returned to the CSSD, which acted as the center of management and distribution. The CSSD also tracked and solved problems that occurred and reevaluated practice guidelines. User satisfaction was evaluated and statistic data were collected and analyzed. Results: Wards no longer reserve medical equipment. Thus, no repeated sterilization was needed for unused medical equipment from the participated 13 wards, and sufficient medical equipment was available for various wards when needed. This project helped reduce the cost of purchasing medical equipment, especially for a newly opened ward. The storage of all medical equipment and devices complied with the practice guidelines because the CSSD storage room had a standard temperature and humidity control system. Conclusions: In this project, the CSSD cooperated with the 13 participating wards. As the result of centralizing the supplies, the CSSD has sufficient medical equipment and devices for all other wards, including a newly opened ward. The hospital benefitted from reduced costs of purchasing new medical equipment for a newly opened ward as well as the cost savings of eliminating unnecessary resterilization of unused devices and equipment.

Immunity of medical equipment to radiated radio frequency (RF) electromagnetic (EM) fields is a priority issue owing to the functions that the equipment is intended to perform. This is reflected in increasingly stringent normative requirements that medical electrical equipment has to conform to. A new version of the standard concerning electromagnetic compatibility of medical electrical equipment IEC 60601-1-2:2014 has recently been published. The paper discusses major changes introduced in this edition of the standard. The changes comprise more rigorous immunity requirements for medical equipment as regards radiated RF EM fields and a new requirement for testing the immunity of medical electrical equipment to disturbances coming from digital radio communication systems. Further on, the paper presents two typical designs of the input block: involving a multi-level filtering and amplification circuit and including a solution which integrates an input amplifier and an analog-to-digital converter in one circuit. Regardless of the applied solution, presence of electromagnetic disturbances in the input block leads to demodulation of the disturbance signal envelope. The article elaborates on mechanisms of amplitude detection occurring in such cases. Electromagnetic interferences penetration from the amplifier's input to the output is also described in the paper. If the aforementioned phenomena are taken into account, engineers will be able to develop a more conscious approach towards the issue of immunity to RF EM fields in the process of designing input circuits in medical electrical equipment.

BackgroundHospitals in the United States often have an abundance of unused medical supplies and equipment while many developing countries are in considerable need of these resources. Many nongovernmental organizations (NGOs) have donated medical equipment to health centers in low-resource settings to rectify this issue; however, studies show many of these donations are not usable by the facilities that receive them. To better serve the partner hospitals of our NGO, Oasis Medical Relief, we investigated the perspectives and insights of Ethiopian healthcare workers (HCWs) on the medical equipment distribution paradigm of the country.MethodologyQualitative analysis including semi-structured, open-ended interviews was conducted. Semi-structured interviews (n = six) were conducted with HCWs (four physicians and two hospital administrators) working in hospitals in Addis Ababa and Southern Nations, Nationalities, and Peoples’ Region (SNNPR) of Ethiopia. Interviews were recorded and transcribed. Categorical content analysis was utilized to develop themes. The topical areas addressed by our questions include populations served, prevalence of diseases, laws, and strategies guiding medical equipment distribution, funding and budget for medical equipment, etc.ResultsThree themes related to perspectives and insights of HCWs on the current medical equipment distribution paradigm in Ethiopia interviewed include: (1) state of healthcare concerns, (2) medical equipment scarcity, and (3) policy shaping medical distribution paradigm.ConclusionsPre-donation assessments utilized to understand equipment needs are recognized by the World Health Organization to more effectively address medical equipment/supply. However, to further strengthen such efforts, qualitative interviews with HCWs are a tool that can be utilized to better understand the intricacies of Ethiopia’s complex medical distribution paradigm. This can potentially lead to more effective partnerships between NGOs and their partner hospitals. Furthermore, increasing decentralized methods of procuring medical equipment should be further explored to mitigate issues with national distribution of medical supplies.

Used medical equipment is a valuable asset that has to be preserved. If used medical equipment is re-used it needs to be processed in a dedicated way to avoid risks for users, patients and healthcare providers to make sure that the medical equipment is as safe and effective as when it was new. The concept “Good Refurbishment Practice” (GRP), defined and published by COCIR [1], [2] describes such a dedicated way to process used medical equipment. Knowing the quality requirements for refurbishment and regarding the lack of clear guidelines for refurbishment, the companies organized in COCIR developed an standard on GRP that defines the requirements for refurbishment.

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The qualification of CE, incorporating both engineering and medicine, was first established in 1987. The CE is a health care professional who ensures the safety and effectiveness of medical equipment. A basic duties guideline for CEs was devised in 2010. The main duties of the CE are classified as respiratory therapy, cardiopulmonary bypass , dialysis units, intensive care units, cardiac catheterization, hyperbaric oxygen therapy, pacemakers and medical equipment management. To enhance the ability of CEs to engage in more extensive duties and develop specialties, there is a certification system in each field. The CE plays a role that is socially important by ensuring the safety of medical equipment and its effective maintenance. Purpose of establishment of CE Recent progress with medical equipment has extended the range of medical care, and specialists who can operate and maintain many complex pieces of equipment are required. The qualification of CE, incorporating both engineering and medicine, was first established in 1987, and CEs began to work in Japan from 1988. The CE is a health care professional who ensures the safety and effectiveness of medical equipment. Current state of CE education A CE must graduate from a CE training school (university, junior college, or technical school) and pass a national examination. The training schools devised guidelines for the national examination to maintain a certain standard of CE education. The examination covers questions from the fields of medicine, engineering, and medical technology. The number of questions is 180 (90 in the morning and 90 in the afternoon) and the examination is carried out over 2 sessions of 2.5 hours each. There are some universities setting up graduate schools for CE education, and there are some CEs who already have a master’s degree or a doctorate in the field of BME. Present status of CEs As of 2012, there are approximately 12,000 CEs in Japan. A basic duties guideline for CEs was devised in 2010[1]. The main duties of the CE are classified as respiratory therapy, maintenance of cardiopulmonary bypass units, dialysis equipment, and surgical equipment, intensive care Koichi Umimoto Department of Biomedical Engineering Osaka Electro-Communication University, Osaka, Japan (Tel: 072-876-5376, Fax: 072-876-5281 e-mail: umimoto@isc.osakac.ac.jp). units, cardiac catheterization, hyperbaric oxygen therapy, other treatment (defibrillators, pacemakers, and implantable cardioverter defibrillators) and medical equipment management. A team of CEs are involved in dialysis. The duties of CEs in the dialysis unit are preparation of the dialysis sets, blood access, operation of the equipment and monitoring patient during treatment, and maintenance of the dialysis equipment. Certification for CEs in each field To enhance the ability of CEs to engage in more extensive duties and develop specialties, as well as provide better health care services, there is a certification system in each field. This involves certification by the Japanese CE Society and the Associated Societies. Regarding certification by the Japanese CE Society, there is a CE certification system for specialization in blood purification, a pacemaker-related CE specialty, and a respiratory treatment specialty. Regarding certification by the Associated Societies, there are qualifications in dialysis technology, extracorporeal circulation technology, respiratory therapy, clinical medical engineering equipment technologist, hyperbaric oxygen therapy, and apheresis treatment. Future prospects Since the CE was born in 1988, 24 years have passed. The CE plays a role that is socially important by ensuring the safety of medical equipment and its effective maintenance. In addition to technology, we must develop managerial skills for medical equipment like CEs in the USA. Therefore it is important to establish an advanced CE education system in Japan like that of the American College of Clinical Engineering[2].

The continuous progress in modern medicine is not only the level of medical technology, but also various high-tech medical auxiliary equipment. With the rapid development of hospital information construction, medical equipment plays a very important role in the diagnosis, treatment, and prognosis observation of the disease. However, the continuous growth of the types and quantity of medical equipment has caused considerable difficulties in the management of hospital equipment. In order to improve the efficiency of medical equipment management in hospital, based on cloud computing and the Internet of Things, this paper develops a comprehensive management system of medical equipment and uses the improved particle swarm optimization algorithm and chicken swarm algorithm to help the system reasonably achieve dynamic task scheduling. The purpose of this paper is to develop a comprehensive intelligent management system to master the procurement, maintenance, and use of all medical equipment in the hospital, so as to maximize the scientific management of medical equipment in the hospital. Scientific Management. It is very necessary to develop a preventive maintenance plan for medical equipment. From the experimental data, it can be seen that when the system simultaneously accesses 100 simulated users online, the corresponding time for submitting the equipment maintenance application form is 1228 ms, and the accuracy rate is 99.8%. When there are 1000 simulated online users, the corresponding time for submitting the equipment maintenance application form is 5123 ms, and the correct rate is 99.4%. On the whole, the medical equipment management information system has excellent performance in stress testing. It not only predicts the initial performance requirements, but also provides a large amount of data support for equipment management and maintenance.

This paper deals with the development of standard In-service Training and Education of Users and Maintenance personnel on Medical Imaging Equipment in the health services of Bangladesh. Users and Maintenance personnel of equipment should be trained to do routine simple maintenance on equipment. This will increase user care of equipment and cooperation with maintenance technicians to reduce equipment breakdowns. At the same time, this will promote the culture of equipment care and maintenance to improve the quality of health care. Proper use and maintenance of medical equipment are essential to obtain sustained benefits and to preserve capital investment. In-service education and training have a direct impact on the quality of care. Various obstacles for expanding medical equipment use and maintenance capabilities in Bangladesh have been discussed. Proper operation and maintenance problems are complicated by the ever-increasing use of medical imaging equipment as health care is modernized. To date, the operation and maintenance situation in Bangladesh are getting worse and requires special attention. Use and maintenance capabilities are considered during the initial stage of making a decision to acquire equipment. Proper use and maintenance problems can be minimized through in-service training and education. The mission is to ensure that equipment used for patient care is safe, available, accurate, and affordable. In this paper, it has been described the problems and methodology to improve the existing in-service training and education of users and maintenance personnel on MIE. In this study, we designed a framework of in-service training and education of medical imaging equipment (MIE) uses and maintenance system used for in-house clinical engineering department.