Standards For Medical Equipment Research Articles

IEMS: An IoT-Empowered Wearable Multimodal Monitoring System in Neurocritical Care

IoT-empowered wearable multimodal monitoring system (IEMS), an IEMS for neurocritical care is developed to perform simultaneous monitoring of 8-channel electroencephalogram (EEG), 2-channel regional cerebral oxygen saturation (rSO2) based on near-infrared spectrum (NIRS), body surface temperature, electrocardiogram (ECG), photoplethysmography (PPG), and bioimpedance (Bio-Z). The IoT platform and wireless devices enable the patients’ signals available for remote diagnosis. Besides, analysis functions and artificial intelligence (AI) algorithms could be embedded in both the bedside platform and the cloud server to support physicians with clinical decisions. In the multimodal neural monitoring device, the following designs are adopted to face the neurological intensive care unit (NICU) application. Active electrodes and preamplifying free topology provide better signal quality and a larger dynamic range (DR). Dedicated low-power designs ensure the device lasts 10 h of operation. A nonwoven headset improves long-term wearability, which is also quick and easy to install. In the cardiovascular patch, the disposable electrode patch based on elastic materials ensures tight and comfortable contact with skin. Besides, the reusable wireless sensing module is tiny (20 mm <inline-formula xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink"> <tex-math notation="LaTeX">$\times16$ </tex-math></inline-formula> mm <inline-formula xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink"> <tex-math notation="LaTeX">$\times9$ </tex-math></inline-formula> mm) but could measure ECG, PPG, and Bio-Z simultaneously. Electrical tests and human subject (healthy volunteers and NICU patients) studies were conducted to examine the performance. The EEG channels show 130.75-dB DR and 0.84- <inline-formula xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink"> <tex-math notation="LaTeX">$\mu {}\text{V}_{\mathrm{ RMS}}$ </tex-math></inline-formula> input-referred noise, which also yields signals with high quality during human EEG monitoring. The NIRS channels exhibit good linearity and are able to operate under severe ambient interference. The temperature sensors show ±0.2 °C accuracy. Moreover, the system complies with mandatory standards for medical equipment. Overall, an IEMS can meet the requirements for NICU applications and could provide better comfort during long-term wearing.

Značaj biomedicinskih inženjera u zdravstvenom sistemu

In order for the Health Technology Management Policy at the state level to be successfully implemented, first of all, adequate personnel are necessary, and among these, biomedical engineers play an important role. Biomedical engineers (clinical engineers) work in a wide range of settings and disciplines in the health sector and play a key role in: innovation, design and development of new technologies in health care; testing, implementation and development of new diagnostic tools and medical equipment; defining safety standards for medical equipment; maintenance of (complex) medical equipment. The Ministry of Health of the Republic of Serbia labeled the biomedical engineering workforce as a "critical workforce". This critical workforce is defined as "a workforce that contributes to critical and essential elements of health technology management, especially in the domain of maintenance and replacement of (complex) medical equipment, now and in the future".

Standardization of Medical Equipment

From six aspects of medical equipment standardization management, this paper introduces the system of medical equipment standardization management in hospital and some relevant practices, and expounds the importance of strengthening medical equipment standardization management in the early period of medical community policy. Through the combination of the current department equipment and other corresponding characteristics, so as to solve the problems existing in the current equipment and the future standardization of equipment after the use of some positive effects.

The physical healthcare of patients in secure hospitals: setting standards for medical equipment

AimsThe increased morbidity and mortality relating to the poor physical health of patients with severe mental illness has repeatedly been an area identified as requiring improvement. Despite this, no national minimum standard has been published around the minimum level of physical health equipment that should be available within an inpatient psychiatric setting.The aim of this project was to improve and standardise availability of physical health equipment across the five clinical areas within a medium secure inpatient forensic setting, thus enabling optimal and timely medical care and physical examination of patients to occur.MethodThis project used a combination of audit and quality improvement practices. An audit standard was created and current practice was established within the 5 clinical areas of a Medium Secure Forensic Unit. Improvements were made in a systematic and measured way and two audit cycles were completed.ResultAt baseline, the attainment of audit standard ranged from 14-76%. Clinical areas were sharing equipment and there was an inconsistency as to where and how equipment was being stored. Changes implemented included redistribution and reorganisation of equipment which increased attainment to between 48% - 86%. Following this further equipment was ordered and the equipment was separated into that which was required on a daily basis to conduct physical observations and more specialist specific examination equipment. Re-audit found attainment across the five clinical areas being between 90-100%.ConclusionMonitoring of physical health within psychiatric inpatient settings is a key area of patient care, and is frequently identified as requiring improvement. Without access to equipment to monitor and assess physical health, this becomes challenging and potentially poorly completed. By standardizing available equipment and furthermore through practical steps such as separating the equipment required on a daily basis and that used less frequently the retention of equipment improved. This enables delivery of high quality, timely and thorough monitoring and assessment of physical health to be achievable.

2017 Joint Commission Medical Equipment Standards

2017 Joint Commission Medical Equipment Standards

Modelling of Dynamic Electrical Bioimpedance and Measurements Safety

This paper is based on mathematical and electrical modelling of living tissues and their electrical bioimpedance. Impedance is complex, dynamic, depends on frequency and changes with time. The equivalent electrical circuit of a tissue in the Fricke-Morse and Debye model as well as the electrical safety checks for medical devices and the standards for medical equipment and how to measure leakage currents are presented in this paper.

Flug- und Höhenmedizin für Anästhesisten - Teil 3: Notfälle an Bord von Verkehrsflugzeugen

The demographic trend of industrialized societies is also reflected in commercial airlines' passengers: passengers are older nowadays and long-haul flights are routine mode of transport despite considerable chronic and acute medical conditions. Moreover, duration of non-stop flight routes and the number of passengers on board increase. Thus, the probability of a medical incident during a particular flight event increases, too.Due to international regulations minimum standards for medical equipment on board, and first aid training of the crews are set. However, it is often difficult to assess whether a stopover at a nearby airport can improve the medical care of a critically ill passenger. Besides flight operations and technical aspects, the medical infrastructure on the ground has to be considered carefully.Regardless of the amount of experience of a physician medical emergencies on board an aircraft usually represent a particular challenge. This is mainly due to the unfamiliar surroundings, the characteristics of the cabin atmosphere, the often existing cultural and language barriers and legal liability concerns.

Equipment of Medical Backpacks in Mountain Rescue

We conducted a survey of equipment in medical backpacks for mountain rescuers and mountain emergency physicians. The aim was to investigate whether there are standards for medical equipment in mountain rescue organizations associated with the International Commission for Mountain Emergency Medicine (ICAR MEDCOM). A questionnaire was completed by 18 member organizations from 14 countries. Backpacks for first responders are well equipped to manage trauma, but deficiencies in equipment to treat medical emergencies were found. Paramedic and physicians' backpacks were well equipped to provide advanced life support and contained suitable drugs. We recommend that medical backpacks should be equipped in accordance with national laws, the medical emergencies in a given region, and take into account the climate, geography, medical training of rescuers, and funding of the organization. Automated external defibrillator provision should be improved. The effects of temperature on the drugs and equipment should be considered. Standards for training in the use and maintenance of medical tools should be enforced. First responders and physicians should only use familiar tools and drugs.

Analysis: New Hospital Accreditation Agency Falls Short

Analysis: New Hospital Accreditation Agency Falls Short

Musculoskeletal Trauma Services in Serbia

Serbia, a middle-income country, is located in southeastern Europe, with territory of 88,361 km(2) and 9,400,000 inhabitants. Average month salary is US$542 and the registered unemployment rate is 22%. The country is administratively divided into 30 districts (193 municipalities). The healthcare system is territorially organized. In the state capital there are five clinical hospitals with musculoskeletal traumatology departments, as well as one in each of the four university centers. In addition, there are orthopaedic departments in 40 smaller hospitals throughout the country and in three military hospitals, along with several pediatric surgical departments involved in managing musculoskeletal trauma. There are 524 orthopaedic trauma surgeons (1:18,000 people), with a minor number of additionally trained general and pediatric surgeons who care for musculoskeletal problems. Bonesetters are neither recognized nor included in the healthcare system. Orthopaedic traumatology services are well organized, with variable accessibility depending on the distance between injury site and nearest medical facility. Preventive strategies are well developed and mainly consider agricultural, industrial, and traffic injuries. Distribution of medical institutions is satisfactory. Future activities should include continuing medical education of specialists, exclusion of inappropriate specialists, improvement of preventive strategies and medical transport facilities, as well as standardization of medical equipment, diagnostics, and treatment protocols.

IEC standards for radiological equipment: issues for the industry and for end users

The International Electrotechnical Commission (IEC) is a global standard organisation established under the Presidency of Lord Kelvin in 1906. All medical equipment standards in IEC are dealt with by Technical Committee (TC) 62, and within this, Medical Imaging Equipment Standards are developed under the guidance of Subcommittee (SC) 62B. In September 2005, a special meeting of a Steering Group of IEC SC 62B was held to review X-ray standards and to identify an approach to new standards in this field. The agenda for new standards arising from this was definitively established and consolidated, concentrating on whole systems, with the aspiration of returning later to acceptance test and QA standards. A liaison was also established between SC 62B and SENTINEL. In addition, it was decided to review SC 62B's liaisons with the International Atomic Energy Agency and International Commission on Radiological Protection and some national/international professional bodies.

Towards international standardization of the anesthesia machine

THE practice of anesthesia and critical care has become increasingly dependent on medical technology. Almost every day we read articles in journals and newspapers and view on television some aspect of patient safety. It’s a trendy topic. Much is written on the fact that we must improve patient safety, but what is really being done about it? We have evolved from the old anesthesia machine which was a hodge-podge assembly of separate components, a Fluotec Mark II vaporizer, Ventimeter ventilator, Dial-a-Flo mixer, oxygen analyzer, low pressure alarm, one-channel electrocardiogram monitor, a manual mercury blood pressure cuff and stethoscope that was bolted together by a handyman in the basement of the hospital. We now have integrated anesthetic gas delivery and monitoring systems and in the future, the automated anesthesia glass cockpit. The term “standardization” when used in the context of making all equipment similar in design and function is really nowadays a misnomer. It’s just a small part of what medical equipment standards writers consider when writing a “standard”. What we are really trying to do is to write the minimum requirements for the “basic safety and essential performance” or in other words minimum engineering specifications for medical equipment in general; or for a particular device. Why the minimum, you may ask? Published standards must be sufficiently flexible to provide enough latitude to promote innovation. Standards that require the addition of numerous safety features increase the complexity of a device which may render the device unusable or more prone to failure. The law of diminishing returns takes over once again. An overview of standards development process has been published previously.1 There is no longer just one safety standard for the “anesthesia machine”, but a family of safety standards for almost every component of the “anesthesia system.”A In addition to the “particular” anesthesia system standard,B there are also additional standards covering radio frequency interference,C software, usabilityD and alarm systems.E Jeffrey Cooper in his classic article originally published in 1978 and reprinted in 2002 in the journal Quality and Safety in Health Care2 pointed out that only 14% of critical incidents in anesthesia were related to equipment failure, but 84% of preventable incidents were due to human error. Usability refers to the qualities of a device whereby it is easy to learn, easy to remember, and requires as few steps as possible to perform a task. Usability also implies that the system should have a low error rate and if errors are made, they should be easy to recognize and easy to fix. The device should be pleasant to use and should not frustrate or annoy the user. EDITORIAL 613

Increase Patient Safety by Creating a Quieter Hospital Environment

ers, alarms, machines, telephones, voices, are considered “usual and customary”—normal to those who work there and those who watch the television show “ER.” To patients, however, the sounds of the hospital are far from normal. Depending on age, hearing acuity, medication levels, culture, and fears, these sounds are antagonistic, worsening a situation that is already difficult. Beyond difficult, however, prolonged exposure to environmental noise can increase anxiety and stress, ultimately impacting patient safety. But the good news is that it is possible to address the noise issue and create an environment for patients that is not only of better quality, but also inherently safer.

JCAHO Connection

Editor's Note: AAMI and JCAHO are working together to provide AAMI members with more information about JCAHO initiatives and medical equipment standards. AAMI members can pose questions to JCAHO standards experts and obtain responses, which will be published in the Joint Commission Resources' Environment of Care News and in BI&amp;T. AAMI members can pose their questions by e-mailing Steve Campbell at scampbell@aami.org. Questions will be answered by JCAHO's Standards Interpretation Group, the official interpreters of JCAHO standards language.Q: I am a certified biomedical equipment technician. Over the last several years, I have noticed a nationwide trend—hospitals hiring electronic technicians without medical training. In some cases an electronic tech is put in charge of the biomedical engineering department or is the only biomed tech for the hospital. Has the Joint Commission addressed this issue?A: The Joint Commission does not specify a particular qualification or background for individuals working with medical equipment. While EC.6.10 (rationale) says medical equipment should be maintained by “qualified individuals,” the standard leaves it to the organization to make a reasonable determination about what those qualifications are.Joint Commission leadership and human resources standards do require health care organizations to ensure staff are competent to perform their assigned work, and an understanding of physiology is clearly an important factor in the ability to handle biomedical engineering duties. This is not to say, however, that technicians without a physiology background cannot be employed in biomedical engineering departments. A health care organization may reasonably consider entry-level technicians qualified to work on equipment not used clinically on patients-for example, nurse call systems. Under HR.2.30, which requires organizations to offer ongoing education to improve staff competence, such technicians could be given opportunities to develop the knowledge base and expertise to work with medical equipment.Q. Is there a standard of practice for the nursing personnel charged with care of inpatient dialysis patients? Specifically, are we required to have ACLS-certified RN/LPN caregivers on site?A. Joint Commission standards do not specify a particular background or qualification for caregivers in charge of dialysis patients. However, the Joint Commission does regard patient type as one of the factors that go into assessing caregiver qualifications. When evaluating staff competence, health care organizations must consider the patient population (HR.3.10, EP1) and the complexity of required services (LD.3.70, rationale). The potential risks associated with dialysis are serious enough to warrant a careful look at caregiver qualifications in this area.Note: State laws or CMS regulations may require specific qualifications for inpatient dialysis nurses.Q. We were recently told by one of our customers that doctor's offices are not subject to the Joint Commission's preventive maintenance regulations. Is that correct? If so, why?A. It's correct only if the doctor's office is not accredited by the Joint Commission. If the office is accredited by the Joint Commission, then it must comply with Joint Commission standards on medical equipment, including preventive maintenance standards.The only exception would be if the office is a behavioral health care facility. The Joint Commission's medical equipment standards (EC.6.10 and EC.6.20) do not apply to behavioral health.Q. What is the difference between a “random unannounced survey” and an “unannounced accredited survey”?A. An unannounced accredited survey is simply a Joint Commission accreditation survey that has not been announced ahead of time to the surveyed organization. Starting January 1, 2006, all Joint Commission surveys will be unannounced.A random, unannounced survey is a one-day survey conducted several months after an organization's full accreditation survey. The purpose of this abbreviated visit is to validate the effectiveness of the full survey. Every year, 5% of surveyed organizations are randomly selected for a one-day validation survey.

Changing Standards for Medical Equipment

Changing Standards for Medical Equipment

Changing Standards for Medical Equipment

Changing Standards for Medical Equipment

Health technology assessment in Portugal.

The Portuguese healthcare system is often portrayed as a National Health Service (NHS) model, characterized by universal coverage, comprehensive benefits, nearly free services, national tax financing, and public ownership or control of the factors of production. However, in reality the system fails to accomplish these features in a complete way. There coexist a number of occupation-related health insurance schemes that were originally intended to be integrated into the NHS. In addition, in key areas the NHS does not provide the wide range of services it promises. The public sector has a predominant role in the provision of hospital stays and general practitioner consultations, but the private sector provides a major portion of specialist consultations, dental consultations, and diagnostic services. Major problems in the system led to health reforms in the 1990s. New reform proposals include some specific steps concerning health technology, including standards for medical equipment based on quality, geographic distribution, sustainability, and cost-effectiveness. A new National Plan of Health Equipment was completed in 1998, aimed at improving the distribution of equipment. Despite reforms, healthcare expenditures continue to rise. There is general agreement that gains in efficiency could be made. This situation is beginning to encourage interest in health technology assessment (HTA) in Portugal, although these activities are not yet very developed. Recently, legislation requiring presentation of economic evaluations for new pharmaceutical products was enacted. Present plans also call for the creation in the future of a national agency for HTA.

MANAGEMENT OF MEDICAL TECHNOLOGY: AN ENIGMA

Health care facilities, whether in developed or developing countries, are increasingly finding themselves carrying out a balancing act between the available financial resources and demand for rapidly changing medical technology. The current situation on management of medical technology, especially sophisticated medical equipment, in India and developed countries is discussed and managerial methods suggested to make technology more need-based than demand-based. Lack of standardization of medical equipment in India is highlighted and the formation of an internal technology assessment group in each hospital is recommended along with scientific planning and evaluation of each new medical equipment to be brought into use.

Draft of International Medical Equipment Standards Under Review

Draft of International Medical Equipment Standards Under Review

Draft of International Medical Equipment Standards Under Review

Draft of International Medical Equipment Standards Under Review