How to improve regulatory practices for refurbished medical devices.

Modern health-care facilities rely on medical devices and equipment. However, keeping up with the development of new technology is unfeasible for many health facilities, especially in low-resource settings. Thus, the demand for refurbished medical devices is increasing worldwide, especially in low- and middle-income countries. Refurbished medical devices are restored devices that are rebuilt to meet safety and performance requirements comparable to their condition when new, without changing the intended use of the original device. While new medical devices are controlled by well-established and stringent safety and quality regulations, a great variation in the regulations of refurbished medical devices exists across countries. Here we discuss the different regulations and practices specific to refurbished medical devices in countries of major markets. We also explore the opportunities and challenges for expanding the refurbished medical device market. Finally, we suggest that regulatory guidelines pertaining to the import, sale, labelling and use of a refurbished medical product are needed, and authorities should implement these guidelines to ensure a high quality and safety standard of refurbished devices.

Les établissements de soins de santé modernes dépendent d'équipements et dispositifs médicaux. Pour nombre de ces établissements, il est toutefois impossible de suivre l'évolution des nouvelles technologies, surtout dans les lieux manquant de ressources. La demande en dispositifs médicaux remis à neuf est donc en hausse partout dans le monde, en particulier dans les pays à revenu faible et intermédiaire. Il s'agit de dispositifs restaurés, remaniés pour répondre aux mêmes exigences de sécurité et de performances que lorsqu'ils sont neufs, sans que l'usage prévu du dispositif d'origine ne soit modifié. Alors que les dispositifs médicaux neufs sont soumis à des normes de qualité et de sécurité strictes et bien établies, leurs équivalents restaurés font l'objet de règles nettement plus variables d'un pays à l'autre. Dans le présent document, nous évoquons les différentes réglementations et pratiques spécifiques aux dispositifs médicaux remis à neuf dans les pays qui abritent les principaux marchés. Nous nous intéressons en outre aux opportunités et aux défis liés à un développement du marché des dispositifs médicaux remis à neuf. Enfin, nous suggérons l'adoption de lignes directrices réglementaires concernant l'importation, la vente, l'étiquetage et l'utilisation de tels dispositifs; ces lignes directrices sont à faire appliquer par les autorités afin de garantir les normes les plus élevées en matière de qualité et de sécurité.

Los centros sanitarios modernos dependen de dispositivos y equipos médicos. Sin embargo, mantenerse al día en el desarrollo de las nuevas tecnologías no es viable para muchos centros sanitarios, sobre todo en los de escasos recursos. Por este motivo, la demanda de dispositivos médicos renovados está aumentando en todo el mundo, especialmente en los países de ingresos bajos y medios. Los dispositivos médicos renovados son dispositivos restaurados que se reconstruyen para que cumplan unos requisitos de seguridad y rendimiento comparables a los que tenían cuando eran nuevos, sin cambiar el uso previsto del dispositivo original. Mientras que los dispositivos médicos nuevos están sujetos a reglamentos estrictos y bien establecidos en materia de seguridad y calidad, los reglamentos de los dispositivos médicos renovados varían mucho de un país a otro. En este artículo, se analizan los diferentes reglamentos y prácticas específicos de los dispositivos médicos renovados en los países de los principales mercados. También se exploran las oportunidades y los desafíos que plantea la expansión del mercado de dispositivos médicos renovados. Por último, se propone que se establezcan directrices reglamentarias relativas a la importación, venta, etiquetado y uso de los dispositivos médicos renovados y que las autoridades las apliquen para asegurar su calidad y seguridad.

[Discussion on Quality Evaluation Method of Medical Device During Life-Cycle in Operation Based on the Analytic Hierarchy Process].

The content related to the quality during life-cycle in operation of medical device includes daily use, repair volume, preventive maintenance, quality control and adverse event monitoring. In view of this, the article aims at discussion on the quality evaluation method of medical devices during their life cycle in operation based on the Analytic Hierarchy Process (AHP). The presented method is proved to be effective by evaluating patient monitors as example. The method presented in can promote and guide the device quality control work, and it can provide valuable inputs to decisions about purchase of new device.

[Evaluation of Medical Instruments Cleaning Effect of Fluorescence Detection Technique].

OBJECTIVE: To compare the cleaning effect of automatic cleaning machine and manual cleaning on coupling type surgical instruments. METHODS: A total of 32 cleaned medical instruments were randomly sampled from medical institutions in Putuo District medical institutions disinfection supply center. Hygiena System SUREII ATP was used to monitor the ATP value, and the cleaning effect was evaluated. RESULTS: The surface ATP values of the medical instrument of manual cleaning were higher than that of the automatic cleaning machine. CONCLUSION: Coupling type surgical instruments has better cleaning effect of automatic cleaning machine before disinfection, the application is recommended.

[Mobility of metrological support in military-medical organisations of the Ministry of Defence].

Mobility of metrological support in military-medical organisations of the Ministry of Defence. With the increasing availability of high-tech medical care increases the value of its quality. One of the most important conditions to achieve an adequate level of medical service activity by this criterion is correct and reliable operation of medical equipment. Almost all medical equipment, which is used at the diagnostic and therapeutic departments of military medical institutions, belongs to the category of measuring instruments. Its accuracy and reliability of operation are provided with metrological procedures; which are considered an integral part of providing the diagnostic and treatment process. The article defines the activities of modern metrological tasks tipped the military medical service. The data on the state and prospects of development of metrological provision of health care institutions, increasing its mobility.

[The Application of the Fault Tree Analysis Method in Medical Equipment Maintenance].

In this paper, the traditional fault tree analysis method is presented, detailed instructions for its application characteristics in medical instrument maintenance is made. It is made significant changes when the traditional fault tree analysis method is introduced into the medical instrument maintenance: gave up the logic symbolic, logic analysis and calculation, gave up its complicated programs, and only keep its image and practical fault tree diagram, and the fault tree diagram there are also differences: the fault tree is no longer a logical tree but the thinking tree in troubleshooting, the definition of the fault tree's nodes is different, the composition of the fault tree's branches is also different.

[Equipment of field units of the medical service of the Armed Forces with modern medical complexes on the basis of pneumo-frame modules, and procedure of the use].

Equipment of field units or ine meaical service of the Armed Forces with modem medical complexes on the basis of pneumo-frame modules, and procedure of the use. On the basis of experience of medical supply in local wars and modern armed conflicts, when liquidating medical and sanitary disaster consequences the authors revealed the main organizational problems in army echelon of the medical service. It is shown that these problems can be solved by means of deployment of medical units and subunits. Requirements for means of deployment are defined. Present organic equipment is assessed. The authors showed advantages ofpneumo- framed modules, their tactic and technical characteristics, variants of the use when deploying army levels of field medical evacuation.

Pilot statewide study of pediatric emergency department alignment with national guidelines.

BACKGROUND: The American Academy of Pediatrics, American College of Emergency Physicians, and Emergency Nursing Association have developed consensus guidelines for pediatric emergency department policies, procedures, supplies, and equipment. Kentucky received funding from the Health Resources and Services Administration through the Emergency Medical Services for Children program to pilot test the guidelines with the state's hospitals. In addition to providing baseline data regarding institutional alignment with the guidelines, the survey supported development of grant funding to procure missing items. METHODS: Survey administration was undertaken by staff and members of the Kentucky Board of Emergency Medical Services Emergency Medical Services for Children work group and faculty and staff of the University of Kentucky College of Public Health and the University of Louisville School of Medicine. Responses were solicited primarily online with repeated reminders and offers of assistance. RESULTS: Seventy respondents completed the survey section on supplies and equipment either online or by fax. Results identified items unavailable at 20% or more of responding facilities, primarily the smallest sizes of equipment. The survey section addressing policy and procedure received only 16 responses. CONCLUSIONS: Kentucky facilities were reasonably well equipped by national standards, but rural facilities and small hospitals did not stock the smallest equipment sizes because of low reported volume of pediatric emergency department cases. Thus, a centralized procurement process that gives them access to an adequate range of pediatric supplies and equipment would support capacity building for the care of children across the entire state. Grant proposals were received from 28 facilities in the first 3 months of funding availability.

Biodegradable polymer drug-eluting stents versus durable polymer drug-eluting stents for percutaneous coronary intervention: a contemporary registry-based analysis.

AIMS: We aimed to compare the long-term outcomes of patients undergoing percutaneous coronary intervention (PCI) with biodegradable polymer drug-eluting stents (BP-DES) versus durable polymer drug-eluting stents (DP-DES). METHODS AND RESULTS: Among 11 517 PCIs with second-generation DES performed in our institution between 2007 and 2019, we identified 8042 procedures performed using DP-DES and 3475 using BP-DES. The primary outcome was target lesion failure, the composite target lesion revascularization (TLR), target vessel myocardial infarction and death. Propensity score matching was used to create a well-balanced cohort. Mean follow-up was 4.8 years. Of the 3413 matched pairs, 21% were females, and the mean age was 66 years. At 1 year, the primary outcome occurred in 8.3% patients versus 7.1% (P = 0.07), and TLR rate was 3% versus 2% (P = 0.006) in patients with DP-DES and BP-DES respectively. Within 5 years, the primary outcome occurred in 23.1% versus 23.4% (P = 0.44), and the rate of TLR was 7.2% versus 6.5% (P = 0.07) in patients with DP-DES and BP-DES, respectively. CONCLUSION: Similar rates of the composite outcome were observed throughout the entire follow-up. Target lesion revascularization rates were lower in the BP-DES group at 1-year but equalized within 5 years.

[Organization of medical equipment and stock supply of military medical facilities and groups of Disaster Medicine Service of the Russian Defense Ministry in emergency situations].

The article outlined the modern concept of medical equipment and stock supply of medical facilities and groups of Disaster Medicine Service of the Russian Defense Ministry involved into the remedial of the medical actions of emergency situations. The structure of the units of medical supplies in these conditions is presented.

Impact of the TEAM Wheels eHealth manual wheelchair training program: Study protocol for a randomized controlled trial.

BACKGROUND: Variable, and typically inadequate, delivery of skills training following manual wheelchair (MWC) provision has a detrimental impact on user mobility and participation. Traditional in-person delivery of training by rehabilitation therapists has diminished due to cost, travel time, and most recently social distancing restrictions due to COVID-19. Effective alternative training approaches include eHealth home training applications and interactive peer-led training using experienced and proficient MWC users. An innovative TEAM Wheels program integrates app-based self-training and teleconference peer-led training using a computer tablet platform. OBJECTIVE: This protocol outlines implementation and evaluation of the TEAM Wheels training program in a randomized control trial using a wait-list control group. SETTING: The study will be implemented in a community setting in three Canadian cities. PARTICIPANTS: Individuals ≥ 18 years of age within one year of transitioning to use of a MWC. INTERVENTION: Using a computer tablet, participants engage in three peer-led teleconference training sessions and 75-150 minutes of weekly practice using a video-based training application over 4 weeks. Peer trainers individualize the participants' training plans and monitor their tablet-based training activity online. Control group participants also receive the intervention following a 1-month wait-list period and data collection. MEASUREMENTS: Outcomes assessing participation; skill capacity and performance; self-efficacy; mobility; and quality of life will be measured at baseline and post-treatment, and at 6-month follow-up for the treatment group. IMPACT STATEMENT: We anticipate that TEAM Wheels will be successfully carried out at all sites and participants will demonstrate statistically significant improvement in the outcome measures compared with the control group.

Evaluation of the medtronic exponent self-expanding carotid stent system with the medtronic guardwire temporary occlusion and aspiration system in the treatment of carotid stenosis: combined from the MAVErIC (Medtronic AVE Self-expanding CaRotid Stent System with distal protection In the treatment of Carotid stenosis) I and MAVErIC II trials.

BACKGROUND AND PURPOSE: Embolic protection devices and improved stent technology have advanced the endovascular treatment of carotid artery disease. A combined analysis was performed of the MAVErIC (Medtronic AVE Self-expanding CaRotid Stent System with distal protection) I and II trials to evaluate the safety and feasibility of this system among patients at high risk for surgical endarterectomy. METHODS: Four hundred ninety-eight patients were enrolled in the MAVErIC I (99 patients) and MAVErIC II (399 patients) studies from June 2001 to October 2004. The results were pooled for statistical analysis of a common primary end point, the 365-day rate of major adverse events. Clinical follow-up took place at 30 days, 6 months, and 365 days postprocedure. RESULTS: The 365-day major adverse event rate, defined as death, stroke, or myocardial infarction within 30 days, and death, ipsilateral stroke, or myocardial infarction from days 31 to 365 was 12.5%. The incidence of neurological death through 365 days was 1.1%. The 30-day major adverse event rate was 5.4%. Subgroup analyses showed no notable differences in the 365-day major adverse event rate for symptomatic patients compared with asymptomatic patients. CONCLUSIONS: Treatment of carotid artery disease with carotid artery stenting with a self-expanding stent and distal embolic protection results in a low 30-day adverse event rate, including the occurrence of stroke in patients at high risk for carotid endarterectomy.

[Introduce the quality control of equipment of hemodialysis center].

This paper introduces the quality control of equipment of hemodialysis center, which includes the wate of hemodialysis, disinfection of the equipment, maintenance, check and calibration of the equipment.

Are melodic medical equipment alarms easily learned?

BACKGROUND: We tested melodic auditory alarms recommended in the IEC 60601-1-8 standard for medical electrical equipment for ease of learning and discrimination, and for effectiveness during a timeshared task. METHODS: Twenty-two critical care nurses learned the IEC 60601-1-8 melodic alarms over two training sessions more than a week apart, with or without mnemonics suggested in the standard. Subsequently, the nurses identified alarms arriving at quasi random intervals while performing a timeshared arithmetic task. RESULTS: Only one nurse (4.5%) identified the alarms with 100% accuracy after two training sessions. Mnemonics did not improve overall alarm identification accuracy (mnemonic = 56%, nonmnemonic = 55%) but led to a narrower range of confusions between alarms. Nurses responded faster (P < 0.0001) and more accurately (P = 0.032) to medium priority than high priority alarms, despite rating high priority alarms as sounding more urgent (P < 0.0001). Nurses with at least 1 yr of formal musical training identified the alarms much more accurately (musical training = 73%, no musical training = 38%, P < 0.0001), perceived a greater distinction between high and medium priority alarms (P = 0.002), and found identifying the alarms easier overall (P = 0.023). During the timeshared task, nurses' responses were slower (P = 0.002) and became less accurate (P = 0.02). CONCLUSIONS: The slow rate of learning and persistent confusions suggest that the IEC 60601-1-8 melodic alarms should be redesigned before they are adopted for clinical practice.

Mounting device for external cerebrospinal fluid drainage: the Freiburg Stativ.

BACKGROUND: External drainage of cerebrospinal fluid (CSF) is one of the most common neurosurgical procedures. It is important to maintain a stable drainage rate, but with the commonly available mountings for CSF drainage this can be difficult to achieve. The drainage rate is dependent on the height-difference between the CSF space and the drip chamber of the device. Most mountings for open CSF drainage cannot be satisfactorily fixed at the bed of the patient; especially if the head of the bed is moved, there is a risk of over- or underdrainage. MATERIALS AND METHODS: We have therefore constructed a mounting for open CSF drainage which allows appropriate adjustment of the rate of CSF outflow, even if the patient's head part of the bed is moved. FINDINGS: The device was easily mountable or exchangeable at any hospital bed and served equally well for ventricular or for lumbar drainage. CONCLUSION: We think that this device can help to reduce serious complication of over- or underdrainage in external CSF drainage.

Heat transfer coefficient: Medivance Arctic Sun Temperature Management System vs. water immersion.

BACKGROUND AND OBJECTIVE: To improve heat transfer, the Medivance Arctic Sun Temperature Management System (Medivance, Inc., Louisville, CO, USA) features an adhesive, water-conditioned, highly conductive hydrogel pad for intimate skin contact. This study measured and compared the heat transfer coefficient (h), i.e. heat transfer efficiency, of this pad (hPAD), in a heated model and in nine volunteers' thighs; and of 10 degrees C water (hWATER) in 33 head-out immersions by 11 volunteers. METHODS: Volunteer studies had ethical approval and written informed consent. Calibrated heat flux transducers measured heat flux (W m-2). Temperature gradient (DeltaT) was measured between skin and pad or water temperatures. Temperature gradient was changed through the pad's water temperature controller or by skin cooling on immersion. RESULTS: The heat transfer coefficient is the slope of W m-2/DeltaT: its unit is W m-2 degrees C-1. Average with (95% CI) was: model, hPAD = 110.4 (107.8-113.1), R2 = 0.99, n = 45; volunteers, hPAD = 109.8 (95.5-124.1), R2 = 0.83, n = 51; and water immersion, hWATER = 107.1 (98.1-116), R2 = 0.86, n = 94. CONCLUSION: The heat transfer coefficient for the pad was the same in the model and volunteers, and equivalent to hWATER. Therefore, for the same DeltaT and heat transfer area, the Arctic Sun's heat transfer rate would equal water immersion. This has important implications for body cooling/rewarming rates.

Equipping your facility for bariatric patients.

As the number of extremely obese people increases worldwide, all healthcare facilities-not just those with bariatric surgical programs-are treating patients who have special equipment and space requirements. Is your facility ready? This article will help you analyze your current capabilities and identify the steps you still need to take to accommodate this segment of the population.

[Evaluation of sanitary-and-epidemiological safety of medical wares].

The medical personnel operating currently available medical equipment can be exposed to physical factors. To prevent the adverse consequences of these exposures, medical equipment undergoes sanitary-and-epidemiological examination, resulting in the drawing up of a sanitary-and-epidemiological report. For regulation of this procedure, a management directive has been worked out, which determines an examination procedure, a hygienic classification of medical equipment, allowable values for controlled safety indices during operation, etc. Introduction of the directive makes it possible to upgrade the quality of sanitary-and-epidemiological equipment audit, to improve working conditions, and to keep health in the personnel operating the present-day high-technology equipment.

[On meeting sanitary legal requirements in technical regulation of medical equipment safety].

The article covered observance of sanitary legal requirements in special technical regulations "On requirements to medical equipment and medical products safety". The authors discussed problems of applied terminology, classification of medical products, occupational risk, control over observance of safety requirements on all stages of medical products circulation--design, production, usage.