Development status and prospects of international standardization of medical devices of Traditional Chinese Medicine.

As Traditional Chinese Medicine (TCM) becomes widely used in many countries around the world, global demand for intelligent and modernized medical devices of TCM is increasing. Medical devices of TCM have played an important role in diagnosis and treatment of disease. Standardization on medical devices of TCM cannot only be beneficial to ensuring the life safety of patients, but also to enhancing the effectiveness of diagnosis and treatment. This paper includes (1) classification and trends in medical devices of TCM; (2) status review on international standardization of medical devices of TCM; (3) key technical factors in developing international standards for medical devices of TCM and (4) prospects for international standardization development of medical devices of TCM.

[Health technology assessment of innovative medical devices: Timing and decision at national and local level]. / Accès au marché des dispositifs médicaux innovants : articulation entre évaluations nationales et hospitalières.

INTRODUCTION: The Medical Device Committee (CODIMS) evaluates all innovative medical devices (MD) before their introduction in the hospitals of the Assistance publique-hôpitaux de Paris (AP-HP). At the national level, the Medical Device and Health Technology Evaluation Committee (CNEDiMTS) provides recommendation for MD with respects to reimbursement by the National Health Insurance Fund. The aim of this study is to compare the recommendations of both committees and to analyze their timing on a six-year period. MATERIAL AND METHOD: We selected all innovative MD assessed by the CODIMS between 2013 and 2018. We retrieved all the recommendations for these MD from the CNEDiMTS. We performed quantitative and qualitative analysis of data collected. RESULTS: On 30 innovative MD assessed by both the CODIMS and the CNEDiMTS, 11 (37%) evaluations were performed by the CODIMS before the CNEDiMTS evaluation. They occurred approximately a year before the CNEDiMTS recommendation (an average of 378 days). Among the 25 MD with a recommendation of both committees, the two opinions were consistent in 88 per cent of all cases. DISCUSSION/CONCLUSION: This study highlights that there is a good consistency between the recommendations of both committees. This suggests that the MD evaluations conducted at the hospital level are relevant and timely. Finally, a better coordination between the national and local levels should be promoted for the MD assessment.

Failure of an Innovative Low-Cost, Noninvasive Thermotherapy Device for Treating Cutaneous Leishmaniasis Caused by Leishmania tropica in Pakistan.

Cutaneous leishmaniasis (CL), a neglected parasitic skin disease, is endemic in Pakistan, where Leishmania tropica and Leishmania major are the causative protozoan species. Standard treatment with antimonial injections is long, painful, and costly; has toxic side effects; and is not always available in public hospitals. Small pilot studies have previously evaluated a low-cost and noninvasive hand-held exothermic crystallization thermotherapy for cutaneous leishmaniasis (HECT-CL) device. We aimed to further establish the effectiveness, safety, and feasibility of HECT-CL in L. tropica. In a prospective observational study, patients with parasitological confirmation of CL were treated using the HECT-CL heat pack for 3 minutes with an initial temperature of 52-53°C for 7 consecutive days. Dried blood spot samples were taken for species identification by polymerase chain reaction (PCR). Effectiveness was assessed by using medical photographs and measurements of the lesion size at baseline and subsequent follow-up visits, for up to 180 days. We intended to enroll 317 patients. The HECT-CL treatment was easy to apply and well tolerated. Species identification demonstrated the presence of L. tropica. Interim analysis of 56 patients showed a failure rate of 91% at follow-up (median 45 days after treatment, interquartile range 30-60 days). Enrollment of patients was prematurely suspended because of futility. This study showed a high failure rate for HECT-CL thermotherapy in this setting. Leishmania tropica is known to be less sensitive to antileishmanial drugs, more temperature-resistant, and spontaneous healing is slower than that in L. major. More research is needed to identify low-cost, effective, and more patient-friendly treatment for L. tropica.

19 Channel Z-Score and LORETA Neurofeedback: Does the Evidence Support the Hype?

Neurofeedback is a well-investigated treatment for ADHD and epilepsy, especially when restricted to standard protocols such as theta/beta, slow cortical potentials and sensori-motor rhythm neurofeedback. Advances in any field are welcome and other techniques are being pursued. Manufacturers and clinicians are marketing 'superior' neurofeedback approaches including 19 channel Z-score neurofeedback (ZNFB) and 3-D LORETA neurofeedback (with or without Z-scores; LNFB). We conducted a review of the empirical literature to determine if such claims were warranted. This review included the above search terms in Pubmed, Google scholar and any references that met our criteria from the ZNFB publication list and was restricted to group based studies examining improvement in a clinical population that underwent peer review (book chapters, magazine articles or conference presentations are not included since these are not peer reviewed). Fifteen relevant studies emerged with only six meeting our criterion. Based on review of these studies it was concluded that empirical validation of these approaches is sorely lacking. There is no empirical data that supports the notion that 19-channel z-score neurofeedback is effective or superior. The quality of studies for LNFB was better compared to ZNFB and some suggestion for efficacy was demonstrated for ADHD and Tinnitus distress. However, these findings need to be replicated, extended to other populations and have yet to show any "superiority." Our conclusions continue to emphasize the pervasive lack of evidence supporting these approaches to neurofeedback and the implications of this are discussed.

Reliability of the Cervical Spine Device for the Assessment of Cervical Spine Range of Motion in Asymptomatic Participants.

OBJECTIVE: The purpose of this study was to assess the inter- and intra-assessor reliability of the cervical spine device (Formetric, DIERS International GmbH, Schlangenbad, Germany) in measuring cervical range of motion. METHODS: The cervical spine device was used to measure the cervical range of motion of 65 asymptomatic participants. Flexion-extension, right and left rotation, and right and left lateral flexion were analyzed. Two different assessors performed the measurements on the same day to estimate inter-assessor reliability and 2 days later to examine intra-assessor reliability. Intra-assessor and inter-assessor reliability was assessed using the intraclass correlation coefficient (ICC). The standard error of measurement (SEM) and the smallest detectable difference (SDD) were also estimated. RESULTS: Inter-assessor reliability ICCs for flexion + extension and total lateral flexion movements were >0.90. The ICCs for rotation movements and for left lateral flexion were >0.70. The ICCs for flexion (0.64), extension (0.58), and right lateral flexion (0.56) indicated moderate correlation. Mean SEMs ranged from 2.28° (SDD = 6.31°) for left rotation to 8.08° (SDD = 22.38°) for total rotation. As for intra-assessor test-retest reliability, all ICCs were >0.70. Mean SEMs ranged from 3.14° (SDD = 8.70°) for total lateral flexion to 7.50° (SDD = 20.77°) for extension. CONCLUSION: Both inter- and intra-observer reproducibility correlation values are moderate to high for measurements obtained using the cervical spine device.

Esterilizador a baja temperatura STERIZONE(R) VP4. Esterilización por Peróxido de Hidrógeno Vaporizado y Ozono / No disponible

Presentamos el nuevo STERIZONE(R) VP4, un esterilizador de baja temperatura (41ºC) que utiliza tanto peróxido de hidrógeno (H2O2) como ozono (O3) en un proceso multifásico. El esterilizante primario es peróxido de hidrógeno vaporizado. En el proceso, el peroxido de hidrógeno se introduce en la cámara hasta que se alcanza una presión diferencial de 19 torr. Manteniendo dicha presión constante. Tanto la dosis de esterilización como el tiempo de exposición pueden variar en función de la carga, lo que permite utilizar un único ciclo para esterilizar una amplia variedad de cargas con diferentes tamaños, materiales y geometría. La letalidad se consigue debido al efecto del peróxido de hidrógeno tanto en las fases de vapor como en las de microcondensación. El ozono se añade posteriormente a la cámara para descomponer el peróxido de hidrógeno residual y aumentar aún más la letalidad en el proceso. El rendimiento del dispositivo se ha validado mediante pruebas de medio ciclo, simuladas y en uso

The new STERIZONE(R) VP4, a low temperature (41° C) sterilizer that uses both hydrogen peroxide (H2O2) and ozone (O3) in a multiphase process. The primary sterilant is vaporized hydrogen peroxide. In the process, the hydrogen peroxide is introduced into the chamber until a differential pressure of 19 Torr is reached, keeping that pressure constant. Both the sterilization dose and the exposure time can vary depending on the load, allowing a single cycle to be used to sterilize a wide variety of loads with different sizes, materials and geometry. The lethality is achieved due to the effect of hydrogen peroxide in both the vapor and microcondensation phases. Ozone is then added to the chamber to decompose the residual hydrogen peroxide and increase lethality in the process. The device can also sterilize up to 34 Kg. of medical instruments in a single load (1 Cicle). Device performance has been validated by not only half-cycle testing, but also simulated-use and in-use (within a hospital) testing

Safety Assessment of Alumina and Aluminum Hydroxide as Used in Cosmetics.

This is a safety assessment of alumina and aluminum hydroxide as used in cosmetics. Alumina functions as an abrasive, absorbent, anticaking agent, bulking agent, and opacifying agent. Aluminum hydroxide functions as a buffering agent, corrosion inhibitor, and pH adjuster. The Food and Drug Administration (FDA) evaluated the safe use of alumina in several medical devices and aluminum hydroxide in over-the-counter drugs, which included a review of human and animal safety data. The Cosmetic Ingredient Review (CIR) Expert Panel considered the FDA evaluations as part of the basis for determining the safety of these ingredients as used in cosmetics. Alumina used in cosmetics is essentially the same as that used in medical devices. This safety assessment does not include metallic or elemental aluminum as a cosmetic ingredient. The CIR Expert Panel concluded that alumina and aluminum hydroxide are safe in the present practices of use and concentration described in this safety assessment.

[The evaluation of pharmacological drugs, medical devices, and non-pharmacological or public health interventions: Experimental design limitations. Moving towards new methods?] / Évaluer les effets d'un médicament, de dispositifs médicaux et d'interventions non médicamenteuses ou de santé publique : limites de l'essai expérimental. Vers de nouvelles méthodes ?

In the field of health, evidence-based medicine and associated methods like randomised controlled trials (RCTs) have become widely used. RCT has become the gold standard for evaluating causal links between interventions and health results. Originating in pharmacology, this method has been progressively expanded to medical devices, non-pharmacological individual interventions, as well as collective public health interventions. Its use in these domains has led to the formulation of several limits, and it has been called into question as an undisputed gold standard. Some of those limits (e.g. confounding biases and external validity) are common to these four different domains, while others are more specific. This paper describes the different limits, as well as several research avenues. Some are methodological reflections aiming at adapting RCT to the complexity of the tested interventions, and at overcoming some of its limits. Others are alternative methods. The objective is not to remove RCT from the range of evaluation methodologies, but to resituate it within this range. The aim is to encourage choosing between different methods according to the features and the level of the intervention to evaluate, thereby calling for methodological pluralism.

[Discussion on the industry standard: electroacupuncture therapy device].

Studying the industry standard of electroacupuncture therapy device (YY 0780-2010), collaborating with the clinical practice of acupuncture and moxibustion, in view of academy and safety, the comments and suggestions are proposed on the content of the standard. The standard describes manipulation norms, terms and definitions, dianjizhen and the output energy of single pulse, etc. It is expected that these comments and suggestions can be taken in consideration in the revision of industry standard or the development of national standard so as to improve the scientific level and feasibility of the technique standard of electroacupuncture therapy device.

Assessment and non-clinical impact of medical devices.

Medical devices (MDs) cover a wide variety of products. They accompany changes in medical practice in step with technology innovations. Innovations in the field of MDs can improve the conditions of use of health technology and/or modify the organisation of care beyond the strict diagnostic or therapeutic benefit for the patients. However, these non purely clinical criteria seem to be only rarely documented or taken into account in the assessment of MDs during reimbursement decisions at national level or for formulary listing by hospitals even though multidimensional models for the assessment of health technologies have been developed that take into account the views of all stakeholders in the healthcare system In this article, after summarising the background concerning the assessment of health technologies in France, a definition of non-clinical criteria for the assessment of MDs is proposed and a decision tree for the assessment of MDs is described. Future lines of approach are proposed as a conclusion.

Muscle plasticity and ankle control after repetitive use of a functional electrical stimulation device for foot drop in cerebral palsy.

BACKGROUND/OBJECTIVES: The primary goal was to determine whether repetitive functional electrical stimulation (FES) for unilateral foot drop increases tibialis anterior (TA) muscle size compared with an untreated baseline and the contralateral side in cerebral palsy (CP). Secondary goals were to determine whether positive changes in muscle size and gait, if found, accumulated during the 3 intervals during which participants used the device. FES devices differ from traditional orthoses that often restrict muscle activation and may exacerbate weakness, promote continued dependence on orthoses, or precipitate functional decline. METHODS: Participants were 14 independent ambulators with inadequate dorsiflexion in swing, with a mean age of 13.1 years, evaluated before and after the 3-month baseline, 1-month device accommodation, 3-month primary intervention, and 3-month follow-up phases. The FES device (WalkAide) stimulated the common fibular nerve to dorsiflex the ankle and evert the foot while monitoring use. TA muscle ultrasound, gait velocity, and ankle kinematic data for barefoot and device conditions are reported. RESULTS: Ultrasound measures of TA anatomic cross-sectional area and muscle thickness increased in the intervention compared with baseline and with the contralateral side and were maintained at follow-up. Maximum ankle dorsiflexion decreased at baseline but improved or was maintained during the intervention phase with and without the device, respectively. Muscle size gains were preserved at follow-up, but barefoot ankle motion returned to baseline values. CONCLUSIONS: This FES device produced evidence of use-dependent muscle plasticity in CP. Permanent improvements in voluntary ankle control after repetitive stimulation were not demonstrated.

[Utility of medical devices: approaches to planning and conducting clinical trials]. / Nutzen von Medizinprodukten: Lösungsansätze bei der Planung und Durchführung von Studien.

Medicines and medical devices do not only differ in the approval process, but also in the aim and conduct of clinical trials. We first discuss important differences between medicinal products and medical devices. Emphasis is put on the differences in the framework for clinical trials. We point out that a different analysis set should be used in clinical trials of medical devices when compared with medicinal products and medical devices in the USA. Specifically, regulators generally ask for the full analysis set based on the intention-to-treat principle as proof of efficacy of medicines. A central aspect of clinical trials of medical devices is that they have to be tested under normal conditions of use according to the performance data. As a result, all data acquired while the medical device was not during normal conditions of use should be excluded from statistical analyses. We discuss statistical methodological particularities of medical devices, such as blinding and the control of placebo effects. Using the conservative treatment of anal incontinence as an example, we show that comprehensive technical and physical knowledge is required for assessing the utility of medical devices. Finally, we consider reporting of severe adverse events and of severe adverse device effects of medical devices.

[Examples of practice: clinical trials for medical devices and their application: wound care]. / Praxisbeispiele zu klinischen Studien mit Medizinprodukten und deren Anwendung: Wundversorgung.

BACKGROUND: According to definition, chronic wounds do not show any tendency for healing over months. From the socio-economic perspective they are of great importance due to their frequency, patient burden and costs for the health system. In wound care, medical devices play a crucial, even more important role than drugs as nearly every wound needs at least a dressing. CLINICAL CARE AND RESEARCH: A wound passes through several phases of wound healing, which often demand different therapies and differentiated wound dressings in the sense of a "phase-adapted" wound therapy. "Modern wound care" reflects a cross-sectoral, interdisciplinary and interprofessional approach founded on evidence-based and quality-assured procedures according to the most recent medical knowledge. Clinical research on chronic wounds is characterised by a great variety of wound types and conditions, the strong impact of pathogenetic factors and complications, a multifaceted, frequently still manual therapy and long periods of healing. In many instances, several treatments are applied intermediately in the same patient, which serve different purposes and thus require different study endpoints. An analysis of the European Wound Management Association (EWMA) revealed that, on an international level, only few of the published clinical trials on chronic wounds meet the basic quality requirements. Accordingly, it is the objective to establish national and international consensus on standards of the methodology and interpretation of wound outcomes, such as the most recent EWMA activities and the German national consensus conference started in 2012. EXAMPLE OF A HIGH-QUALITY CLINICAL WOUND STUDY: As an example of a high quality randomised study on chronic wounds, hyperbaric oxygen treatment (HBOT) was evaluated as adjuvant treatment for diabetic foot ulcers compared to placebo (Löndahl et al., 2010). This trial is characterised by a diligent study design, a substantiated study rationale and an independent steering committee. Precise and reliable definitions for the end points were selected, their evaluation performed in a double-blinded manner, and the ITT and PP analyses were described transparently. Outcomes included both clinical and patient-reported parameters. Reporting according to the consort criteria revealed a significantly higher healing rate in the HBOT group. CONCLUSION AND PERSPECTIVES: Chronic wound therapy is a complex intervention with highly variable clinical conditions. Parts of missing quality and validity in therapeutic studies on chronic wounds, however, might be improved without noteworthy efforts if existing guidance is followed. This includes the motto: "better fewer but better conducted studies". Clinical research should focus on key principles and products, and it should prioritise research questions. Research on central principles of action in wound products between companies could further increase global research efficiency.

Evaluation of portable single-gas monitors for the detection of low levels of hydrogen sulfide and sulfur dioxide in petroleum industry environments.

Many portable single-gas monitors are used for the detection of low concentrations of hydrogen sulfide (H(2)S) and sulfur dioxide (SO(2)) in the workplace. With the recent lowering of the H(2)S and SO(2) ACGIH® threshold limit value (TLV®) the ability of these devices to selectively respond to these new lower levels is not well documented in petroleum industry environments, which often have potential interfering gases and vapors present as well as varying environmental conditions. Tests were carried out to measure the ability of various monitors with their respective sensors to correctly quantify and respond to H(2)S and SO(2) in a simulated petroleum industry environment. This included the identification of selected interference effects and estimation of the reliable lower limit of detection for real workplace environments. None of the H(2)S monitors responded at 0.1 times the new TLV (0.1 ppm), only some of them responded at the new TLV concentration (1 ppm), and all the monitors exposed to five times the new TLV (5 ppm) responded with reasonable accuracy. There was generally little effect of interferent gases and vapors on the H(2)S monitors. None of the SO(2) monitors responded at 0.1 and 1 times the new TLV (0.025 ppm and 0.25 ppm) concentrations, and all but one of them exposed to five times the new TLV (1.25 ppm) responded. There was much greater cross-sensitivity to interferents at the tested concentrations with the SO(2) monitors, which responded to six out of eight of the interferents tested. Results demonstrate that these monitors cannot reliably alarm and measure H(2)S or SO(2) concentrations at the new TLVs with an acceptable degree of accuracy. However, these monitors are designed to alarm as a safety device; these results do not change this important function.

Decision process to assess medical equipment for hyperbaric use.

There are very few items of medical equipment specifically designed for hyperbaric use; and little information is available about medical equipment already tested for hyperbaric use. Hyperbaricists are usually left to their own devices in making a determination about the safe and effective use of standard medical equipment in the hyperbaric setting. This article proposes a logical and systematic process to arrive at this determination. The process involves seven steps beginning with a need assessment and ending with endorsement by appropriate individuals. The discussion of decision steps includes identifying risk elements, compliance with safety standards, testing, and documentation.