Repeatability, Reproducibility, and Concurrent Validity of a Stethoscope and Health App System for the Quantification of Breath Rate in Healthy Adults: Repeatability and Validity Study.

BACKGROUND: Apps for smartphones that can measure the breathing rate easily can be downloaded. OBJECTIVE: The aim of this study was to demonstrate agreement in measuring breath rates between the stethoscope and Breath Counter health app. METHODS: We performed a repeatability study with 56 healthy volunteers. The patient's demographic data and breathing rates per minute were collected. Breathing rates were measured via two methods: (1) using a stethoscope placed in the upper area of the right lung and (2) a Breath Counter app developed by Vadion on a Samsung Fold smartphone. RESULTS: This study demonstrated high repeatability and validity with respect to the breathing rate parameter of healthy adults using the aforementioned 2 systems. Intrasession repeatability measure using the intraclass correlation coefficient was >0.962, indicating excellent repeatability. Moreover, the intraclass correlation coefficient between methods was 0.793, indicating good repeatability, and coefficients of variation of method errors values were 1.83% with very low values in terms of other repeatability parameters. We found significant correlation coefficients and no systematic differences between the app and stethoscope methods. CONCLUSIONS: The app method may be attractive to individuals who require repeatability in a recreational setting.

Double-Network Hydrogel-Based Photonic Crystal Sensor for Mechanical Force Naked Eye Sensing and Its Application in Medical Compressive or Stretchy Instruments.

Herein, we coalesced a poly(acrylamide-co-N-Acryloyl phenylalanine)/polyacrylamide double-network (P(AM-co-APA)/PAM DN) hydrogel with a photonic crystal array, fabricating a mechanochromic sensor for application in flexible medical instruments by naked eye monitoring. The intensified mechanical properties of the DN hydrogel were proved by the mechanical property tests, which are attributed to the interactions of chemical bonds and hydrogen bonds between the two polymer networks. In the range of stress from 0 to 328 kPa, the reflected light wavelength of this sensor changed from 659 to 480 nm and the color changed from red to blue in response; in the range of pressure from 0 to 85 kPa, the sensor exhibited a spectrum changing from 658 nm to 467 nm, covering almost the whole visible color range. The prepared sensor was incorporated into medical instruments including the femoral artery hemostat and bandage to indicate pressure and tensile stress in practical applications. Within the appropriate pressure for wound recovery, the sensitivity and correlation between the external stimulus of pressure and wavelength of this integrated sensor were 5.58 nm·kPa-1 and over 0.99, respectively. Ultimately, the sensor proved to be tough, sensitive, and durable, showing a broad prospect of a series of future applications.

Five-in-one: a novel, cost-effective yet simple use of micro needle holder.

AIM: To achieve a balance between efficiency and cost in the management of medical instrument by the use of micro needle holder. METHODS: In this study, the novel multifunctional use of micro needle holders was performed between 2018 and 2019 at the Department of Ophthalmology in the 4 hospitals in Shaanxi Province. In this innovation, the micro needle holders were initially used as micro forceps to remove sutures, as eye spud to safety extract foreign body from cornea, as ciliary forceps to remove trichiasis, as well as punctal dilator to dilate most small puncta. RESULTS: Using this technique, the medical costs of both procurement and sterilization were cut off in the selected 4 hospitals. The purchase cost has dropped by roughly 50%. The sterilization cost was decreased by about 30%. CONCLUSION: The innovation in the five-in-one multifunctional use of micro needle holders saves the medical costs.

Smart handheld device with flexible wrist and electrical bioimpedance sensor for tissue inspection.

With the evolving demands of surgical intervention, there is a strong need for smaller and functionally augmented instruments to improve surgical outcomes, operational convenience, and diagnostic safety. Owing to the narrow and complicated anatomy, the probe head of the medical instrument is required to possess both good maneuverability and compact size. In addition, the development of medical instrument is moving toward patient-specialized, of which the articulation positions can be customized to reach the target position. To fulfill these requirements, this study presents the design of a smart handheld device which equips with a low cost, easy control, disposable flexible wrist, and an electrical bioimpedance sensor for medical diagnosis. Prototype of the device is made and tested. The experimental results demonstrate that the proposed device can provide accurate manipulation and effective tissue detection, showing a great potential in various medical applications.

Proof of concept for the sapphire scalpel combining tissue dissection and optical diagnosis.

OBJECTIVES: The development of compact diagnostic probes and instruments with an ability to direct access to organs and tissues and integration of these instruments into surgical workflows is an important task of modern physics and medicine. The need for such tools is essential for surgical oncology, where intraoperative visualization and demarcation of tumor margins define further prognosis and survival of patients. In this paper, the possible solution for this intraoperative imaging problem is proposed and its feasibility to detect tumorous tissue is studied experimentally. METHODS: For this aim, the sapphire scalpel was developed and fabricated using the edge-defined film-fed growth technique aided by mechanical grinding, polishing, and chemical sharpening of the cutting edge. It possesses optical transparency, mechanical strength, chemical inertness, and thermal resistance alongside the presence of the as-grown hollow capillary channels in its volume for accommodating optical fibers. The rounding of the cutting edge exceeds the same for metal scalpels and can be as small as 110 nm. Thanks to these features, sapphire scalpel combines tissue dissection with light delivering and optical diagnosis. The feasibility for the tumor margin detection was studied, including both gelatin-based tissue phantoms and ex vivo freshly excised specimens of the basal cell carcinoma from humans and the glioma model 101.8 from rats. These tumors are commonly diagnosed either non-invasively or intraoperatively using different modalities of fluorescence spectroscopy and imaging, which makes them ideal candidates for our feasibility test. For this purpose, fiber-based spectroscopic measurements of the backscattered laser radiation and the fluorescence signals were carried out in the visible range. RESULTS: Experimental studies show the feasibility of the proposed sapphire scalpel to provide a 2-mm-resolution of the tumor margins' detection, along with an ability to distinguish the tumor invasion region, which results from analysis of the backscattered optical fields and the endogenous or exogenous fluorescence data. CONCLUSIONS: Our findings justified a strong potential of the sapphire scalpel for surgical oncology. However, further research and engineering efforts are required to optimize the sapphire scalpel geometry and the optical diagnosis protocols to meet the requirements of oncosurgery, including diagnosis and resection of neoplasms with different localizations and nosologies.

Effects of 60 Min Electrostimulation With the EXOPULSE Mollii Suit on Objective Signs of Spasticity.

Background: The EXOPULSE Mollii method is an innovative full-body suit approach for non-invasive electrical stimulation, primarily designed to reduce disabling spasticity and improve motor function through the mechanism of reciprocal inhibition. This study aimed to evaluate the effectiveness of one session of stimulation with the EXOPULSE Mollii suit at different stimulation frequencies on objective signs of spasticity and clinical measures, and the subjective perceptions of the intervention. Methods: Twenty patients in the chronic phase after stroke were enrolled in a cross-over, double-blind controlled study. Electrical stimulation delivered through EXOPULSE Mollii was applied for 60 min at two active frequencies (20 and 30 Hz) and in OFF-settings (placebo) in a randomized order, every second day. Spasticity was assessed with controlled-velocity passive muscle stretches using the NeuroFlexor hand and foot modules. Surface electromyography (EMG) for characterizing flexor carpi radialis, medial gastrocnemius, and soleus muscles activation, Modified Ashworth Scale and range of motion were used as complementary tests. Finally, a questionnaire was used to assess the participants' perceptions of using the EXOPULSE Mollii suit. Results: At group level, analyses showed no significant effect of stimulation at any frequency on NeuroFlexor neural component (NC) and EMG amplitude in the upper or lower extremities (p > 0.35). Nevertheless, the effect was highly variable at the individual level, with eight patients exhibiting reduced NC (>1 N) in the upper extremity after stimulation at 30 Hz, 5 at 20 Hz and 3 in OFF settings. All these patients presented severe spasticity at baseline, i.e., NC > 8 N. Modified Ashworth ratings of spasticity and range of motion did not change significantly after stimulation at any frequency. Finally, 75% of participants reported an overall feeling of well-being during stimulation, with 25% patients describing a muscle-relaxing effect on the affected hand and/or foot at both 20 and 30 Hz. Conclusions: The 60 min of electrical stimulation with EXOPULSE Mollii suit did not reduce spasticity consistently in the upper and lower extremities in the chronic phase after stroke. Findings suggest a need for further studies in patients with severe spasticity after stroke including repeated stimulation sessions. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04076878, identifier: NCT04076878.

Exploration of quality management system of medical device clinical trials / 中华医学科研管理杂志

Objective:The standardized medical device clinical trials in China began in a short time, and the quality of trials needs to be improved.This article intends to explore possible ways for the improvement of quality management of the medical device clinical trials.Methods:Through working practice and literature review, analyze the current status of medical device clinical trials and in vitro diagnostic reagent in China; put forward targeted improved measures for the quality management system; as well as verify its feasibility through practice.Results:This article summarizes three factors that limit the improvement of the quality of medical device clinical trials, including the insufficient research and development strength of sponsors, the limited professional level of research teams, and the differences in verification and drugs, based on the risk-based quality management concepts, puts forward improved measures from three aspects, which including building risk-based quality certification system, making full use of electronic information systems to ensure the trial quality, and strengthening training of clinical trial capacity of researchers, and verifies the feasibility of these measures via the practical experience of our hospital since 2016.Conclusions:The application of risk-based quality management system, electronic information system and clinical trial capacity training can improve the management quality for medical device clinical trial centers.

An examination of nurse-authored patents: Implications for nursing practice.

BACKGROUND: Recognition for medical inventions and innovations is largely associated with physician-researchers, scientists, and engineers. The term "nurse" is largely absent from patents awarded in the United States. Yet, as front-line healthcare providers, who better to add to the current population of inventors and innovators of new, meaningful scientific and engineering medical discoveries than specialized advanced practice nurses and their registered nurse colleagues? Although medical inventions and innovations are not entirely new activities for nurses, the authors speculate that greater opportunities exist for these healthcare professionals to lead in and be officially recognized for medical care discoveries and advancements by having their names on patents awarded. Also, we surmise that without the active and dedicated participation of nurses, important and significant discoveries may be missed. AIMS: The purpose of this paper is to address the importance of having nurses at all levels and specialties engaged in healthcare inventions and innovations. The foundation for this thesis begins by describing the findings from the first quantitative analysis of nurses' participation and/or recognition for the invention and innovation of medical devices and instruments, defined by having their names on awarded United States patents. In addition, we identify meaningful pathways for nurses to engage in this space. METHODS: Data to evaluate nurse participation and recognition for medical device and instrument inventions and innovations were collected through a publicly accessible website, the United States Patent and Trademark Office database, and analyzed with respect to whether the patent author(s) were nurses or nonnurses. RESULTS: More than 65 000 patents were identified with the terms "medical device" and "medical instrument." From the 65 000+ patent-population, 100 random patents were analyzed for the purposes of this first study and none were determined to have a nurse listed as a participating inventor or innovator. As a result of this analysis, the authors: (a) identify that nurses are largely unrecognized in the medical device invention and innovation space and (b) create models that explain nurses' engagement in this space from (i) historical and contemporary perspectives and (ii) for enhanced future involvement in healthcare patent activities. The future model is especially important as it provides a pathway for nurses to enhance their inventive and innovative competencies, effectiveness, and efficiency through new professional roles, additional education, creation of new educational programs, and formation of professional collaborations. It also calls for organizations that employ nurses to overtly allocate time, resources, and support for invention and innovation activities. We posit that fostering and facilitating nurses to enter the medical invention and innovation space stimulates discoveries that can improve patient care experiences, operations, and outcomes, reduce healthcare costs and provide myriad benefits to these professionals and the organizations that employ them. Examples of benefits from nursing inventions and innovations include prestige, scholarship, and the financial assets associated with intellectual property (ie, patents awarded) for both the nurse and the employing institution. Furthermore, direct involvement and engagement in inventions and innovations define a new practice space and contribution for nurses.

Pythagorean 2-Tuple Linguistic Taxonomy Method for Supplier Selection in Medical Instrument Industries.

Supplier selection in medical instrument industries is a classical multiple attribute group decision making (MAGDM) problem. The Pythagorean 2-tuple linguistic sets (P2TLSs) can reflect uncertain or fuzzy information well and solve the supplier selection in medical instrument industries, and the original Taxonomy is very appropriate for comparing different alternatives with respect to their advantages from studied attributes. In this study, we present an algorithm that combines Pythagorean 2-tuple linguistic numbers (P2TLNs) with the Taxonomy method, where P2TLNs are applied to express the evaluation of decision makers on alternatives. Relying on the Pythagorean 2-tuple linguistic weighted average (P2TLWA) operator or Pythagorean 2-tuple linguistic weighted geometric (P2TLWG) operator to fuse P2TLNs, the new general framework is established for Pythagorean 2-tuple linguistic multiple attribute group decision making (MAGDM) under the classical Taxonomy method. Ultimately, an application case for supplier selection in medical instrument industries is designed to test the novel method's applicability and practicality and a comparative analysis with three other methods is used to elaborate further.

Cleaning quality of different cleaning methods for reusable laparoscopic instruments / 中国感染控制杂志

Objective To evaluate the cleaning quality of different cleaning methods for laparoscopic instruments, ensure the cleaning quality of instruments.Methods The used laparoscopic instruments were classified into two categories: non-lumen instruments and lumen instruments. Three cleaning methods, traditional manual cleaning (A), manual cleaning + ultrasonic cleaning (B), manual cleaning + automatic cleaning disinfector (C), were adopted respectively for treating instruments. Cleaning quality of instruments were detected with ATP bioluminescence assay.Results The qualified rates of laparoscopic non-lumen instruments cleaned by methods A, B, and C were 78.75％, 95.71％, and 96.00％ respectively, difference was significant (χ2=16.453, P＜0.001);qualified rate of methods B and C for cleaning non-lumen instruments was higher than that of method A (P＜0.016), there was no significant difference between methods B and C (P＞0.016). Qualified rates of laparoscopic lumen instruments cleaned by methods A, B, and C were 76.47％, 98.75％, and 91.55％ respectively, difference was significant (χ2=21.087, P＜0.001); qualified rates of methods B and C for cleaning lumen instruments were both higher than that of method A (P＜0.016), there was no significant difference between methods B and C (P＞0.016). Conclusion Effect of manual cleaning + ultrasonic cleaning and manual cleaning + automatic cleaning disinfector on used laparoscopic instruments are both better than that of traditional manual cleaning method, can effectively guarantee the cleaning quality of instruments and help to ensure the operation safety of patients.

Exploration of teaching approach of medical instrument development course with national defense features / 中华医学教育探索杂志

The aim of the development course in university is to expand the multidisciplinary knowledge.The students,who choose development course,are coming from many subjects.Therefore,the design and teaching methods of this course should have their own characteristics.This study introduces the exploration of medical instrument course with defense features and talent training mode.The core ideas of curriculum reform include the following.The course contents should be professionally subdivided,so that all the students from different majors can obtain the knowledge.Teaching methods should be guided by the national defense requirements using lectures and discussions.Multiply assessment modes,such as speech,discussion,paper poster,and creative exhibition,can be used to evaluate the students.The present reforms have been implemented in the reality of course teaching practice.The reform contents in this paper have a great significance to the creation of development courses based on the integration of preponderant disciplines in the university.

The measurement of DLNO and DLCO: A manufacturer's perspective.

The simultaneous measurement of the lung transfer factor for carbon monoxide (DLCO) and nitric oxide (DLNO) is now available as a powerful method for studying the alveolar-capillary gas exchange. However, application of the DLNO-CO technique in daily settings is still limited by some technical drawbacks. This paper provides a manufacturer's overview of the measuring principles, technical challenges and current available solutions for implementing the DLNO-CO measurement in to a marketed device. This includes the recent developments in technology for NO sensors, latest findings on NO uptake and new statistical methods.

Classification of Normal and Pathological Gait in Young Children Based on Foot Pressure Data.

Human gait recognition, an active research topic in computer vision, is generally based on data obtained from images/videos. We applied computer vision technology to classify pathology-related changes in gait in young children using a foot-pressure database collected using the GAITRite walkway system. As foot positioning changes with children's development, we also investigated the possibility of age estimation based on this data. Our results demonstrate that the data collected by the GAITRite system can be used for normal/pathological gait classification. Combining age information and normal/pathological gait classification increases the accuracy of the classifier. This novel approach could support the development of an accurate, real-time, and economic measure of gait abnormalities in children, able to provide important feedback to clinicians regarding the effect of rehabilitation interventions, and to support targeted treatment modifications.

Current status of medical instrument cleaning in 127 hospitals in five coastal provinces or cities in China / 中华护理杂志

Objective To investigate the current situation of medical instrument cleaning in Central Sterile Supply Departments(CSSD),in order to identify problems and provide references for further improvements of equipment cleaning.Methods Questionnaire survey was adopted,data of 127 CSSDs in five coastal provinces or cities in China in 2017 were collected,and status of each link of medical instrument cleaning was analyzed.Results The allocation rate of ultrasonic cleaner and spray cleaner were 96.6％ and 78.7％,respectively;62.2％ of hospitals used tap water to pre-rinse,and 10.2％ used normal saline or sterile water to pre-rinse,11.0％ used tap water for finial rinsing;78.7％ of hospitals did not perform continuous humidification in transit,and 18.1％ of hospitals did not perform continuous humidification and their time of transit was more than 2 hours;66.9％ of CSSDs only used multi-enzyme detergent.More than half of the hospitals did not record time for manual rinsing/manual final rinsing.Conclusion The configuration of medical instrument cleaning equipment of 127 CSSDs is good.However,it is necessary to pay more attention to cleaning details.Specifications for instrument cleaning water should be established;continuous humidification during transportation of medical instruments should be promoted;cleaning methods and cleaning detergents should be selected reasonably;standardized rinsing should be enhanced to ensure quality of medical instrument cleaning.

Application of quality control circle in reducing damaging rate of ophthalmic instruments / 医疗卫生装备

Objective To study the application of quality control circle (QCC) in reducing the damaging rate of ophthalmic instruments.Methods A QCC group was established,and a QCC knowledge training themed by reducing the damaging rate of ophthalmic instruments was conducted,then a series of measures were taken,such as making an activity plan,grasping the current situation,setting up a goal,executing analysis,making a countermeasure,implementing the countermeasure and verifying effectiveness.Results After implementing QCC activity,a scientific and reasonable flow chart of ophthalmic instruments management was made,and the damaging rate of ophthalmic instruments was reduced from 9.80％ to 5.20％ (P ＜ 0.05),improved by 46.94％.The control rate reached 94.66％;and still was kept higher than 90％ in the effectiveness maintenance period.Also,8 kinds of abilities of QCC members were improved as well.Conclusion Damaging rate of ophthalmic instruments could be greatly reduced by carrying out QCC activities,and the utilization rate of ophthalmic instruments is increased;meanwhile,the satisfaction degree of doctors and patients is enhanced,and abilities of members of QCC also are promoted.

Clinical application of novel oxygen humidification bottle drying rack / 医疗卫生装备

Objective To explore the practicability and feasibility of the oxygen humidification bottle drying rack for drying wet bottle and inner core.Methods Totally 600 sets of recovered humidification bottles and inner cores were cleaned and sterilized,and then divided equally into an experimental group and a control group.The experimental group used the oxygen humidification bottle and the control group applied the basket.The bottles and inner cores in the experimental group were placed upside down on the drying rack,and then underwent 3-h drying in the electric thermostatic drying cabinet (45 ℃).The bottles in the control group were placed in the plastic basket closely,and the inner cores were inserted in the gap between the bottles,then the bottles and inner cores went through 3-h drying in the electric thermostatic drying cabinet (45 ℃) as well.The two groups had 30 sets of bottles and inner cores dried at each time.Results The experimental had the drying rate (96％) significantly higher than that (68％) in the control group (x2=79.675,P＜0.005),while the rollover rate (0％) statistically lower than that (17.67％) in the control group (x2=58.14,P＜0.005).It's indicated that the experimental group behaved obviously better than the control group in drying rate and rollover rate.Conclusion The oxygen humiliation bottle drying rack has a good effect on fixing and drying wet bottles.The device can ensure the quality of disinfection,shorten the drying time and improve the working efficiency.

Application of quality control circle in reducing damaging rate of ophthalmic instruments / 医疗卫生装备

Objective To study the application of quality control circle (QCC) in reducing the damaging rate of ophthalmic instruments.Methods A QCC group was established,and a QCC knowledge training themed by reducing the damaging rate of ophthalmic instruments was conducted,then a series of measures were taken,such as making an activity plan,grasping the current situation,setting up a goal,executing analysis,making a countermeasure,implementing the countermeasure and verifying effectiveness.Results After implementing QCC activity,a scientific and reasonable flow chart of ophthalmic instruments management was made,and the damaging rate of ophthalmic instruments was reduced from 9.80％ to 5.20％ (P ＜ 0.05),improved by 46.94％.The control rate reached 94.66％;and still was kept higher than 90％ in the effectiveness maintenance period.Also,8 kinds of abilities of QCC members were improved as well.Conclusion Damaging rate of ophthalmic instruments could be greatly reduced by carrying out QCC activities,and the utilization rate of ophthalmic instruments is increased;meanwhile,the satisfaction degree of doctors and patients is enhanced,and abilities of members of QCC also are promoted.

Clinical application of novel oxygen humidification bottle drying rack / 医疗卫生装备

Objective To explore the practicability and feasibility of the oxygen humidification bottle drying rack for drying wet bottle and inner core.Methods Totally 600 sets of recovered humidification bottles and inner cores were cleaned and sterilized,and then divided equally into an experimental group and a control group.The experimental group used the oxygen humidification bottle and the control group applied the basket.The bottles and inner cores in the experimental group were placed upside down on the drying rack,and then underwent 3-h drying in the electric thermostatic drying cabinet (45 ℃).The bottles in the control group were placed in the plastic basket closely,and the inner cores were inserted in the gap between the bottles,then the bottles and inner cores went through 3-h drying in the electric thermostatic drying cabinet (45 ℃) as well.The two groups had 30 sets of bottles and inner cores dried at each time.Results The experimental had the drying rate (96％) significantly higher than that (68％) in the control group (x2=79.675,P＜0.005),while the rollover rate (0％) statistically lower than that (17.67％) in the control group (x2=58.14,P＜0.005).It's indicated that the experimental group behaved obviously better than the control group in drying rate and rollover rate.Conclusion The oxygen humiliation bottle drying rack has a good effect on fixing and drying wet bottles.The device can ensure the quality of disinfection,shorten the drying time and improve the working efficiency.

Thickness Influence on In Vitro Biocompatibility of Titanium Nitride Thin Films Synthesized by Pulsed Laser Deposition.

We report a study on the biocompatibility vs. thickness in the case of titanium nitride (TiN) films synthesized on 410 medical grade stainless steel substrates by pulsed laser deposition. The films were grown in a nitrogen atmosphere, and their in vitro cytotoxicity was assessed according to ISO 10993-5 [1]. Extensive physical-chemical analyses have been carried out on the deposited structures with various thicknesses in order to explain the differences in biological behavior: profilometry, scanning electron microscopy, atomic force microscopy, X-ray photoelectron spectroscopy (XPS), X-ray diffraction and surface energy measurements. XPS revealed the presence of titanium oxynitride beside TiN in amounts that vary with the film thickness. The cytocompatibility of films seems to be influenced by their TiN surface content. The thinner films seem to be more suitable for medical applications, due to the combined high values of bonding strength and superior cytocompatibility.