Extended device profiles and testing procedures for the approval process of integrated medical devices using the IEEE 11073 communication standard

2018 ◽  
Vol 63 (1) ◽  
pp. 95-103 ◽  
Author(s):  
Armin Janß ◽  
Johannes Thorn ◽  
Malte Schmitz ◽  
Alexander Mildner ◽  
Jasmin Dell’Anna-Pudlik ◽  
...  
Keyword(s):  
Operating Room ◽  
Medical Devices ◽  
Testing Procedure ◽  
Third Party ◽  
Approval Process ◽  
Test Procedures ◽  
Open Communication ◽  
Testing Procedures ◽  
Ieee 11073 ◽  
Communication Standard

AbstractNowadays, only closed and proprietary integrated operating room systems (IORS) from big manufacturers are available on the market. Hence, the interconnection of components from third-party vendors is only possible with increased time and costs. In the context of the German Federal Ministry of Education and Research (BMBF)-funded project OR.NET (2012–2016), the open integration of medical devices from different manufacturers was addressed. An integrated operating theater based on the open communication standard IEEE 11073 shall give clinical operators the opportunity to choose medical devices independently of the manufacturer. This approach would be advantageous especially for hospital operators and small- and medium-sized enterprises (SME) of medical devices. Actual standards and concepts regarding technical feasibility and the approval process do not cope with the requirements for a modular integration of medical devices in the operating room (OR), based on an open communication standard. Therefore, innovative approval strategies and corresponding certification and test procedures, which cover actual legal and normative standards, have to be developed in order to support the future risk management and the usability engineering process of open integrated medical devices in the OR. The use of standardized device and service profiles and a three-step testing procedure, including conformity, interoperability and integration tests are described in this paper and shall support the manufacturers to integrate their medical devices without disclosing the medical devices’ risk analysis and related confidential expertise or proprietary information.

scholarly journals Evaluation of an IEEE 11073 SDC Connection of two KUKA Robots towards the Application of Focused Ultrasound in Radiation Therapy

2019 ◽  
Vol 5 (1) ◽  
pp. 149-152 ◽  
Author(s):  
Johann Berger ◽  
Michael Unger ◽  
Lisa Landgraf ◽  
Andreas Melzer
Keyword(s):  
Radiation Therapy ◽  
Operating Room ◽  
Medical Devices ◽  
Focused Ultrasound ◽  
Round Trip Time ◽  
Network Stability ◽  
Round Trip ◽  
Trip Time ◽  
Ieee 11073 Sdc ◽  
Ieee 11073

AbstractThe integration of surgical robotics into the operating room requires reliable and flexible communication with other medical devices. The IEEE 11073 SDC standard can provide the necessary requirements to deploy robotics for the application of focused ultrasound in radiation therapy. The aim of this work was to implement and evaluate an SDC compliant connection between two collaborative robots. For this purpose, the KUKA LBR iiwa 7 R800 was adapted and the connectivity modelled and then tested successfully with 42 transmittable properties. Latency measurements were conducted to evaluate the network stability, resulting in a median round trip time of 10.13 ms.

Multiplicity Issues in Microarray Experiments

2005 ◽  
Vol 44 (03) ◽  
pp. 431-437 ◽  
Author(s):  
J. Landgrebe ◽  
E. Brunner ◽  
F. Bretz
Keyword(s):  
Multiple Testing ◽  
Testing Procedure ◽  
Microarray Data Analysis ◽  
Familywise Error Rate ◽  
Test Procedures ◽  
Multiple Testing Procedure ◽  
P Values ◽  
Microarray Experiments ◽  
Testing Procedures ◽  
Multiple Test

Summary Objectives: Discussion of different error concepts relevant to microarray experiments. Review of some commonly used multiple testing procedures. Comparison of different approaches as applied to gene expression data. Methods: This article focuses on familywise error rate (FWER) and false discovery rate (FDR) controlling procedures. Methods under investigation include: Bonferroni-type methods and their improvements (including resampling approaches), modified Bonferroni methods, data-driven approaches, as well as the linear step-up method and its modifications. Particular emphasis lies on the description of the assumptions, advantages and limitations for the investigated methods. Results: FWER controlling procedures are often too conservative in high dimensional screening studies. A better balance between the raw P-values and the stringent FWER-adjusted P-values may be required in many situations, as provided by FDR controlling and related procedures. Conclusions: The questions remain open, which error concept to apply and which multiple testing procedure to use. Although we believe that the FDR or one of its variants will be applied more often in the future, longterm experience with microarray technology is missing and thus the validity of appropriate multiple test procedures cannot yet be assessed for microarray data analysis.

scholarly journals Integration of Robotic Applications in Open and Safe Medical Device IT Networks Using IEEE 11073 SDC

10.29007/fmqx ◽  
2018 ◽  
Author(s):  
Manuel Vossel ◽  
Benjamin Strathen ◽  
Martin Kasparick ◽  
Meiko Müller ◽  
Klaus Radermacher ◽  
...  
Keyword(s):  
Real Time ◽  
Medical Devices ◽  
Service Oriented Architecture ◽  
Dynamic Networks ◽  
Third Party ◽  
Human Machine Interaction ◽  
Input Devices ◽  
Service Oriented ◽  
Ieee 11073 ◽  
Robotic Applications

Modern operating rooms (OR) undergo a constant rise in the amount and complexity of technical systems. Due to a lack of inter-device communication and integration, each device works stand-alone resulting in redundant sensors, input devices, monitors and—last but not least—crowded ORs and error prone human- machine-interaction. Therefore, various manufacturers such as Brainlab and Karl Storz provide proprietary integrated workstations. However, those “monolithic” solutions restrict the flexibility of the users and the clinical operators regarding integration of innovative third party devices.In view of this, the OR.NET initiative (www.ornet.org) strives to develop international open standards for secure dynamic networks of medical devices in ORs. In the scope of the OR.NET project, based on service oriented architecture (SOA), the SDC (Service-oriented Device Connectivity) approach is currently in the process of standardization under IEEE 11073 to link medical devices in the OR (short OR.NETwork). It paves the way to interoperability between various medical devices due to its independence of license holders.However, the SDC network does not suit real time (RT) requirements of a deterministic data transmission and low maximum latency, e.g. for robotic applications. This paper shows an approach to extend the secure dynamic OR by a real-time capable network to allow the integration of robotic systems. Exemplarily, this paper outlines an orthopaedic robotic system that is released by a universal configurable footswitch. This significantly extends the scope of applications for integrated ORs with the IEEE 11073 standard.

Not all experts are equal in the eyes of the International Auditing and Assurance Standards Board: On the application of ISA510 and ISA620 by South African registered auditors

2021 ◽  
Vol 24 (1) ◽  
Author(s):  
Marianne Kok ◽  
Warren Maroun
Keyword(s):  
South African ◽  
Audit Quality ◽  
Legal Liability ◽  
Third Party ◽  
Audit Committees ◽  
Test Procedures ◽  
Technical Application ◽  
Auditing Standards ◽  
Testing Complex ◽  
African Context

Background: The article focuses on inconsistencies in audit approaches when auditors place reliance on the work performed by others. It examines differences in the approach followed by auditors when relying on the work of a predecessor versus the work of an auditor’s expert.Setting: The study contributes to the limited body of auditing research focusing on the technical application of International Auditing Standards and the functioning of actual audit practice in a South African context. It outlines how auditors apply their professional judgement when using technical auditing standards when comparing the work of a similarly trained expert in the field of accounting and auditing (per ISA510) versus the work of an expert in a field other than accounting and auditing (per ISA620).Aim: The purpose of this article is to examine and identify inconsistencies in the interpretation and application of ISA510 and ISA620 by a purposefully selected number of registered auditors in South Africa. It considers how inconsistencies in the approach followed when an auditor places reliance on the work of another auditor or an auditor’s expert points to underlying efforts to seek legitimacy and manage legal liability.Method: Detailed interviews are used to explore auditors’ experiences and challenges with the application of these two ISAs.Results: Audit quality is not necessarily a function of compliance with professional standards. While ISA510 and ISA620 deal with a situation where an auditor places reliance on the work of a third party, they are interpreted and applied very differently.Conclusion: The application of ISA510 is part of a rules-based approach to auditing aimed at reducing an auditor’s legal liability rather than enhancing audit quality. The same logic applies to ISA620 except that auditors perceive that their risk exposure is lower because the standard is limited to a single transaction or balance rather than to the entire audit engagement. The application of ISA620 is also useful for convincing internal reviewers, external regulators or audit committees that sufficient appropriate evidence for a complex line item has been obtained. The need to ensure a more robust process for testing complex balances and transactions is not, however, the primary consideration. Regulators and standard setters should not assume that compliance with auditing standards results in better quality audits. At the operational level, the need to manage legal liability and to signal the credibility of test procedures may be more relevant for the execution of audits than ensuring that audit opinions are supported by sufficient appropriate audit evidence. As only two standards, applied in a single jurisdiction, are used to illustrate this point, additional research will be required to determine the extent of inconsistency in the application of auditing standards and how this can result in lower levels of audit quality.

Acute Sleep Restriction Affects Sport-Specific But Not Athletic Performance in Junior Tennis Players

2020 ◽  
pp. 1-6
Author(s):  
Jacopo A. Vitale ◽  
Matteo Bonato ◽  
Lorenzo Petrucci ◽  
Giorgio Zucca ◽  
Antonio La Torre ◽  
...  
Keyword(s):  
Athletic Performance ◽  
Test Session ◽  
Sleep Restriction ◽  
Test Procedures ◽  
Ability Test ◽  
Tennis Players ◽  
Individual Level ◽  
Testing Procedures ◽  
Junior Tennis ◽  
Left And Right

Purpose: Little is known about the effect of sleep restriction (SR) on different domains of athletes’ physical performance. Therefore, the aim of this randomized, counterbalanced, and crossover study was to evaluate the effect of acute SR on sport-specific technical and athletic performance in male junior tennis players. Methods: Tennis players (N = 12; age 15.4 ± 2.6 y) were randomly allocated to either a sleep-restriction condition (SR, n = 6), where they experienced acute sleep restriction the night before the test session (≤5 h of sleep), or to a control condition (CON, n = 6), where they followed their habitual sleep–wake routines. Testing procedures included 20 left and right serves, 15 forehand and backhand crosscourt shots, and a repeated-sprint-ability test (RSA). The accuracy of serves and shots was considered for further analysis. One week later, players of SR joined CON, and players of CON experienced SR, and all test procedures were repeated. Results: Significant decrease in the accuracy of right (−17.5%, P = .010, effect size [ES] = 1.0, moderate) and left serve (−14.1%, P = .014, ES = 1.2, large), crosscourt backhand (−23.9%, P = .003, ES ≥ 2.0, very large), and forehand shot (−15.6%, P = .014, ES = 1.1, moderate) were observed in SR compared to CON, while RSA was similar in both conditions. Conclusion: Coaches and athletes at the team and individual level should be aware that 1 night of SR affects sport-specific but not athletic performance in tennis players.

Connecting the clinical IT infrastructure to a service-oriented architecture of medical devices

2018 ◽  
Vol 63 (1) ◽  
pp. 57-68 ◽  
Author(s):  
Björn Andersen ◽  
Martin Kasparick ◽  
Hannes Ulrich ◽  
Stefan Franke ◽  
Jan Schlamelcher ◽  
...  
Keyword(s):  
Medical Devices ◽  
Service Oriented Architecture ◽  
Point Of Care ◽  
Qualitative Evaluation ◽  
It Infrastructure ◽  
It Systems ◽  
Service Oriented ◽  
Clinical Environments ◽  
Integrated Operating Room ◽  
Ieee 11073

AbstractThe new medical device communication protocol known as IEEE 11073 SDC is well-suited for the integration of (surgical) point-of-care devices, so are the established Health Level Seven (HL7) V2 and Digital Imaging and Communications in Medicine (DICOM) standards for the communication of systems in the clinical IT infrastructure (CITI). An integrated operating room (OR) and other integrated clinical environments, however, need interoperability between both domains to fully unfold their potential for improving the quality of care as well as clinical workflows. This work thus presents concepts for the propagation of clinical and administrative data to medical devices, physiologic measurements and device parameters to clinical IT systems, as well as image and multimedia content in both directions. Prototypical implementations of the derived components have proven to integrate well with systems of networked medical devices and with the CITI, effectively connecting these heterogeneous domains. Our qualitative evaluation indicates that the interoperability concepts are suitable to be integrated into clinical workflows and are expected to benefit patients and clinicians alike. The upcoming HL7 Fast Healthcare Interoperability Resources (FHIR) communication standard will likely change the domain of clinical IT significantly. A straightforward mapping to its resource model thus ensures the tenability of these concepts despite a foreseeable change in demand and requirements.

Usefulness of Cation Exchange High Performance Liquid Chromatography as a Testing Procedure

PEDIATRICS ◽  
1989 ◽  
Vol 83 (5) ◽  
pp. 849-851
Author(s):  
Titus H. J. Huisman
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Cation Exchange ◽  
Cellulose Acetate ◽  
Isoelectric Focusing ◽  
High Performance ◽  
Testing Procedure ◽  
Cellulose Acetate Electrophoresis ◽  
Blood Samples ◽  
Testing Procedures

Testing of cord blood or newborn blood samples for hemoglobin abnormalities should include clinically important hemoglobinopathies other than sickle cell anemia (SS), such as SC, SD, SO, S-β- thalassemia (thal), EE, SE, and α-thal, and should place the quality of the testing procedures (ie, accuracy of diagnosis) above quantity (ie, number of samples tested over a given period). There is no single method available that is suitable for the identification of each of the numerous abnormalities; thus, at least two, and often more than two, procedures must be used to reach a definitive diagnosis. For this reason, blood samples collected in vacutainers with ethylenediaminetetraacetic acid as anticoagulant are preferred to those collected on filter papers. The latter approach also has the disadvantage that, under a less than optimal transport system, hemoglobin is readily modified (oxidation, glycosylation, protein-protein interaction), producting extra bands or peaks in electrophoretic or chromatographic separations that interfere with an appropriate identification of various genetically determined hemoglobin variants. In our laboratories, in which hemoglobin identification has been routine for more than 25 years, we consider the following procedures acceptable primary testing methods: starch gel electrophoresis at pH 8.9, cellulose acetate electrophoresis at pH 8.5 to 8.9, isoelectric focusing, and fast cation exchange high performance liquid chromatography (HPLC). The following five methods are excellent confirmatory testing procedures: citrate agar electrophoresis at pH 6.1, cation or anion exchange macrochromatography, isoelectric focusing, cation exchange HPLC, and immunologic procedures. Combinations of these techniques will often lead to acceptable data, and the general approach followed in our institute is given in Fig 1. Cellulose acetate electrophoresis at alkaline pH is still the primary testing procedure, and citrate agar electrophoresis at pH 6.1 and micro-HPLC procedures are the main confirmatory methods.

Testing Procedures on Materials to Formulate the Ink for 3D Printing

2020 ◽  
Vol 2674 (2) ◽  
pp. 21-32 ◽  
Author(s):  
Malo Charrier ◽  
Claudiane Ouellet-Plamondon
Keyword(s):  
3D Printing ◽  
Yield Stress ◽  
Three Dimensional ◽  
Testing Procedure ◽  
Full Potential ◽  
Cement Pastes ◽  
Slump Test ◽  
Testing Procedures ◽  
Transportation Sector ◽  
Printing Ink

Three-dimensional (3D) printing has been used in various fields to tackle applications difficult for conventional manufacturing. To realize the full potential of this technology in the transportation sector, it is imperative to identify suitable tests and mixtures for printing “inks” made of mortar. In this study, several conventional and non-conventional tests on mortars and cement pastes were conducted. This work highlights the correlation between the results of slump test and the deformation test that indicates the comportment of the mixture under a stack of printed layers. Moreover, a strong connection between yield stress and mini-slump is observed, demonstrating a simplification of the testing procedure, and a link between the mortar and the cement paste is developed. In the printing ink design phase, this association enables the prediction of flowability. The yield stress and the final radius of the mini-slump tests were very well correlated for the admixture tested. The use of the mini-slump test simplifies the testing procedure and allows for quicker formulations of admixtures in the printing ink.

scholarly journals Property Values

2011 ◽  
Vol 133 (03) ◽  
pp. 32-34
Author(s):  
Leslie I. Bookoff ◽  
Dinesh N. Melwani
Keyword(s):  
Intellectual Property ◽  
Medical Device ◽  
Medical Devices ◽  
Patent Protection ◽  
Property Values ◽  
Third Party ◽  
Property A ◽  
Startup Company ◽  
Target Company ◽  
Medical Device Company

This article focuses on the importance of intellectual property (IP) in startup companies to attract investment. Various examples of startup companies dealing with medical devices were also discussed. Much of a medical device startup’s assets, however, lie in ideas or concepts it hopes to develop into a commercial product. Patent protection often is considered a critical component of corporate transactions involving medical technologies because it can protect the significant upfront investments required for R'D and regulatory activities. Investors evaluating the IP of a target medical device company are attracted to a demonstrated awareness of IP and to a clean house as it relates to administrative issues potentially affecting the company’s intellectual property. A target company also may make investment more attractive by minimizing or eliminating contractual restrictions on the transfer of its IP. A startup company seeking its portion of investment dollars must pay attention to its IP: it must ensure that its technology is freely marketable without infringing third-party rights and that its IP portfolio is free of encumbrances and has the necessary protection.

Development and experimental evaluation of an alarm concept for an integrated surgical workstation

2016 ◽  
Vol 61 (2) ◽  
Author(s):  
Eva-Maria Zeißig ◽  
Armin Janß ◽  
Jasmin Dell’Anna-Pudlik ◽  
Martina Ziefle ◽  
Klaus Radermacher
Keyword(s):  
Patient Safety ◽  
Operating Room ◽  
Primary Task ◽  
Technical Equipment ◽  
Open Communication ◽  
Memory Efficiency ◽  
Efficiency And Effectiveness ◽  
Perceived Workload ◽  
Integrated Operating Room ◽  
Speed Accuracy

AbstractAlarm conditions of the technical equipment in operating rooms represent a prevalent cause for interruptions of surgeons and scrub nurses, resulting in an increase of workload and potential reduction of patient safety. In this work, an alarm concept for an integrated operating room system based on open communication standards is developed and tested.In a laboratory experiment, the reactions of surgeons were analysed, comparing the displaying of alarms on an integrated workstation and on single devices: disruptive effects of alarm handling on primary task (ratings of perceived distraction, resumption lag, deterioration of speed, accuracy, and prospective memory), efficiency and effectiveness of identification of alarms, as well as perceived workload were included.The identification of the alarm cause is significantly more efficient and effective with the integrated alarm concept. Moreover, a slightly lower deterioration of performance of the primary task due to the interruption of alarm handling was observed.Displaying alarms on an integrated workstation supports alarm handling and consequently reduces disruptive effects on the primary task. The findings show that even small changes can reduce workload in a complex work environment like the operating room, resulting in improved patient safety.

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