Ludescher B.,University of Tubingen |
Rommel M.,Ypsomed AG |
Willmer T.,University of Tubingen |
Fritsche A.,University of Tubingen |
And 2 more authors.
Clinical Endocrinology | Year: 2011
Objective One of the aims of a subcutaneous (SC) injection is to avoid intradermal or intramuscular injections. Pen systems are an alternative solution to single-use syringes and have become standard for example diabetes therapy. Shorter and smaller needles minimize pain and the risk of intramuscular injections. The thickness of subcutaneous adipose tissue (SCAT) varies with position and with body mass index (BMI). The aim of this study was the creation of a map of SCAT thickness at typical spots for SC self-injection. Materials and methods MRI scans of 116 prospectively enroled volunteers (56 men and 60 women) were analysed. SCAT thickness was determined at 17 spots over the abdominal wall, left thigh, buttocks and upper arm, typical sites for subcutaneous self-injection. SCAT thicknesses were correlated with BMI and waist-to-hip ratio (WHR), and a linear curve fit was performed. The best fitting linear functions for the prediction of the SCAT thickness dependent on BMI and WHR were derived. Results Correlations between SCAT and BMI were higher (0·67-0·21) than with WHR (-0·67 to 0·09). In women, correlation coefficients between SCAT data at the abdomen and BMI/WHR were higher than in men. On the other hand, data showed better correlations at the extremities in men. Conclusions The data, with correlation between BMI and fat thickness at different injection sites in relation to gender, provide guidance in selecting an adequate pen needle length for deep and safe subcutaneous self-injection. WHR was a much weaker predictor when compared to BMI. © 2011 Blackwell Publishing Ltd.
Landolt S.,AAC Infotray |
Hirschel J.,Ypsomed AG |
Schlienger T.,TreeSolution Consulting GmbH |
Businger W.,Bern University of Applied Sciences |
Zbinden A.M.,Bern University of Applied Sciences
Journal of Medical Internet Research | Year: 2012
Background: Availability of information in hospitals is an important prerequisite for good service. Significant resources have been invested to improve the availability of information, but it is also vital that the security of this information can be guaranteed. Objective: The goal of this study was to assess information security in hospitals through a questionnaire based on the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) standard ISO/IEC 27002, evaluating Information technology - Security techniques - Code of practice for information-security management, with a special focus on the effect of the hospitals' size and type. Methods: The survey, set up as a cross-sectional study, was conducted in January 2011. The chief information officers (CIOs) of 112 hospitals in German-speaking Switzerland were invited to participate. The online questionnaire was designed to be fast and easy to complete to maximize participation. To group the analyzed controls of the ISO/IEC standard 27002 in a meaningful way, a factor analysis was performed. A linear score from 0 (not implemented) to 3 (fully implemented) was introduced. The scores of the hospitals were then analyzed for significant differences in any of the factors with respect to size and type of hospital. The participating hospitals were offered a benchmark report about their status. Results: The 51 participating hospitals had an average score of 51.1% (range 30.6% - 81.9%) out of a possible 100% where all items in the questionnaire were fully implemented. Room for improvement could be identified, especially for the factors covering "process and quality management" (average score 1.3 ± 0.8 out of a maximum of 3) and "organization and risk management" (average score 1.3 ± 0.7 out of a maximum of 3). Private hospitals scored significantly higher than university hospitals in the implementation of "security zones" and "backup" (P = .008). Conclusions: Half (50.00%, 8588/17,177) of all assessed hospital beds in German-speaking Switzerland are in hospitals that have a score of 49% or less of the maximum possible score in information security. Patient data need to be better protected because of the data protection laws and because sensitive, personal data should be guaranteed confidentiality, integrity, and availability.
Lange J.,Ypsomed AG |
Richard P.,Ypsomed AG |
Medical Devices: Evidence and Research | Year: 2014
This article presents a late-stage formative usability study of a pen-injector platform device. Such devices are used for the subcutaneous delivery of biopharmaceuticals, primarily for self-administration by the patient. The study was conducted with a broad user population, defined to represent user characteristics across a range of indications. The goals of the study were to confirm that the pen could be used without recurring patterns of use errors leading to hazardous situations, to evaluate the comprehension of the instructions for use (IFU), and to determine if training is necessary. In the study, a total of 36 participants in six groups (health care providers, caregivers, adolescents, diabetics with retinopathy, diabetics with neuropathy, and patients with arthritis) each read the IFU, prepared the device, and performed two simulated injections into an injection pad. Any use errors, near misses, or deviations from the IFU procedure were recorded. The overall success rate (injection completed by the participant without need for assistance) was 94% for the first and 100% for the second injection. Ninety-two percent of the participants reported that they felt confident using the device, 100% found the IFU helpful, and 75% found the device positively comfortable to use. Overall, a total average of 3.35 deviations and errors per user and injection were recorded (there were no near misses). Subtracting the errors without any potential for negative consequences for the injection or the user (trivial deviations), as well as those related to attaching and removing the pen needle (independent of the design of the pen itself), led to an average of 1.31 potentially relevant deviations per user and injection. It was concluded that the pen injector together with the IFU could be safely and efficiently used by all user groups without any training, and thus that the device and IFU in their current form are well suited for use in a range of specific applications. © 2014 Lange et al.
Lange J.,Ypsomed AG |
Urbanek L.,Ypsomed AG |
Burren S.,Ypsomed AG
Medical Devices: Evidence and Research | Year: 2016
This article describes the use of analytical models and physical measurements to characterize and optimize the tribological behavior of pen injectors for self-administration of biopharmaceuticals. One of the main performance attributes of this kind of device is its efficiency in transmitting the external force applied by the user on to the cartridge inside the pen in order to effectuate an injection. This injection force characteristic is heavily influenced by the frictional properties of the polymeric materials employed in the mechanism. Standard friction tests are available for characterizing candidate materials, but they use geometries and conditions far removed from the actual situation inside a pen injector and thus do not always generate relevant data. A new test procedure, allowing the direct measurement of the coefficient of friction between two key parts of a pen injector mechanism using real parts under simulated use conditions, is presented. In addition to the absolute level of friction, the test method provides information on expected evolution of friction over lifetime as well as on expected consistency between individual devices. Paired with an analytical model of the pen mechanism, the frictional data allow the expected overall injection system force efficiency to be estimated. The test method and analytical model are applied to a range of polymer combinations with different kinds of lubrication. It is found that material combinations used without lubrication generally have unsatisfactory performance, that the use of silicone-based internal lubricating additives improves performance, and that the best results can be achieved with external silicone-based lubricants. Polytetrafluoroethylene-based internal lubrication and external lubrication are also evaluated but found to provide only limited benefits unless used in combination with silicone. © 2016 Lange et al.