scholarly journals Standard manual reprocessing of angiographic systems in the hybrid OR

2017 ◽  
Vol 3 (2) ◽  
pp. 405-407
Author(s):  
Sebastian Buhl ◽  
Carina Werner ◽  
Clemens Bulitta
Keyword(s):  
Pilot Study ◽  
Medical Devices ◽  
Initial Assessment ◽  
Hybrid Operating Room ◽  
Medical Products ◽  
Fda Guidance ◽  
Microbiological Examination ◽  
Artis Zeego ◽  
Cleaning And Disinfection ◽  
A Current

AbstractA current FDA guidance demands the validation of cleaning and disinfecting protocols even for non-sterile medical devices. The aim of this work is to clarify whether this is already possible using the guidance itself as well as the German DIN EN ISO 17664. An angiography system (Artis Zeego / Pheno - Siemens) was selected as a test object for the validation of a cleaning and disinfection protocol for medical devices in a hybrid operating room. In pilot study prior to the trial, critical points of the system were evaluated by means of questionnaires to clinical users (OTA, surgical technicians). An initial assessment of the in-house cleaning protocols used in the hospitals was done by using a fluorescence assay. The microbiological examination took place subsequently by contact plates and swabbing to determine the amount and type of germs on the surfaces of the system. These experiments were done at three different clinical sites. It was found that there was a significant germ count on several surfaces of the product even after in-house cleaning and disinfection (C&D). After application of an enhanced C&D plan, these germs could be greatly reduced at all verified sites. In addition, it could be shown that DIN EN ISO 17664 can in principle be applied to non-sterile medical products.

scholarly journals TOWARDS A VERIFICATION AND VALIDATING TESTING FRAMEWORK TO DEVELOP BESPOKE MEDICAL PRODUCTS IN RESEARCH-FUNDED PROJECTS

2021 ◽  
Vol 1 ◽  
pp. 3199-3208
Author(s):  
Emanuel Balzan ◽  
Pierre Vella ◽  
Philip Farrugia ◽  
Edward Abela ◽  
Glenn Cassar ◽  
...  
Keyword(s):  
Medical Devices ◽  
Early Stage ◽  
Design Stage ◽  
Concept Design ◽  
Proof Of Concept ◽  
Detailed Design ◽  
Testing Framework ◽  
Medical Products ◽  
Manufacturing Technologies ◽  
Validation Testing

AbstractResearch funded projects are often concerned with the development of proof-of-concept products. Consequently, activities related to verification and validation testing (VVT) are often not considered in depth, even though various design iterations are carried out to refine an idea. Furthermore, the introduction of additive manufacturing (AM) has facilitated, in particular, the development of bespoke medical products. End bespoke products, which will be used by relevant stakeholders (e.g. patients and clinicians) are fabricated with the same manufacturing technologies used during prototyping. As a result, the detailed design stage of products fabricated by AM is much shorter. Therefore, to improve the market-readiness of bespoke medical devices, testing must be integrated within the development from an early stage, allowing better planning of resources. To address these issues, in this paper, a comprehensive VVT framework is proposed for research projects, which lack a VVT infrastructure. The framework builds up on previous studies and methods utilised in industry to enable project key experts to capture risks as early as the concept design stage.

scholarly journals INVESTIGATION ON METHODS AND CHARACTERISTICS IN MEDICAL DEVICE DEVELOPMENT

2020 ◽  
Vol 1 ◽  
pp. 1969-1978 ◽  
Author(s):  
J. Kuhl ◽  
O. Sankowski ◽  
D. Krause
Keyword(s):  
Risk Assessment ◽  
Medical Devices ◽  
Design Methods ◽  
User Centered Design ◽  
Design Validation ◽  
Medical Products ◽  
Device Development ◽  
Assessment Design ◽  
Technical Issues ◽  
User Centered

AbstractA targeted development of safe medical products can be supported by design methods. This paper analyses which design methods are applied in the development of medical devices and whether they are adapted for considering medical devices’ special features (legal, human and technical issues). In particular, variety management, risk assessment and user-centered design for medical devices are examined. Typically, interdisciplinary risk assessment is methodically supported. Additionally, user-centered design methods for requirements assessment, design verification and design validation are applied.

The Position of the German Association of Biomedical Engineering on ‘Ergonomics in Medical Technologies’

2005 ◽  
Vol 49 (11) ◽  
pp. 960-964
Author(s):  
U. Matern
Keyword(s):  
Medical Devices ◽  
Biomedical Engineering ◽  
Medical Equipment ◽  
Medical Engineering ◽  
Technical Committee ◽  
Purchase Decisions ◽  
Medical Products ◽  
Medical Quality ◽  
German Association

With an increasing employment of technology the medical quality of treatment may rise. But, at the same time, the complexity of the medical equipment rises as well. This leads to an increase of the required interactions between user and technology. Therefore, a higher work loading for the medical and nursing personal is consequential. New requirements to the safety and the quality of use of medical devices and systems result from the increasing employment of technology. For the acquisition of devices users and operators need to pay attention to the possible sources of error in handling and use as well as to the possibility to decrease operating and process costs by foresighted purchase decisions. The German Association of Biomedical Engineering (DGBMT) considered the ergonomics of medical products as an important topic and established the Technical Committee of Ergonomics in Medical Engineering. The members of this technical committee compiled a paper describing the most important issues and intentions being partly presented in the following.

Children as Consumer Participants of Child and Adolescent Mental Health Services

2009 ◽  
Vol 17 (4) ◽  
pp. 287-290 ◽  
Author(s):  
Margaret Mitchell-Lowe ◽  
Matthew Eggleston
Keyword(s):  
Mental Health ◽  
Pilot Study ◽  
Mental Health Services ◽  
Health Services ◽  
Developmentally Appropriate ◽  
Adolescent Mental Health ◽  
Child And Adolescent ◽  
Initial Assessment ◽  
Key Issues ◽  
Children’S Views

Objective: This pilot study explored children's perspectives of an initial assessment at outpatient child and adolescent mental health services (CAMHS). Method: A semi-structured qualitative interview was undertaken with nine children aged 7–12 years. Transcribed interviews were analyzed to reveal common themes. Results: Children generally coped well with the interview. They identified themes involving stigma, qualities and approaches of staff, aspects of the CAMHS environment, and anxiety about attending CAMHS as key issues. Conclusions: This pilot study suggests that it is feasible to interview children regarding their perspectives on attending a CAMHS. Children's views of CAMHS are required to help inform developmentally appropriate service delivery.

Company News

2001 ◽  
Vol 05 (14) ◽  
pp. 291-301
Keyword(s):  
Medical Devices ◽  
Strategic Alliance ◽  
State Of The Art ◽  
Life Sciences ◽  
Medical Products ◽  
First Order ◽  
Commercial Use ◽  
Sign Distribution ◽  
Wastewater Recycling ◽  
Set Up

Cell Robotics' Medical Devices Well Received in China. US National Nutritional Foods Association and China's Sanjiu Pharmaceutical Establish Historic Partnership. Novacor LVAS Approved for Commercial Use in Japan. NOMOS and Lynmed to Jointly Distribute Medical Products in China and HK. Eli Lilly to Buy Out Ranbaxy's Stake. US-based Dragon Expands Business in Hong Kong and China. Australia's Global Doctor and US MedAire Announce Strategic Alliance. Taiwan's Gene Born Biotech Corp Adopts Thermogenesis's BioArchive System. Cepheid and BioSynTech Sign Distribution Agreement To Enter Life Sciences Research Market in Southeast Asia. Harbin Pharmaceutical Completes China's Largest Antibiotic Wastewater Recycling Project. Eli Lilly to Set Up State-of-the-Art Systems Biology R&D Center in Singapore. Varian Receives First Order for World's Most Powerful NMR Spectrometer from Japan.

scholarly journals Design and Evaluation of a Novel Instrument Gripper for Handling of Surgical Instruments

2021 ◽  
Vol 7 (1) ◽  
pp. 1-5
Author(s):  
Jan Heibeyn ◽  
Nils König ◽  
Nadine Domnik ◽  
Matthias Schweizer ◽  
Max Kinzius ◽  
...  
Keyword(s):  
Medical Devices ◽  
State Of The Art ◽  
Surgical Instruments ◽  
Risk Of Infection ◽  
Force Transmission ◽  
Common Features ◽  
Force Closure ◽  
Pick And Place ◽  
Manual Labour ◽  
Cleaning And Disinfection

Abstract Introduction: Contaminated surgical instruments are manually prepared for cleaning and disinfection in the reprocessing unit for medical devices (RUMED). Manual labour exposes staff to the risk of infection and is particularly stressful at peak times due to the large volume of instruments. Partial automation of processes by a robot could provide a solution but requires a gripper that can handle the variety of surgical instruments. This paper describes the development and first evaluation of an instrument gripper. Methods: First, an analysis of gripping geometries on basic surgical instruments is carried out. Based on the identified common features and a review of the state of the art of gripper technology, the SteriRob gripper concept is developed. The concept is compared with a force closure gripper in a series of tests using seven criteria. Results: Both gripping approaches investigated can be used for handling surgical instruments in a pick-and-place process. However, the SteriRob gripper can transmit significantly higher acting forces and torques. In addition, the gripping process is more robust against deviations from the expected instrument position. Conclusion: Overall, it has been shown that the developed instrument gripper is suitable for about 60% of reusable surgical instruments due to the focus on horizontal cylindrical geometries. Because of the large possible force transmission, this gripping approach is particularly suitable for tasks in which the robot assists with cleaning processes.

scholarly journals Medical records: Doctors' and patients' experiences of copying letters to patients

2004 ◽  
Vol 28 (2) ◽  
pp. 40-42 ◽  
Author(s):  
Harpal Nandhra ◽  
Graham Murray ◽  
Nigel Hymas ◽  
Neil Hunt
Keyword(s):  
General Practitioner ◽  
Pilot Study ◽  
General Practitioners ◽  
Medical Records ◽  
Letter Writing ◽  
Initial Assessment ◽  
Clinical Implications ◽  
Usual Practice ◽  
To Receive ◽  
Writing Practice

Aims and MethodWe conducted a pilot study to determine patients' views on receiving a copy of the assessment letter sent to their general practitioner and to determine how psychiatrists' letter writing practice would be altered in the knowledge that patients would receive copies of such letters. Seventy-six consecutive new outpatients received copies of the initial assessment letter sent to general practitioners. Patients were asked to complete a short questionnaire on how the practice affected them. For each letter, psychiatrists were asked to provide details of anything of importance that had been omitted from the letter that in their normal practice they would have included.ResultsThere was a broad range of responses on how patients felt about the letters. Only two patients found the letters unhelpful, and 83% expressed a positive desire to continue receiving letters, even though initially 18% found the letter distressing. For 56 out of 76 patients, psychiatrists stated that they composed and sent out the letter to the GP in accordance with their usual practice and copied the letter to the patient in an unaltered form. For 17 patients, the psychiatrist stated that some information he/she would usually have included in the GP letter was omitted in the copy the patient received. In a further 3 cases, the psychiatrist sent no letter to the patient.Clinical ImplicationsPatients found it helpful to receive copies of their assessment letters. Psychiatrists might require training and reassurance about this policy before implementation.

Evaluating systems of care.

2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 100-100
Author(s):  
Sarah Ford Duggan Goldstein ◽  
Jennifer Wisner ◽  
Carole Redding Flamm
Keyword(s):  
Pilot Study ◽  
Cancer Care ◽  
Systems Of Care ◽  
National Research Council ◽  
Initial Assessment ◽  
Institute Of Medicine ◽  
Patient Centered ◽  
Patient Navigators ◽  
Quality Cancer Care ◽  
Blue Shield

100 Background: Blue Cross and Blue Shield Association (BCBSA) is an association of 38 independent, locally operated Blue Cross and/or Blue Shield Plans (each, a BCBS Company). BCBSA and the 38 Blue Companies developed the Blue Distinction (BD) Program, a hospital based quality recognition program with clinical focus on six areas of specialty care, including complex and rare cancers. In 2010, BCBSA and 7 BCBS companies engaged in a pilot study with 25 systems of cancer care, to examine the feasibility of measuring key components of quality that were developed with input from a national multidisciplinary expert panel. Breast and/or colon cancer programs were examined on a range of settings, to understand similarities and differences between systems of cancer care in various regions across the country. Methods: A series of structured discussions and a three-part survey were used to gather information about systems of cancer care. The surveys explored various structures and processes of care that support multidisciplinary, coordinated, evidence-based and patient-centered care across the continuum of care. Results: A diverse group of established multidisciplinary systems of cancer care [n =17 responses (68%)] participated, representing tertiary, community, urban, and rural settings from various regions. Approximately one-third of the responding systems provided written treatment plans or written treatment summaries to patients, and less than one-half had formal processes for comprehensive survivorship care. A majority provided patient navigators, care coordination, or case management services, and a similar majority communicated with the primary care provider at identified points in course of patient’s treatment (e.g., initial assessment, change in treatment, completion of treatment). Conclusions: The pilot study identified gaps in oncology care, similar to those found by the Institute of Medicine (National Cancer Policy Board, Institute of Medicine, and National Research Council. Ensuring Quality Cancer Care. Washington, DC: The National Academies Press, 1999) and others. Opportunities exist for oncology stakeholders to promote quality improvement efforts to narrow these gaps and to improve the quality of cancer care.

Self-Assessment of Biomedical Activity Related to Medical Devices Embedded in EMS Ambulances: Towards a Roadmap for an Efficient Improvement

2021 ◽  
Vol 15 (1) ◽  
pp. 119-130
Author(s):  
Abdelghani Moussaid ◽  
Hassan Bouaouine ◽  
Nabil Ngote
Keyword(s):  
Medical Devices ◽  
Biomedical Engineering ◽  
Assessment Tools ◽  
Initial Assessment ◽  
Actual Situation ◽  
Self Assessment ◽  
Good Practices ◽  
Standard Criterion ◽  
Engineering Standards ◽  
Almost All

Objective: The present investigation is focused on a self-assessment of the biomedical activity related to embedded Medical Devices on board a fleet of 46 EMS medicalized ambulances, according to the High Authority of Health standard (criterion 8K) and the Guide of the Good Practices of Biomedical Engineering. Materials and Methods: The methodology adopted for this purpose is based on an analysis allowing the evaluation and observation of practices related to biomedical activity in these ambulances. An initial assessment, carried out in March 2021, made it possible to measure the gaps between the actual situation and the recommendations of the two self-diagnosis tools (High Authority of Health and Guide of the Good Practices of Biomedical Engineering standards). A series of corrective actions were proposed and then implemented. A second self-assessment took place after 6 months, in October 2021. Results: Between March and October 2021, an improvement in the scores for almost all the axes of the two self-assessment tools was noted. Indeed, the score of the self-assessment for the High Authority of Health reference system rose from 44% in March 2021 to 63% in October 2021, i.e. an increase of 19%, and that of the Guide of the Good Practices of Biomedical Engineering increased from 67.54% in March 2021 to 80.96% in October 2021, i.e. an increase of 13.42%. Conclusion: The implementation of a maintenance strategy integrating the notion of quality, relevant procedures and pertinent work tools has made it possible to significantly improve the biomedical activity within the medical ambulances and to optimise the embedded medical devices.

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