What is important to young medical technologists for radiology when choosing a job? / Was ist dem MTR-Nachwuchs bei der Stellenwahl wichtig?

AIM: Given the intensifying competition in Germany for medical technologists for radiology (MTR), our aim was to identify job-related preferences among MTR trainees. MATERIALS AND METHODS: For this purpose, a survey was carried out among MTR trainees at the MTR schools in Düsseldorf, Mainz, and Heidelberg. The focus was on the individual influence of 40 work- and employer-related factors and on the preferred place of work (hospital, practice) and area of operation (radiology, nuclear medicine, radiation therapy) after completing training. RESULTS: 90 MTR trainees took part in the survey. On average, they indicated a pleasant working atmosphere, regular compensation for overtime, and good teamwork as the most important criteria for applying for an MTR position. With regard to their preferred place of work, more than two-thirds stated that they would initially apply to a hospital after completing their training. Moreover, the majority of the respondents prefer to start their MTR careers in diagnostic and interventional radiology, followed by radiation therapy and nuclear medicine. CONCLUSION: Imaging clinics and practices can use the present results for targeted personnel recruitment in order to make their MTR positions as attractive as possible from the point of view of young MTRs. KEY POINTS: · The increasing competition for qualified young talent also affects imaging centers.. · The aim of the survey was to gain insight into the career- and job-related preferences of MTRs.. · Imaging clinics/practices can use these results as a starting point for establishing specific human resources measures for technologists.. · An increase in perceived employer attractiveness can lead to competitive advantages with respect to attracting and retaining qualified MTRs.. CITATION FORMAT: · Zippel C, Wirth P, Biedenstein S et al. What is important to young medical technologists for radiology when choosing a job?. Fortschr Röntgenstr 2024; DOI: 10.1055/a-2221-3971.

[Breakeven Analysis for Imaging Devices: Basic Introduction with Presentation of a User-Friendly Tool for in-clinic Calculation Using PET/CT as an Example]. / Gewinnschwellenanalyse bei Bildgebungsgeräten: Grundlegende Einführung mit Vorstellung eines nutzungsfreundlichen Tools zur klinikinternen Kalkulation am Beispiel PET/CT.

BACKGROUND: Imaging devices such as PET/CT are becoming increasingly important in view of the growing range of innovative nuclear medicine diagnostic procedures. Since the procurement and commissioning as well as the ongoing operation of imaging devices leads to comparatively high costs, it is of great interest for clinics and practices to know the number of scans from which the (planned) device operation leads to a profit. In the following, we will introduce the breakeven point analysis and present a calculation tool that users in nuclear medicine clinics and practices can use in everyday operations using PET/CT as an example. METHODS: In the breakeven point analysis, the intersection point is determined from which the organisation- or device-specific revenues exceed the total costs incurred for personnel, material resources, etc. For this purpose, the fixed and variable (planned) cost components for the procurement and operation of the device must be prepared on the cost side and the respective device-related (planned) revenue structure on the revenue side. RESULTS: The authors present the break-even analysis method with the data processing required for this using the example of the planned procurement or ongoing operation of a PET/CT. In addition, a calculation tool was developed, that interested users can use to prepare a device-specific break-even analysis. For this purpose, various cost and revenue data are discussed, which have to be compiled and processed within the clinic and entered into prepared spreadsheets. CONCLUSION: The breakeven point analysis can be used to determine the profit/loss (point) for the (planned) operation of imaging devices such as PET/CT. Users from imaging clinics/practices and administration can adapt the calculation tool presented to their specific facility and thus use it as a basic document for both the planned procurement and the ongoing operational control of imaging devices in everyday clinical practice.

Rise of Clinical Studies in the Field of Machine Learning: A Review of Data Registered in ClinicalTrials.gov.

Although advances in machine-learning healthcare applications promise great potential for innovative medical care, few data are available on the translational status of these new technologies. We aimed to provide a comprehensive characterization of the development and status quo of clinical studies in the field of machine learning. For this purpose, we performed a registry-based analysis of machine-learning-related studies that were published and first available in the ClinicalTrials.gov database until 2020, using the database's study classification. In total, n = 358 eligible studies could be included in the analysis. Of these, 82% were initiated by academic institutions/university (hospitals) and 18% by industry sponsors. A total of 96% were national and 4% international. About half of the studies (47%) had at least one recruiting location in a country in North America, followed by Europe (37%) and Asia (15%). Most of the studies reported were initiated in the medical field of imaging (12%), followed by cardiology, psychiatry, anesthesia/intensive care medicine (all 11%) and neurology (10%). Although the majority of the clinical studies were still initiated in an academic research context, the first industry-financed projects on machine-learning-based algorithms are becoming visible. The number of clinical studies with machine-learning-related applications and the variety of medical challenges addressed serve to indicate their increasing importance in future clinical care. Finally, they also set a time frame for the adjustment of medical device-related regulation and governance.

[PSMA radioligand therapy could pose infrastructural challenges for nuclear medicine: results of a basic calculation for the capacity planning of nuclear medicine beds in the German hospital sector]. / PSMA-Radioligandentherapie könnte Nuklearmedizin vor infrastrukturelle Herausforderungen stellen: Ergebnisse einer Basiskalkulation zur Kapazitätsplanung nuklearmedizinischer Betten im deutschen Krankenhaussektor.

BACKGROUND: With the increasing use of the Lu-177-PSMA-RLT for the treatment of advanced castrate resistant prostate cancer (mCRPC), an estimation of the necessary therapy beds in nuclear medicine departments is of great importance in the view of the high number of cases of advanced prostate cancer, and as a basis to avoid a potentially infrastructure-related bottleneck for patient care in this field. METHODS: The number of therapy beds available in German nuclear medicine departments was included in a basic calculation in view of the overall potential for therapy beds to be expected in the event of a possible approval of a therapeutic agent for the Lu-177-PSMA-RLT for mCRPC patients. A potential expansion of the Lu-PSMA-therapy indications was not taken into account. RESULTS: The basic calculation shows for a nationwide nuclear medicine bed capacity of approx. 234 000 treatment days a relatively small bed reserve of approx. 19 000 nuclear medicine bed days, which corresponds to a reserve of 63 beds for the research question. There are regional differences in bed capacity: while for some federal states there is an under-capacity of nuclear medicine therapy beds with an approved Lu-177-PSMA-RLT, this is less the case for other federal states. DISCUSSION: This basic calculation shows that the capacity of nuclear medicine therapy beds is likely to be very well utilized with a prospectively approved therapeutic agent for Lu-177-PSMA-RLT, and could even reach its limits in some German federal states. With a prospective expansion of the range of indications or the foreseeable clinical establishment of further therapeutic radiopharmaceuticals, the number of therapy beds could represent a bottleneck factor for the comprehensive patient treatment in the medium term.

Current Status of PSMA-Radiotracers for Prostate Cancer: Data Analysis of Prospective Trials Listed on ClinicalTrials.gov.

The recent development of dedicated prostate-specific membrane antigen (PSMA) targeted radioligands shows the potential to change and improve the diagnosis and therapy of prostate cancer. There is an increasing number of prospective trials to further establish these tracers in the clinical setting. We analyzed data from the ClinicalTrials.gov registry including all listed prospective trials with PSMA-ligands for prostate cancer as of October 2019 concerning the different tracers and study characteristics. We found n = 104 eligible studies with a total of n = 25 different tracers in use: most frequently [68Ga]Ga-PSMA-11 (32%), followed by [18F]DCFPyL (24%) and [177Lu]Lu-PSMA-617 (10%). 85% are single-center, 15% multi-center studies. 95% national and 5% international studies. 34% are phase-II, 24% phase-I, 13% phase-I/-II, 12% phase-II/-III and phase-III and 7% early-phase-I. The primary purpose was classified as diagnostic in 72% of cases and therapeutic in 23% of cases. Most studies were executed in the USA (70%), followed by Canada (13%) and France (6%). This quantitative descriptive registry analysis indicates the rapid and global clinical developments and current status of PSMA-radioligands with emphasis on radiopharmaceutical and organizational aspects. It will be very interesting to see which tracers will prevail in the clinical setting.

[Initiation of clinical multicentre studies with local radiotracer production - Regulatory environment and radiopharmaceutical-organisational aspects]. / Initiierung klinischer Multicenter-Studien mit lokaler Radiotracer-Herstellung.

The aim of this paper is to highlight key aspects to be considered from a radiopharmaceutical point of view when performing prospective multicentre clinical trials using short-lived PSMA-PET-radiopharmaceuticals as investigational medicinal product (IMP). Early prospective multicentre clinical trials are playing an increasingly important role in nuclear medicine translational research; in order to be able to establish new PET tracers with a short physical half-life (e. g. for prostate cancer diagnostics) in the regulatory approval process, nuclear medicine centres are working together across multiple sites in order to be able to achieve the required number of patients to be included within the clinical study in a reasonable time frame. In the following, we discuss the necessary regulatory environment for the preparation of PSMA PET-radiopharmaceuticals as corresponding investigational medicinal product (IMP) using the example of the prospective multicentre clinical trial (phases-I and -II) "[68Ga]Ga-PSMA-11 in high-risk prostate cancer", and discuss regulatory and organisational issues that need to be taken into account in a decentralized PSMA-PET tracer production from the radiopharmacy perspective.

Post market surveillance in the german medical device sector - current state and future perspectives.

Medical devices play a central role in the diagnosis and treatment of diseases but also bring the potential for adverse events, hazards or malfunction with serious consequences for patients and users. Medical device manufacturers are therefore required by law to monitor the performance of medical devices that have been approved by the competent authorities (post market surveillance). Conducting a nationwide online-survey in the German medical device sector in Q2/2014 in order to explore the current status of the use of post market instruments we obtained a total of 118 complete data sets, for a return rate of 36%. The survey included manufacturers of different sizes, producing medical devices of all risk classes. The post market instruments most frequently reported covered the fields of production monitoring and quality management as well as literature observation, regulatory vigilance systems, customer knowledge management and market observation while Post Market Clinical Follow-up and health services research were being used less for product monitoring. We found significant differences between the different risk classes of medical devices produced and the intensity of use of post market instruments. Differences between company size and the intensity of instruments used were hardly detected. Results may well contribute to the development of device monitoring which is a crucial element of the policy and regulatory system to identify device-related safety issues.

Innovation for Safe and Effective Medical Devices: Contributions From Postmarket Surveillance.

BACKGROUND: Recent years have seen great interest in finding new ways to develop innovative, safe, and effective medical devices. While there has been considerable research on the lead user and open innovation approach, relatively little attention has been given to postmarket surveillance as a valuable source of safety-related information on medical devices. METHODS: An online questionnaire was sent to 118 postmarket surveillance experts throughout Germany to find out (1) what instruments medical device manufactures use to promote an internal transfer of postmarket surveillance knowledge and (2) to what extent this can lead to impulses for research and development meant to improve or develop new medical devices. RESULTS: Our results showed that technical and human resource-related instruments are of particularly high importance for the intraorganizational transfer of postmarket knowledge. CONCLUSIONS: The transfer of this postmarket-related device knowledge can have a positive impact on the improvement or development of (especially incremental) medical device innovations, thus contributing to a company's success and strengthening device-related patient safety at the same time.

[Prevention of medical device-related adverse events in hospitals: Specifying the recommendations of the German Coalition for Patient Safety (APS) for users and operators of anaesthesia equipment]. / Prävention Medizintechnik-assoziierter Risiken im Krankenhaus: Spezifizierung der APS-Empfehlungen für Anwender und Betreiber von Anästhesiegeräten.

BACKGROUND: The use and organisation of medical technology has an important role to play for patient and user safety in anaesthesia. OBJECTIVES: Specification of the recommendations of the German Coalition for Patient Safety (APS) for users and operators of anaesthesia equipment, explore opportunities and challenges for the safe use and organisation of anaesthesia devices. METHODS: We conducted a literature search in Medline/PubMed for studies dealing with the APS recommendations for the prevention of medical device-related risks in the context of anaesthesia. In addition, we performed an internet search for reports and recommendations focusing on the use and organisation of medical devices in anaesthesia. Identified studies were grouped and assigned to the recommendations. The division into users and operators was maintained. RESULTS: Instruction and training in anaesthesia machines is sometimes of minor importance. Failure to perform functional testing seems to be a common cause of critical incidents in anaesthesia. There is a potential for reporting to the federal authority. Starting points for the safe operation of anaesthetic devices can be identified, in particular, at the interface of staff, organisation, and (anaesthesia) technology. CONCLUSIONS: The APS recommendations provide valuable information on promoting the safe use of medical devices and organisation in anaesthesia. The focus will be on risks relating to the application as well as on principles and materials for the safe operation of anaesthesia equipment.