Melde- und Informationssystem für bedeutsame Vorkommnisse bei Strahlenanwendungen in der Medizin: Struktur,Zuständigkeiten und Meldekriterien

The increasing frequency and complexity of medical radiation exposures to humans inevitably result in higher risks of harmful unintended or accidental radiation exposures. To ensure a high level of protection and its continuous improvement, the Directive 2013/59/Euratom thus requires to systematically record and analyze both events and near-miss events as well as, in the case of their significance, to disseminate information regarding lessons learned from these events promptly and nationwide to improve radiation protection in medicine. These requirements have been transposed into German legislation by the new radiation protection law and radiation protection ordinance that entered into force simultaneously on December 31^th, 2018. The reporting and information system as provided by these regulations as well as the tasks, duties and powers of the parties involved are presented in the first part of this review article. In the second part, the established application-specified criteria for the significance – and thus the notification requirement - of (near-miss) events are itemized and explicated.     

Update: medical treatment of onychomycosis

The diagnosis of onychomycosis should be made clinically and mycologically: clinically, by one of seven subtypes of onychomycosis, and mycologically, by evidence of dermatophytes or verified presence of molds and/or yeasts. Dermatophytes are usually considered as pathogens, whereas non‐dermatophyte molds and yeasts are saprophytes. Basic anamnesis and close inspection should be performed to eliminate combined diseases (e.g., onychomycosis and trauma). The gold standard treatment for onychomycosis is basically systemic. Combination with topical agents, such as nail lacquer and/or chemical nail avulsion, produces better results than systemic treatment alone. Topical treatment as monotherapy is not efficient, excluding minor cases. Terbinafine is superior to itraconazole for dermatophyte onychomycosis. Evaluation of the outcome of clinical cure, mycological cure and total cure should be based on the well‐defined worldwide criteria; otherwise, comparison of results is impossible due to lack of uniformity in different studies. In case of treatment failure, the reasons for each failure should be carefully considered.     

Effects of acute kidney injury on clinical outcomes in patients with upper gastrointestinal bleeding

Aim Upper gastrointestinal bleeding (UGIB) is a very frequently encountered condition that has a high morbidity and which increases treatment costs. Duration of hospital stay and mortality increases in patients with UGIB complicated by acute kidney injury (AKI). The aim of this study was to reveal risk factors in patients with UGIB developing AKI and to compare clinical outcomes and hospital costs between patients with UGIB developing AKI and those with UGIB not developing AKI.

Material and methods This retrospective study included 245 patients admitted to the emergency unit and the intensive care unit for internal diseases at Ankara Numune Education and Research Hospital, Turkey. Results The difference in mortality rates between the patients with AKI and those without AKI was significant (p?0.001). The mean duration of intensive care unit stay was 0.2?±?1.1 days in the patients without AKI (n?=?143) and 2.5?±?5.6 days in the patients with AKI. It was significantly higher in the patients with AKI (p?0.001). Hospital stay was significantly longer in the patients with AKI than those without AKI, and as severity of AKI increased, hospital stay became considerably longer (p?0.001). Hospital costs were significantly higher in the patients with AKI than those without AKI, and as severity of AKI increased, hospital costs considerably rose (p?0.001). Conclusion AKI is a condition that lengthens hospital stay, increases hospital costs and creates a burden on health care systems. Detect kidney injury earlier and administering an appropriate treatment can improve clinical outcomes in patients with UGIB developing AKI.     

Performance of blood glucose meters in compliance with current and future clinical ISO15197 accuracy criteria

Since 2003, blood glucose meters for patient self testing are approved in Europe based on the accuracy performance criteria as defined by the ISO15197 guideline. A new draft ISO guideline is currently under regulatory review, which suggests more strict accuracy acceptance criteria, and which may not be entirely fulfilled by currently commercialized blood glucose meter systems. In order to investigate the compliance of BG*Star and iBG*Star and several other blood glucose meters with the new draft ISO guideline, we performed a post-hoc analysis of data obtained from a recently performed ISO-conforming clinical accuracy performance study. This study was performed with 106 patients, clinically presenting with blood glucose levels distributed over the entire measurement range and in line with the glucose distribution requirements as demanded by the guideline. The YSI 2300 STAT Plus analyzer (glucose oxidase) served as reference method.

While all tested meters had been in a high degree of compliance with the current ISO criteria, performance was lower when analyzed in accordance with the new acceptance criteria (95% of readings have to be within ±15?mg/dL for values <100?mg/dL, and within ±15% for values ≥100?mg/dL). The following meters met the new criteria: Accu-Chek Aviva (95.5%/98.6%), BG*Star (98.5%/97.3%), iBG*Star (98.5%/97.3%), FreeStyle Freedom Lite (95.5%/96.6%), and OneTouch Ultra2 (95.5%/96.5%). One meter failed with low blood glucose values (Contour: 90.9%/95.9%).

In conclusion, BG*Star and iBG*Star and several other branded meters met the new draft ISO15197 acceptance criteria, when tested in accordance with the instructions for use and with the ISO accuracy testing protocol in a clinical setting.