The Calculated Risk—A Safety Criterion

1977 ◽  
pp. 49-72 ◽  
Author(s):  
G.D. Bell
Keyword(s):  
Safety Criterion ◽  
Calculated Risk

Skin exposure: requirements to methods determining active ingredient of pesticides in washings

2019 ◽  
pp. 43-48
Author(s):  
V. N. Rakitskii ◽  
N. E. Fedorova ◽  
I. V. Bereznyak ◽  
N. G. Zavolokina ◽  
L. P. Muhina
Keyword(s):  
Lower Limit ◽  
Limit Of Detection ◽  
Solid Phase ◽  
Absorbed Dose ◽  
Ambient Air ◽  
Safety Coefficient ◽  
Limit Value ◽  
Calculated Risk ◽  
Nature Studies ◽  
Active Substances

The article presents results of studies exemplified by diquat on analysis concerning influence of lower limit value of quantitative assessment in washing sample for safety coefficient in exposure and in absorbed dose, if acting substance is absent in workplace ambient air samples and in dermal washings of workers. To control diquat in dermal washings, there is a method based on ion-pair liquid chromatography with ultraviolet detection (working wavelength 310 nm). To concentrate sample, cartridges for solid-phase extraction, containing ion exchange sorbent (Oasis MCX 6cc/500 mg), are used. Lower limit of assessment in washing sample — 0,15 micrograms. Experimentally set washing completeness is within range of 80–92%, standard deviation of repetition is 7,0% at most. The method created was tested in nature studies determining dermal exposure in workers subjected to 5 various preparations based on diquat dibromide when used for surface spraying from tractor and from aircraft. For lower limit of detection in washing sample (0,15 micrograms/washing), calculated risk value of exposure varied within 0,26–0,36; risk of absorbed dose was low — 0,23 (the allowable one ≤1). Findings are that present measuring methods which provide lower limit of detection 1 and 5 micrograms in washing sample could result in unallowable risk establishment even with absence of the substance in all samples of workplace air and dermal washings. The calculation formula suggested enables to give theoretic basis for requirements to lower limit of detecting active substances in dermal washing samples for evaluating risk of pesticides use in agriculture.

scholarly journals Risk Estimate of Duodenoscope-Associated Infections in The Netherlands

2020 ◽  
Vol 41 (S1) ◽  
pp. s436-s437
Author(s):  
M. Vos ◽  
Judith Kwakman ◽  
Marco Bruno
Keyword(s):  
The Netherlands ◽  
Multidrug Resistant ◽  
National Database ◽  
Clinical Infection ◽  
Minimum Risk ◽  
Medical Practitioners ◽  
Healthcare Facilities ◽  
Calculated Risk ◽  
Original Calculation ◽  
Bare Minimum

Background: The likelihood of endoscopy-associated infections (EAIs) is often referenced from a paper published in 1993 by Kimmery et al1 in which a risk of 1 exogenous infection for every 1.8 million endoscopies (0.00006%) is proclaimed. Even though Ofstead et al2 pointed out in 2013 that this was at least an underestimation by 6-fold because of erroneous assumptions and mathematical errors, the original calculation is still often referred to. In the past decade, multiple outbreaks of multidrug-resistant microorganisms (MDROs) related to contaminated duodenoscopes have been reported worldwide. This leads to the assumption that the former risk calculation is indeed incorrect. Objective: We calculated the duodenoscope-associated infection (DAI) risk for the Dutch ERCP practice. Methods: We searched and consolidated all Dutch patients reported in the literature to have suffered from a clinical infection linked to a contaminated duodenoscope between 2008 and 2018. From a national database, the number of ERCPs performed per year in The Netherlands were retrieved. Actual numbers were available from 2012 to 2018. Numbers from 2008 to 2011 were estimated and assumed to be equal to 2012. Results: In 2008–2018, 3 MDRO outbreaks in Dutch hospitals were reported in the literature, with 21 patients suffering from a clinical infection based on a microorganism proven to be transmitted by a duodenoscope. In that period, ∼203,500 ERCP procedures were performed. Hence, for every 9,690 procedures, 1 patient developed a clinically relevant infection (DAI risk, 0.010%). Conclusions: The risk of developing a DAI is at least 30–180 times higher than the risks that were previously reported for all types of endoscopy-associated infections. Importantly, the current calculated risk of 0.010% constitutes a bare minimum risk of DAI because endoscope-related infections are underreported. Apart from DAI risk, a patient is also at risk of becoming colonized with a microorganism through contaminated endoscopes but without developing symptoms of clinical infection. These data call for consorted action of medical practitioners, industry, and government agencies to minimize and ultimately eliminate the risk of exogenous endoscope-associated infections and contamination. As a first step, the FDA recently recommended that healthcare facilities and manufacturers begin transitioning to duodenoscopes with disposable components.3Funding: NoneDisclosures: None

scholarly journals A literature review and meta-analysis of safety profiles of SGLT2 inhibitors in Japanese patients with diabetes mellitus

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Junichi Mukai ◽  
Shinya Kanno ◽  
Rie Kubota
Keyword(s):  
Diabetes Mellitus ◽  
Meta Analysis ◽  
Japanese Patients ◽  
Sglt2 Inhibitors ◽  
Patients With Diabetes ◽  
Language Restriction ◽  
Calculated Risk ◽  
Favorable Safety ◽  
Type 1 Dm

AbstractThe safety profiles of sodium-glucose co-transporter 2 (SGLT2) inhibitors may depend on races/ethnicities. We aimed to assess the safety profiles of SGLT2 inhibitors in Japanese patients with diabetes mellitus (DM). The electronic databases MEDLINE, CENTRAL, and Ichushi-web were searched for studies with no language restriction from their inception to August 2019. Trials were included in the analysis if they were randomized controlled trials (RCTs) comparing the effects of SGLT2 inhibitors with a placebo in Japanese patients with DM > 18 years and reporting HbA1c and at least 1 adverse event. We calculated risk ratios with 95% CIs and used a random-effects model. Of the 22 RCTs included in our review, only 1 included patients with type 1 DM. The durations of RCTs ranged between 4 and 24 weeks. In comparison with a placebo, SGLT2 inhibitors were associated with similar risks of hypoglycemia, urinary tract infection, genital infection, hypovolemia, and fracture. The outcomes of treatment with SGLT2 inhibitors among Japanese patients with DM suggest favorable safety profiles. However, further evidence from studies with a longer duration, involving more diverse populations, such as patients with different types of DM, or including individual SGLT2 inhibitors is needed to resolve the limitations of the present study.

scholarly journals A detailed analysis of pediatric surgical malpractice claims in Germany: what is the probability of a pediatric surgeon to be accused or convicted?

2021 ◽  
Author(s):  
Sara Mahler ◽  
Emilio Gianicolo ◽  
Oliver J. Muensterer
Keyword(s):  
Medical Malpractice ◽  
Pediatric Surgeon ◽  
Technical Errors ◽  
Surgical Technical ◽  
Malpractice Claims ◽  
Incorrect Diagnosis ◽  
Calculated Risk ◽  
Medical Malpractice Claims ◽  
Observation Period

Abstract Aim of the study Pediatric surgeons treat a vulnerable population in which unfavorable outcome can lead to substantial long-term costs, placing them at risk for malpractice claims. This study aims to characterize the frequency and circumstances in which malpractice claims were successfully brought against pediatric surgeons in Germany over the last 5 years. Materials and methods Anonymous data on medical treatment errors and payments were acquired from the Federal Chamber of Physicians from 2014 through 2018 and analyzed for most frequent diagnoses and circumstances that resulted in accusation or conviction. Those claims that were successfully rebutted were compared to as controls. Lifetime risk for being involved in litigation and its outcome was calculated. Results There were 129 medical malpractice claims over the 5-year observation period. Medical error was confirmed in 56 cases (43%); the rest were successfully appealed. The risk of the prototypical German pediatric surgeon to be accused was 5.24% and to be convicted 2.27% per year in practice. The most common reasons for conviction (alone or in combination) were surgical-technical errors (23%), treatment delay (21%), insufficient workup (17%), incorrect diagnosis (17%), and incomplete consent (16%).The most frequent circumstances leading to a conviction were trauma (27%), inguinal hernia (7%), circumcision (7%), testicular torsion (7%), acute abdomen (7%), and appendicitis (5%). Conclusion Over a 40-year career, pediatric surgeons in Germany face an average calculated risk of 2.1 to be accused and 0.9 to be convicted of malpractice claims. Certain circumstances pose higher risks for litigation than others. Knowledge of these patterns may help practitioners avoid medicolegal confrontation.

scholarly journals Human Behaviour Analysis of Barrier Deviations Using a Benefit-Cost-Deficit Model

2009 ◽  
Vol 2009 ◽  
pp. 1-10 ◽  
Author(s):  
Philippe Polet ◽  
Frédéric Vanderhaegen ◽  
Patrick Millot
Keyword(s):  
Experimental Study ◽  
Human Behaviour ◽  
Safety Criterion ◽  
Human Errors ◽  
Deficit Model ◽  
Behaviour Analysis ◽  
Barrier Removal ◽  
Human Operators ◽  
Benefit Cost

A Benefit-Cost-Deficit (BCD) model is proposed for analyzing such intentional human errors as barrier removal, the deliberate nonrespect of the rules and instructions governing use of a given system. The proposed BCD model attempts to explain and predict barrier removal in terms of the benefits, costs, and potential deficits associated with this human behaviour. The results of an experimental study conducted on a railway simulator (TRANSPAL) are used to illustrate the advantages of the BCD model. In this study, human operators were faced with barriers that they could choose to deactivate, or not. Their decisions were analyzed in an attempt to explain and predict their choices. The analysis highlights that operators make their decisions using a balance between several criteria. Though barriers are safety-related elements, the decision to remove them is not guided only by the safety criterion; it is also motivated by such criteria as productivity, workload, and quality. Results of prediction supported by the BCD demonstrate the predictability of barrier violation

Justification of engineering safety criteria for undermining of water-proof layer in the Upper Kama Salt Deposit

2021 ◽  
pp. 57-63
Author(s):  
A. A. Baryakh ◽  
L. O. Tenison
Keyword(s):  
Water Soluble ◽  
Russian Science ◽  
Mining Operations ◽  
Subsidence Trough ◽  
Safety Criterion ◽  
Mining Depth ◽  
Mine Sites ◽  
Main Thing ◽  
Water Proof

Safety of a water-proof pillar between the stoping void and the aquifers defines the key feature of water-soluble mineral mining. In this regard, the most important element of geomechanical supervision of mining operations, especially, at the mine project stage, is the engineering safety criteria aimed at the adequate valuation of safe undermining of water-proof strata (WPS). The WPS safety procedures now in force calculate only maximal sagging of undermined beds and disregard deformation in the edge area of WPS. In the meanwhile, the edges of WPS are the areas of localization of maximal horizontal strains, and the hazard of vertical jointing is the highest in these areas. In this connection, in the capacity of the index of the manmade load on WPS, it is proposed to use the maximal slope of the edge area of the subsidence trough. The evaluations were carried out in 6 Uralkali’s mine sites selected from the mathematical modeling and geophysical survey data which exhibited considerable damage of WPS. Based on the implemented research and justifications, it is recommended to use the generalized safety criterion for undermining of WPS as a maximal subsidence/mining depth ratio which is directly proportional to the ground slope. This engineering procedure describes more adequately the fracture mechanism in WPS rocks, in particular, damage localization in edge areas of the subsidence trough, or influence of mining depth on WPS stability and, which is main thing, is based on the criteria derived from the long-term observations and measurements performed in the Upper Kama deposit. The study was supported by the Russian Science Foundation, Grant No. 19-77-30008.

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