Humans ; Consensus ; East Asian People ; Perioperative Care/standards* ; Risk Assessment ; Surgical Procedures, Operative ; Cardiovascular Diseases/therapy*

Coronavirus disease 2019 (COVID-19) is a grade B infectious disease caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). In pace with the spreading of the disease, biosafety risk of the biological specimen preservation in biobanks has been significantly increased and biosafety protection during biological specimen preservation become increasingly important. According to the related national rules and the corresponding guidelines of Chinese Medical Association, this paper introduced the etiology about SARS-CoV-2, epidemiology about COVID-19, and the biosafety protection principles of individuals and biological specimen storage places in the process of personal protection, protection of collection, transport, handling, preservation, detection, post-detection disposal and emergencies of biological specimen. Emphasized to carry out a strict biosafety-risk assessment on biological specimen basing on virus load information, infectivity, and sample type (possible contact transmission, aerosol transmission, and fecal oral transmission).
Betacoronavirus ; isolation & purification ; Containment of Biohazards ; standards ; Coronavirus Infections ; epidemiology ; prevention & control ; transmission ; Humans ; Pandemics ; prevention & control ; Pneumonia, Viral ; epidemiology ; prevention & control ; transmission ; Prevalence ; Risk Assessment ; Specimen Handling ; standards

To achieve a comprehensive understanding of heavy metals and harmful elements residues in Niuhuang Qingwei Pills,49 samples from 18 manufactures were collected from 31 provinces in China.Risk assessment and control preparations were applied innovatively in evaluation of exogenous pollution in traditional Chinese Medicine.Determination methods for Pb,Cd,As,Hg and Cu were established by inductively coupled plasma mass spectrometry(ICP-MS).Based on the procedures including hazard identification,hazard characterization,exposure assessment and risk characterization,risk assessment was performed and residual limits for Pb,Cd,As,Hg and Cu in the drug were formulated.The results showed that the hazardous quotients(HQ) of the elements were decreased in the following order:Pb>As>Cu>Hg>Cd,and the total hazardous index(HI) of heavy metals and harmful elements in Niuhuang Qingwei Pills was above 1,implying health risk of the drug.Under the proposed limits,5 elements in the control preparation as well as Cd and Cu in the samples were within the limits range,but the excess rates of Pb,As and Hg in the samples were 12%,12% and 14%,respectively.For the first time,basic steps for risk assessment of Chinese patent medicine were established,which provided model and reference for risk assessment and limit formulation of other drugs.
China ; Drug Contamination ; Drugs, Chinese Herbal ; analysis ; standards ; Metals, Heavy ; analysis ; Risk Assessment

The threshold of toxicological concern (TTC), a risk estimation method based on compound structurally-related toxicity data, has been widely used by many countries and regions for the safety risk assessment of food packaging materials and additives etc. Toxicological risk estimation is of importance in the biological evaluation of medical devices. Application of the TTC approach to leachable from medical devices may reduce or replace some unnecessary biocompatibility tests, but consideration should be taken for contact duration and route differences, which could affect the applicability of TTC. We herein focused on analyzing the eligibility of TTC for its further application in biological evaluation of medical devices.
Equipment and Supplies ; standards ; Food Packaging ; standards ; Risk Assessment ; Toxicological Phenomena

To evaluate the safety of heavy metals contaminated Astragalus membranaceus,an appropriate protocol was established to study the heavy metals pollution level by health risk assessment. This study provided a detailed procedure to assess the medicinal herbs in quality control and safety evaluation,and expected to create awareness among the public on the safety of consuming of A. membranaceus or any other kinds of medicinal herbs. The heavy metals content of Cu,As,Cd,Pb and Hg in a total of 45 batches of A. membranaceus were carefully analyzed with a developed inductively coupled plasma mass spectrometry( ICP-MS). Besides,the heavy metal contamination level was further evaluated through 4 main assessment parameters,including maximum residue limit( MRL) set by International Standard Organization,estimated daily intake( EDI) set by IUPAC,target hazard quotients( THQ) and Total THQ set by USEPA and total THQs in raw herbs of A. membranaceus. In addition,the recommended MRLs of 5 main heavy metals aimed to A. membranaceus were calculated based on the regulated consumption quantity. The result showed that,under the ISO international standard of Chinese medicine-Chinese herbal medicine heavy metals,the unqualified rate was 8. 89% for A. membranaceus,which including 4 batches of A. membranaceus exceeded the MRL of As. Here,the standard THQ value of A. membranaceus was firstly proposed as 0. 02 and 0. 011 25 for adults and children,respectively,which were calculated with the recommended consumption quantity of 30 g and 9 g for adults and children. Furthermore,the values of THQ for As and total THQs in adults and children were exceeded the standard THQ in A. membranaceus,and the recommended MRLs of Pb,Cd,Hg and Cu in above medicinal materials that calculated based on health risk assessment model were higher than the regulated MRLs that set by ISO and Chinese Pharmacopeia. The research showed that the contents of heavy metals in A. membranaceus were not in the safe range and the certain non-carcinogenic risks to human body cannot be neglected. Based on above investigation result,it is easily known that the common evaluation method for raw herbs based on the comparison of MRL of heavy metals was not precise enough,and the international model of health risk assessment should be built for each medicinal herb. Above all,this study provided a more realistic research approach for safety evaluation of any other kinds of heavy metals contaminated medicinal herbs,including the establishment of heavy metals standard limit in a specified medicinal herb under recommended consumption quantity,and it is expected to create awareness among the public on the safety of consuming any other medicinal herbs.
Astragalus propinquus ; chemistry ; Drug Contamination ; Drugs, Chinese Herbal ; analysis ; standards ; Humans ; Metals, Heavy ; analysis ; Plants, Medicinal ; chemistry ; Risk Assessment

The study aims at taking risk assessment of pesticide residues in ginseng and high risk pesticides were picked up in order to provide a scientific basis for the establishment of maximum residue limits(MRLs) for pesticides in ginseng. Residues of 246 pesticides in 80 ginseng samples collected from different place were detected by GC-MS/MS and LC-MS/MS method. Acute and chronic intake risks were evaluated by using deterministic approach, and the matrix ranking developed by the Veterinary Residues Committee of the United Kingdom was referred to assess risk score of pesticides. The 25 kinds of pesticide residues were detected in ginseng samples, the detection rate of quintozene(PCNB) was 78%, which was the most frequently detectable pesticide. The chronic dietary intake risks of 25 pesticide residues expressed as %ADI were 0.00%-2.6%, and their acute dietary intake risks expressed as %ARfD were 0.00%-104.2%. Among them the acute dietary intake risks of PCNB was 104%,which was the highest. The 25 pesticides were divided into 3 groups by risk score, high risk group(4 pesticides), medium risk group(6 pesticides), and low risk group(15 pesticides). Hexachlorobenzene, phorate, PCNB and BHC were classified as high risk group. It is necessary and effective to establish the limit of residual organic chlorine in ginseng from Chinese Pharmacopoeia(2015 edition). MRLs for PCNB and hexachlorobenzene in ginseng were proposed to be revised based on the results of risk assessment.
Chromatography, Liquid ; Drugs, Chinese Herbal ; standards ; Panax ; chemistry ; Pesticide Residues ; analysis ; Risk Assessment ; Tandem Mass Spectrometry

The anastomotic complications following radical gastrectomy mainly include anastomotic leakage, anastomotic hemorrhage, and anastomotic stricture. Theanastomotic complications are not rare and remain the most common complications resulting in the perioperativedeath of patients with gastric cancer. Standardized training could let surgeons fully realize that strict selection of operative indications, thorough preoperative assessment and preparation, and refined operation in surgery are the essential measures to prevent the anastomotic complications following radical gastrectomy. In addition, identifying these complications timely and taking effective measures promptly according to the clinical context are the keys to treating these complications, reducing the treatment cycle, and decreasing the mortality.
Anastomosis, Surgical ; adverse effects ; Anastomotic Leak ; prevention & control ; therapy ; Constriction, Pathologic ; prevention & control ; therapy ; Gastrectomy ; adverse effects ; methods ; Gastrointestinal Hemorrhage ; prevention & control ; therapy ; Humans ; Postoperative Complications ; diagnosis ; therapy ; Preoperative Care ; methods ; standards ; Risk Assessment ; methods ; standards ; Risk Factors ; Stomach Neoplasms ; complications ; mortality ; surgery

Postoperative complications are important outcome measurements for surgical quality and safety control. However, the complication registration has always been problematic due to the lack of definition consensus and the other practical difficulties. This narrative review summarizes the data registry system for single institutional registry, national data registry, international multi-center trial registries in the western world, aiming to share the experience of complication classification and data registration. We interviewed Dr. Koh from Royal Prince Alfred Hospital in Australia for single institutional experience, Dr. van der Wielen and Dr. Desideriofor, from two international multi-center trial(STOMACH) and registry (IMIGASTRIC) respectively, and Prof. Dr. Wijnhoven from the Dutch Upper GI Audit(DUCA). The major questions include which complications are obligated to report in the respective registry, what are the definitions of those complications, who perform the registration, and how are the complications evaluated or classified. Four telephone conferences were initiated to discuss the above-mentioned topics. The DUCA and IMGASTRIC provided the definition of the major complications. The consent definition provided by DUCA was based on the LOW classification which came out after a four-year discussion and consensus meeting among international experts in the according field. However, none of the four registries asked for an obligatory standardization of the diagnostic criteria among the participating centers or surgeons. Instead, all the registries required a detailed recording of the diagnostic strategy and classification of the complications with the Clavien-Dindo scoring system. Most data were registered by surgeons or data managers during or immediately after the hospitalization. The investigators or an independent third party conducted the auditing of the data quality. Standardization of complication diagnosis among different centers is a difficult task, consuming much effort and time. On top of that, standardization of the complication registration is of critical and practical importance. We encourage all centers to register complications with the diagnostic criteria and following intervention. Based on this, the Clavien-Dindo classification can be properly justified, which has been widely accepted by most centers and should be routinely used as the standard evaluation system for postoperative complications in gastric tumor surgery.
Australia ; epidemiology ; Data Collection ; standards ; statistics & numerical data ; Diagnostic Techniques and Procedures ; standards ; statistics & numerical data ; Digestive System Surgical Procedures ; adverse effects ; statistics & numerical data ; Health Care Surveys ; Humans ; Netherlands ; epidemiology ; Postoperative Complications ; classification ; diagnosis ; epidemiology ; Registries ; standards ; Risk Assessment ; methods ; standards ; Stomach Neoplasms ; complications ; surgery

Radical surgery of gastric cancer (D2 lymph node dissection) as the standard operation is widely used in clinical practice and satisfactory prognosis can be obtained in patients who receive radical gastrectomy. But surgical invasion can cause high morbidity of complications and mortality. The data of large-scale evidence-based medical clinical trials and large databases in Japan and Korea showed that anastomotic leakage, pancreatic leakage and abdominal abscess were the most common complications after gastrectomy, and the morbidity of complication was about 20% and mortality was about 1%. The risk factors such as elderly, obesity, and comorbidities may increase the morbidity of complications and mortality, and these factors were regarded as poor predictors after operation. Postoperative complications criteria of gastric cancer surgery is mainly used with Clavien-Dindo classification of surgical complications as international standard, and this criteria is also used in Korea. The postoperative complications are evaluated with the Common Terminology Criteria for Adverse Events (CTCAE v4.0) and Japanese Clinical Oncology Group(JCOG) postoperative complications criteria for grading definitions of postoperative complications after gastric surgery in Japan. These classifications of postoperative complications criteria were adopted widely in Japan with large-scale evidence-based medical clinical trials of gastric cancer. PS, ASA, POSSUM, E-PASS, APACHE-II(, Charison weighted index of comorbidities (WIC), Frailty Score was used in predicting postoperative mortality and morbidity in gastric cancer patients. These risk factors were assigned points in scoring systems to objectively evaluate risk of surgery, and surgical operation method was one of the risk factors on the basis of these scoring systems. We can use these scoring systems for choosing reasonable surgical methods and proper perioperative management.
APACHE ; Gastrectomy ; adverse effects ; methods ; Health Status Indicators ; Humans ; Japan ; Korea ; Lymph Node Excision ; adverse effects ; Patient Care Planning ; standards ; Perioperative Care ; methods ; Postoperative Complications ; classification ; diagnosis ; mortality ; prevention & control ; Prognosis ; Risk Assessment ; methods ; Risk Factors ; Stomach Neoplasms ; complications ; surgery

China ; Humans ; Occupational Diseases ; prevention & control ; Occupational Exposure ; prevention & control ; Occupational Health ; standards ; Research ; Risk Assessment ; methods