Displaying publications 1 - 20 of 807 in total

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  1. Liu C, Wang ST, Tan CH, Lin ZE, Lee WJ
    PMID: 38422382 DOI: 10.1080/19440049.2024.2319271
    Glycidyl esters (GEs) and 3-monochloropropanediol esters (3-MCPDEs) are process contaminants commonly found in refined edible oils which are often added to infant formulas. The Taiwan Food and Drug Administration (TFDA) launched regulations for GEs in infant formulas that went into effect on 1 July 2021. To investigate levels of GEs and 3-MCPDEs in infant formula powder, 45 products were sampled and analysed during 2020-2021. The contents of GEs and 3-MCPDEs in formulas of different brands significantly varied, but their concentrations in all of the formulas complied with European Union (EU) regulations. Infant formulas containing palm oil had significantly higher 3-MCPDE levels in both extracted oils and milk powder than those without palm oil. Concentrations of GEs and 3-MCPDEs in infant formula powder and extracted oils were significantly lower in products from Europe than those from Australia and New Zealand. Infants aged 0-1 years in Taiwan who consumed only infant formula showed a margin of exposure (MoE) exceeding 25,000. Mean consumer exposures to 3-MCPDEs stayed below the tolerable daily intake (TDI), while high exposures at the 95th percentile (P95) exceeded the TDI by 1.7-fold. Herein, we present the changing trends in the risk assessment results of infant formula across various countries in the decade. Implementation of regulations and mitigation strategy effectively reduced the risk of infants being exposed to GEs and 3-MCPDEs through infant formula.
    Matched MeSH terms: Risk Assessment
  2. Ratnasingam J, Niyaz M, Mariyappan S, Ong T, Chan SP, Hew FL, et al.
    Arch Osteoporos, 2024 Mar 20;19(1):18.
    PMID: 38503995 DOI: 10.1007/s11657-024-01371-w
    Fracture risk stratification is crucial in countries with limited access to bone density measurement. 24.8% women were in the high-risk category while 30.4% were in the low-risk category. In the intermediate risk group, after recalculation of fracture risk with bone density, 38.3% required treatment. In more than half, treatment decisions can be made without bone density.

    PURPOSE: We aimed to examine the role of age-dependent intervention thresholds (ITs) applied to the Fracture Risk Assessment (FRAX) tool in therapeutic decision making for osteoporosis in the Malaysian population.

    METHODS: Data were collated from 1380 treatment-naïve postmenopausal women aged 40-85 years who underwent bone mineral density (BMD) measurements for clinical reasons. Age-dependent ITs, for both major osteoporotic fracture (MOF) and hip fracture (HF), were calculated considering a woman with a BMI of 25 kg/m2, aged between 40 and 85years, with a prior fragility fracture, sans other clinical risk factors. Those with fracture probabilities equal to or above upper assessment thresholds (UATs) were considered to have high fracture risk. Those below the lower assessment thresholds (LATs) were considered to have low fracture risk.

    RESULTS: The ITs of MOF and HF ranged from 0.7 to 18% and 0.2 to 8%, between 40 and 85years. The LATs of MOF ranged from 0.3 to 11%, while those of HF ranged from 0.1 to 5.2%. The UATs of MOF and HF were 0.8 to 21.6% and 0.2 to 9.6%, respectively. In this study, 24.8% women were in the high-risk category while 30.4% were in the low-risk category. Of the 44.8% (n=618) in the intermediate risk group, after recalculation of fracture risk with BMD input, 38.3% (237/618) were above the ITs while the rest (n=381, 61.7%) were below the ITs. Judged by the Youden Index, 11.5% MOF probability which was associated with a sensitivity of 0.62 and specificity of 0.83 and 4.0% HF probability associated with a sensitivity of 0.63 and a specificity 0.82 were found to be the most appropriate fixed ITs in this analysis.

    CONCLUSION: Less than half of the study population (44.8%) required BMD for osteoporosis management when age-specific assessment thresholds were applied. Therefore, in more than half, therapeutic decisions can be made without BMD based on these assessment thresholds.

    Matched MeSH terms: Risk Assessment
  3. Tek PPY, Ng CC
    Environ Monit Assess, 2024 Mar 19;196(4):382.
    PMID: 38502262 DOI: 10.1007/s10661-024-12508-2
    The accumulation of potentially toxic elements (PTEs) has raised public awareness due to harmful contamination to both human and marine creatures. This study was designed to determine the concentration of copper (Cu), zinc (Zn), cadmium (Cd), and nickel (Ni) in the intestine, kidney, muscle, gill, and liver tissues of local commercial edible fish, fourfinger threadfin (Eleutheronema tetradactylum), and black pomfret (Parastromateus niger) collected from Morib (M) and Kuala Selangor (KS). Among the studied PTEs, Cu and Zn were essential elements to regulate body metabolism with certain dosages required while Cd and Ni were considered as non-essential elements that posed chronic and carcinogenic risk. The concentration of PTEs in fish tissue samples was analyzed using flame atomic absorption spectrometry (F-AAS). By comparing the concentration of PTEs in fish tissues as a bioindicator, the environmental risk of Morib was more serious than Kuala Selangor because both fish species collected from Morib resulted in a higher PTEs concentration. For an average 62 kg adult with a fish ingestion rate (FIR) of 0.16 kg/person/day in Malaysia, the estimated weekly intake (EWI) of Cd from the consumption of E. tetradactylum (M: 0.0135 mg/kg; KS: 0.0134 mg/kg) and P. niger (M: 0.0140 mg/kg; KS: 0.0132 mg/kg) had exceeded the provisional tolerable weekly intake (Cd: 0.007 mg/kg) established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and oral reference dose (ORD) values of Cd (0.001 mg/kg/day) as provided by the United States Environmental Protection Agency (USEPA) regional screening level, thus it posed chronic risks for daily basis consumption. Besides, the value of the carcinogenic risk of Cd (0.7-3 to 0.8-3) and Ni (0.5-3 to 0.6-3) were in between the acceptable range (10-6 to 10-4) of the health index that indicates a relatively low possibility cancer occurrence to the consumers in both Morib and Kuala Selangor. This study recommended FIR to be 0.80 kg/person/day to reduce the possibility of posing chronic and carcinogenic risks while at the same time obtaining the essential nutrients from the fish.
    Matched MeSH terms: Risk Assessment
  4. Pourhassan B, Beigzadeh Z, Nasirzadeh N, Karimi A
    Biol Trace Elem Res, 2024 Mar;202(3):811-823.
    PMID: 37347403 DOI: 10.1007/s12011-023-03717-w
    Welding fumes have an important role to create the adverse health effects. So, the aim of this study was to use of multiple occupational health risk assessment models for metal fumes in welding process. This cross-sectional study was conducted among welding workers. Sampling of heavy metals such as Sn, Zn, Al, Fe, Cd, Pb, Cu, Mn, Ni, Cr, and As was provided based on the National Institute for Occupational Safety and Health (NIOSH) method 7300 and analyzed by inductively coupled plasma mass spectroscopy (ICP-MS). Risk assessment was managed by four methods including Malaysia's method, Control of Substances Hazardous to Health Essentials (COSHH model), Chinese OHRA standard (GBZ/T 298-2017), and EPA method. Also, Monte Carlo simulation was used to examine the uncertainties by using the Crystal Ball tool. To compare the models, the risk levels of each model were converted into the risk ratio and the SPSS 22.0 software was used to the statistical analysis. The consistency of the two occupational health risk assessment models was examined by Cohen's Kappa. Risk ration was the highest level for Cr (VI) fumes in all models. Also, carcinogenic risk was unacceptable for all examined fumes. Moreover, non-carcinogenic risk was the highest (HI > 1) for As fumes. Mont Carlo simulations suggested that exposure time (ET) had a significant effect on the risk. Also, there was a good consistency between Malaysia method/GBZ/T 298-2017 and COSHH model/GBZ/T 298-2017. Therefore, it is recommended that the engineering and administrative controls should be provided to reduce exposure.
    Matched MeSH terms: Risk Assessment
  5. Alhammad A, Yusof MM, Jambari DI
    Expert Rev Med Devices, 2024 Mar;21(3):217-229.
    PMID: 38318674 DOI: 10.1080/17434440.2024.2315024
    INTRODUCTION: Medical device (MD)-integrated (I) electronic medical record (EMR) (MDI-EMR) poses cyber threats that undermine patient safety, and thus, they require effective control mechanisms. We reviewed the related literature, including existing EMR and MD risk assessment approaches, to identify MDI-EMR comprehensive evaluation dimensions and measures.

    AREAS COVERED: We searched multiple databases, including PubMed, Web of Knowledge, Scopus, ACM, Embase, IEEE and Ingenta. We explored various evaluation aspects of MD and EMR to gain a better understanding of their complex integration. We reviewed numerous risk management and assessment frameworks related to MD and EMR security aspects and mitigation controls and then identified their common evaluation aspects. Our review indicated that previous evaluation frameworks assessed MD and EMR independently. To address this gap, we proposed an evaluation framework based on the sociotechnical dimensions of health information systems and risk assessment approaches for MDs to evaluate MDI-EMR integratively.

    EXPERT OPINION: The emergence of MDI-EMR cyber threats requires appropriate evaluation tools to ensure the safe development and application of MDI-EMR. Consequently, our proposed framework will continue to evolve through subsequent validations and refinements. This process aims to establish its applicability in informing stakeholders of the safety level and assessing its effectiveness in mitigating risks for future improvements.

    Matched MeSH terms: Risk Assessment
  6. Yang M, Mohammad Yusoff WF, Mohamed MF, Jiao S, Dai Y
    J Environ Manage, 2024 Feb;351:119798.
    PMID: 38103426 DOI: 10.1016/j.jenvman.2023.119798
    With climate change and urbanization, flood disasters have significantly affected urban development worldwide. In this study, we developed a paradigm to assess flood economic vulnerability and risk at the urban mesoscale, focusing on urban land use. A hydrological simulation was used to evaluate flood hazards through inundation analyses, and a hazard-vulnerability matrix was applied to assess flood risk, enhancing the economic vulnerability assessment by quantifying the differing economic value and flood losses associated with different land types. The case study of Wangchengpo, Changsha, China, found average total economic losses of 126.94 USD/m2, with the highest risk in the settlement core. Residential areas had the highest flood hazard, vulnerability, and losses (61.10% of the total loss); transportation areas accounted for 27.87% of the total economic losses due to their high flooding depth. Despite low inundation, industrial land showed greater economic vulnerability due to higher overall economic value (10.52% of the total). Our findings highlight the influence of land types and industry differences on flood vulnerability and the effectiveness of land-use inclusion in urban-mesoscale analyses of spatial flood characteristics. We identify critical areas with hazard and economic vulnerability for urban land and disaster prevention management and planning, helping to offer targeted flood control strategies to enhance urban resilience.
    Matched MeSH terms: Risk Assessment
  7. Upadhyay DR, Koirala G, Shah BR, Tajudin SM, Khanal R
    Environ Monit Assess, 2024 Jan 23;196(2):190.
    PMID: 38261087 DOI: 10.1007/s10661-023-12284-5
    Soil samples from vegetable farmland in densely populated wards of Nepal were analyzed for natural radionuclide levels, employing a NaI(Tl) 3" [Formula: see text] 3" gamma detector. The study aimed to evaluate the causes of radiation risk, attributing it to soil contamination resulting from the rapid urbanization and concretization that followed the earthquake in 2015. The activity concentration of radium-226, thorium-232, and potassium-40 and the ranges observed are 2.080±0.084-33.675±1.356 Bq kg[Formula: see text], 17.222±0.198-119.949±1.379 Bq kg[Formula: see text], and 11.203 ± 0.325-748.828±21.716 Bq kg[Formula: see text], respectively. The average values obtained for hazard indices are as follows: radium equivalent activity (82.779 Bq kg[Formula: see text]), absorbed dose rate (36.394 nGy h[Formula: see text]), annual effective dose equivalent (0.045 mSv yearr[Formula: see text]), gamma index (0.291), external hazard index (0.224), internal hazard index (0.253), excess lifetime cancer risk (0.159), annual gonadal dose equivalent (243.278 mSv year[Formula: see text]), alpha index (0.054), and activity utilization index (0.716). However, in most places, thorium-232 concentration is greater than those of the world average and recommended values. In specific locations such as Ward 4 in Baluwatar, the soil was found to have concentrations of Ra[Formula: see text] and K[Formula: see text] exceeding recommended limits. Despite this localized concern, the overall analysis of hazard indices across the studied areas revealed that most values were within permissible limits. This suggests that, on a broader scale, radiation exposure may not be a significant concern in the investigated regions. Nonetheless, the study recommends regular monitoring in additional locations to ensure a comprehensive and ongoing assessment of radiation levels.
    Matched MeSH terms: Risk Assessment
  8. Mohd Hanapi IR, Behnke JM, Sahimin N, Saifulazmi NF, Golam Mohammad Khan ASJ, Abdul Mutalib RNS, et al.
    Trans R Soc Trop Med Hyg, 2024 Jan 02;118(1):18-32.
    PMID: 37497742 DOI: 10.1093/trstmh/trad047
    BACKGROUND: Global studies show intestinal parasitic infections (IPIs) have been introduced and spread with refugee inflows from low to high socio-economic countries. However, there is relatively limited information on the prevalence of infections among the community.

    METHODS: A 2-year cross-sectional study was conducted to determine the prevalence and associated risk factors for infections among urban refugees in the Klang Valley, Malaysia. A total of 418 faecal samples were collected and examined by microscopy.

    RESULTS: Faecal screening revealed moderate levels (32.3%) of infections in the community. Three nematode (Ascaris lumbricoides, Trichuris trichiura and hookworm) and three protozoan species (Entamoeba, Giardia and Cryptosporidium) were recorded, with the highest prevalence being A. lumbricoides (20.6%) followed by T. trichiura (10.3%), while other infections were <5%. Statistical analysis found that young males with less education were more likely to be infected with helminths. Additionally, living near waste disposal sites, the presence of stray animals, eating with bare hands, bare footedness, poor handwashing practices and no anthelmintic treatment constituted significant risk factors for helminth infections. Protozoan infections were linked to drinking tap water or from water dispensers and poor handwashing practices.

    CONCLUSIONS: These findings emphasize the importance of health education in addition to introduction of biannual anthelmintic treatment to promote community health and well-being.

    Matched MeSH terms: Risk Assessment
  9. Kasim S, Amir Rudin PNF, Malek S, Aziz F, Wan Ahmad WA, Ibrahim KS, et al.
    PLoS One, 2024;19(2):e0298036.
    PMID: 38358964 DOI: 10.1371/journal.pone.0298036
    BACKGROUND: Traditional risk assessment tools often lack accuracy when predicting the short- and long-term mortality following a non-ST-segment elevation myocardial infarction (NSTEMI) or Unstable Angina (UA) in specific population.

    OBJECTIVE: To employ machine learning (ML) and stacked ensemble learning (EL) methods in predicting short- and long-term mortality in Asian patients diagnosed with NSTEMI/UA and to identify the associated features, subsequently evaluating these findings against established risk scores.

    METHODS: We analyzed data from the National Cardiovascular Disease Database for Malaysia (2006-2019), representing a diverse NSTEMI/UA Asian cohort. Algorithm development utilized in-hospital records of 9,518 patients, 30-day data from 7,133 patients, and 1-year data from 7,031 patients. This study utilized 39 features, including demographic, cardiovascular risk, medication, and clinical features. In the development of the stacked EL model, four base learner algorithms were employed: eXtreme Gradient Boosting (XGB), Support Vector Machine (SVM), Naive Bayes (NB), and Random Forest (RF), with the Generalized Linear Model (GLM) serving as the meta learner. Significant features were chosen and ranked using ML feature importance with backward elimination. The predictive performance of the algorithms was assessed using the area under the curve (AUC) as a metric. Validation of the algorithms was conducted against the TIMI for NSTEMI/UA using a separate validation dataset, and the net reclassification index (NRI) was subsequently determined.

    RESULTS: Using both complete and reduced features, the algorithm performance achieved an AUC ranging from 0.73 to 0.89. The top-performing ML algorithm consistently surpassed the TIMI risk score for in-hospital, 30-day, and 1-year predictions (with AUC values of 0.88, 0.88, and 0.81, respectively, all p < 0.001), while the TIMI scores registered significantly lower at 0.55, 0.54, and 0.61. This suggests the TIMI score tends to underestimate patient mortality risk. The net reclassification index (NRI) of the best ML algorithm for NSTEMI/UA patients across these periods yielded an NRI between 40-60% (p < 0.001) relative to the TIMI NSTEMI/UA risk score. Key features identified for both short- and long-term mortality included age, Killip class, heart rate, and Low-Molecular-Weight Heparin (LMWH) administration.

    CONCLUSIONS: In a broad multi-ethnic population, ML approaches outperformed conventional TIMI scoring in classifying patients with NSTEMI and UA. ML allows for the precise identification of unique characteristics within individual Asian populations, improving the accuracy of mortality predictions. Continuous development, testing, and validation of these ML algorithms holds the promise of enhanced risk stratification, thereby revolutionizing future management strategies and patient outcomes.

    Matched MeSH terms: Risk Assessment
  10. Sulieman A, Mahgoub O, Salah H, Tamam N, Taha A, Dawood S, et al.
    Appl Radiat Isot, 2023 Dec;202:111071.
    PMID: 37871398 DOI: 10.1016/j.apradiso.2023.111071
    Due to the extended localized fluoroscopy, many radiographic exposures, and multiple procedures that might result in tissue reaction, patients and personnel received a significant radiation dose during interventional cardiology (IR) procedures. This study aims to calculate the radiation risk and assess patient and staff effective doses during IC procedures. Thirty-two patients underwent a Cath lab treatment in total. Ten Cath lab personnel, including six nurses, two cardiologists, and two X-ray technologists. Optical stimulating-luminescent dosimeters (OSL) (Al2O3:C) calibrated for this purpose were used to monitor both occupational and ambient doses. Using an automated OSL reader, these badges were scanned. The Air Kerma (mGy) and Kerma Area Products (KAP, mGy.cm2) have a mean and standard deviation (SD) of 371 ± 132 and 26052, respectively. The average personal dose equivalent (mSv) and its range for cardiologists, nurses and X ray technologists were 1.11 ± 0.21 (0.96-1.26), 0.84 ± 0.11 (0.68-1.16), and 0.68 ± 0.014 (0.12-0.13), respectively. The current study findings showed that the annual effective dose for cardiologists, nurses, and X-ray technologists was lesser than the yearly occupational dose limit of 20 mSv recommended by national and international guidelines. The patients' doses are comparable with some previously published studies and below the tissue reaction limits.
    Matched MeSH terms: Risk Assessment
  11. Song Z, Zhang W, Jiang Q, Deng L, Du L, Mou W, et al.
    Int J Surg, 2023 Dec 01;109(12):3848-3860.
    PMID: 37988414 DOI: 10.1097/JS9.0000000000000862
    BACKGROUND: The early detection of high-grade prostate cancer (HGPCa) is of great importance. However, the current detection strategies result in a high rate of negative biopsies and high medical costs. In this study, the authors aimed to establish an Asian Prostate Cancer Artificial intelligence (APCA) score with no extra cost other than routine health check-ups to predict the risk of HGPCa.

    PATIENTS AND METHODS: A total of 7476 patients with routine health check-up data who underwent prostate biopsies from January 2008 to December 2021 in eight referral centres in Asia were screened. After data pre-processing and cleaning, 5037 patients and 117 features were analyzed. Seven AI-based algorithms were tested for feature selection and seven AI-based algorithms were tested for classification, with the best combination applied for model construction. The APAC score was established in the CH cohort and validated in a multi-centre cohort and in each validation cohort to evaluate its generalizability in different Asian regions. The performance of the models was evaluated using area under the receiver operating characteristic curve (ROC), calibration plot, and decision curve analyses.

    RESULTS: Eighteen features were involved in the APCA score predicting HGPCa, with some of these markers not previously used in prostate cancer diagnosis. The area under the curve (AUC) was 0.76 (95% CI:0.74-0.78) in the multi-centre validation cohort and the increment of AUC (APCA vs. PSA) was 0.16 (95% CI:0.13-0.20). The calibration plots yielded a high degree of coherence and the decision curve analysis yielded a higher net clinical benefit. Applying the APCA score could reduce unnecessary biopsies by 20.2% and 38.4%, at the risk of missing 5.0% and 10.0% of HGPCa cases in the multi-centre validation cohort, respectively.

    CONCLUSIONS: The APCA score based on routine health check-ups could reduce unnecessary prostate biopsies without additional examinations in Asian populations. Further prospective population-based studies are warranted to confirm these results.

    Matched MeSH terms: Risk Assessment/methods
  12. Ahamat H, Sa'ban H, Manap NA
    Health Care Anal, 2023 Dec;31(3-4):196-207.
    PMID: 37477838 DOI: 10.1007/s10728-023-00465-9
    The seriousness of the COVID-19 pandemic requires a look into the implementation of drug registration rules for COVID-19 vaccines. Amidst the surrounding exigencies, vaccines being a biological product, require comprehensive and continuing pre and post registration rules to ensure their safety and efficacy. The study focuses on Malaysia which has rules on drug registration that have been successfully applied to vaccines. The study shows that the rules have been tailor-made to emergency situations. At the moment, special rules have been introduced including to allow use of COVID-19 vaccines as unregistered product. Recognition of COVID-19 Vaccines Global Access (COVAX) facility and requirement for government sale only, are among the safety valves. The study shows that these however are temporary measures against the backdrops of possible entry of private players in the vaccination process. Therefore, regulatory responses to intellectual property (IP) related conditions underlying drug registration, and measures to ensure risk management involved in vaccine production, approval and administration are needed in the progressive rules pending further development of research in the area.
    Matched MeSH terms: Risk Assessment
  13. Rahman MB, Hussain M, Kabiraz MP, Nordin N, Siddiqui SA, Bhowmik S, et al.
    Food Chem, 2023 Nov 30;427:136761.
    PMID: 37406446 DOI: 10.1016/j.foodchem.2023.136761
    Formaldehyde is added illegally to food to extend its shelf life due to its antiseptic and preservation properties. Several research has been conducted to examine the consequences of adulteration with formaldehyde in food items. These findings suggest that adding formaldehyde to food is considered harmful as it accumulates in the body with long-term consumption. In this review includes study findings on food adulteration with formaldehyde and their assessment of food safety based on the analytical method applied to various geographical regions, food matrix types, and their sources in food items. Additionally, this review sought to assess the risk of formaldehyde-tainted food and the understanding of its development in food and its impacts on food safety in light of the widespread formaldehyde adulteration. Finally, the study would be useful as a manual for implementing adequate and successful risk assessment to increase food safety.
    Matched MeSH terms: Risk Assessment
  14. Nadhiya A, Khandaker MU, Mahmud S, Abdullah WH
    Radiat Prot Dosimetry, 2023 Nov 02;199(18):2224-2228.
    PMID: 37934996 DOI: 10.1093/rpd/ncad213
    Concentrations of heavy metals in Yellowfin and Skipjack tuna fishes from the Laccadive sea were determined by inductively coupled plasma optical emission spectroscopy (ICP-OES) to evaluate the human health hazards via their consumption. The samples were collected from different atolls of Maldives to ensure a good representation of sample distribution. The metal concentration in tuna fish is found to be below the maximum tolerable limit set by different international organisations. The target hazard quotient values for individual metals were well below the limiting value of 1, indicating an insignificant health risk via the dietary intake of fish. The maximum targeted cancer risk value was 10 -4, indicating low carcinogenic risk from the consumption of tuna fish from the Maldives. Hence, the consumption of tuna from the Laccadive Sea is safe for human health.
    Matched MeSH terms: Risk Assessment
  15. Seet WT, Mat Afandi MA, Ishak MF, Hassan MNF, Ahmat N, Ng MH, et al.
    Stem Cell Res Ther, 2023 Oct 20;14(1):298.
    PMID: 37858277 DOI: 10.1186/s13287-023-03536-9
    Treatments for skin injuries have recently advanced tremendously. Such treatments include allogeneic and xenogeneic transplants and skin substitutes such as tissue-engineered skin, cultured cells, and stem cells. The aim of this paper is to discuss the general overview of the quality assurance and quality control implemented in the manufacturing of cell and tissue product, with emphasis on our experience in the manufacturing of MyDerm®, an autologous bilayered human skin substitute. Manufacturing MyDerm® requires multiple high-risk open manipulation steps, such as tissue processing, cell culture expansion, and skin construct formation. To ensure the safety and efficacy of this product, the good manufacturing practice (GMP) facility should establish a well-designed quality assurance and quality control (QA/QC) programme. Standard operating procedures (SOP) should be implemented to ensure that the manufacturing process is consistent and performed in a controlled manner. All starting materials, including tissue samples, culture media, reagents, and consumables must be verified and tested to confirm their safety, potency, and sterility. The final products should also undergo a QC testing series to guarantee product safety, efficacy, and overall quality. The aseptic techniques of cleanroom operators and the environmental conditions of the facility are also important, as they directly influence the manufacturing of good-quality products. Hence, personnel training and environmental monitoring are necessary to maintain GMP compliance. Furthermore, risk management implementation is another important aspect of QA/QC, as it is used to identify and determine the risk level and to perform risk assessments when necessary. Moreover, procedures for non-conformance reporting should be established to identify, investigate, and correct deviations that occur during manufacturing. This paper provides insight and an overview of the QA/QC aspect during MyDerm® manufacturing in a GMP-compliant facility in the Centre for Tissue Engineering and Regenerative Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia.
    Matched MeSH terms: Risk Assessment
  16. Parveen A, Anjum M, Mahmood S, Nawaz R, Khalid A
    Environ Monit Assess, 2023 Aug 26;195(9):1100.
    PMID: 37632590 DOI: 10.1007/s10661-023-11710-y
    Pakistan is the fourth largest yarn producer in the world heavily that relies on cotton crop which receives a substantial 62% of all pesticide applications. The present study was conducted to quantify the levels of pesticides such as bifenthrin, spirotetramat, pyriproxyfen, imidacloprid, and diafenthiuron in soil and plants residue at selected cotton fields of Multan District, Pakistan. In addition to pesticides, the assessment of heavy metal concentration was also conducted in order to determine the overall risks that these compounds to both plants and human population. For this analysis, 20 soil samples and 10 plant samples were collected from 10 selected cotton fields. Pesticides and heavy metals in soil and plant samples were analyzed using high-performance liquid chromatography (HPLC) and Inductively Coupled Plasma-Optical Emission Spectroscopy (ICP-OES), respectively. It was observed that all samples collected from selected fields contained pesticide residue in top soil (0-15 cm). However, no pesticides were detected in the lower soil layer (16-30 cm). In case of heavy metals, the highest concentration of Fe, Pb, and Mn was observed in both soil and plant residue samples. The heavy metals were found in the order of Fe > Mn > Pb > Zn > Cu > Cd in the soil. The total carcinogenic risk values for a few pesticides were found to range from 10-6 to 10-2, indicating that residents of the study area have low to higher chances of developing cancer. A positive correlation was observed among the pesticides (r = 0.18-0.95) as well as in metals related parameters (r = 0.49-0.96), where a weak negative correlation was found among metal to pesticide parameters except Pd where the maximum r value was 0.62. In general, the finding of this study encourages the development and adoption of sustainable agricultural practices that lower the dependence on toxic pesticides and endorse environmentally friendly alternatives.
    Matched MeSH terms: Risk Assessment
  17. Panda BP, Mohanta YK, Parida SP, Pradhan A, Mohanta TK, Patowary K, et al.
    Environ Pollut, 2023 Aug 01;330:121796.
    PMID: 37169242 DOI: 10.1016/j.envpol.2023.121796
    Metals are micropollutants that cannot be degraded by microorganisms and are infiltrated into various environmental media, including both freshwater and marine water. Metals from polluted water are absorbed by many aquatic species, especially fish. Fish is a staple food in the diets of many regions in the world; hence, both the type and concentration of metals accumulated and transferred from contaminated water sources to fish must be determined and assessed. In this study, the heavy metal concentration was determined and assessed in fish collected from freshwater sources via published literature and Estimated Daily Intake (EDI), Target hazard quotient (THQ), and Carcinogenic Risk (CR) analyses, aiming to examine the metal pollution in freshwater fish. The fish was used as a bioindicator, and Geographic information system (GIS) was sued to map the polluted regions. The results confirmed that Pb was detected in fish sampled at 28 locations, Cr at 24 locations, Cu and Zn at 30 locations, with values Pb detected ranging from 0.0016 mg kg-1 to 44.3 mg kg-1, Cr detected ranging from 0.07 mg kg-1 to 27 mg kg-1, Cu detected ranging from 0.031 mg kg-1 to 35.54 mg kg-1, and Zn detected ranging from 0.242 mg kg-1 to 103.2 mg kg-1. The strongest positive associations were discovered between Cu-Zn (r = 0.74, p 
    Matched MeSH terms: Risk Assessment
  18. Ong MF, Soh KL, Saimon R, Myint WW, Pawi S, Saidi HI
    Int J Nurs Pract, 2023 Aug;29(4):e13083.
    PMID: 35871775 DOI: 10.1111/ijn.13083
    AIMS: The aim of this study is to evaluate an evidence-based fall risk screening tool to predict the risk of falls suitable for independent community-dwelling older adults guided by the World Health Organization's International Classification of Functioning, Disability and Health (WHO-ICF) components, and to examine the reliability and validity of the fall risk screening tool to predict fall risks, and to examine the feasibility of tools among independent community-dwelling older adults.

    METHODS: A systematic literature search guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was performed using the EBSCOHost® platform, ScienceDirect, Scopus and Google Scholar between July and August 2021. Studies from January 2010 to January 2021 were eligible for review. Nine articles were eligible and included in this systematic review. The risk of bias assessment used the National Institutes of Health quality assessment tool for observational cohort and cross-sectional studies. The WHO-ICF helped to guide the categorization of fall risk factors.

    RESULTS: Seven screening tools adequately predicted fall risk among community-dwelling older adults. Six screening tools covered most of the components of the WHO-ICF, and three screening tools omitted the environmental factors. The modified 18-item Stay Independent Brochure demonstrated most of the predictive values in predicting fall risk. All tools are brief and easy to use in community or outpatient settings.

    CONCLUSION: The review explores the literature evaluating fall risk screening tools for nurses and other healthcare providers to assess fall risk among independent community-dwelling older adults. A fall risk screening tool consisting of risk factors alone might be able to predict fall risk. However, further refinements and validations of the tools before use are recommended.

    Matched MeSH terms: Risk Assessment
  19. Navaretnam R, Hassan HN, Isa NM, Aris AZ, Looi LJ
    Environ Sci Pollut Res Int, 2023 Aug;30(37):87695-87720.
    PMID: 37423935 DOI: 10.1007/s11356-023-28459-z
    Rice is a predominant staple food in many countries. It is a great source of energy but can also accumulate toxic and trace metal(loid)s from the environment and pose serious health hazards to consumers if overdosed. This study aims to determine the concentration of toxic metal(loid)s [arsenic (As), cadmium (Cd), nickel (Ni)] and essential metal(loid)s [iron (Fe), selenium (Se), copper (Cu), chromium (Cr), cobalt (Co)] in various types of commercially available rice (basmati, glutinous, brown, local whites, and fragrant rice) in Malaysia, and to assess the potential human health risk. Rice samples were digested following the USEPA 3050B acid digestion method and the concentrations of metal(loid)s were analyzed using an inductively coupled plasma mass spectrometry (ICP-MS). Mean concentrations (mg/kg as dry weight) of metal(loid)s (n=45) across all rice types were found in the order of Fe (41.37)>Cu (6.51)>Cr (1.91)>Ni (0.38)>As (0.35)>Se (0.07)>Cd (0.03)>Co (0.02). Thirty-three percent and none of the rice samples surpassed, respectively, the FAO/WHO recommended limits of As and Cd. This study revealed that rice could be a primary exposure pathway to toxic metal(loid)s, leading to either noncarcinogenic or carcinogenic health problems. The non-carcinogenic health risk was mainly associated with As which contributed 63% to the hazard index followed by Cr (34%), Cd (2%), and Ni (1%). The carcinogenic risk to adults was high (>10-4) for As, Cr, Cd, and Ni. The cancer risk (CR) for each element was 5 to 8 times higher than the upper limit of cancer risk for an environmental carcinogen (<10-4). The findings from this study could provide the metal(loid)s pollution status of various types of rice which are beneficial to relevant authorities in addressing food safety and security-related issues.
    Matched MeSH terms: Risk Assessment
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