Article
Pharmacology & Pharmacy
X. U. Xiao-Ting, Hong-Hao Tang, Zhen Sang
Summary: This paper discusses the importance of traditional Chinese medical devices and the current status and future prospects of international standardization.
PHARMACOLOGICAL RESEARCH
(2021)
Article
Engineering, Chemical
Vincent McGrane, Olivia McDermott, Anna Trubetskaya, Angelo Rosa, Michael Sony
Summary: This study investigates the differences in timelines involved in Lean Six Sigma project deployment in regulated and unregulated industries. The transfer of manufacturing lines in the medical device and electronics manufacturing sites is compared through two case studies. The study highlights the impact of regulatory procedures on project implementation and timelines.
Article
Gastroenterology & Hepatology
Michael Bretthauer, Yuichi Mori, Jasmin Zessner-Spitzenberg, Michal F. F. Kaminski, Peter D. D. Siersema, Thierry Ponchon, Helmut Messmann, Ian M. M. Gralnek, Raf Bisschops, Cesare Hassan
Summary: The European Union has introduced stricter regulations for the approval of medical devices, affecting both endoscopists and patients. The new regulations require more clinical trials and observational studies to ensure the clinical benefit and reduce patient harm. The European Society of Gastrointestinal Endoscopy (ESGE) will play an active role in establishing the new system.
Review
Medicine, General & Internal
Jonathan J. Darrow, Jerry Avorn, Aaron S. Kesselheim
Summary: Medical device regulation in the US has become more complex over the past 45 years, with various regulatory pathways and evolving evidence requirements. Increased FDA support from industry and concerns about flexible authorization requirements highlight the ongoing tension between efficient access and ensuring patient safety.
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
(2021)
Article
Health Care Sciences & Services
Sylvia Pelayo, Romaric Marcilly, Tommaso Bellandi
Summary: Medical device (MD) misuse-related patient injuries or deaths can be reduced by adopting an effective human factors and ergonomics (HFE) approach, which is now mandatory for MD manufacturers seeking the European Union's CE Mark. Small- and medium-sized MD manufacturers in Europe face challenges in complying with CE Mark regulations, while varying levels of knowledge about HFE among regulatory organizations can lead to different expectations. The HFE regulation requires a specific use-related risk management approach and focuses on future challenges in reducing MD use errors by considering the emerging properties of technologies and involving all stakeholders.
INTERNATIONAL JOURNAL FOR QUALITY IN HEALTH CARE
(2021)
Article
Medicine, General & Internal
Michael Bretthauer, Sara Gerke, Cesare Hassan, Omer F. Ahmad, Yuichi Mori
Summary: The European Union has implemented stricter regulations for medical devices through the Medical Device Regulation (MDR), which includes increased requirements for clinical trials and surveillance throughout the device's life cycle. New expert panels have been established to assess devices for certification, and the role of previous notified bodies has been expanded. All existing medical devices must be recertified under the MDR, with a deadline extension to 2027 or 2028. Meeting these new requirements may be uncertain for most manufacturers and the MDR is expected to have significant consequences for various stakeholders.
ANNALS OF INTERNAL MEDICINE
(2023)
Review
Dermatology
J. Malvehy, R. Ginsberg, L. Sampietro-Colom, J. Ficapal, M. Combalia, P. Svedenhag
Summary: The new Medical Device Regulation (MDR) in the EU from May 2021 will significantly impact suppliers of medical devices, dermatologists, and other clinicians. The changes are expected to lead to improved quality of devices but may also result in availability issues and price increases.
JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY
(2022)
Article
Health Care Sciences & Services
Emilia Niemiec
Summary: This article discusses the impact of the Medical Device Regulation on improving the safety and performance of medical artificial intelligence devices. The Regulation introduces new requirements for risk classification, clinical evaluation, post-market surveillance, and notified bodies, which aim to enhance the safety and performance of these devices. The guidance provided by the Medical Device Coordination Group also addresses some of the issues identified in studies on medical artificial intelligence devices.
Article
Chemistry, Analytical
Saketh R. Peri, Forhad Akhter, Robert A. De Lorenzo, R. Lyle Hood
Summary: Airway clearance is the process of clearing airway blockages caused by foreign objects, but currently available portable suction devices are sparingly used in clinical settings due to a lack of clinical relevance in design and testing standards. Therefore, updated standards are needed to promote valid engineering designs and manufacturing standards.
Review
Pharmacology & Pharmacy
Pau Antich-Isern, Julia Caro-Barri, Juan Aparicio-Blanco
Summary: Medical devices and medicinal products have many similarities and are often used in combination to provide additional benefits for patients. However, their higher technical complexity requires stronger authorization and certification requirements. The new European regulation on medical devices introduces more comprehensive requirements and classification rules to strengthen the regulation in this area.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2021)
Article
Health Care Sciences & Services
Stephen Gilbert, Matthew Fenech, Martin Hirsch, Shubhanan Upadhyay, Andrea Biasiucci, Johannes Starlinger
Summary: The current regulatory framework in healthcare for AI and machine learning models poses challenges, especially when models learn from real-time data. Regulators are planning fundamental changes to enable innovation in healthcare through AI/ML-based approaches while ensuring patient safety. International perspectives from organizations like the WHO and FDA propose oversight of quality management systems and defined algorithm change protocols for a balanced approach.
JOURNAL OF MEDICAL INTERNET RESEARCH
(2021)
Review
Ophthalmology
Girish K. Srivastava, Vivekanandan Kalaiselvan, Cristina Andres-Iglesias, Shatrunajay Shukla, Rohit Saxena, Jose Carlos Pastor
Summary: This review paper emphasizes the importance of conducting appropriate biological tests and chemical analysis when measuring cytotoxicity of PFCLs (perfluorocarbon liquids). The recent ISO guideline (ISO 16672:2020) recommends performing direct cytotoxicity tests as an option to measure PFCL quality.
GRAEFES ARCHIVE FOR CLINICAL AND EXPERIMENTAL OPHTHALMOLOGY
(2022)
Editorial Material
Multidisciplinary Sciences
Achuta Kadambi
Summary: Studying computer science can help ensure that medical devices are fair for all races and sexes.
Proceedings Paper
Computer Science, Theory & Methods
Richard A. Harpster
Summary: Inadequate risk management in the medical device industry is negatively impacting customer safety, product quality, and profitability. The current methods used by medical device providers are ineffective at defining the root causes of risk exposure. Risk Based Medical Device Lifecycle Management (TM) offers an effective approach to reducing the root causes of poor quality by systematically managing risk throughout the device's lifecycle. The existing paradigms in the industry hinder the implementation of this approach.
2022 68TH ANNUAL RELIABILITY AND MAINTAINABILITY SYMPOSIUM (RAMS 2022)
(2022)
Review
Engineering, Biomedical
Miriam Fraga-Garcia, Raquel Talens-Visconti, Octavio Diez-Sales, Amparo Nacher
Summary: Borderline medical devices are products that belong to a "gray area" and can be classified differently in different countries, which has economic consequences. This article compares the American and European regulatory systems and emphasizes the need for international consensus to avoid trade barriers and promote innovation. Although both regulations have room for improvement, the American system appears to be more efficient according to the data from the EU Manual, but it may be challenging to replicate its strengths due to the intrinsic characteristics of the European system. However, further studies with quantitative data are needed to validate this statement.
EXPERT REVIEW OF MEDICAL DEVICES
(2022)
Article
Chemistry, Analytical
Michel Rocha Baqueta, Augusto Cesar Costa-Santos, Ana Paula Rebellato, Gisele Marcondes Luz, Juliana Azevedo Lima Pallone, Federico Marini, Alexsandro Lara Teixeira, Douglas N. Rutledge, Patricia Valderrama
Summary: This study reports the essential element composition of new Brazilian Canephora coffees and applies chemometric tools for analysis. The results demonstrate the suitability of this method for origin and species discrimination based on the inorganic fraction of coffee.
MICROCHEMICAL JOURNAL
(2024)
Article
Chemistry, Analytical
Mengjie Li, Jiapeng Wang, You Zhou, Yang Chen, Lingying Xia
Summary: A novel photoelectrochemical biosensor based on gold nanoparticles and specific structures was developed for highly sensitive detection of mercury ion. The multiple sandwich structures hindered electron supply and light harvesting, resulting in a weakened PEC signal, while the specific structures extinguished the PEC signal, enabling quantitative detection of Hg2+. The sensor exhibited high selectivity and stability, with potential applications in environmental detection, biological analysis, and medical research.
MICROCHEMICAL JOURNAL
(2024)
Article
Chemistry, Analytical
Mohamed A. Korany, Rasha M. Youssef, Marwa A. A. Ragab, Mostafa A. Afify
Summary: A stability-indicating fit-for-purpose method was developed for the determination of HC, TL, and PS in syrup dosage form. The method successfully separated CL from THY and quantified the analytes using HPLC-DAD. The robustness of the method was assessed through statistical analysis and self-validation.
MICROCHEMICAL JOURNAL
(2024)
Article
Chemistry, Analytical
Lingling Lin, Minyu Li, Ping Li, Chenqing Ye, Huanglong Zhuang, Shaohuang Weng, Feng Chen
Summary: This study developed a highly sensitive and selective electrochemical sensor for simultaneous detection of dopamine and uric acid. The sensor exhibited excellent anti-interference and stability, and could accurately measure dopamine and uric acid in human urine samples.
MICROCHEMICAL JOURNAL
(2024)
Article
Chemistry, Analytical
Peifang Chen, Caiyun Jiang, Zhouping Wang, Hong-zhen Lian, Xiaoyuan Ma
Summary: In this study, a high-performance SERS-active aptasensor was successfully developed for the quantitative analysis of AFB1 in cereal grains, which is of great significance in the field of food safety.
MICROCHEMICAL JOURNAL
(2024)
Article
Chemistry, Analytical
E. Abas, C. Marina-Montes, C. Perez-Marin, J. Puimedon, J. Anzano
Summary: This study conducted a comprehensive measurement of natural and anthropogenic radionuclides in soil, water, and air in different locations around Deception Island in Antarctica. The results revealed significant levels of 210Pb and anthropogenic 137Cs in soil samples near old human settlements and facilities, as well as detectable levels of 137Cs and 60Co in water samples from old hunting areas. The findings also suggested potential resuspension processes based on higher-than-expected air quality results.
MICROCHEMICAL JOURNAL
(2024)
Article
Chemistry, Analytical
Joao Franciso Allochio, Nayara A. dos Santos, Nathalia dos S. Conceicao, Clara S. D. Baptista, Keyller B. Borges, Valdemar Lacerda Jr, Wanderson Roma
Summary: This study developed a fiber spray ionization mass spectrometry (FSI-MS) method, which shows great potential in detecting illicit drugs. Compared with paper spray ionization mass spectrometry (PSI-MS), FSI-MS demonstrates higher sensitivity in COC detection.
MICROCHEMICAL JOURNAL
(2024)
Article
Chemistry, Analytical
Dina A. Ahmed, Ola G. Hussein, Mamdouh R. Rezk, Mohamed Abdelkawy, Yasmin Rostom
Summary: The main goal of this study was to develop two green chromatographic techniques, HPLC and TLC, for the determination of alcaftadine (ALF) in pharmaceutical formulation and biological samples. The developed HPLC technique showed high efficiency and minimal environmental impact, successfully identifying ALF in the presence of its degradate. The TLC method provided a stability indicating study for ALF and was determined to be safe, green, and eco-friendly.
MICROCHEMICAL JOURNAL
(2024)
Article
Chemistry, Analytical
Abdullah Taner Bisgin
Summary: A green, speedy, and handy method for separation and determination of four commonly used food colorants was established using vortex assisted sequential-simultaneous liquid phase micro-extraction (VA-SS-LPME). The method does not require any instrumental chromatographic techniques. The procedure includes sequential separation steps using different extractants and simultaneous UV-vis spectrophotometric determination steps. The method is environmentally friendly and applicable for determination of colorants in food and pharmaceuticals.
MICROCHEMICAL JOURNAL
(2024)
Article
Chemistry, Analytical
Yifan Zhang, Tong Zhang, Wenjing Ba, Li Liu, Yuan Rao, Xiaodan Zhang, Hanhan Zhang, Xiu Jin
Summary: This paper proposes a novel spectral transfer modelling method based on neural network architecture searching for the asymptomatic prediction of Akizuki pear cork spot disorder. The experiments show that the model by this method is more effective, achieving an accuracy of 82.61%.
MICROCHEMICAL JOURNAL
(2024)
Article
Chemistry, Analytical
Krzysztof Greda, Maja Welna, Anna Szymczycha-Madeja, Pawel Pohl
Summary: For the first time, a dispersive micro-solid phase extraction (D-mu SPE) based on graphene oxide was used for the ultrasensitive determination of Cd. With this method, Cd can be efficiently extracted from a mixture of alkali and alkaline earth metals without the need for an elution step. The combination of D-mu SPE and SAGD OES significantly reduces matrix effects and improves the tolerance of Cd to alkali metals. The method shows simplicity in the measurement system and the commercially available nanosorbent used.
MICROCHEMICAL JOURNAL
(2024)
Article
Chemistry, Analytical
P. K. Fathima Anjila, G. R. Tharani, Anand Sundaramoorthy, Venkat Kumar Shanmugam, Karthikeyan Subramani, Shanmugavel Chinnathambi, Ganesh N. Pandian, Vimala Raghavan, Andrews Nirmala Grace, Singaravelu Ganesan, Mangaiyarkarasi Rajendiran
Summary: This work proposes a rapid and sensitive spectroscopic method for detecting melamine in food products using rare-earth Terbium-doped Graphene Quantum Dots (Tb-GQDs) synthesized by microwave and simple chemical conjugation methods. The synthesized Tb-GQDs show a spherical shape with a size of approximately 6 nm and a quantum yield of 52%. The maximum detection limit for melamine concentration in milk and milk products is found to be 0.31 μM. The dual emitting Tb-GQDs provide a sensitive and effective platform for real-time detection of melamine in food samples, particularly in milk, and show promising potential in the food industry.
MICROCHEMICAL JOURNAL
(2024)
Review
Chemistry, Analytical
Piyush Dey, Mandeep Kaur, Akhil Khajuria, Dilmeet Kaur, Manpreet Singh, Hema Kumari Alajangi, Neha Singla, Gurpal Singh, Ravi Pratap Barnwal
Summary: Environmental issues, such as the uncontrolled release of dangerous pollutants, have significant impacts on human health. Traditional methods for detecting pollutants require specialized personnel and equipment, but nanotechnology has improved the performance of biosensors. This article discusses the use of nanotechnology in pollutant detection and the associated techniques.
MICROCHEMICAL JOURNAL
(2024)
Article
Chemistry, Analytical
Sa Dong, Qiuyun Shi, Lingjun Guan, Yulong Wang, Pengyan Liu, Cunzheng Zhang, Jianguo Feng
Summary: In this study, a highly sensitive indirect competitive chemiluminescence enzyme immunoassay (icCLEIA) method was developed for the determination of sodium pentachlorophenolate (PCP-Na) and its metabolite pentachlorophenol (PCP). The method showed high specificity and affinity with a detection limit of 0.0032 ng/mL for PCP-Na and 0.0192 ng/mL for PCP. The method had no cross reaction with other chlorophenols compounds except for PCP. The average recoveries in chicken, pork and fish samples were 81.3-105.8% with low coefficient of variation (CV).
MICROCHEMICAL JOURNAL
(2024)
Article
Chemistry, Analytical
Palaniappan Ilayaraja, Murugan Manivannan, Paramasivam Parthiban
Summary: Nirmatrelvir, an antiviral drug used for the treatment of COVID-19, has been recommended by the World Health Organization. We developed an optimized analytical method for the quantification of Nirmatrelvir and its products, with high sensitivity and a wide linear range. The method also meets the requirements for greenness evaluation.
MICROCHEMICAL JOURNAL
(2024)