Medical Devices Regulation (MDR) 2017/745 - Part I Purpose, Scope, DefinitionsArete-Zoe, LLC
This document provides an overview and summary of key changes and requirements in the new Medical Device Regulation (EU) 2017/745, which replaces previous directives. Some of the main changes include expanding the scope of regulated devices, implementing a Unique Device Identifier system for traceability, increasing requirements for clinical evidence and post-market surveillance, and removing grandfathering provisions. The purpose, scope, definitions and objectives are outlined to define the rules for placing medical devices on the EU market while ensuring a high level of safety and performance.
European MDR - Understanding Safety and Performance RequirementsKirsten Bertelsen
This presentation is the first of a series of short presentations by medicQA introducing key parts of the new MDR and their impact on medical device manufacturers.
CE marking and CE certification what is it why you need it who can apply
CE marking certification for medical devices. Medical Device Regulations. It Is Easy To Make Mistakes In The Regulatory Process That Can Delay.
Visit: http://www.meddevicecorp.com/
The US FDA regulates medical devices to ensure they are safe and effective. There are three classes of medical devices with increasing regulatory controls based on risk. Class I devices have general controls, Class II devices have general and special controls, and Class III devices require premarket approval. To market a device in the US, manufacturers must classify their device, submit the appropriate premarket notification or application, and complete an establishment registration and device listing. The FDA reviews submissions to ensure devices reasonably assure safety and effectiveness.
The document discusses the regulation of medical devices in the United States. It begins by defining what constitutes a medical device according to the Code of Federal Regulations. It then outlines the key regulatory bodies that oversee medical devices, including the Center for Devices and Radiological Health and the Office of Combination Products. The document provides an overview of the classification system for medical devices and the different regulatory pathways for approval, including 510(k) premarket notification, investigational device exemptions, premarket approval, and humanitarian device exemption. It also summarizes the key requirements and processes for each approval pathway.
Medical Devices Regulation (MDR) 2017/745 - Part I Purpose, Scope, DefinitionsArete-Zoe, LLC
This document provides an overview and summary of key changes and requirements in the new Medical Device Regulation (EU) 2017/745, which replaces previous directives. Some of the main changes include expanding the scope of regulated devices, implementing a Unique Device Identifier system for traceability, increasing requirements for clinical evidence and post-market surveillance, and removing grandfathering provisions. The purpose, scope, definitions and objectives are outlined to define the rules for placing medical devices on the EU market while ensuring a high level of safety and performance.
European MDR - Understanding Safety and Performance RequirementsKirsten Bertelsen
This presentation is the first of a series of short presentations by medicQA introducing key parts of the new MDR and their impact on medical device manufacturers.
CE marking and CE certification what is it why you need it who can apply
CE marking certification for medical devices. Medical Device Regulations. It Is Easy To Make Mistakes In The Regulatory Process That Can Delay.
Visit: http://www.meddevicecorp.com/
The US FDA regulates medical devices to ensure they are safe and effective. There are three classes of medical devices with increasing regulatory controls based on risk. Class I devices have general controls, Class II devices have general and special controls, and Class III devices require premarket approval. To market a device in the US, manufacturers must classify their device, submit the appropriate premarket notification or application, and complete an establishment registration and device listing. The FDA reviews submissions to ensure devices reasonably assure safety and effectiveness.
The document discusses the regulation of medical devices in the United States. It begins by defining what constitutes a medical device according to the Code of Federal Regulations. It then outlines the key regulatory bodies that oversee medical devices, including the Center for Devices and Radiological Health and the Office of Combination Products. The document provides an overview of the classification system for medical devices and the different regulatory pathways for approval, including 510(k) premarket notification, investigational device exemptions, premarket approval, and humanitarian device exemption. It also summarizes the key requirements and processes for each approval pathway.
7 Steps - How to Get a CE Marking Certification for Medical Devices?Puneet sharma
The document outlines the 7 steps to obtain CE marking certification for a medical device: 1) Classify the device, 2) Identify relevant standards and regulations, 3) Compile technical documentation and testing results, 4) Appoint a European authorized representative if located outside the EU, 5) Obtain certification from a notified body for class II/III devices or self-certify for class I, 6) Affix the CE marking, and 7) Comply with any national requirements. The service described can assist manufacturers with all aspects of the certification process.
Medical Device Regulation (MDR) overview for Technion, May 25, 2021Levi Shapiro
On May 26, 2021, the EU introduced the most sweeping changes to the Medical Device legal framework since the mid 90's. Ulf Grundmann, Senior Partner, King & Spalding (Frankfurt), reviews some of these regulatory changes, from the perspective of medical device innovators. The presentation includes Scope and Definitions, Classification and Conformity Assessment, Placing a Device on the EU Market, UDI and EUDAMED, Supply Chain Obligations, PMS and Vigilance
This document summarizes medical device regulations in the United States, European Union, and India. It discusses how medical devices are classified based on risk in each region, with Class I being lowest risk and Class III being highest. The regulatory approval processes for medical devices in each location are also outlined, including applying for certification marks like the FDA clearance in the US or CE Marking in the EU. Finally, the document provides statistics on the global market share of the medical device industry and references used.
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
Risk Based Classification of Medical Devices and groupingPaulyne Wairimu
The document discusses risk-based classification and grouping of medical devices in Kenya. It describes how medical devices will be classified into categories A, B, C, and D based on factors like invasiveness and risk level. It also discusses how devices can be grouped into single devices, device families that include variations of a device, and device systems which are groups of compatible devices that serve a common purpose. Proper classification and grouping is important for the registration of medical devices in Kenya.
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
The document summarizes key points about the transition from the Medical Device Directive (MDD) Class I to the new Medical Device Regulation (MDR) Class I, which takes effect on May 26, 2020. It notes that some MDD Class I devices will be upclassified under the MDR. These devices have until May 26, 2024 to obtain an MDR certificate through a two-step soft transition process. There are also significant gaps between the MDD and MDR requirements regarding technical documentation, quality management systems, clinical evidence requirements, and other areas that will take time for manufacturers to address.
This document provides an overview of FDA regulation of medical devices in the United States. It defines key terms, describes the classification system for devices and corresponding levels of regulatory control. It outlines major premarket and postmarket requirements including establishment registration, 510(k) premarket notification, premarket approval, labeling, quality system regulation, medical device reporting and complaint handling. Major sections cover classification, premarket submissions, labeling and other compliance requirements enforced by the FDA to ensure device safety and effectiveness.
How to Prepare for the New EU Medical Device Regulations (MDR)Greenlight Guru
The new MDR is expected to be formally published in late 2016 or early 2017, and there will be a three-year transition period to be compliant.
Many forward thinking medical device companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
In this presentation you will learn:
-Why the European regulations are changing
-An overview of the text being voted on
-What does the new regulation mean for manufactures
-Examine the risk based approach to classification
-Strategy for technical documentation preparation
-Changes to clinical evidence for devices
-Post market surveillance and vigilance for medical devices
-What you can do to start preparing now
-What are all the significant changes
You can watch the recording of this presentation here: https://www.greenlight.guru/webinar/eu-medical-device-regulations-mdr
EU Medical Device Regulatory Framework_Dec, 2022Levi Shapiro
Overview of the EU medical technology and digital health regulatory framework by Ulf Grundmann and Elisabeth Kohoutek of King & Spalding LLP. Topics include regulatory scope and definitions, classification and conformity assessment, placing a device on the EU Market, UDI and EUDAMED, Supply Chain Obligations, PMS and Vigilance. MDR covers diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of a disease. ‘Medical Devices’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings. The Regulation covers all devices for cleaning, sterilizing or disinfecting other medical devices, reprocessed single-use medical devices, and certain devices with no intended medical purpose.
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Swapnil Fernandes
Covers the following details -
- What is QMS ?
- QMS subparts
- QMS Inspection
- What is a label ?
- What is labelling ?
- Labelling requirements and regulations
- Labelling based on the types of submission
The document summarizes the key changes introduced by Directive 2007/47/EC, which amended several European medical device directives. Some of the main changes include expanded definitions and requirements for medical software, single-use devices, transparency and reporting of device information, clinical investigations and evaluations, and conformity assessment procedures. The directive aimed to improve regulation of medical devices in the EU.
This document provides an overview of the key aspects of the Medical Device Directive 93/42/EEC as amended by 2007/42/EC. It defines important terms like medical device, manufacturer, intended purpose and conformity assessment routes. It describes the classification of devices based on duration of contact and degree of invasiveness. It outlines the conformity assessment procedures under Annexes II, III, IV, V and VI and notes when they are applicable based on device class. Guidance documents from the EU Commission are also referenced.
The UDI system was created, developed and maintained by the device manufacturer based on global device identification standards. Today, it also helps with procurement and reimbursement. The Regulations allow for random inspections of producers’ facilities after devices have been placed on the market.
The document summarizes the regulation of in vitro diagnostic (IVD) medical devices in Australia. It outlines the regulatory framework, classification system, conformity assessment process, and key aspects of an inclusion application for IVD devices to be entered into the Australian Register of Therapeutic Goods (ARTG). The summary highlights that IVD devices are regulated under the Therapeutic Goods Act and must comply with essential principles, be appropriately classified, and have evidence of conformity assessment submitted with ARTG applications, which may be subject to audit.
Europe IVD medical registration and approval chart - EMERGOEMERGO
The document summarizes the regulatory process for in vitro diagnostic devices (IVDs) in Europe under the In Vitro Diagnostic Directive (98/79/EC). It outlines the classification of IVDs, requirements for quality management systems and technical files, roles of notified bodies and authorized representatives, and timelines and costs associated with the approval process depending on the IVD classification. The process can take from 3-5 months for self-certified IVDs to 9-12 months for list A IVDs and involves implementing quality systems, obtaining notified body audits, and registering with authorities.
PECB Webinar: Hands on medical devices risk assessmentPECB
The webinar covers:
• Risk assessment in medical device management systems
• Key issues pertaining to ISO 13485
• FMEA model in medical devices management systems
Presenter:
This webinar will be presented by Mohmed EL Mahdy, PECB Certified Trainer who has extensive experience in Lead Auditor ISO 13485.
This document discusses medical devices and their classification and regulation. It defines medical devices as instruments or articles intended for medical purposes like diagnosis, treatment or prevention of disease. Medical devices are classified based on risk into Class I, II or III, with Class III posing the highest risk. The document then outlines the key phases in the lifecycle of a medical device from development and manufacturing to packaging, labeling, advertising, sale, use and disposal. It emphasizes that proper design, manufacturing practices and use are important to ensure medical device safety.
7 Steps - How to Get a CE Marking Certification for Medical Devices?Puneet sharma
The document outlines the 7 steps to obtain CE marking certification for a medical device: 1) Classify the device, 2) Identify relevant standards and regulations, 3) Compile technical documentation and testing results, 4) Appoint a European authorized representative if located outside the EU, 5) Obtain certification from a notified body for class II/III devices or self-certify for class I, 6) Affix the CE marking, and 7) Comply with any national requirements. The service described can assist manufacturers with all aspects of the certification process.
Medical Device Regulation (MDR) overview for Technion, May 25, 2021Levi Shapiro
On May 26, 2021, the EU introduced the most sweeping changes to the Medical Device legal framework since the mid 90's. Ulf Grundmann, Senior Partner, King & Spalding (Frankfurt), reviews some of these regulatory changes, from the perspective of medical device innovators. The presentation includes Scope and Definitions, Classification and Conformity Assessment, Placing a Device on the EU Market, UDI and EUDAMED, Supply Chain Obligations, PMS and Vigilance
This document summarizes medical device regulations in the United States, European Union, and India. It discusses how medical devices are classified based on risk in each region, with Class I being lowest risk and Class III being highest. The regulatory approval processes for medical devices in each location are also outlined, including applying for certification marks like the FDA clearance in the US or CE Marking in the EU. Finally, the document provides statistics on the global market share of the medical device industry and references used.
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
Risk Based Classification of Medical Devices and groupingPaulyne Wairimu
The document discusses risk-based classification and grouping of medical devices in Kenya. It describes how medical devices will be classified into categories A, B, C, and D based on factors like invasiveness and risk level. It also discusses how devices can be grouped into single devices, device families that include variations of a device, and device systems which are groups of compatible devices that serve a common purpose. Proper classification and grouping is important for the registration of medical devices in Kenya.
To comprehend the regulatory requirements to import medical Medical devices and authorization procedures in regulated markets of the United States and Australia
The document summarizes key points about the transition from the Medical Device Directive (MDD) Class I to the new Medical Device Regulation (MDR) Class I, which takes effect on May 26, 2020. It notes that some MDD Class I devices will be upclassified under the MDR. These devices have until May 26, 2024 to obtain an MDR certificate through a two-step soft transition process. There are also significant gaps between the MDD and MDR requirements regarding technical documentation, quality management systems, clinical evidence requirements, and other areas that will take time for manufacturers to address.
This document provides an overview of FDA regulation of medical devices in the United States. It defines key terms, describes the classification system for devices and corresponding levels of regulatory control. It outlines major premarket and postmarket requirements including establishment registration, 510(k) premarket notification, premarket approval, labeling, quality system regulation, medical device reporting and complaint handling. Major sections cover classification, premarket submissions, labeling and other compliance requirements enforced by the FDA to ensure device safety and effectiveness.
How to Prepare for the New EU Medical Device Regulations (MDR)Greenlight Guru
The new MDR is expected to be formally published in late 2016 or early 2017, and there will be a three-year transition period to be compliant.
Many forward thinking medical device companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
In this presentation you will learn:
-Why the European regulations are changing
-An overview of the text being voted on
-What does the new regulation mean for manufactures
-Examine the risk based approach to classification
-Strategy for technical documentation preparation
-Changes to clinical evidence for devices
-Post market surveillance and vigilance for medical devices
-What you can do to start preparing now
-What are all the significant changes
You can watch the recording of this presentation here: https://www.greenlight.guru/webinar/eu-medical-device-regulations-mdr
EU Medical Device Regulatory Framework_Dec, 2022Levi Shapiro
Overview of the EU medical technology and digital health regulatory framework by Ulf Grundmann and Elisabeth Kohoutek of King & Spalding LLP. Topics include regulatory scope and definitions, classification and conformity assessment, placing a device on the EU Market, UDI and EUDAMED, Supply Chain Obligations, PMS and Vigilance. MDR covers diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of a disease. ‘Medical Devices’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings. The Regulation covers all devices for cleaning, sterilizing or disinfecting other medical devices, reprocessed single-use medical devices, and certain devices with no intended medical purpose.
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Swapnil Fernandes
Covers the following details -
- What is QMS ?
- QMS subparts
- QMS Inspection
- What is a label ?
- What is labelling ?
- Labelling requirements and regulations
- Labelling based on the types of submission
The document summarizes the key changes introduced by Directive 2007/47/EC, which amended several European medical device directives. Some of the main changes include expanded definitions and requirements for medical software, single-use devices, transparency and reporting of device information, clinical investigations and evaluations, and conformity assessment procedures. The directive aimed to improve regulation of medical devices in the EU.
This document provides an overview of the key aspects of the Medical Device Directive 93/42/EEC as amended by 2007/42/EC. It defines important terms like medical device, manufacturer, intended purpose and conformity assessment routes. It describes the classification of devices based on duration of contact and degree of invasiveness. It outlines the conformity assessment procedures under Annexes II, III, IV, V and VI and notes when they are applicable based on device class. Guidance documents from the EU Commission are also referenced.
The UDI system was created, developed and maintained by the device manufacturer based on global device identification standards. Today, it also helps with procurement and reimbursement. The Regulations allow for random inspections of producers’ facilities after devices have been placed on the market.
The document summarizes the regulation of in vitro diagnostic (IVD) medical devices in Australia. It outlines the regulatory framework, classification system, conformity assessment process, and key aspects of an inclusion application for IVD devices to be entered into the Australian Register of Therapeutic Goods (ARTG). The summary highlights that IVD devices are regulated under the Therapeutic Goods Act and must comply with essential principles, be appropriately classified, and have evidence of conformity assessment submitted with ARTG applications, which may be subject to audit.
Europe IVD medical registration and approval chart - EMERGOEMERGO
The document summarizes the regulatory process for in vitro diagnostic devices (IVDs) in Europe under the In Vitro Diagnostic Directive (98/79/EC). It outlines the classification of IVDs, requirements for quality management systems and technical files, roles of notified bodies and authorized representatives, and timelines and costs associated with the approval process depending on the IVD classification. The process can take from 3-5 months for self-certified IVDs to 9-12 months for list A IVDs and involves implementing quality systems, obtaining notified body audits, and registering with authorities.
PECB Webinar: Hands on medical devices risk assessmentPECB
The webinar covers:
• Risk assessment in medical device management systems
• Key issues pertaining to ISO 13485
• FMEA model in medical devices management systems
Presenter:
This webinar will be presented by Mohmed EL Mahdy, PECB Certified Trainer who has extensive experience in Lead Auditor ISO 13485.
This document discusses medical devices and their classification and regulation. It defines medical devices as instruments or articles intended for medical purposes like diagnosis, treatment or prevention of disease. Medical devices are classified based on risk into Class I, II or III, with Class III posing the highest risk. The document then outlines the key phases in the lifecycle of a medical device from development and manufacturing to packaging, labeling, advertising, sale, use and disposal. It emphasizes that proper design, manufacturing practices and use are important to ensure medical device safety.
Presentation: Conformity Assessment EvidenceTGA Australia
An introduction to conformity assessment procedures for medical devices, good manufacturing practice (GMP), some of the problems commonly experienced by sponsors and TGA, and helpful hints.
Health apps regulation and quality control case studies and session 2 present...3GDR
The document discusses regulation and quality control of health apps. It begins with an overview of the digital health landscape and how different types of apps may be regulated to varying degrees. It then discusses challenges in managing chronic diseases and how data from apps and devices could potentially help transform care if delivered in an actionable way. The rest of the document discusses regulatory frameworks for medical software and apps, standards that may apply, and issues to consider like safety, security, usability and how to demonstrate safety for apps and systems that include software.
Health apps regulation and quality control case studies and session 2 present...3GDR
The document discusses regulation and quality control of health apps. It begins with an overview of the digital health landscape and how different types of apps may be regulated to varying degrees. It then discusses challenges in managing chronic diseases and how data from apps and devices could potentially help patients if transformed and delivered in an actionable way. The rest of the document discusses regulatory frameworks for medical software and apps, standards that may apply, and issues to consider like safety, security, usability and more. It also provides examples of how safety cases are used in other industries like nuclear to help build confidence in critical systems.
Good manufacturing practices (GMP) regulations ensure consistency and quality in pharmaceutical manufacturing. GMP covers facilities, equipment, personnel, production, packaging and quality control. Key requirements include designated clean areas for operations, qualified personnel, documented procedures, process validation, environmental monitoring, component testing and record keeping. GMP aims to prevent contamination and errors through strict quality standards at all stages of production.
This presentation f=gives Overview of Quality Risk Management Process and presents case studies for application of QRM in Manufacturing Operations.
◦ Drug Substance Attributes
◦ Excipient Selection
◦ Process Selection
◦ Formulation Development & Optimisation
◦ “Manufacturing Process Development
Utilization of Medical Devices Standards to Demonstrate SafetyUN SPHS
Standards play an important role in demonstrating the safety of medical devices. Faisal Ali Al-Shehri's presentation discusses how standards are used across the medical device lifecycle from design to post-market activities. It provides examples of how Saudi Food and Drug Authority (SFDA) utilized recognized medical device standards to evaluate products during the COVID-19 pandemic such as face masks and ventilators. The presentation also outlines SFDA's regulatory framework and key guidance documents published to support local manufacturers in providing solutions while maintaining safety.
This document discusses various issues related to environment, health, and safety management. It covers topics like process safety, occupational health, safety management, hazards identification, risk assessment, safety standards and regulations, accident analysis, safety training, and benefits of occupational health and safety management systems. The key aspects of developing a proactive safety culture in organizations are also highlighted.
The regulation of medical devices in AustraliaTGA Australia
The regulation of medical devices in Australia involves classifying devices based on their intended use and risk level. Higher risk devices undergo more rigorous assessment procedures to ensure they meet essential safety and performance principles before being approved for market. Ongoing monitoring is also conducted after devices enter the market to protect public health. The TGA regulates medical devices to confirm they are suitable for their intended purpose and that their benefits outweigh any risks when used correctly.
PROMOTING SAFETY IN HEALTH CARE ENVIRONMENT.pptxBinal Joshi
This document discusses various aspects of promoting safety in healthcare environments. It outlines key factors that affect patient safety, including developmental stages, individual risk factors, lifestyles, sensory or mobility impairments, and risks within healthcare agencies like medical errors, falls, inherent accidents, and equipment-related accidents. It also discusses environmental safety, ensuring adequate lighting, ventilation, fire safety measures. Ensuring safety of equipment, installations, laboratories, and following guidelines for surgical, blood, sanitation, and infection control. Reducing medical errors requires identifying risks, monitoring them, prioritizing control measures, and continual monitoring.
The document provides an overview of the product development cycle for medical devices. It discusses that medical devices are highly regulated and must meet regulatory standards to be approved for use. The development process involves risk analysis, usability testing, clinical evaluation and verification to ensure safety and effectiveness for the intended use before a device can be certified and placed on the market. Standards provide guidelines for quality management, risk management, and specific product categories that must be followed.
The document discusses regulatory requirements for patient information leaflets for implantable medical devices. It must include:
1) Device identification information and intended purpose.
2) Instructions for use, intended performance, and potential side effects.
3) Residual risks and any risks from interactions with other equipment, as well as monitoring requirements.
4) Materials used and manufacturing residuals that pose risks.
5) Requirements to report incidents to the manufacturer and regulatory agency.
The leaflet is intended to safely inform patients and be updated over time with new evidence, working in conjunction with the static implant card. Feedback is sought on scope, format and delivery of information.
Introduction to medical equipments safety and testingMEHABOOB RAHMAN
Medical equipment can present a variety of hazards including mechanical, electrical, fire-related, and those resulting from improper function or incorrect output. It is important to properly maintain equipment and perform safety testing using calibrated equipment to minimize risks to patients and users. Regular performance testing helps ensure medical devices are functioning as intended.
Cathal Brennan , Medical Device Assessor- Human Products Authorisation and Re...Investnet
This document discusses the regulation of standalone software as a medical device. It begins by defining standalone software and noting the EU directive that amended the definition of a medical device to include software intended for medical purposes. It then covers how to qualify standalone software as a medical device and classify it. The document reviews essential requirements, harmonized standards, conformity assessment procedures including CE marking, and registration requirements. It provides advice for manufacturers on ensuring compliance and for users on reporting issues. The role of the Irish regulator HPRA in providing guidance and conducting oversight is also discussed.
PET - Regulation of PET Raiopharmaceutials in SaudiArabia@Saudi_nmc
This document discusses regulation of positron emission tomography (PET) radiopharmaceuticals in Saudi Arabia. It provides definitions of radiopharmaceuticals and describes their uses in oncology, cardiology, and neurology. It discusses regulations from the National Radiation Commission (NRC), International Commission on Radiological Protection (ICRP), and outlines good manufacturing practices (GMP) for PET radiopharmaceuticals including facilities, equipment, materials management, production, quality control, and documentation. The objectives of radiation protection are outlined to prevent both deterministic and stochastic effects through dose limits for occupational exposure and public exposure.
Hospital device and equipment safety pptRebecka David
Hospital devices and equipment require safety protocols to ensure proper functioning and protect patients and medical professionals. Key stakeholders in safety include manufacturers, vendors, and users. Manufacturers must design and test devices to safety standards, vendors must ensure compliant products and provide training, and users need proper qualifications and training. A hospital's equipment safety program involves planning, management, implementation including inspection, preventative maintenance and corrective actions, and monitoring. The goal is optimized and cost-effective care through reliable equipment and hazard prevention.
Similar to Medical Devices Regulation (MDR) 2017/745 - Annex I (20)
Availability of essential medicines in the Czech Republic (2017)Arete-Zoe, LLC
This report analyzes availability of essential medicines as defined in the World Health Organization (WHO) Essential List Medicines (Report of the WHO Expert Committee) in the Czech Republic. The WHO list of essential medicines contains most effective and safe medicines needed to meet the most important needs in health systems, and is frequently used by countries to create their own national lists. Without these drugs, some conditions will not be able to receive optimal therapy. Availability gap represents serious public health concern.
Expert Committee of the World Health Organization selects Essential Medicines Lists in accordance with approved procedures. The Committee evaluates the scientific evidence on the basis of the comparative effectiveness, safety and cost–effectiveness of the medicines. Both lists (adult and pediatric) went through major revisions in 2015, as the Committee considered 77 applications, including 29 treatment regimens for cancer, hepatitis C and tuberculosis (The Selection And Use Of Essential Medicines. Report Of The WHO Expert Committee, 2015).
Local availability is expressed as registration, in the form of total number of licensed products, and number of marketed products, i.e. products that were on the market in Q3 2016. Of the total number of 13,256 individual registrations for essential medicines, only 2,110 (14%) were actively marketed in Q3 2016. Total number of licensed and marketed product equals all strengths, formulations and dosage forms counted separately. The dataset is current as of December 30, 2016. Any revisions to the database made in the period between data download and publication of this report are not considered. Locally available products were compared to the WHO list of essential medicines. The material is presented in graphs and summary tabulations as listed in the table of contents.
Of the 427 essential drugs, 311 are registered in the Czech Republic, 292 were registered and marketed in Q3 2016, 19 were registered but not marketed, and 135 (32%) were unavailable. Most affected classes are antibacterials, antituberculars, antiretrovirals, antiparasitics, and dermatologicals. Essential medicines availability gap overlaps significantly with drugs that are in shortage globally.
The report provides overview of the situation in the Czech Republic. Essential medicines availability gap represents both public health concern and risk of harm to individual patients. Substitute and second line therapies are often less effective, more toxic, or more expensive. Improvisation and the use of less familiar medicines are more likely to lead to medication errors. Mitigation of shortages and creation of shared contingency supplies puts additional strain on understaffed hospitals, in addition to human toll inflicted by social stress. Drug shortages make it impossible to follow evidence-based practice guidelines, and force decisions to prioritize certain group of people over another.
Post-marketing safety surveillance of medical devices and drug-device combina...Arete-Zoe, LLC
ISoP Medical Device SIG Webinar on Post-marketing safety surveillance of medical devices and drug-device combination products
https://isoponline.org/special-interest-groups/medical-devices-group/
PMS is an integral part of a quality management system described in ISO 13485. ISO 13485 references inclusion of applicable regulatory requirements on post market surveillance into the quality management system.
Regulatory requirements are country specific and are continuously evolving. The regulatory processes for devices are significantly different than for drugs. Moreover, the requirements for drug-device combination products are not always clearly articulated.
• In Europe, according to the EU MDR, post-market surveillance shall also allow a comparison to be made between the device and similar products available on the market.
• The first challenge is identifying similar products on the market, that is out of the scope of this webinar. The second challenge is finding relevant information on equivalent and similar products.
• Since EUDAMED does not currently have a post-marketing module, manufacturers have to rely on a large number of national databases. The focus of this webinar is on regulatory requirements in major jurisdictions. There will be another webinar coming soon that will focus on how to obtain the information required to comply with all these requirements.
• With some effort, it is possible to locate information on advisory notices.
• However, adverse events or incidents are not publicly available. This is a major difference from medicinal products.
• In addition, certain AEs are subject to the National Competent Authority Report (NCAR) Exchange. These reports are shared between agencies and can potentially result in FSCA. So even when unable to monitor competitor product adverse event profile, it is important to know about their FSCAs.
Sexual assault cases regularly make headlines and can potentially cause serious reputational harm to law enforcement agencies and police departments for mishandling the cases or not pursuing them vigorously enough.
The picture on the left shows the latest developments in a long-term problem of sexual assault on college campuses. In June, Candice Johnson, OCR Acting Assistant Secretary for Civil Rights issued a memo that effectively stalled investigation of civil rights violations including sexual assault on campuses. A month later, Democratic Senators Kirsten Gillibrand from New York State and Claire McCaskill from Missouri urged Secretary of Education Betsy Devos to reverse this decision as unlawful because of failure to protect students under Title IX. Full text of the memo and Title IX, Sec. 1681 Sex are part of your lesson handout.
Similar problem with widespread sexual assault, and especially against minors, is a long-term problem at cruise ships. Because of the nature of cruise ships, there is no immediate response by law enforcement and the ship guards that investigate the matter are the cruise company’s employees therefore often unlikely to be of meaningful help to the victims. Jurisdiction can be federal, state or foreign, depending on the ship’s flag.
Finally, sexual violence in a workplace can be difficult to address because of the unequal relationship between parties and under-reporting. Recently, car company Tesla appeared in the news as a hostile workplace to women.
Mitigating consequences of a drug-facilitated sexual assault .pdfArete-Zoe, LLC
Mitigating consequences of a drug-facilitated sexual assault
First published: 27 Jan 2017
Revised: 19 Jan 2020
Drug-facilitated sexual assault (DFSA) is not just bad sex. It occurs either without the victim’s consent or with consent that cannot be considered valid due to incapacitation of the victim by alcohol or drugs. While opportunistic DFSA is carried out once the victim has been rendered unconscious by own actions, pro-active DFSA describes situations when the perpetrator spikes the victim’s drinks covertly.
The most frequently used drug in DFSA is alcohol. Other drugs often involved include flunitrazepam (Rohypnol), gamma-hydroxybutyrate (GHB), gamma-butyrolactone (GBL), carisoprodol (Soma) and ketamine. Ecstasy (MDMA) and other benzodiazepines are occasionally used also. These drugs rapidly induce drowsiness, sedation and muscle relaxation. Typical symptom is decreased inhibition. Most of the drugs used for DFSA are odorless and tasteless, with the exception of GBL that has a bitter taste. Memoryy loss is common, most victims have little to no recollection of the previous night.
The most common way of obtaining these drugs is through the darknet. Benzodiazepines, GHB (Xyrem), and ketamine (an anesthetic used in human and veterinary medicine) are often diverted from legitimate medical use for illicit purposes.
In 2012, in U.S. v. Caronia became one of the landmark cases in the promotion of prescription drugs for unapproved (off-label) indications. Physicians who prescribe Xyrem (GHB) have to pass special certification to ensure safe prescription, handling, and storage of the drug (REMS).
Sedative or tranquilizer Flunitrazepam is still legally manufactured in Europe and some countries in Latin America. The drug has been reformulated, so it imparts an easily identifiable blue color to clear beverages and haziness to colored drinks. Drugs obtained from illegal manufacturing sources naturally do not display this effect.
DFSAs are increasingly popular in bars, clubs, and raves, but also fraternities and at college campuses. Mishandling of cases of sexual assault at college campuses has been subject to much criticism.
It is very difficult to estimate the total number of DFSAs. The main reason for failure to report sexual assault is the reluctance of the victims to go to the police. Indications exist that the numbers are on the increase. Because of memory loss associated with these drugs, victims often feel embarrassed or guilty. Additional reasons for not reporting sexual assault include need to avoid further stigmatization, especially when the evidence does not seem to be sufficient to support the claim confidently. Forensic evidence is difficult to obtain and often lost after first urination the morning after. All drugs used for DFSA are metabolized rapidly by the body, rendering them undetectable within 24 to 48 hours after ingestion.
Approach to preparing for a biological attack (2017)Arete-Zoe, LLC
Approach to preparing for a biological attack
June 2017
Hospital risk management series
The debate on critical issues in science, health, and security encompasses many controversies and ethical challenges. The difference between a naturally occurring outbreak and criminal act of bioterrorism is often challenging to establish, and emergencies have to be handled as they come, regardless of the origin of the incident. The post-incident forensic analysis may or may not offer satisfactory answers in regards to attribution, liability, and the responsibility for compensation. The underlying issue for all ethical concerns examined in this work is the balance between individual rights and the needs of public health systems to protect others.
Improving the resilience of vulnerable populationsArete-Zoe, LLC
Vulnerable populations in terms of health care disparities include the economically disadvantaged and uninsured, the elderly, and people with chronic health conditions. Low-education status compounds the problem and leads to poorer outcomes than in people with the same disease but higher educational status. Significant disparities include namely risk factors relating to morbidity and mortality and access to healthcare. In the domain of physical health, the worst affected are people with chronic health conditions such as respiratory diseases and metabolic syndrome, including hyperlipidemia and diabetes, and resulting in heart diseases and hypertension. Vulnerable populations often experience accumulation of problems that are multiplied by poor health, yet the medical and non-medical needs of these populations are still underestimated. A significant number of vulnerable people with at least one chronic condition skip purchasing prescription drugs because of the costs involved. The most relevant risk factors that result in poor access to health care include low income and uninsured status, in combination with a lack of regular care. Chronic conditions such as dyslipidemia may not be particularly apparent now, yet represent a high risk of future disability (“Vulnerable Populations: Who Are They?”, 2006).
Medical innovation, increasing the complexity of care, and the relationships between stakeholders gradually lead to the increase in prices of healthcare for consumers. Lack of transparency affects the cost of premiums as well as out-of-pocket expenses. Policymakers in their considerations need to include more indicators than just insurance coverage that, without other measures, will not curb soaring healthcare expenses. Delayed care is a public health concern because of the risk of disability and under-treatment of otherwise treatable conditions. The presentation of data to non-technical audiences, including decision-makers, has to be understandable to convey the information reliably. Systems modeling techniques should be considered to estimate stakeholder behavior in a dynamic system accurately. Currently, many instances of abuse exist within the system. As an example, chargemaster fees apply to uninsured or out-of-network patients. Hospital fees are, however, tackled by state laws rather than at the federal level. Consumers in health care tend to behave differently than in other industries and often think less about the costs involved. Physicians’ education should include the delivery of cost-conscious care to prevent financial harm to their patients. Transparency of cost is one of the most effective mechanisms that enable patients and providers to make informed choices.
Handling a high-risk HIPAA Breach Published April 2017 Part of scenarios for patient privacy crisis management Every hospital encounters patients, who for the reason of their social circumstances, dependent status, personal characteristics, or the nature of their condition, are more vulnerable than the general population. While compliance with HIPAA is indeed important, because of the potential to inflict significant liability on the hospital resulting from compliance failure, it should not be the only consideration when caring for vulnerable patients. Mere compliance with the minimum requirements of HIPAA does not guarantee the safety of vulnerable patients. In the case study scenario, the hospital emergency department in a small town admitted a 15-year-old female with emergency labor. After delivery in the emergency room, the mother and the baby were moved to Obstetrics and Neonate. Despite appropriate care, the infant presented with multiple medical problems, which may or may not be resolved in the future. A nurse, who took care of the young mother, accidentally disclosed the patient’s identity and condition to her young daughter, who spread the news in all high schools in the area by the following day. The 15-year-old managed to hide her pregnancy from her family. To complicate matters, the young mother’s mother and aunt work in the same hospital.
Addressing pediatric medication errors in ED setting utilizing Computerized P...Arete-Zoe, LLC
Pediatric patients who are treated in general acute care hospitals are at increased risk of medication errors. The main reasons are the lack of experience with the special needs of pediatric patients, their lower ability to tolerate medication errors, medication-related problems such as forms and packaging designed primarily for adults and labeling with insufficient information on the dosing of pediatric patients. Medication errors can be reduced significantly by appropriate medication management systems. Computerized Provider Order Entry (CPOE) systems reduce the frequency of medication errors in all stages of the process. IT technology introduces an additional vulnerability in the form of IT-related medication errors. Nurses are the last individuals in the medication management process who can detect and intercept a medication error and prevent incorrect medication orders from reaching and harming their patients. To be able to do so, nurses have to be familiar with the medication management system in their hospital and escalate incorrect orders as appropriate and relevant.
Let's talk causality attribution: Current practices and path forward Arete-Zoe, LLC
Consistent and reliable causality attribution at the case level is the cornerstone of confident signal detection.
The current practice relies on study investigators to establish causal relationships based on their observations. The Sponsor (Company) can add their assessment based on additional information about the drug. The current industry standard, E2B (R3), accounts for multiple assessment methods and presents the data elements for each drug-event pair evaluated by multiple sources in a matrix.
There are many causality assessment methods used within the industry, some universal, others more specialized. Most commonly used methods include WHO-UMC, Naranjo, Roussel-Uclaf (RUCAM) - to detect drug-associated liver injury, Karch and Lasagna, the French PV Algorithm, Bayesian Adverse Reactions Diagnostic Instrument (BARDI), MacBARDI, and Updated Logistic method. Expert judgment remains the most common method used.
Serious challenges prevent the practical implementation of existing algorithms by the industry. Many of the algorithms cannot be applied rigorously because of missing data. Additionally, an accurate definition of clinical harm is often lacking (e.g., peripheral neuropathy, vasculitis). Brighton Collaboration Case Definitions partly address this component.
Algorithms do not consider medication errors and are not easy to use with interactions, contributory causation, or secondary harms. Information obtained from the reporter is usually insufficient to establish a causal relationship, and follow-up requests for information must be sent, often repeatedly. The result is a very high share of unassessable reports and poor internal consistency of existing assessments.
I suggest modifying the ADE reporting to incorporate components enabling structured causality assessment directly by the reporting physician (postmarket) or investigator (clinical trials). Guiding questions would assist the reporting physician in determining causal relationships and facilitate algorithmic attribution upon submission:
Temporal relationship is a key component of causality assessment. Safety databases routinely calculate latency and last dose latency that feed the algorithm.
Dechallenge and Rechallenge represent key concepts in pharmacovigilance. This information is typically missing from reports. A series of questions regarding Outcome and Response (Action taken with drug) guide the reporting physician through a checklist for all suspect and interacting drugs, reliably and consistently calculating dechallenge/rechallenge for each drug-event pair.
Biological plausibility is a complex component requiring knowledge of the drug and the patient's medical condition.
Finally, it is important to ask the reporting physician about any underlying diseases that could have contributed to the event. A clear answer to this question is an essential component of the causality assessment algorithms.
Clinical documentation for medical devices Arete-Zoe, LLC
Clinical documentation for medical devices
Medical Devices Regulation (EU) 2017/745
We prepare EU MDR-compliant clinical documentation for medical device manufacturers for submission to notified bodies and national regulatory authorities.
EU MDR-compliant clinical documentation (English, Czech):
- Clinical evaluation (plan, report)
- Post-Market Clinical Follow-Up, -
- PMCF (plan, report, study design)
- Post-Market Surveillance System (plan, report)
- Clinical investigation design to complement existing evidence
- Biological Evaluation
- Literature review
Consulting
- Strategy how to generate clinical evidence
- Design of PMCF studies and clinical investigations
Additional support:
- Clinical expert for multiple medical specialties
- Risk management specialist
- Technical documentation
Zpracování klinické dokumentace dle EU MDR 2017/745 Arete-Zoe, LLC
Zpracování klinické dokumentace dle EU MDR 2017/745
- Strategie generování klinického důkazu
- Zpracování klinické dokumentace
- Design PMCF studií a zkoušek
- Návrhy aktualizací existující dokumentace
Služby
Poradenství
Strategie generování klinického důkazu
Design PMCF studií a zkoušek
Zpracování klinické dokumentace (ČJ, AJ)
Klinické hodnocení (plán/zpráva)
PMCF, PMS (plán/zpráva), PSUR
Biologické hodnocení
Návrh aktualizace související dokumentace
Stavba týmu dle potřeb zákazníka:
Klinický expert relevantní pro daný lékařský obor
Specialista na management rizika
Laboratoř na testování software, včetně AI/ML
Zpracování ostatních částí technické dokumentace
Klinické hodnocení (Plán, Zpráva)
Protokol literární rešerše
Biologické hodnocení
Post-Market Clinical Follow-Up (PMCF) (Plán, Zpráva)
Post-Market Surveillance (PMS) (Plán, Zpráva)
Periodic Safety Update Report (PSUR)
Anthrax is a serious infectious disease caused by the bacteria Bacillus anthracis. People or animals can contract anthrax from contact with infected animals or contaminated animal products. Bacillus anthracis forms spores than can survive in the environment, especially soil or animal products (e.g., rawhide) for decades. The most common route of exposure is via skin scrapes when working with infected animals resulting in cutaneous anthrax. Gastrointestinal infection occurs following eating raw or undercooked infected or contaminated meat. The most dangerous form of anthrax follows after inhalation of aerosolized anthrax spores, typically during industrial processing of infected animal products (e.g., rawhide, wool). In the United States, anthrax is very rare. Vaccination of livestock is recommended in areas with historical occurrences of anthrax. Moreover, all food animals are examined before slaughter (Mayo Clinic, Guide to Understanding Anthrax, ACIP).
Anthrax spores had been mass-produced as a bioweapon by the Soviet Union (STAT News). In 2001, anthrax was also used as a bioweapon when letters laced with anthrax were mailed to several news media offices and Democratic Senators Tom Daschle and Patrick Leahy, killing five and sickening 17 (Amerithrax investigation). Anthrax vaccine BioThrax is given to adults at increased risk of exposure in five doses, with a booster dose each year. It is also used as post-exposure prophylaxis in combination with antibiotics.
VAERS Explorer https://www.aretezoe.com/vaers-explorer
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Adenoviruses commonly cause respiratory illnesses ranging from the common cold to pneumonia, croup, and bronchitis, but also gastroenteritis, conjunctivitis, cystitis, or neurological disease. Adenoviruses have been a common cause of acute respiratory illness in military recruits. As non-enveloped viruses, adenoviruses are relatively resistant to common disinfectants. There are more than 50 types of immunologically distinct adenoviruses. People with weakened immune systems are at high risk of developing a severe disease caused by adenovirus infection (CDC, Health.mil). The vaccine is mandatory for all enlisted military recruits (Army Regulation 40-562).
Vaccine: Adenovirus Type 4 and Type 7 Vaccine, Live, Oral (US)
Pharmacovigilance Workshop
The workshop is designed to introduce pharmacovigilance to graduate students and working professionals interested in drug safety as a career field. After a brief introduction of publicly available data sources, each team received a case study that detailed a specific safety concern that resulted in a significant safety update of product labeling or product withdrawal.
Medicines may be withdrawn from markets because of risks to patients or business reasons. Change of benefit: risk profile is usually prompted by adverse effects that were either not previously detected, are more frequent, or more severe than anticipated based on the results of Phase III clinical trials. Market withdrawals are triggered by adverse events that were only made apparent from postmarketing surveillance data collected from population-wide use over more extended periods of time. The sources of information the regulatory agencies use when deciding on market withdrawal include meta-analyses and pooled analyses of data from clinical trials, clinical trials, spontaneous case reports, laboratory studies, observational studies, animal studies, and reviews of existing safety data.
In the U.S., individual case safety reports are collected in the FDA Adverse Event Reporting System (FAERS). In Europe, medication side effects are sent to national regulatory authorities and in the EU pharmacovigilance database EudraVigilance. The participants learned where to find clinical trials, market authorizations, and product labeling.
After the introductory presentation, each team received a case study that detailed a specific safety issue that resulted in a significant safety update of product labeling or product withdrawal. Each case study received product labeling and several scientific publications that discussed the safety concern in depth. Each team prepared a presentation with detailed overview of their assigned case study.
Are you interested in drug safety?
Try this for yourself!
Case studies:
Mylotarg (Gemtuzumab ozogamicin): no benefit, risk of death
Roaccutane (isotretinoin): teratogenic effect
Lariam (mefloquine): neuropsychiatric side effects
Zyprexa (olanzapine): stroke in patients with dementia
Avandia (rosiglitazone): myocardial infarction, death due to cardiovascular causes
Seroxat (paroxetine): suicidality
Xyrem (sodium oxybate): diversion, abuse
Coumadin (warfarin): bleeding
https://www.aretezoe.com/pharmacovigilance-workshop
The workshop is designed to introduce pharmacovigilance to graduate students and working professionals interested in drug safety as a career field. After a brief introduction of publicly available data sources, each team received a case study that detailed a specific safety concern that resulted in a significant safety update of product labeling or product withdrawal.
Medicines may be withdrawn from markets because of risks to patients or business reasons. Change of benefit: risk profile is usually prompted by adverse effects that were either not previously detected, are more frequent, or more severe than anticipated based on the results of Phase III clinical trials. Market withdrawals are triggered by adverse events that were only made apparent from postmarketing surveillance data collected from population-wide use over more extended periods of time. The sources of information the regulatory agencies use when deciding on market withdrawal include meta-analyses and pooled analyses of data from clinical trials, clinical trials, spontaneous case reports, laboratory studies, observational studies, animal studies, and reviews of existing safety data.
In the U.S., individual case safety reports are collected in the FDA Adverse Event Reporting System (FAERS). In Europe, medication side effects are sent to national regulatory authorities and in the EU pharmacovigilance database EudraVigilance. The participants learned where to find clinical trials, market authorizations, and product labeling.
After the introductory presentation, each team received a case study that detailed a specific safety issue that resulted in a significant safety update of product labeling or product withdrawal. Each case study received product labeling and several scientific publications that discussed the safety concern in depth. Each team prepared a presentation with detailed overview of their assigned case study.
Are you interested in drug safety?
Try this for yourself!
https://www.aretezoe.com/pharmacovigilance-workshop
Published April 2017
Part of hospital test scenarios, escalation to ethics committee
Patients with a terminal illness who communicate their wish to die to a nurse shall receive appropriate care that is in line with institutional procedures, local laws, and their personal preferences. A nurse should be able to rely on the support of the institution he or she works for in terms of training, clear line of responsibility for such decisions, and unambiguously communicated expectations defined in organizational procedures. Assisted suicide is legal in Switzerland and several other European countries, in several states in the U.S., and in Canada. The mental capacity of the patient has to be considered in addition to locally applicable laws. Medical Power of Attorney is helpful if the patient previously described his or her wishes regarding end-of-life decisions and became incapacitated in the meantime. Financial toxicity, in addition to dubious effectiveness, contributes to the reluctance of some patients to undergo aggressive and invasive therapies. German physician Albert Moll in his book Medical Ethics (1902), argues that aggressive care in incurably ill patients is unethical. Healthcare staff, including nurses, can conscientiously object to assisting with suicide.
Deteriorating Patient with Sepsis: Early Diagnosis and Intervention (2017)Arete-Zoe, LLC
JB, a 23-year-old female, presented to the emergency department with fever, chills, nausea and abdominal pain. She was diagnosed with sepsis and treated initially with antibiotics and IV fluids. Her condition deteriorated after being transferred to a non-emergency ward, as key safety parameters like hypotension and elevated lactate were missed during handover. By Sunday, her symptoms met the criteria for septic shock, including low blood pressure, increased heart rate, and elevated lactate levels, indicating critical organ dysfunction from sepsis.
The biomechanics of running involves the study of the mechanical principles underlying running movements. It includes the analysis of the running gait cycle, which consists of the stance phase (foot contact to push-off) and the swing phase (foot lift-off to next contact). Key aspects include kinematics (joint angles and movements, stride length and frequency) and kinetics (forces involved in running, including ground reaction and muscle forces). Understanding these factors helps in improving running performance, optimizing technique, and preventing injuries.
Nutritional deficiency Disorder are problems in india.
It is very important to learn about Indian child's nutritional parameters as well the Disease related to alteration in their Nutrition.
- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Debunking Nutrition Myths: Separating Fact from Fiction"AlexandraDiaz101
In a world overflowing with diet trends and conflicting nutrition advice, it’s easy to get lost in misinformation. This article cuts through the noise to debunk common nutrition myths that may be sabotaging your health goals. From the truth about carbohydrates and fats to the real effects of sugar and artificial sweeteners, we break down what science actually says. Equip yourself with knowledge to make informed decisions about your diet, and learn how to navigate the complexities of modern nutrition with confidence. Say goodbye to food confusion and hello to a healthier you!
Summer is a time for fun in the sun, but the heat and humidity can also wreak havoc on your skin. From itchy rashes to unwanted pigmentation, several skin conditions become more prevalent during these warmer months.
Computer in pharmaceutical research and development-Mpharm(Pharmaceutics)MuskanShingari
Statistics- Statistics is the science of collecting, organizing, presenting, analyzing and interpreting numerical data to assist in making more effective decisions.
A statistics is a measure which is used to estimate the population parameter
Parameters-It is used to describe the properties of an entire population.
Examples-Measures of central tendency Dispersion, Variance, Standard Deviation (SD), Absolute Error, Mean Absolute Error (MAE), Eigen Value
Osvaldo Bernardo Muchanga-GASTROINTESTINAL INFECTIONS AND GASTRITIS-2024.pdfOsvaldo Bernardo Muchanga
GASTROINTESTINAL INFECTIONS AND GASTRITIS
Osvaldo Bernardo Muchanga
Gastrointestinal Infections
GASTROINTESTINAL INFECTIONS result from the ingestion of pathogens that cause infections at the level of this tract, generally being transmitted by food, water and hands contaminated by microorganisms such as E. coli, Salmonella, Shigella, Vibrio cholerae, Campylobacter, Staphylococcus, Rotavirus among others that are generally contained in feces, thus configuring a FECAL-ORAL type of transmission.
Among the factors that lead to the occurrence of gastrointestinal infections are the hygienic and sanitary deficiencies that characterize our markets and other places where raw or cooked food is sold, poor environmental sanitation in communities, deficiencies in water treatment (or in the process of its plumbing), risky hygienic-sanitary habits (not washing hands after major and/or minor needs), among others.
These are generally consequences (signs and symptoms) resulting from gastrointestinal infections: diarrhea, vomiting, fever and malaise, among others.
The treatment consists of replacing lost liquids and electrolytes (drinking drinking water and other recommended liquids, including consumption of juicy fruits such as papayas, apples, pears, among others that contain water in their composition).
To prevent this, it is necessary to promote health education, improve the hygienic-sanitary conditions of markets and communities in general as a way of promoting, preserving and prolonging PUBLIC HEALTH.
Gastritis and Gastric Health
Gastric Health is one of the most relevant concerns in human health, with gastrointestinal infections being among the main illnesses that affect humans.
Among gastric problems, we have GASTRITIS AND GASTRIC ULCERS as the main public health problems. Gastritis and gastric ulcers normally result from inflammation and corrosion of the walls of the stomach (gastric mucosa) and are generally associated (caused) by the bacterium Helicobacter pylor, which, according to the literature, this bacterium settles on these walls (of the stomach) and starts to release urease that ends up altering the normal pH of the stomach (acid), which leads to inflammation and corrosion of the mucous membranes and consequent gastritis or ulcers, respectively.
In addition to bacterial infections, gastritis and gastric ulcers are associated with several factors, with emphasis on prolonged fasting, chemical substances including drugs, alcohol, foods with strong seasonings including chilli, which ends up causing inflammation of the stomach walls and/or corrosion. of the same, resulting in the appearance of wounds and consequent gastritis or ulcers, respectively.
Among patients with gastritis and/or ulcers, one of the dilemmas is associated with the foods to consume in order to minimize the sensation of pain and discomfort.
Spontaneous Bacterial Peritonitis - Pathogenesis , Clinical Features & Manage...Jim Jacob Roy
In this presentation , SBP ( spontaneous bacterial peritonitis ) , which is a common complication in patients with cirrhosis and ascites is described in detail.
The reference for this presentation is Sleisenger and Fordtran's Gastrointestinal and Liver Disease Textbook ( 11th edition ).
STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS E7shruti jagirdar
Unit 4: MRA 103T Regulatory affairs
This guideline is directed principally toward new Molecular Entities that are
likely to have significant use in the elderly, either because the disease intended
to be treated is characteristically a disease of aging ( e.g., Alzheimer's disease) or
because the population to be treated is known to include substantial numbers of
geriatric patients (e.g., hypertension).
2. PAGE 2
Devices shall achieve the performance intended by their manufacturer and shall be designed and
manufactured in such a way that, during normal conditions of use, they are suitable for their intended
purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety
of patients, or the safety and health of users or, where applicable, other persons, provided that any
risks which may be associated with their use constitute acceptable risks when weighed against the
benefits to the patient and are compatible with a high level of protection of health and safety, taking
into account the generally acknowledged state of the art.
Annex I, Chapter 1, Article 1
3. PAGE 3
RISK MANAGEMENT SYSTEM
• Risk management plan for each device
• Identify foreseeable hazards
• Evaluate risks associated with use and
reasonably foreseeable misuse
• Eliminate or control the risks
• Evaluate impact of information from
production and post-market surveillance
• Amend control measures
4. PAGE 4
RISK CONTROL MEASURES
• Residual risks associated with each
hazard must be acceptable
• Overall residual risks associated with
each hazard must be acceptable
• Eliminate risks through design and
manufacture
• Protection measures (alarms)
• Information for users - warnings,
precautions, contraindications, training
Risk control measures adopted by
manufacturers for the design and
manufacture of the devices shall conform
to safety principles, taking account of the
generally acknowledged State of the Art.
5. PAGE 5
USE ERROR
• Reduce risks relating to ergonomic
features and environment
• Consider user technical
knowledge, experience,
education, training
• Consider use environment
• Consider medical and physical
condition of intended users
6. PAGE 6
RISK MANAGEMENT SYSTEM
• Performance of the device shall last
during the lifetime of the device if
used and maintained properly
• Appropriate design and packaging for
storage and transport
• Minimize foreseeable risks and
undesirable side-effects
9. Chemical, physical, biological properties
Design and manufacture shall ensure characteristics and performance of
the device in normal use.
Choice of materials and substances considering their toxicity and flammability
Compatibility considering intended use and substances it will be in contact with
Compatibility with different parts of a device
The impact of processes on material properties
Biophysical or modelling research
Mechanical properties
Surface properties
Confirmation that the device meets any defined chemical and/or physical specifications
Minimize the risk posed by contaminants and residues
PAGE 9
10. Substances
Minimize risk posed by substances, particles, debris and degradation products
Prevent unintentional ingress of substances into the device
Reduce as far as possible risk of release of particles into human body (nanomaterials)
LIMITS: 0,1% weight (w/w) limit
Devices that are in direct contact with human body, fluids or are used to administer medicines
Carcinogenic, mutagenic and toxic to reproduction (CMR)
Endocrine disruptors
Phthalates
LABELING
Concentrations >0,1% have to be declared
Precautions for vulnerable groups in instructions for use
PAGE 10
11. Infection and microbial
contamination
Design and manufacture shall
Reduce the risk of infection
Risks from unintended cuts and pricks
Easy and safe handling
Prevent microbial leakage
Prevent microbial contamination
Facilitate safe cleaning, disinfection, re-sterilization
Remain sterile during transport and storage
Breach of sterile packaging obvious to user
Validated methods of sterilization
Packaging systems shall maintain integrity and cleanliness
Labelling shall clearly distinguish sterile and non-sterile devices
PAGE 11
12. Devices incorporating a medicinal product
Devices that are composed of substances that are
absorbed or locally dispersed
Devices that contain a medicinal product are subject to
conformity assessment under this Regulation
Medicinal products shall be evaluated for absorption,
distribution, metabolism, excretion, local tolerance,
toxicity, interactions and potential for adverse reactions
(Annex I to Directive 2001/83/EC)
PAGE 12
13. Devices incorporating materials of biological origin
Devices manufactured utilizing non-viable derivatives of
tissues or cells of human and animal origin:
Donation, procurement and testing of components of
human origin subject to Directive 2004/23/EC
Sourcing, procurement and testing of components of
animal origin subject to Regulation (EU) No 722/2012
Processing, preservation and handling (human and
animal) shall provide safety for patients, users and
other persons.
viruses and other transmissible agents inactivated
traceability system (Directive 2004/23/EC, Directive
2002/98/EC)
Animal components subjected to veterinary controls
Geographical origin of the animals known
PAGE 13
https://althealthworks.com/12473/brazilian-doctors-put-tilapia-on-their-
patients-skin-what-happens-next-will-shock-youyelena/
14. PAGE 14
Construction, interaction with environment
Combinations of devices, including the connection
system shall be safe and shall not impair performance
Any restrictions on use shall be declared on the label
Minimize risk of misconnection
Consider foreseeable external influences:
magnetic fields, electrical, electromagnetic
Electrostatic discharge
Radiation (X-rays, CT)
Variations in pressure, humidity, temperature
acceleration
radio signal interferences
15. PAGE 15
Construction, interaction with environment
Contact with materials, liquids, and substances during normal conditions of use
Negative interaction between software and IT environment
Accidental ingress of substances into the device
Reciprocal interference with other devices
Ageing of materials
Risks of fire or explosion
Safe and effective calibration and maintenance
Reliable and safe interoperability and compatibility
Ergonomically designed measurement, monitoring or display scale
Safe disposal described in instructions for use.
16. PAGE 16
DEVICES WITH A DIAGNOSTIC
OR MEASURING FUNCTION
• Accuracy, precision and
stability
• Limits of accuracy specified
• Metric units (Directive
80/181/EEC)
17. GENERAL PROTECTION AGAINST RADIATION
Exposure reduced as far as possible
Reducing risks inherent to
installation
Detailed operating instructions
Performance testing
Maintenance procedure
PAGE 17
18. INTENDED RADIATION
Benefits outweigh the risks
User is able to control the emissions
Visual displays, audible warnings
Risk of unintended exposure
minimized
PAGE 18
19. PAGE 19
https://hackaday.com/2015/10/26/killed-by-a-machine-the-therac-25/
• Overconfidence in Software
• Confusing Reliability with Safety
• Lack of Defensive Design
• Unrealistic Risk Assessments
• Inadequate Investigation of
Incidents Follow-up on Accident
Reports
• Inadequate Software and System
Engineering Practices
• Software Reuse
• Safe versus “Friendly” User
Interfaces
• Reliance on outdated standards
https://www.computer.org/csdl/magazine/co/201
7/11/mco2017110008/13rRUxAStVR
20. PAGE 20
IONIZING RADIATION
Directive 2013/59/Euratom
Ability to control and monitor
quantity, quality and geometry of
radiation during treatment
Balance image quality and
exposure to patient
Reliable monitoring
Control of delivered dose
21. PAGE 21
ELECTRONIC PROGRAMMABLE
SYSTEMS & SOFTWARE
• Repeatability, reliability and
performance in line with intended use
• State of the art principles of security,
verification and validation
• Mobile apps features appropriate
• Minimum requirements on hardware,
IT network and security
Engadget, 2017
22. PAGE 22
NON-IMPLANTABLE ACTIVE
DEVICES
• Devices with internal power supply shall be
equipped with warnings
• Devices with external power supply alarms
must have to signal power failure
• Alarm systems on clinical monitors
• Reduce electromagnetic interference
• Reduce risk of electric shocks
• Protect against unauthorized access
23. PAGE 23
ACTIVE IMPLANTABLE DEVICES
• Minimize risk of current leakage and overheating
• Reduce risks from other treatments –
defibrillators, high-frequency surgery
• Risks arising from lack of maintenance and
calibration
• Compatibility with substances they administer
• Reliable source of energy
• Identifiable devices and components
• Code readable w/o surgery
24. PAGE 24
MECHANICAL & THERMAL
RISKS
• Resistance to movement, instability and moving parts
• Risk arising from vibration
• Reduce noise
• Safe terminals and connectors
• Prevent errors during refitting parts
• Accessible parts shall not overheat
25. PAGE 25
DEVICES SUPPLYING ENERGY
• Amount can be accurately controlled
• Prevent accidental release of dangerous
amount of energy
• Indicators of inadequate amounts
• Controls and indicators clearly specified
26. PAGE 26
DEVICES USED BY LAYPERSONS
• Devices designed to accommodate
the abilities of lay people
• Instructions for use understandable
to lay people
• Risk of unintended cuts and pricks
• Risk of error
• Procedure for laypersons to verify
functionality
28. LABEL & INSTRUCTIONS FOR USE
Identify the device and manufacturer
Safety and performance information
Appropriate medium and content
Provided on device or packaging
Human-readable, optional RFID
Conditions for electronic IFU
Residual risks - limitations, contra-
indications, precautions, warnings
Internationally recognized symbols
PAGE 28
29. Information on the label
PAGE 29
Identify the device
Manufacturer or
authorized
representative
Registered place of
business
Information on
medicinal products
and human or
animal tissues
Lot #, serial #, UDI Time limitations
Storage and
handling conditions
30. Information on the label
PAGE 30
Sterile state,
sterilization
method
Single use device
Information on
medicinal products
CMR substances
and endocrine
disruptors if above
0.1% w/w
Reprocessed single
use device
Warnings and
precautions
Medical device /
investigational
device
Serial # for active
implantable
devices
31. PAGE 31
Sterile packaging
• Indication how to recognize sterile packaging
• Declaration of sterile condition
• Method of sterilization
• Manufacturer’s name and address
• Description of device
• Month and year of manufacture
• Time limit for using/implanting the device
• Instruction to check integrity of packaging before use
• “Exclusively for clinical investigations”
• “Custom-made device”
32. PAGE 32
Instructions for use
• Intended purpose, clinical benefits
• Links to summary of safety and clinical
performance
• Performance characteristics
• Corresponding software and accessories
• Residual risks, contra-indications, side
effects
• Degree of accuracy if the device has a
measuring function
• Preparatory treatment, assembly,
calibration, disinfection
• Special facilities or training
• How to verify the device is installed
properly
• Sterilization and re-sterilization instructions
• How to combine device with other
equipment
• Warnings, precautions, side effects
• Information on safe disposal
• Medicinal substances if combination
devices
• Exposure to materials if implantable