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
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...Greenlight Guru
The Medical Device Single Audit Program (MDSAP) is an international initiative spearheaded by the International Medical Device Regulatory Forum (IMDRF) to develop a standardized global approach to auditing and inspecting of medical device manufacturers that will be accepted by multiple regulators to address QMS/GMP requirements.
Although the program has seen relatively low participation to date, the promise to help reduce compliance cost for device makers by eliminating the need for multiple quality system audits and inspections means there is much to be gained by industry from a successful implementation the program.
This presentation will cover:
-Understand the goals and benefits of the MDSAP program
-What are the main differences between MDSAP and standard auditing
-How to benchmark your QMS against the MDSAP
-How the new non-conformance grading system works
-How to prepare your company for a successful MDSAP implementation
Watch the presentation here: https://www.greenlight.guru/webinar/medical-device-single-audit-program-mdsap
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
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...Greenlight Guru
The Medical Device Single Audit Program (MDSAP) is an international initiative spearheaded by the International Medical Device Regulatory Forum (IMDRF) to develop a standardized global approach to auditing and inspecting of medical device manufacturers that will be accepted by multiple regulators to address QMS/GMP requirements.
Although the program has seen relatively low participation to date, the promise to help reduce compliance cost for device makers by eliminating the need for multiple quality system audits and inspections means there is much to be gained by industry from a successful implementation the program.
This presentation will cover:
-Understand the goals and benefits of the MDSAP program
-What are the main differences between MDSAP and standard auditing
-How to benchmark your QMS against the MDSAP
-How the new non-conformance grading system works
-How to prepare your company for a successful MDSAP implementation
Watch the presentation here: https://www.greenlight.guru/webinar/medical-device-single-audit-program-mdsap
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.
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
New European Medical Device Regulations: Keeping Your Orthopaedic and Spine ...April Bright
For years, notified bodies and industry experts have warned orthopaedic device companies to prepare for the forthcoming EU Medical Device Regulation (MDR). Though the regulation is expected to be officially published in the first half of 2017, a recent study shows that not only are companies not prepared, but regulatory and quality affairs professionals say that they have not studied the regulation closely.
The regulation includes new requirements for orthopaedic (and especially spine) companies that must be met in a timely manner to keep products on the market. Among the MDR changes are more stringent clinical evidence, identification of a “qualified person,” implementation of UDI and rigorous postmarket oversight.
Dr. Li covers highlights of the regulation and the provided transition period toward fulfillment of the new expectations. He explains the impact of device up-classification and the need for additional clinical data toward passing this new regulation successfully and toward fulfilling the postmarket reporting requirements accordingly.
The new Medical Device Regulation Classification is changing with the (EU) 2017/745. I prepared an infographic and free forms to use to define if the class of your product changed. This Cheat Sheet is helping you to see a summary of each rule. Medical Devices are classified in 4 class from the one with lower risk to the one with higher risk. Each class is defining how you can get the CE mark of your product. Come and learn on easymedicaldevice.com how to be an expert on medical devices.
The EU’s medical device regulation
Medical device manufacturers seeking market access
to the European Union (EU) will soon face major changes
in the EU’s decades-old regulatory framework. The EU’s
Medical Device Regulation (MDR) was officially published
on 5 May 2017 and came into force on 25 May 2017.
The MDR will replace the EU’s current Medical Device
Directive (93/42/EEC) and the EU’s Directive on active
implantable medical devices (90/385/EEC).
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.
The Unique Device Identification System for Class I and Unclassified DevicesEMMAIntl
In September 2013, FDA published a final rule establishing a Unique Device Identification (UDI) system to identify devices through distribution and use. At this time, requirements have already been phased in for Class II and Class III devices. Manufacturers for Class I/unclassified devices still have time to comply with the UDI system...
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.
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.
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
New European Medical Device Regulations: Keeping Your Orthopaedic and Spine ...April Bright
For years, notified bodies and industry experts have warned orthopaedic device companies to prepare for the forthcoming EU Medical Device Regulation (MDR). Though the regulation is expected to be officially published in the first half of 2017, a recent study shows that not only are companies not prepared, but regulatory and quality affairs professionals say that they have not studied the regulation closely.
The regulation includes new requirements for orthopaedic (and especially spine) companies that must be met in a timely manner to keep products on the market. Among the MDR changes are more stringent clinical evidence, identification of a “qualified person,” implementation of UDI and rigorous postmarket oversight.
Dr. Li covers highlights of the regulation and the provided transition period toward fulfillment of the new expectations. He explains the impact of device up-classification and the need for additional clinical data toward passing this new regulation successfully and toward fulfilling the postmarket reporting requirements accordingly.
The new Medical Device Regulation Classification is changing with the (EU) 2017/745. I prepared an infographic and free forms to use to define if the class of your product changed. This Cheat Sheet is helping you to see a summary of each rule. Medical Devices are classified in 4 class from the one with lower risk to the one with higher risk. Each class is defining how you can get the CE mark of your product. Come and learn on easymedicaldevice.com how to be an expert on medical devices.
The EU’s medical device regulation
Medical device manufacturers seeking market access
to the European Union (EU) will soon face major changes
in the EU’s decades-old regulatory framework. The EU’s
Medical Device Regulation (MDR) was officially published
on 5 May 2017 and came into force on 25 May 2017.
The MDR will replace the EU’s current Medical Device
Directive (93/42/EEC) and the EU’s Directive on active
implantable medical devices (90/385/EEC).
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.
The Unique Device Identification System for Class I and Unclassified DevicesEMMAIntl
In September 2013, FDA published a final rule establishing a Unique Device Identification (UDI) system to identify devices through distribution and use. At this time, requirements have already been phased in for Class II and Class III devices. Manufacturers for Class I/unclassified devices still have time to comply with the UDI system...
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.
If you are selling medical devices in the US, your devices are subject to new regulatory requirements under the FDA Unique Device Identification (UDI) rule.
UL experts have been actively working with customers with gap assessments, project planning and more to support compliance with these requirements. In this webinar, Ms. Linda Chatwin, RAC will be sharing some of our key learnings.
UL offers a full suite of services to support compliance with FDA's UDI Rule.
For more information, please contact us and request a sell sheet at Medical.Inquiry@ul.com, visit our UDI webpage or speak directly with one of our experts at 1-877-854-3577 or +91 804 138 4434
http://industries.ul.com/blog/us-fda-unique-device-identification-udi-implementation-deadline-in-place-for-medical-devices
Insights about changes to the EU's MDR (Medical Device Regulations) by Ulf Grundmann, Partner, King & Spalding, August 17, 2020. Includes scope and definitions, classification and conformity assessment, placing a device on the EU marketin, UDI and EUDAMED, supply chain obligations, PMS, compliance and vigilance.
introduction, classification, regulatory approval process for medical devices (510k) premarket notification, pre market approval (PMA), investigational device exemption (IDE) and invitro diagnostics, quality system requirements 21 CFR PART 820, labeling requirements 21 CFR part 801, UDI
On September 24, 2013, the U.S. Food and Drug Administration announced the new requirement to identify medical devices that affect its safe and effective use through the use of UDI. Explore on how Freyr can help medical device companies achieve UDI compliance.
UDI: What & How within the overall Medical Device value chainnancykathlen
Free Webinar on Unique Device Identification (UDI): What & How within overall Medical Device Value Chain June 18th 2015. This webinar provides insights into various aspects of UDI, discuss the operational aspects of implementing and integrating UDI within the overall Medical Device value chain.
Overview and update of chinese medical device regulationCIRS China
In this presentation, it interprets the latest changes of China's medical device regulations which involves UDI, MAH, etc. and provide practical advices for overseas medical device enterprises to register and marketing in China under the new regulations.
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.
For the complete report, get in touch with us at : info@netscribes.com
Abstract:
Netscribes’ latest market research report titled Medical Devices Market in India 2014 captures the technologically driven aspect currently prevailing within the Indian healthcare sector. The booming Indian economy is also witnessing a tremendous surge in the domestic healthcare scenario which, in turn, is leading to perpetual demand for high quality medical products. The demand for high-end, quality devices is especially driven by the private healthcare sector in its efforts to provide sophisticated treatment to patients. However, India lags behind in manufacture of technologically advanced high-end medical equipment, and instead has to rely upon imports from multinationals with extensive service networks. On the other hand, the market for less cost intensive medical supplies and disposable equipment is dominated by domestic manufacturers.
Due to the industry’s dependence on imports, multinationals are showing interest in relocation of manufacturing facilities to India as well as in forging alliances with healthcare sector stakeholders in order to capture greater market share. This brings into focus a key role played by the government that involves taxation and import regulations. The government also takes up several initiatives for the benefit of the market.
Coverage
• Overview of the medical devices market in India and forecasted market size data over 2012 to 2018
• Market Segmentation of medical devices by types
• Overview of the medical devices market in India by types and forecasted market size data over 2012 to 2018
• Snapshot of market segmentation of medical equipment
New and Refurbished Medical Equipment
Regional Demand for Medical Equipment
• Export-import overview of medical devices, value of export-import over 2009-10 to 2012-13 and country-wise value of export-import for 2011-12 and 2012-13
• Qualitative analysis of market drivers, challenges, trends and regulatory measures taken by the government
• Overview of the government bodies and their responsibilities
• Analysis of the competitive landscape and detailed profiles of major players
Why Buy
• Get a clear understanding of the medical devices market in India, how it operates and the various stages of the value chain
• Understand the current market segmentation and future growth potential of the medical devices market in India till 2018 and plan strategies to gain from it
• Strategize marketing, market-entry, market expansion, and other business plans by understanding factors influencing growth in the market
• Understand your competitors’ business structures, strategies and prospects, and respond accordingly
• Make more informed business decisions with the help of insightful recommendations provided to succeed in the Indian medical devices market
Similar to Medical Devices Regulation (MDR) 2017/745 - Identification, traceability (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.
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
Deteriorating Patient with Sepsis: Early Diagnosis and Intervention
First published April 2017
Part of test scenarios for implementation of new sepsis guidelines
Why merging medical records, hospital reports, and clinical trial data is a v...Arete-Zoe, LLC
Medical privacy and breaches of personal health information (PHI) has been a hot topic for several years. For the clinical trial industry, the main concerns are decline in recruitment resulting from lack of confidence in data handling and instances of breaches that affect data integrity that adversely affect NDA and MA applications in major markets, which precipitates administrative action taken by national regulators in response to local incidents.
European legislators rely extensively on administrative measures implemented by national competent authorities. Although specific and detailed EU-level legislation exists, specific information about data breaches, cases and incidents, volume and type of affected data, root causes and analysis of consequences is largely missing. According to Howard and Gulyas (2014), this lack of organized event records is currently an empirical obstacle but provides opportunity to generate new knowledge about data and privacy protection that could bolster future trial recruitment.
In the U.S., summary details of breaches that involved more than 500 individuals are available at the OCR portal called Wall of Shame for everyone to analyze. Disclosure obligations in HIPAA made the problem of data breaches in healthcare obvious and protection of the privacy of patients has been an important part of physicians’ code of conduct. This offers lessons learned to mitigate systemic vulnerabilities that undermine trial participation.
Obesity in adults is defined as having a body mass index (BMI) of 30 or more, while overweight stands for BMI between 25 and 30 (Baker, 2017). BMI, adjusted for age and gender, is used to measure obesity in children, taking into account different growth patterns among boys and girls for each age group. The British 1990 growth reference (UK90) serves as the growth standard. The threshold is 85th percentile for overweight and 95th percentile for obese. The increase in BMI was observed in both genders (The Health and Social Care Information Centre, 2013). At present, nearly a third of UK children are either overweight or obese. Children with excess weight are more likely to become overweight adults and suffer from a range of related ailments such as type-2 diabetes, heart disease, and depression. Excess weight is linked to academic underachievement and economic deprivation, as well as increased costs on the public social and welfare systems (Department of Health, 2017).
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Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- 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
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
2. UDI System
Appropriate level of traceability of medical
devices within supply chain
BASIC UDI-DI identifies device model
UDI-DI identifies model and serves as access
key to UDI database
UDI-PI identifies the unit of device production
Internationally recognized nomenclature
The obligation for UDI assignment applies as
of 26 May 2020 for medical devices
EUDAMED’s launch will be done together for
medical and in-vitro devices in May 2022.
PAGE 2
https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-basics
4. EUDAMED
The new EUDAMED database will include:
Registration of devices
Unique Device Identifiers
Registration of economic operators (except for
distributors)
Notified bodies, Certificates
Clinical investigations
Vigilance, Post-market surveillance
Market surveillance (inspections, non-
compliance, health protection measures)
PAGE 4
Article 29, 30, 31
Part A of Annex VI
https://ec.europa.eu/docsroom/documents/33862/attachments/1/translations/en/renditions/native
Functional specifications defined by EC and
Medical Device Coordination Group (MDCG)
Information accessible to general public
information on UDIs facilitates traceability
Information on clinical investigations
Reporting serious incidents
Field Safety Corrective Actions
EUDAMED will serve EU/EEA authorities to
cooperate and exchange information
6. PAGE 6
REGISTRATION OF DEVICES
Before placing a device on the
market, manufacturers shall assign
Basic UDI-DI
Whoever places procedure packs
on the market shall assign Basic
UDI-DI
Enter/verify information in
Eudamed
7. Registration of
economic operators
Manufacturers, Authorized Representatives and Importers must register in EUDAMED
Competent Authority obtains and issues a Single Registration Number (SRN)
The manufacturer shall use SRN when applying to Notified Body for Conformity Assessment
Any changes shall be reported within 1 week
Semi-annual confirmation of correctness of data
Competent authority verifies data from economic subjects
Information submitted to EUDAMED shall be available to the public
Competent authorities can use information from EUDAMED to collect fees
PAGE 7
Article 31
Part A of Annex VI
8. Summary of Safety and Clinical Performance
Implantable and Class III devices
Summary must be clear to intended user
Draft shall be submitted to Notified body
as part of Conformity Assessment
Available via EUDAMED after validation
PAGE 8
Article 32
Part A of Annex VI
CONTENT
Identification, Basic UDI-DI, SRN
Intended purpose, indications
Contraindications
Target populations
Description of the device
Diagnostic and therapeutic alternatives
Reference to any harmonized standards
Summary of clinical evaluation
Suggested profile and training for users
Residual risks, undesirable effects, warnings, precautions