http://dialysis-lawsuits.org has more information about dialysis patient safety and CDC protocols to guard against dialysis bloodstream infections, sepsis, and death due to septic schlock.
Safety alerts for human medical products dialysate concentrates used in hem...Michael J. Evans
This document summarizes a safety communication from the FDA regarding potential alkali dosing errors during hemodialysis treatment. The FDA issued a recall for certain dialysate concentrates that contain acetic acid or acetate, which can contribute to elevated bicarbonate levels and metabolic alkalosis in patients. Healthcare providers are advised to review the components of dialysate concentrates and be aware that metabolic alkalosis increases the risk of adverse health issues like cardiopulmonary arrest. Patients and providers are encouraged to report any adverse events to the FDA.
The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.
This document discusses blood management strategies using automated self-dispensing devices. It describes the software and safety features of devices from Mediware and Heamonetics that can issue blood for exams, emergency situations, and transfusions. The devices allow real-time monitoring and tracking of blood inventory and use. Hospitals can better manage their blood supply and cut costs using these automated systems compared to traditional information systems.
Data standards manual (monographs) dosage formLê Thùy
This document defines and provides details on dosage form, including:
1) It describes dosage form as the physical form of a drug product as administered to a patient and lists factors considered in determining dosage form.
2) It provides specifications and requirements for coding and recording dosage form in FDA and CDER databases.
3) It includes a table listing over 50 specific dosage form terms along with definitions, codes, and other attributes.
A presentation on Pharmacovigilance System in United States.
We at PharmXL International Pvt. Ltd., offer wide range of services for pharma industry like Pharmacovigilance services, Clinical Trials services, Regulatory Affairs services, Medical writing services etc to comply with required regulatory obligations across major regions.
For details visit: www.PharmXL.com
Email us: contact@pharmxl.com
Bellus Health Corporate Presentation June 2016BellusHealth
- The document is a corporate presentation for Bellus Health Inc. discussing their rare disease drug pipeline and lead product candidate KIACTA for AA amyloidosis.
- KIACTA showed positive results in a Phase 2/3 trial, reducing risk of worsening kidney events. A Phase 3 confirmatory study has completed enrollment with results expected in Q2 2016.
- If successful, KIACTA has the potential for regulatory approval and commercialization through a partnership, as Bellus' partner Auven Therapeutics is funding the entire development program.
Bellus Health Corporate Presentation May 2016BellusHealth
- The document is a corporate presentation for Bellus Health Inc. discussing their rare disease drug pipeline and lead product candidate KIACTA for AA amyloidosis.
- KIACTA has shown positive results in a Phase 2/3 trial, significantly reducing kidney function decline. A Phase 3 confirmatory study has completed enrollment with results expected in Q2 2016.
- If successful, KIACTA has the potential for regulatory approval and commercialization through a partnership, providing funding to advance Bellus' pipeline of rare disease programs.
This document provides information on medical devices used in equine medicine. It defines a medical device as an instrument or article that is used to diagnose, cure, mitigate, treat or prevent disease, and which does not achieve its purpose through chemical action or metabolism. For human medicine, devices are classified from Class I to III based on risk. While the FDA regulates human medical devices, there is no approval process for veterinary devices, though they cannot be misbranded or mislabeled. Practitioners can use veterinary devices for their intended purposes but should be aware they have not been evaluated for safety or efficacy if used as pharmaceuticals.
Safety alerts for human medical products dialysate concentrates used in hem...Michael J. Evans
This document summarizes a safety communication from the FDA regarding potential alkali dosing errors during hemodialysis treatment. The FDA issued a recall for certain dialysate concentrates that contain acetic acid or acetate, which can contribute to elevated bicarbonate levels and metabolic alkalosis in patients. Healthcare providers are advised to review the components of dialysate concentrates and be aware that metabolic alkalosis increases the risk of adverse health issues like cardiopulmonary arrest. Patients and providers are encouraged to report any adverse events to the FDA.
The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.
This document discusses blood management strategies using automated self-dispensing devices. It describes the software and safety features of devices from Mediware and Heamonetics that can issue blood for exams, emergency situations, and transfusions. The devices allow real-time monitoring and tracking of blood inventory and use. Hospitals can better manage their blood supply and cut costs using these automated systems compared to traditional information systems.
Data standards manual (monographs) dosage formLê Thùy
This document defines and provides details on dosage form, including:
1) It describes dosage form as the physical form of a drug product as administered to a patient and lists factors considered in determining dosage form.
2) It provides specifications and requirements for coding and recording dosage form in FDA and CDER databases.
3) It includes a table listing over 50 specific dosage form terms along with definitions, codes, and other attributes.
A presentation on Pharmacovigilance System in United States.
We at PharmXL International Pvt. Ltd., offer wide range of services for pharma industry like Pharmacovigilance services, Clinical Trials services, Regulatory Affairs services, Medical writing services etc to comply with required regulatory obligations across major regions.
For details visit: www.PharmXL.com
Email us: contact@pharmxl.com
Bellus Health Corporate Presentation June 2016BellusHealth
- The document is a corporate presentation for Bellus Health Inc. discussing their rare disease drug pipeline and lead product candidate KIACTA for AA amyloidosis.
- KIACTA showed positive results in a Phase 2/3 trial, reducing risk of worsening kidney events. A Phase 3 confirmatory study has completed enrollment with results expected in Q2 2016.
- If successful, KIACTA has the potential for regulatory approval and commercialization through a partnership, as Bellus' partner Auven Therapeutics is funding the entire development program.
Bellus Health Corporate Presentation May 2016BellusHealth
- The document is a corporate presentation for Bellus Health Inc. discussing their rare disease drug pipeline and lead product candidate KIACTA for AA amyloidosis.
- KIACTA has shown positive results in a Phase 2/3 trial, significantly reducing kidney function decline. A Phase 3 confirmatory study has completed enrollment with results expected in Q2 2016.
- If successful, KIACTA has the potential for regulatory approval and commercialization through a partnership, providing funding to advance Bellus' pipeline of rare disease programs.
This document provides information on medical devices used in equine medicine. It defines a medical device as an instrument or article that is used to diagnose, cure, mitigate, treat or prevent disease, and which does not achieve its purpose through chemical action or metabolism. For human medicine, devices are classified from Class I to III based on risk. While the FDA regulates human medical devices, there is no approval process for veterinary devices, though they cannot be misbranded or mislabeled. Practitioners can use veterinary devices for their intended purposes but should be aware they have not been evaluated for safety or efficacy if used as pharmaceuticals.
1) The Image Group is a marketing and branding company that specializes in print and promotional products. They have sales offices in Ohio and Michigan.
2) They offer in-house creative design, printing, product decoration and fulfillment services. They aim to boost clients' visual identity through print, merchandise and online branding.
3) The Image Group is committed to product safety and social compliance and ensures all products meet necessary regulations and standards.
This document provides an overview of water treatment for hemodialysis (HD). It discusses the importance of water quality for HD patients and the toxic effects of various water contaminants. It outlines the components of a water treatment system and describes several incidents where water contamination negatively impacted HD patients, including cases involving aluminum, chloramine, fluoride, and cyanotoxins. The document emphasizes that staff education and adherence to policies are necessary to ensure water safety.
Hyertension in patients on regular hemodialysisEhab Ashoor
Everything about hypertension in patients on regular hemodialysis, including management, Resistant hypertension, Intra-dialytic hypertension and Hypertensive urgencies.
This document discusses the management of a hemodialysis unit. It emphasizes the importance of an interdisciplinary team approach involving physicians, nurses, social workers, dietitians, and patients. It also stresses the need for continuous quality improvement through a Quality Assessment and Performance Improvement (QAPI) team that collects data from various sources to identify problems, analyze causes, develop solutions, implement changes, and reassess outcomes. The goal is to provide high quality care that meets standards and addresses key issues like infection control, dialysis adequacy, anemia management, and patient satisfaction.
Dialysis without anticoagulation (Heparin Free Dialysis)Mahmoud Eid
This document discusses techniques for performing dialysis without anticoagulation. It describes indications for heparin-free dialysis such as recent surgery or bleeding risks. Techniques mentioned include regional citrate anticoagulation, saline flushes, heparin-coated membranes, and citrasate dialysate. Signs of clotting and scoring systems are provided. Tips for priming, high blood flows, and alternatives to heparin locking are also outlined. The key recommendations are to prime properly, have no rushing, follow a written protocol, and focus on patient safety above all else.
This document discusses the management of hepatitis C virus (HCV) in patients with chronic kidney disease. It provides details on the epidemiology and genotypes of HCV. It then outlines treatment recommendations for HCV based on a patient's kidney function and cirrhosis status. Treatment involves direct acting antiviral drugs with or without ribavirin for 12-24 weeks depending on the drugs and patient factors. Adjunctive therapies are also discussed for severe cases. The benefits and risks of treatment are summarized.
Product water and hemodialysis dialysis solutionRafaqat Ali
- An average hemodialysis patient is exposed to 560 liters of water through weekly treatments, more than most people use in a lifetime.
- It is important to treat water for dialysis to remove impurities and excess minerals that can be toxic to patients or damage equipment.
- Methods for purifying water include pre-treatment, primary purification using reverse osmosis or deionization, and distribution through disinfected plastic piping to avoid contamination.
- Standards help ensure water is safely purified through chemical monitoring and testing for contaminants like chloramines daily.
This document provides information on dialysis access and the role of non-dialysis nurses in caring for patients' access. It compares different types of dialysis access including catheters, arteriovenous fistulas, and grafts. It outlines how non-dialysis nurses can aid in educating patients, monitoring access, and reporting potential problems. The document emphasizes the importance of early referral and access creation to avoid using catheters when possible.
This document discusses dry weight, which is the ideal post-dialysis weight that allows a patient to maintain normal blood pressure without medication until their next dialysis session. It explains that extracellular volume overload is a main cause of hypertension in dialysis patients. Achieving the correct dry weight through clinical assessment and trial and error allows blood pressure to be controlled in most patients. Dry weight can be difficult to determine accurately and must be regularly adjusted as patient factors like appetite and nutrition change over time.
The document summarizes the key features of dialysis machines, including their blood pump, dialysate delivery system, safety monitors, and options. The blood pump circulates blood through the dialyzer. The dialysate delivery system prepares and regulates dialysate flow and composition. Safety monitors include arterial and venous pressure monitors, air detectors, and monitors for dialysate conductivity, temperature, and blood leaks. Dialysis machines also have options like a heparin pump and controls for ultrafiltration and disinfection procedures help control bacterial contamination.
This document provides an overview of infection prevention policies and practices for outpatient hemodialysis facilities. It recommends that all staff and patients receive annual influenza and hepatitis B vaccines. It also outlines precautions such as dedicating equipment, disinfecting surfaces, and proper hand hygiene to prevent the spread of infections between patients. Facilities should have policies to separate patients with active infections and conduct routine testing for hepatitis B and C.
This document discusses various protocols for anticoagulation during hemodialysis. It begins by noting that patients on hemodialysis are at risk of both bleeding and thrombosis. It then outlines several protocols for anticoagulation including unfractionated heparin (UFH) administered via constant infusion or intermittent bolus, and low molecular weight heparin (LMWH). LMWH has benefits over UFH like longer half-life and more predictable effects, but is also more expensive. The document also discusses heparin-free dialysis, regional citrate anticoagulation, and other alternatives to standard heparin protocols. Selection of the optimal anticoagulation method requires consideration of individual patient
This document provides information on medical nutrition therapy for a patient with end-stage renal disease undergoing hemodialysis. The patient has a GFR of 12 mL/min and receives hemodialysis twice a week. The goals of medical nutrition therapy are to prevent deficiencies, control fluid balance and electrolytes, and prevent complications related to calcium and phosphorus levels. The dietitian provides calculations to determine the patient's energy, protein, fluid and electrolyte needs and prescribes an appropriate diet.
Vascular access for hemodialysis( AVF )Irfan Elahi
There are three main types of vascular access for hemodialysis: arteriovenous fistulae (AVF), arteriovenous grafts, and catheters. AVFs have the lowest rate of failures and complications and are the preferred type of access.
For an AVF to be suitable for cannulation and dialysis, it must undergo a maturation process where the fistula develops adequate blood flow, wall thickness and diameter. A properly matured fistula will have a minimum diameter of 6mm, be less than 6mm deep, have a blood flow over 600ml/min, and be evaluated at 4-6 weeks after creation.
The physical exam is the best tool to determine if an AV
This is a presentation that I developed and gave to the GMP constituency of a medium-sized biopharmaceutical company to satisfy one of the requirements for ongoing cGMP training. I feel that it very well epitomizes one of my central philosophies surrounding GXP and regulatory topic training -- STORYTELLING.
This document provides an educational module on interactions between herbal and dietary supplements (HDS) and the blood thinner warfarin. It discusses how HDS are regulated, common types of HDS, and research showing that many popular HDS can interact with warfarin in ways that affect the drug's effects. A survey found that many patients on warfarin use HDS but do not report this to their doctors. The module teaches how to use three online resources to identify potential interactions and provides a case study and practice using the resources to assess interaction risks.
- Flushing unused pharmaceuticals is not recommended by the FDA, EPA, or other organizations due to concerns about contaminating water supplies. Trace amounts of drugs have been found in streams, rivers, and drinking water.
- The FDA only recommends flushing a small number of drugs that could cause harm if ingested. For most drugs, the recommended disposal method is to throw them in the trash mixed with an undesirable substance like kitty litter.
- Take-back programs, drug collection sites, and hazardous waste facilities are better options than flushing or throwing drugs in the trash if available in your area. Proper disposal helps protect water quality and the environment.
Fresenius Medical Care North America recalled their Naturalyte and Granuflo Acid Concentrate products used in hemodialysis treatment due to the risk of inappropriate prescription leading to metabolic alkalosis in patients. Metabolic alkalosis poses serious health risks such as low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which could result in cardiopulmonary arrest or death if not treated properly. The recall involved liquid and powder acid concentrate products manufactured between January 2008 and June 2012.
Fresenius Medical Care North America recalled their Naturalyte and Granuflo Acid Concentrate products used in hemodialysis treatment due to the risk of inappropriate prescription leading to metabolic alkalosis in patients. Metabolic alkalosis poses serious health risks such as low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which could result in cardiopulmonary arrest or death if not treated properly. The recall involved liquid and powder acid concentrate products manufactured between January 2008 and June 2012.
The document summarizes FDA's drug review process. Key points:
1. FDA's Center for Drug Evaluation and Research (CDER) ensures drugs marketed in the US are safe and effective. CDER reviews new drug applications but does not test drugs itself.
2. Developing a new drug involves preclinical testing, clinical trials in 3 phases with increasing number of participants, and submitting a New Drug Application for FDA review.
3. The FDA review process evaluates whether clinical trials demonstrate a drug's safety and effectiveness for its intended use. If approved, the FDA continues monitoring the drug for safety after market.
1) The Image Group is a marketing and branding company that specializes in print and promotional products. They have sales offices in Ohio and Michigan.
2) They offer in-house creative design, printing, product decoration and fulfillment services. They aim to boost clients' visual identity through print, merchandise and online branding.
3) The Image Group is committed to product safety and social compliance and ensures all products meet necessary regulations and standards.
This document provides an overview of water treatment for hemodialysis (HD). It discusses the importance of water quality for HD patients and the toxic effects of various water contaminants. It outlines the components of a water treatment system and describes several incidents where water contamination negatively impacted HD patients, including cases involving aluminum, chloramine, fluoride, and cyanotoxins. The document emphasizes that staff education and adherence to policies are necessary to ensure water safety.
Hyertension in patients on regular hemodialysisEhab Ashoor
Everything about hypertension in patients on regular hemodialysis, including management, Resistant hypertension, Intra-dialytic hypertension and Hypertensive urgencies.
This document discusses the management of a hemodialysis unit. It emphasizes the importance of an interdisciplinary team approach involving physicians, nurses, social workers, dietitians, and patients. It also stresses the need for continuous quality improvement through a Quality Assessment and Performance Improvement (QAPI) team that collects data from various sources to identify problems, analyze causes, develop solutions, implement changes, and reassess outcomes. The goal is to provide high quality care that meets standards and addresses key issues like infection control, dialysis adequacy, anemia management, and patient satisfaction.
Dialysis without anticoagulation (Heparin Free Dialysis)Mahmoud Eid
This document discusses techniques for performing dialysis without anticoagulation. It describes indications for heparin-free dialysis such as recent surgery or bleeding risks. Techniques mentioned include regional citrate anticoagulation, saline flushes, heparin-coated membranes, and citrasate dialysate. Signs of clotting and scoring systems are provided. Tips for priming, high blood flows, and alternatives to heparin locking are also outlined. The key recommendations are to prime properly, have no rushing, follow a written protocol, and focus on patient safety above all else.
This document discusses the management of hepatitis C virus (HCV) in patients with chronic kidney disease. It provides details on the epidemiology and genotypes of HCV. It then outlines treatment recommendations for HCV based on a patient's kidney function and cirrhosis status. Treatment involves direct acting antiviral drugs with or without ribavirin for 12-24 weeks depending on the drugs and patient factors. Adjunctive therapies are also discussed for severe cases. The benefits and risks of treatment are summarized.
Product water and hemodialysis dialysis solutionRafaqat Ali
- An average hemodialysis patient is exposed to 560 liters of water through weekly treatments, more than most people use in a lifetime.
- It is important to treat water for dialysis to remove impurities and excess minerals that can be toxic to patients or damage equipment.
- Methods for purifying water include pre-treatment, primary purification using reverse osmosis or deionization, and distribution through disinfected plastic piping to avoid contamination.
- Standards help ensure water is safely purified through chemical monitoring and testing for contaminants like chloramines daily.
This document provides information on dialysis access and the role of non-dialysis nurses in caring for patients' access. It compares different types of dialysis access including catheters, arteriovenous fistulas, and grafts. It outlines how non-dialysis nurses can aid in educating patients, monitoring access, and reporting potential problems. The document emphasizes the importance of early referral and access creation to avoid using catheters when possible.
This document discusses dry weight, which is the ideal post-dialysis weight that allows a patient to maintain normal blood pressure without medication until their next dialysis session. It explains that extracellular volume overload is a main cause of hypertension in dialysis patients. Achieving the correct dry weight through clinical assessment and trial and error allows blood pressure to be controlled in most patients. Dry weight can be difficult to determine accurately and must be regularly adjusted as patient factors like appetite and nutrition change over time.
The document summarizes the key features of dialysis machines, including their blood pump, dialysate delivery system, safety monitors, and options. The blood pump circulates blood through the dialyzer. The dialysate delivery system prepares and regulates dialysate flow and composition. Safety monitors include arterial and venous pressure monitors, air detectors, and monitors for dialysate conductivity, temperature, and blood leaks. Dialysis machines also have options like a heparin pump and controls for ultrafiltration and disinfection procedures help control bacterial contamination.
This document provides an overview of infection prevention policies and practices for outpatient hemodialysis facilities. It recommends that all staff and patients receive annual influenza and hepatitis B vaccines. It also outlines precautions such as dedicating equipment, disinfecting surfaces, and proper hand hygiene to prevent the spread of infections between patients. Facilities should have policies to separate patients with active infections and conduct routine testing for hepatitis B and C.
This document discusses various protocols for anticoagulation during hemodialysis. It begins by noting that patients on hemodialysis are at risk of both bleeding and thrombosis. It then outlines several protocols for anticoagulation including unfractionated heparin (UFH) administered via constant infusion or intermittent bolus, and low molecular weight heparin (LMWH). LMWH has benefits over UFH like longer half-life and more predictable effects, but is also more expensive. The document also discusses heparin-free dialysis, regional citrate anticoagulation, and other alternatives to standard heparin protocols. Selection of the optimal anticoagulation method requires consideration of individual patient
This document provides information on medical nutrition therapy for a patient with end-stage renal disease undergoing hemodialysis. The patient has a GFR of 12 mL/min and receives hemodialysis twice a week. The goals of medical nutrition therapy are to prevent deficiencies, control fluid balance and electrolytes, and prevent complications related to calcium and phosphorus levels. The dietitian provides calculations to determine the patient's energy, protein, fluid and electrolyte needs and prescribes an appropriate diet.
Vascular access for hemodialysis( AVF )Irfan Elahi
There are three main types of vascular access for hemodialysis: arteriovenous fistulae (AVF), arteriovenous grafts, and catheters. AVFs have the lowest rate of failures and complications and are the preferred type of access.
For an AVF to be suitable for cannulation and dialysis, it must undergo a maturation process where the fistula develops adequate blood flow, wall thickness and diameter. A properly matured fistula will have a minimum diameter of 6mm, be less than 6mm deep, have a blood flow over 600ml/min, and be evaluated at 4-6 weeks after creation.
The physical exam is the best tool to determine if an AV
This is a presentation that I developed and gave to the GMP constituency of a medium-sized biopharmaceutical company to satisfy one of the requirements for ongoing cGMP training. I feel that it very well epitomizes one of my central philosophies surrounding GXP and regulatory topic training -- STORYTELLING.
This document provides an educational module on interactions between herbal and dietary supplements (HDS) and the blood thinner warfarin. It discusses how HDS are regulated, common types of HDS, and research showing that many popular HDS can interact with warfarin in ways that affect the drug's effects. A survey found that many patients on warfarin use HDS but do not report this to their doctors. The module teaches how to use three online resources to identify potential interactions and provides a case study and practice using the resources to assess interaction risks.
- Flushing unused pharmaceuticals is not recommended by the FDA, EPA, or other organizations due to concerns about contaminating water supplies. Trace amounts of drugs have been found in streams, rivers, and drinking water.
- The FDA only recommends flushing a small number of drugs that could cause harm if ingested. For most drugs, the recommended disposal method is to throw them in the trash mixed with an undesirable substance like kitty litter.
- Take-back programs, drug collection sites, and hazardous waste facilities are better options than flushing or throwing drugs in the trash if available in your area. Proper disposal helps protect water quality and the environment.
Fresenius Medical Care North America recalled their Naturalyte and Granuflo Acid Concentrate products used in hemodialysis treatment due to the risk of inappropriate prescription leading to metabolic alkalosis in patients. Metabolic alkalosis poses serious health risks such as low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which could result in cardiopulmonary arrest or death if not treated properly. The recall involved liquid and powder acid concentrate products manufactured between January 2008 and June 2012.
Fresenius Medical Care North America recalled their Naturalyte and Granuflo Acid Concentrate products used in hemodialysis treatment due to the risk of inappropriate prescription leading to metabolic alkalosis in patients. Metabolic alkalosis poses serious health risks such as low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which could result in cardiopulmonary arrest or death if not treated properly. The recall involved liquid and powder acid concentrate products manufactured between January 2008 and June 2012.
The document summarizes FDA's drug review process. Key points:
1. FDA's Center for Drug Evaluation and Research (CDER) ensures drugs marketed in the US are safe and effective. CDER reviews new drug applications but does not test drugs itself.
2. Developing a new drug involves preclinical testing, clinical trials in 3 phases with increasing number of participants, and submitting a New Drug Application for FDA review.
3. The FDA review process evaluates whether clinical trials demonstrate a drug's safety and effectiveness for its intended use. If approved, the FDA continues monitoring the drug for safety after market.
Synthetic Drugs/Hormones - Boon or Bane- Concept of Dooshivisha and Gara VishaIJARIIT
21st century is the world full of synthetics and everyone are living in the influence of synthetic substances. Altered life
styles, food habits and irregular sleep pattern had resulted not only Non communicable disease but also resulting in reduced
immunity and is risking the person more for infections. Pharma Industry has grown as big as hierarchy in recent centauries
and introduces new chemical molecules quoting as capable for treating diabetes, hypertension etc. But bitter truth is prolonged
usage these medications itself has adverse effect on liver and kidneys causes hepatotoxicity and nephrotoxicity or organs
specific toxicity.
The document introduces the Pharmanex Antioxidant Laser Scanner, which provides a non-invasive assessment of a patient's antioxidant levels by scanning their hand. It claims the scanner can track improvements in antioxidant levels from diet and supplements like LifePak. The scanner's results are said to be a useful health metric for patients and doctors. Adopting the scanner and LifePak is promoted as a way for healthcare practices to improve patient outcomes and generate new revenue.
The document provides guidelines for managing patients with critical bleeding requiring massive
transfusion, including recommendations for developing a massive transfusion protocol that outlines
the dose, timing and ratio of blood component therapy. It also recommends measuring and
monitoring key physiological parameters, and provides consensus-based practice points on issues
where evidence was insufficient, such as appropriate transfusion triggers and the potential role of
recombinant factor VII. A template is provided for a massive transfusion protocol that can be locally
adapted.
This document summarizes information from the WHO Drug Information journal regarding increasing access to safe blood products in low and middle income countries. It notes that a large amount of plasma separated from whole blood donations in these countries is currently being discarded due to inadequate quality standards and production processes. The document calls for improving infrastructure, knowledge, and regulatory oversight in blood establishments in these countries in order to strengthen local plasma production capacity and reduce wastage. It also advocates adding whole blood and red blood cells to the WHO Model List of Essential Medicines to encourage investment in building local blood systems.
Fda recall of fresenius dialysis drugs granu flo and naturalyte 3 29-2012Michael J. Evans
GranuFlo and NaturaLyte, two drugs made by Fresenius Medical Care for use during kidney dialysis, were recalled by the FDA on March 29, 2012. This is a copy of the FDA recall notice. This was the most serious type of FDA recall, a Class I recall, which means that the drug is likely to cause serious injury or death if used.
GranuFlo and NaturaLyte were recalled after they were found to have a significant risk of causing cardiac problems, heart attacks, and sudden death.
It is possible that the time to file a NaturaLyte or GranuFlo lawsuit could end on March 29, 2014, or even on some earlier date. If you suffered serious cardiac injuries or a heart attack during or after dialysis, or if you lost a family member from cardiac problems during or after dialysis, and if you don't have a lawyer, you need to contact a law firm. The injuries or death may have been caused by GranuFlo or NaturaLyte, and you may be unaware of it. There are lawyers (such as myself) who will evaluate a potential lawsuit free-of-charge. If it appears that the injuries or death may have been linked to NaturaLyte or GranuFlo, lawyers such as myself pay the cost of getting the medical records to find out if those drugs were used. If you suffered injuries or lost a loved one due to cardiac problems during or after dialysis, and this occurred before March 29, 2012, you should consider contacting a law firm immediately. Time may be quickly running out for you to take action to collect a large amount of money damages.
MedWatch is the FDA's program for monitoring the safety of medical products. It allows voluntary reporting of adverse events by the public and healthcare professionals. Reports are collected in a database and monitored by FDA professionals. The FDA uses these reports to identify safety issues, communicate new safety information to the public and healthcare providers, and take regulatory actions like requiring label changes or product recalls when needed. The goal is to help protect public health by ensuring the safety of drugs, medical devices and other medical products.
shortage of medications is a problem confronts each hospital among the world, this a presentation gives a brief information about the problem from a humble research. Ahmed Nouri, PharmD
This document summarizes a presentation given by Maureen Smith on patient involvement in drug coverage reviews in Ontario. It outlines how patient groups can submit evidence to be considered by the Committee to Evaluate Drugs, including registering as a patient group, using the submission template, and meeting submission deadlines. It also provides suggestions for making submissions more impactful, such as prioritizing the most important impacts of a disease and treatment outcomes. The goal is to systematically incorporate the patient perspective into drug review and funding decisions in Ontario.
The panel recommends:
1) Maintaining oxygen saturation of no more than 96% in acutely ill medical patients receiving oxygen therapy.
2) Not starting oxygen therapy for patients with acute stroke or myocardial infarction with saturation ≥93%, and only a weak recommendation for not starting between 90-92% saturation.
3) The evidence may apply to surgical and obstetric patients but was not reviewed for these groups.
1. FDA's Medwatch program allows reporting of adverse events from medical products to help identify safety concerns, with reports on Zyvox and Levoxine/LANOXIN leading to label changes.
2. It is important to report serious adverse events, therapeutic failures, use errors, and product quality issues to the FDA to maintain the Medwatch system.
3. The iPLEDGE program imposed stricter controls on isotretinoin due to depression and suicide risks, requiring registration of prescribers, pharmacies, patients.
Clinical trials established in 2005 the efficacy of Ranibizumab (Lucentis, Genentech) for the treatment of neovascular age-related macular degeneration (wetAMD), the leading cause of legal blindness in the United States.This disease is affecting people over the age of 65 with a prevalence of 1.6 million and 200000 new cases per year in the USA .While awaiting approval for ranibizumab from the Food and Drug Administration, ophthalmologists began treating neovascular AMD with off-label use of bevacizumab (Avastin, Genentech), since the drug had a target specificity similar to that of ranibizumab and was available at low cost for about 50$ per monthly injection Vs 1950$ for Lucentis monthly injection.
Ranibizumab received the FDA approuval in 2006 to treat specifically the wetAMD,there was a huge debate about the cost effectiveness and the reimbursement of Lucentis in comparaison with Avastin for treating the eye disease.
This paper explores the dilemma from different angles.First,it make the emphasize on the need of realizing a head to head comparative study between the two drugs and the means to finance and to launch this study since many roadblocks have been identified.
Then, it explores and analyzes the Genentech reaction facing this problem and their strategy to emphasize on the higher risk of death with Avastin, as compared to Lucentis in one hand and in the other hand their strategy to extend the ophthalmologic indications for Lucentis, including diabetic macula edema (DME).
Finally it explores what value should be put on safety in health technology assessments HTAs by developing that we can’t just consider the dollar value of medicine alone but we need to consider the cost of adverse events caused by the treatment and the cost of living with these adverse events
The MedWatch program allows health professionals and the public to voluntarily report serious reactions to medical products like drugs and devices. These reports are entered into the FDA Adverse Event Reporting System (FAERS) database. The goals of MedWatch are to increase awareness of medical product risks, clarify what should be reported, and provide safety information on FDA-regulated products to healthcare providers and patients. While FAERS supports post-marketing safety surveillance, it has limitations as not all adverse events are reported.
This document provides information on a continuing education activity for pharmacists on the management of anticoagulant-related major bleeding. The activity is accredited for 1.5 contact hours and supported by an educational grant. It reviews key guideline recommendations for managing anticoagulant bleeding, strategies for selecting and dosing reversal agents, and recent clinical data on reversal agents. It also discusses approaches to addressing formulary and institutional policy concerns regarding reversal agent access and use. The activity aims to help pharmacists provide optimal care for patients experiencing anticoagulant-related major bleeding.
The document discusses guidelines for proper disposal of unused or expired medications. It begins by outlining the FDA's recommendations for flushing certain drugs down the toilet or sink, but notes this should only be done for a small number of medications. Alternative disposal methods such as take-back programs or mixing drugs with an undesirable substance and throwing in the trash are generally preferred. The document then covers various perspectives on flushing from other organizations and provides advice from regulatory agencies on safe medication disposal.
1) DRAP is warning the public and healthcare providers about the risk of fatal irregular heart rhythms with the antibiotic azithromycin.
2) A study found an increased risk of cardiovascular death among patients treated with a 5-day course of azithromycin compared to other antibiotics or no drug.
3) DRAP is requiring label changes and updates for azithromycin to describe this risk of QT interval prolongation and potential fatal heart rhythm abnormalities.
Similar to Safety communications fda safety communication dialysate concentrates and alkali dosing errors with hemodialysis higlighted (20)
NaturaLyte and GranuFlo lawsuits in federal court have been consolidated into multidistrict litigation in federal court in Massachusetts. These lawsuits all claim money from the maker of GranuFlo and NaturaLyte, Fresenius Medical Care. NaturaLyte and GranuFlo were drugs used in the process of kidney dialysis. The FDA issued a Class I recall, its most serious, after it was discovered that NaturaLyte and GranuFlo could cause cardiac problems, including heart attacks and sudden death.
NaturaLyte and GranuFlo were recalled March 29, 2012. A copy of the FDA Recall Notice can be found among the documents uploaded by Michael J. Evans here on SlideShare.
Because the two dialysis drugs were presumably not used after March 29, 2013, there is some reason to believe that most, if not all, NaturaLyte and GranuFlo lawsuits could have been filed by March 30, 2012. Therefore, in states which have a two-year statute of limitations, there is an argument that the statute of limitations would run on a NaturaLyte or GranuFlo lawsuit no later than March 29, 2014. Of course, there are some states with longer statutes of limitation, and there are legal arguments, such as tolling, that may allow some people to file NaturaLyte and GranuFlo lawsuits after March 29, 2014.
It seems risky to this lawyer to wait to file a NaturaLyte or GranuFlo lawsuit. On July 29, 2013, the MDL judge entered this order setting a scheduling conference for August 30, 2013. One part of the Order that should be of particular interest to people with NaturaLyte or GranuFlo claims is this: the judge ordered all plaintiffs' attorneys to provide settlement proposals to the defendants' lawyers no later than two weeks prior to the hearing. That deadline ran on August 16, 2013. The lawyers for Fresenius Medical Care are ordered to respond to the proposals at the August 30 hearing.
If you were seriously injured by dialysis, or lost a family member due to dialysis, before the NaturaLyte and GranuFlo recall on March 29, 2013, you should have already had your possible lawsuit reviewed by a law firm which is experienced in representing injured people in pharmaceutical and medical device lawsuits. If you or your loved one experienced serious cardiac problems, including a heart attack or sudden death during or after dialysis while NaturaLyte and GranuFlo were still on the market, you may have a valuable claim for money but be unaware of it. You probably wouldn't be told by Fresenius that you or your family member were injured (or died) due to NaturaLyte or GranuFlo. You may wish to contact a law firm which is willing to spend the money to get copies of the medical records (at no cost to you) to see if NaturaLyte or GranuFlo were used. I am part of a group of law firms that handles such cases, and we would be glad to investigate your possible case of cardiac problems or death due to dialysis. If we don't collect money FOR you, we don't collect and money FROM you. It's a risk-free opportunity.
Dialysis Patients' Bill of Rights and Responsibilities - National Kidney Foun...Michael J. Evans
The document outlines the Dialysis Patients' Bill of Rights and Responsibilities as established by the National Kidney Foundation. It details 18 rights that patients have, including the right to quality care, privacy, treatment options, and information. It also lists 6 responsibilities of patients, such as being informed, following treatment plans, and fulfilling financial obligations. The rights and responsibilities are intended to promote high-quality care and positive relationships between dialysis facilities and their patients.
Drug safety and availability fda drug safety communication fda investigati...Michael J. Evans
The FDA is investigating new findings that suggest incretin mimetic drugs used to treat type 2 diabetes, such as exenatide and liraglutide, may increase the risk of pancreatitis (pancreas inflammation) and pancreatic duct metaplasia (a pre-cancerous condition). The findings are based on examination of pancreatic tissue from deceased patients. The FDA is asking researchers for more details and tissue samples to further study any potential pancreatic risks. The FDA has not reached conclusions and will update the public when its review is complete.
Fda warning letter 3 5-2013 to dialysis drug maker and dialysis provider Fres...Michael J. Evans
The FDA issued a warning letter to Fresenius Medical Care regarding violations found during an inspection of their Ogden, UT facility. The inspection revealed that their Optiflux Polysulfone Dialyzers were adulterated because their design validation and design verification processes did not comply with good manufacturing practice regulations. Specifically, biocompatibility testing was incomplete and additional testing was needed to evaluate dialyzer membrane effects. The company was asked to respond within 15 days detailing corrective actions to address the violations.
This document outlines Rules 23 and 23.1 of the Federal Rules of Civil Procedure regarding class action lawsuits. Rule 23 discusses the prerequisites for class certification, including numerosity, commonality, typicality and adequacy of representation. It also establishes three categories for class action certification and addresses issues related to notice, judgments, particular issues, subclasses, settlement and appeals. Rule 23.1 addresses derivative actions brought by shareholders to enforce rights of a corporation.
Joint motionforpreliminaryapprovalofbp settlementwithdeclofazariex1_4_18_2012Michael J. Evans
The Plaintiffs Steering Committee and BP Defendants jointly moved the court to (1) preliminarily approve a class action settlement, (2) schedule a fairness hearing, (3) approve and issue proposed class action settlement notice, and (4) adjourn the limitation and liability trial until after the fairness hearing. They argued that the proposed settlement is fair, reasonable and adequate, and that the notice plan complies with legal requirements. BP separately requested adjourning the trial, which the court has authority to do.
This document is a complaint filed by the State of Florida against BP Exploration & Production Inc., BP p.l.c., BP America Production Company, and Halliburton Energy Services, Inc. regarding economic damages suffered by Florida from the 2010 Deepwater Horizon oil spill in the Gulf of Mexico. The complaint alleges that BP and Halliburton's negligent actions led to the uncontrolled oil spill, which damaged Florida's tourism-dependent economy. It asserts jurisdiction and provides background on the parties involved. The complaint describes the events leading up to the spill and allegations of negligence against the defendants regarding well design, cementing, and blowout preventer failures. Florida seeks damages for lost tax revenue and economic losses due to impacts on tourism
Bp settlement final_order_and_judgment_on_economic_class_settlementMichael J. Evans
This order grants final approval of the Economic and Property Damages Settlement Agreement relating to the 2010 Deepwater Horizon oil spill in the Gulf of Mexico. It confirms certification of the Economic Class for settlement purposes and confirms the appointments of class counsel, claims administrators, and trustees. The order finds that class notice was adequate, dismisses class members' related claims with prejudice, and retains jurisdiction to implement and enforce the settlement.
Bp settlement order_and_reasons_for_final_approval_of_bp_settlement Michael J. Evans
This order grants final approval of the Economic and Property Damages Settlement Agreement between BP and private plaintiffs resulting from the 2010 Deepwater Horizon oil spill. The settlement resolves economic loss and property damage claims for individuals and businesses in Gulf states and coastal areas through court-supervised programs that have already paid out over $405 million. The order describes the settlement categories, geographic scope, exclusions, lack of caps except for Seafood Compensation, and transparency of the claims framework. A fairness hearing was held on November 8, 2012 to consider final approval and objections.
This document is a status report from the Claims Administrator of the Deepwater Horizon Economic and Property Damages Settlement Agreement to the United States District Court for the Eastern District of Louisiana. It provides updates on the number of claims submitted and reviewed, the identity verification and review processes, exclusions reviews, accounting support reviews, and quality assurance reviews being conducted. The report aims to inform the Court on the current status of implementing the Settlement Agreement.
This BP settlement notice was sent to only about 500,000 business owners and others who had filed claims with BP before the settlement. BP settlement includes all people, businesses and charities in Alabama, Mississippi, Louisiana, and western Florida. BP's Notice Administrator could have bought mailing lists and sent the notice to over a million businesses and charities that are class members that might have claims, but he did not. Sending notice by mail would cost BP money to send the notice, and likely increase the number and amount of claims filed. If you are a business or charity in Alabama, you may visit http://BPOilnews.com or http://BP-Settlement-News to fill out a form to obtain a free legal review of your potential right to collect money from the BP settlement.
This document outlines a proposed class action settlement agreement between BP and plaintiffs regarding economic losses from the 2010 Deepwater Horizon oil spill. It defines the Economic and Property Damages Settlement Class eligible to make claims. The class includes individuals and businesses in Gulf Coast areas and waters affected by the spill. It establishes several categories for compensation, including programs for seafood industry losses, economic damages, subsistence losses, and damages to coastal real property and wetlands. The agreement is subject to court approval and allows class members who sign a release to receive prompt payment prior to final approval.
Bp settlement declaration_cameron_azari_bp_settlement_notice_administrator_4_...Michael J. Evans
This document is the declaration of Cameron Azari, who administered the class action notice plan for the BP Deepwater Horizon Oil Spill Settlement. It explains that Azari is an expert in legal notice and notice plan design. The declaration outlines how the target audience for the BP Settlement notice was intended to match the class definition in the Settlement Agreement. It also highlights Azari's plans to send individual notice by mail to settlement class members.
10 Benefits an EPCR Software should Bring to EMS Organizations Traumasoft LLC
The benefits of an ePCR solution should extend to the whole EMS organization, not just certain groups of people or certain departments. It should provide more than just a form for entering and a database for storing information. It should also include a workflow of how information is communicated, used and stored across the entire organization.
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
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Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
- 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
5-hydroxytryptamine or 5-HT or Serotonin is a neurotransmitter that serves a range of roles in the human body. It is sometimes referred to as the happy chemical since it promotes overall well-being and happiness.
It is mostly found in the brain, intestines, and blood platelets.
5-HT is utilised to transport messages between nerve cells, is known to be involved in smooth muscle contraction, and adds to overall well-being and pleasure, among other benefits. 5-HT regulates the body's sleep-wake cycles and internal clock by acting as a precursor to melatonin.
It is hypothesised to regulate hunger, emotions, motor, cognitive, and autonomic processes.
Safety communications fda safety communication dialysate concentrates and alkali dosing errors with hemodialysis higlighted
1. 7/16/13 Safety Communications > FDA Safety Communication: Dialysate Concentrates and Alkali Dosing Errors with Hemodialysis
www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm305477.htm 1/3
FDA Safety Communication: Dialysate Concentrates and Alkali Dosing Errors with Hemodialysis
Date Issued: May 25, 2012
Audience:
Health care professionals using dialysis equipment and prescribing dialysate concentrates, including nephrologists, nurses, and dialysis
technicians
Hospital and clinic administrators, medical officers, risk managers, and dialysis clinics
Medical Specialty: Nephrology
Product: All Hemodialysis Dialysate Concentrates Containing Acetate, Acetic Acid, or Citrate.
Dialysate is a solution prescribed by physicians for use in the treatment of acute and chronic renal failure during the hemodialysis procedure.
The dialysate solution is used in combination with the hemodialysis machine and dialyzer to remove wastes from the blood.
Dialysate for hemodialysis is regulated as a medical device by the FDA.
Purpose:
To remind nephrologists, dialysis nurses and technicians about acetate, acetic acid and/or citrate levels in dialysate concentrates and the need
to consider the impact of these substances when ordering or administering the patient’s dialysate prescription.
Summary of Problem and Scope:
The FDA received a complaint describing alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic
acid and acetate. When metabolized, these potential sources of alkali can contribute to elevated bicarbonate levels in patients undergoing
hemodialysis. This can contribute to metabolic alkalosis, which is a significant risk factor associated with cardiopulmonary arrest, low blood
pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia.
Health care professionals may not be aware that the dialysate acid concentrate can contain acetic acid, acetate or citrate, and that these
substances can be converted in the body to bicarbonate, potentially contributing to metabolic alkalosis. These substances typically are found in
acid concentrate in amounts ranging from 1.5 to 8 mEq/L. This potential exists for all currently marketed dialysate concentrate products
containing acetate, acetic acid, or citrate.
A recent report from the National Kidney Foundation 2011 Spring Clinical Meetings retrospectively evaluated 50 hemodialysis patients
hospitalized in October 2010. Their outpatient dialysate prescription included a 35 mEq/L bicarbonate solution and an acid concentrate which
contained 8 mEq/L of acetate (total bicarbonate of 43 mEq/L). At presentation, the patients’ mean serum bicarbonate level was 31.3 mEq/L and
54 percent had a serum bicarbonate >30 mEq/L. (Pande S, Raja R, Bloom E, Chewaproug D, Dissanayake I. Effect of dialysate baths on serum
bicarbonate levels in hemodialysis patients. American Journal of Kidney Disease 2011;; 57(4): A75 (Abstract #234))
Recommendations for Health Care Providers:
Be aware that metabolic alkalosis (pre-dialysis serum bicarbonate levels > or = to 27 mEq/L) has been associated with a higher risk of
death in hemodialysis patients.
Before writing the bicarbonate component of the dialysate prescription or using dialysate concentrates:
Review the dialysate acid concentrate labeling for the specific concentrate that you prescribe or use to determine the
components that can contribute to the patient’s bicarbonate level. The levels of acetate, citrate and/or acetic acid vary by
Medical Devices
Home Medical Devices Medical Device Safety Safety Communications
This FDA patient safety communication was uploaded by the
dialysis lawsuit lawyers who sponsor http://dialysis-lawsuits.org,
where you can get more information and a free legal review of
your potential NaturaLyte, GranuFlo or other dialysis lawsuit.
2. 7/16/13 Safety Communications > FDA Safety Communication: Dialysate Concentrates and Alkali Dosing Errors with Hemodialysis
www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm305477.htm 2/3
product and manufacturer.
Be sure to understand how your specific hemodialysis device proportions (mixes) the acid and base concentrates.
Be aware that some dialysate acid concentrates contain acetate, citrate and acetic acid level combinations up to 8 mEq/L, and
some products may contain both acetate and acetic acid.
Discuss laboratory results with your patients as appropriate.
FDA Activities:
The FDA worked with Fresenius Medical Care, one manufacturer of dialysate concentrate, on a notice about this issue1 2 released to their
customers on March 29, 2012.
The FDA continues to evaluate the scientific literature and adverse event reports about dialysates. The FDA will keep the public informed if any
relevant new information becomes available.
Reporting Problems to the FDA:
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a
problem with Dialysate Concentrates, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse
Event Reporting program3. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements4
should follow the reporting procedures established by their facilities. Device manufacturers must comply with the Medical Device Reporting
(MDR) regulations.5
To help us learn as much as possible about the adverse events associated with Dialysate Concentrates, please include the following information
in your reports, if available:
Product Name
Lot Number
Manufacturer
Relevant events prior and subsequent to the referenced problem
Concomitant medical products
Details of the adverse event and medical intervention (if required)
Contact Information:
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance
(DSMICA) at DSMICA@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.
This document reflects the FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing
safety reviews of medical devices.
Page Last Updated: 11/20/2012
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
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