VELSEAL. THE NOVEL The Action Dressing OPEN IT. PLACE IT. TERMINATE THE BLEEDING.

Size: px
Start display at page:

Download "VELSEAL. THE NOVEL The Action Dressing OPEN IT. PLACE IT. TERMINATE THE BLEEDING."

Transcription

1 VELSEAL THE NOVEL The Action Dressing OPEN IT. PLACE IT. TERMINATE THE BLEEDING. Ergonomic Rectangular Design: Fits any wound shape and size, endurant & flexible No Secondary Bleeding No Exfoliation No exothermic reaction Exceptionally light weight, as easy as carrying a paper Ceases bleeding in less than 4 minutes Useful in cases of multiple injury Simple to remove Can be leftover on wound without any harm Proven highly effective in GUNSHOT WOUNDS Stops bleeding immediately in PATIENTS WITH COAGULOPATHY* Increases the safety window to securely mobilize the patient *only for Velseal-T

2 VELSEAL Velseal is a foam based dressing for control of traumatic bleeding. The ready-to-use patch consists of foam impregnated with clot promoting & stabilizing agents. These constituents are held in the vesicular voids of the matrix, on the internal surface sponge. This means they are able to act rapidly when blood flows into the dressing. Once in contact with blood, the dressing enables sealing and stabilization of wound surfaces. The Novel Features: A Novel absorbent dressing containing blood clot promoting & stabilizing agents The entire area is porous providing a high surface area for the clotting process to occur Used on external wounds to stop even severe arterial or venous bleeding within 4 minutes Severe High pressure bleeding In Hospitals and medical practices All types of accidents where excess bleeding / blood loss is a concern. In the aftermath of a catastrophe Battle fields Accidents, Trauma and emergency Prevents secondary bleeding Does not cause exothermic reactions Non cytotoxic, non irritant & non sensitiser Increases the threshold time required to mobilize the patient safely to the hospital Biocompatible and Bioabsorbable Does not stick to the wound No restriction of blood flow, improved wound hygiene Safety and efficacy established even in deep, lacerated wounds or Gunshots (Involving larger wound size or arterial damage) Accidents Happen Anywhere... Anytime...!!! Be Prepared

3 Active Constituents A Novel Polyelectrolyte complex (PEC) of biopolymers. Highly porous and impregnated with clot promoting & stabilizing agents. All constituents are held in the vesicular voids of the matrix onto the internal surface. How it Works The interconnected small voids of porous PEC sponge provides a very large surface area for the flowing blood and hold the natural clot promoting & stabilizing agents A large surface area and micro-areas exert a pseudo-catalytic effect on blood clotting The body s own whole blood coagulation cascade - is activated The blood clotting process occurs within the voids Further, the presence of impregnated naturally derived clotting factors & stabilizer intensifies the clotting action & stabilizes the clot Natural blood clotting continues to the injured blood vessel without affecting flow characteristics of circulating blood Application method VelSeal should be used externally only. Intended for use as a topical dressing for emergency use After injury, VelSeal should be placed on the wound immediately Positioned so that the blood flowing from the wound must come into contact with the matrix to initiate satisfactory blood clotting Hold the device in place upto a time period of 4 minutes Blood clotting is both within the matrix and on its surface Intended users: Medical professionals, Hospitals, Rescue and Emergency services, Chemists, Fire service, Police, Armed forces & Defence services. Schools, First aid, Workplaces, Household, Sports persons, Commercial and Personal Vehicles. INSTRUCTIONS FOR USE Step 1: Open Dressing Extract the sterile dressing from the primary packing. Step 2: Ensure that the correct side is used - Ensure that the side opposite to the marked side of VelSeal is applied on the wound, i.e. the marked side faces upwards after the application. Step 3: Apply directly on source of bleeding - It is critical to place the dressing directly on the source of the bleeding, the area where the blood vessel damage has actually occurred. Step 4: Hold firmly until bleeding is controlled - Apply firm, even pressure on the dressing for 4 minutes. Step 5: Lift and check - if bleeding has been stopped after 4 minutes, else continue pressing.

4 Trauma is one of the leading causes of morbidity and mortality. Uncontrolled haemorrhage related to traumatic event is often major cause of complications and death. 1, 2 Haemorrhage following traumatic injury accounts for 30 40% of deaths 1 Haemorrhage remains a major cause of potentially preventable deaths More than 90% of mortalities occur in low and middle income nations 3 Global road traffic injuries result in 1.2 million deaths per year, with additional million injuries 3 Violence is a large contributor to injury-related mortality as well, with 1.6 million deaths worldwide in 2000, representing 16% of mortality from injury 3 Injury represented 9% of worldwide mortality and 12% of global disease burden Out of the hospital admissions in trauma 20% develop coagulopathy. Mortality is three to four times higher in a patient with coagulopathy 4 More than 6 million deaths occur due to trauma, of which 20% are due to uncontrollable bleeding Why VELSEAL Highly Effective Can be placed directly over affected area Instant action, promotes clotting within less than 4 minutes Useful in all Trauma cases, accident, injury or casualty where bleeding is a concern VelSeal-T can also be used after angiography and angioplasty Highly Effective in GUNSHOT WOUNDS Increases the safety window to securely mobilize the patient Ergonomic Design and Packaging Fits any wound shape and size, available in different sizes. Water proof packaging, single use, sterile packs Safe Well established safety and efficacy, no known contraindications Biocompatible and Bioabsorbable No exothermic reaction Cost Effective Highly economic as compared to other products Researched, designed and developed in India Stops bleeding rapidly and may reduce the need for more expensive treatments None can predict when an accident will occur, but with VELSEAL, you ll be prepared to handle it. 1 Sauaia A, Moore FA, Moore EE, et al. Epidemiology of trauma deaths: a reassessment. J Trauma. 1995;38(2): AANA Journal, December 2013, Vol. 81, No. 6 3 Johansson et al. Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine Peden M, McGee K, Sharma G: The Injury Chart Book: a Graphical Overview of the Global Burden of Injuries. Geneva: World Health Organization; 2002.

5 Shelf Life: Velseal- 2 years Velseal-T-12 months /1 year Available sizes: Size 5 cm x 5 cm 1 piece 7 cm x 7 cm 1 piece 10 cm x 10 cm 1 piece Packaging *Dentistry pack available- (Velseal-T only) Sterilization Method: Gamma irradiation Studies Established Safety: Biocompatibility studies as per international standards. (In-vitro Cytotoxicity, Acute systemic toxicity, intracutaneous reactivity and Skin sensitization). Controlled Animal Study - Gunshot Wound Gunshot wound Hemostasis Failure with Guaze Hemostasis with VelSeal Clinical investigation - Lacerated Wound Lacerated Wound VelSeal application Hemostasis with VelSeal

6 Contraindications: No known contraindications and adverse reactions. Warnings & Precautions: For external use only The dressing should remain in position until the wound can be treated properly Do not use if pack is damaged/or contents are wet. VelSeal is supplied as a sterile, single-use dressing. Do not re-use. Do not re-sterilize If the first attempt at application of the VelSeal is not successful, do not re-apply the same dressing, instead obtain a new dressing for re-application VelSeal must be positioned properly to the bleeding wound /actual source of the bleed. Use promptly after opening. Don t keep open for long time as it may absorb moisture and change property/reduce efficacy. For more information write to Marketing Department Datt Mediproducts Pvt. Limited (An ISO 9001:2008 Certified Company) Admin Office: 56, Community Centre, East of Kailash, New Delhi Works: & 63-64, Roz-ka-Meo Industrial Area, Nuh, Distt. Mewat , Haryana, India sales@dattmedi.com Website: Customer Care Toll Free No.:

Brand Guidelines 2016

Brand Guidelines 2016 Brand Guidelines 2016 Link to page Your brand is one of your company s most important assets. It s therefore essential that everyone understands its value and knows how to use it. Logo Fonts Grids Welcome

More information

PREPARED FOR: U.S. Army Medical Research and Materiel Command Fort Detrick, Maryland

PREPARED FOR: U.S. Army Medical Research and Materiel Command Fort Detrick, Maryland AD Award Number: W81XWH-07-1-0636 TITLE: Silver Foam Technologies Healing Research Program PRINCIPAL INVESTIGATOR: Michael F. Moore, M.D. CONTRACTING ORGANIZATION: Noble Biomaterials REPORT DATE: September

More information

Massive Haemorrhage J Davies B Ferguson

Massive Haemorrhage J Davies B Ferguson Massive Haemorrhage J Davies B Ferguson What is Massive Haemorrhage (MH)? Difficult to apply rules as to how much blood loss defines a major haemorrhage. Easier to define how the patient s condition is

More information

Presenting SURGICEL Powder

Presenting SURGICEL Powder SURGICEL Powder Presenting SURGICEL Powder Built to stop continuous, broad-surface oozing fast1,2 The next generation of SURGICEL Absorbable Hemostats SURGICEL Powder efficiently and effectively controls

More information

55 Industrial Park Road Boothbay, ME USA

55 Industrial Park Road Boothbay, ME USA Introduction Increasing the level of sanitation and sterility of health-care environments is critical in reducing the transmission of health-care associated infections. The Center for Disease Control estimates

More information

What Can We Learn from Animal Models of Coagulopathy and Bleeding (about plasma transfusion)?

What Can We Learn from Animal Models of Coagulopathy and Bleeding (about plasma transfusion)? Test What Can We Learn from Animal Models of Coagulopathy and Bleeding (about plasma transfusion)? William Sheffield Associate Director, Research CBS Centre for Innovation, and Professor, Pathology and

More information

Massive Haemorrhage P Donnelly B Ferguson

Massive Haemorrhage P Donnelly B Ferguson Massive Haemorrhage P Donnelly B Ferguson What is Massive Haemorrhage (MH)? Difficult to apply rules as to how much blood loss defines a major haemorrhage. Easier to define how the patient s condition

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) European Medicines Agency Evaluation of Medicines for Human Use London, 29 July 2004 CPMP/BPWG/1089/00 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE CLINICAL INVESTIGATION OF PLASMA

More information

FREQUENTLY ASKED QUESTIONS

FREQUENTLY ASKED QUESTIONS FREQUENTLY ASKED QUESTIONS 1. What is the Irrisept system? Irrisept is a patented jet lavage system, containing low concentration chlorhexidine gluconate (CHG)* 0.05% in sterile water for irrigation, to

More information

Red Cell Transfusion LESSONS FROM TRAUMA

Red Cell Transfusion LESSONS FROM TRAUMA Red Cell Transfusion LESSONS FROM TRAUMA Sandro Rizoli, MD PhD FRCSC FACS Professor Surgery & Critical Care Medicine Trauma Program Director Chair Trauma Care Disclosure KCI Canada CSL Behring NovoNordisk

More information

Medical Portfolio Overview

Medical Portfolio Overview Army Science & Technology NDIA Science Engineering & Technology Conference Medical Portfolio Overview COL John Teyhen Director, Medical Portfolio Office of the Deputy Assistant Secretary of the Army for

More information

Material Safety Data. Manuka AD Honey-impregnated Absorbent Dressing Sterile Product Code Effective Date:

Material Safety Data. Manuka AD Honey-impregnated Absorbent Dressing Sterile Product Code Effective Date: MSDS Material Safety Data Manuka AD Honey-impregnated Absorbent Dressing Sterile Product Code Effective Date: J1252, J1252A, J1252B 24 Hour Emergency Telephone: INFOTRAC: (800)535-5053 Jorgensen Laboratories,

More information

Enzymatic Hydrolysis of Silk Fibroin Peptide for Hemorrhage Control

Enzymatic Hydrolysis of Silk Fibroin Peptide for Hemorrhage Control 2015 2 nd International Conference on Material Engineering and Application (ICMEA 2015) ISBN: 978-1-60595-323-6 Enzymatic Hydrolysis of Silk Fibroin Peptide for Hemorrhage Control Jingjing Li 1,2, Hailin

More information

Company : Medica Middle East Medica Middle East Vision : Medica Middle East Mission : Medica Middle East Medica Middle East Medica Middle East

Company : Medica Middle East Medica Middle East Vision : Medica Middle East Mission : Medica Middle East Medica Middle East Medica Middle East MME Company Profile Company : Medica Middle East is licensed as a Privet Free Zone Entity to facilitate its importing and exporting activities. Medica Middle East is a subsidiary of THIMAR Holding Group

More information

The Next Big Thing. Dr Anne Weaver Consultant in Emergency Medicine & Pre-hospital Care Clinical Director for Trauma Royal London Hospital

The Next Big Thing. Dr Anne Weaver Consultant in Emergency Medicine & Pre-hospital Care Clinical Director for Trauma Royal London Hospital The Next Big Thing Dr Anne Weaver Consultant in Emergency Medicine & Pre-hospital Care Clinical Director for Trauma Royal London Hospital Things to share with you Good conference / interesting journal

More information

REVIEW OF TRANEXAMIC ACID IN TRAUMA

REVIEW OF TRANEXAMIC ACID IN TRAUMA REVIEW OF TRANEXAMIC ACID IN TRAUMA At the bottom of this article are the links to a couple of pretty good recent reviews about the current state of TXA. But first a bit of background. Coagulopathy in

More information

Biocompatibility: a risk based approach

Biocompatibility: a risk based approach Biocompatibility: a risk based approach Legal framework The regulatory requirements include: Demonstration of safety Demonstration of efficacy Positive balance of risk and benefit The regulatory requirements

More information

Riastap (fibrinogen concentrate, human) Public Summary of Risk Management Plan (Extract from the EU Risk Management Plan Version 3.

Riastap (fibrinogen concentrate, human) Public Summary of Risk Management Plan (Extract from the EU Risk Management Plan Version 3. Riastap (fibrinogen concentrate, human) Public Summary of Risk Management Plan (Extract from the EU Risk Management Plan Version 3.1; 14 Apr 2016) VI.2 VI.2.1 Elements for a Public Summary Overview of

More information

Strategies for transfusion therapy and monitoring

Strategies for transfusion therapy and monitoring Strategies for transfusion therapy and monitoring Jakob Stensballe Consultant Anaesthetist & Transfusion Medicine MD PhD Dept. of Anesthesia, Centre of Head and Orthopedics & Section for Transfusion Medicine,

More information

Applying ROTEM to the Management of Bleeding in Trauma

Applying ROTEM to the Management of Bleeding in Trauma Applying ROTEM to the Management of Bleeding in Trauma Sandro Rizoli, MD PhD FRCSC FACS Professor Surgery & Critical Care Medicine Trauma Program Director Chair Trauma Care Disclosure NONE ROTEM Growing

More information

[kahy-tuh-sam] 2018 SAM MEDICAL PRODUCTS. ALL RIGHTS RESERVED. CTS-PED-G-01 FEB 2018

[kahy-tuh-sam] 2018 SAM MEDICAL PRODUCTS. ALL RIGHTS RESERVED. CTS-PED-G-01 FEB 2018 [kahy-tuh-sam] CHITOSAM [kahy-tuh-sam] https://www.youtube.com/watch?v=wzlsrh_qtxm CHITOSAM [kahy-tuh-sam] CHITOSAM ChitoSAM is a high-performance hemostatic, non-woven chitosan dressing, spun directly

More information

Section 2 Hazard identification

Section 2 Hazard identification MATERIAL SAFETY DATA SHEET PHOSPHORIC ACID Section 1 Identification of Supplier Product identifier: Product Name: Phosphoric Acid Shipping Name: Phosphoric Acid Suppliers Details: Chemical Initiatives

More information

As highlighted above, MLM is requesting that Cahaba move bio-connekt Wound Matrix (Q4161) from Group 3 Codes to Group 2 Codes.

As highlighted above, MLM is requesting that Cahaba move bio-connekt Wound Matrix (Q4161) from Group 3 Codes to Group 2 Codes. July 6, 2016 Cahaba Government Benefit Administrator Reconsiderations for Active LCDs Attention: Medical Director via e-mail at LCDReconsideration@cahabagba.com Dear Medical Director: MLM Biologics (MLM)

More information

Section 2 Hazard identification. Precautions statement: Wear gloves, face protection and protective clothing.

Section 2 Hazard identification. Precautions statement: Wear gloves, face protection and protective clothing. MATERIAL SAFETY DATA SHEET POLYPHOSPHORIC ACID Section 1 Identification of Supplier Product identifier: Product Name: Polyphosphoric Shipping Name: Corrosive Liquid, Inorganic, N.O.S Suppliers Details:

More information

Blood transfusion in special situations and poly-trauma. Dr Marina Karakantza Consultant Haematologist in Transfusion Medicine, LTHT

Blood transfusion in special situations and poly-trauma. Dr Marina Karakantza Consultant Haematologist in Transfusion Medicine, LTHT Blood transfusion in special situations and poly-trauma Dr Marina Karakantza Consultant Haematologist in Transfusion Medicine, LTHT Uncontrolled bleeding is a major preventable cause of death in trauma

More information

Standard gauze field dressings and direct pressure are

Standard gauze field dressings and direct pressure are Special Report The Journal of TRAUMA Injury, Infection, and Critical Care A Special Report on the Chitosan-based Hemostatic Dressing: Experience in Current Combat Operations Ian Wedmore, MD, John G. McManus,

More information

Alberta Health Services - Edmonton Zone Massive Hemorrhage Protocol

Alberta Health Services - Edmonton Zone Massive Hemorrhage Protocol This document applies to all Covenant and AHS sites. Client Resource 23: Alberta Health Services - Edmonton Zone Regional Laboratory Services This document is applicable at site(s): GNH MIS RAH SGH UAH

More information

HEMOSTASIS IN SURGERY

HEMOSTASIS IN SURGERY Greco D.P.- M.D.-F.A.C.S. Director SSD Day Surgery Torino 25-27 november 2010 HEMOSTASIS IN SURGERY The normal physiological response that prevents significant blood loss following vascular injury is called

More information

The evolution of TQIP Best Practices for Massive Transfusion

The evolution of TQIP Best Practices for Massive Transfusion The evolution of TQIP Best Practices for Massive Transfusion Bryan A Cotton, MD, MPH Associate Professor of Surgery Department of Surgery and The Center for Translational Injury Research University of

More information

INSTRUCTIONS FOR USE FOR:

INSTRUCTIONS FOR USE FOR: INSTRUCTIONS FOR USE FOR: en English INSTRUCTIONS FOR USE GORE ENFORM INTRAPERITONEAL BIOMATERIAL Carefully read all instructions prior to use. Observe all instructions, warnings, and precautions noted

More information

Workplace Violence. Workplace Violence. Work Safe: Preventing Injuries and Workplace Violence. Gene R. La Suer Davis Brown Law Firm

Workplace Violence. Workplace Violence. Work Safe: Preventing Injuries and Workplace Violence. Gene R. La Suer Davis Brown Law Firm Work Safe: Preventing Injuries and Gene R. La Suer Davis Brown Law Firm What is workplace violence? Workplace violence is any act or threat of physical violence, harassment, intimidation, or other threatening

More information

PREVELEAK Surgical sealant

PREVELEAK Surgical sealant PREVELEAK Surgical sealant Rx only Instructions for Use DEVICE DESCRIPTION PREVELEAK Surgical sealant (PREVELEAK) is a sealant developed to seal suture holes formed during surgical repair of the circulatory

More information

Regulation of Absorbable Hemostatic Agents: Guidance for. Encouraging Innovation Without Compromising Patient Safety

Regulation of Absorbable Hemostatic Agents: Guidance for. Encouraging Innovation Without Compromising Patient Safety Regulation of Absorbable Hemostatic Agents: Guidance for Encouraging Innovation Without Compromising Patient Safety Jeffrey H. Lawson, M.D. Ph.D. 1, William Spotnitz, M.D. 2, David Albala, M.D. 3, L. Tim

More information

DuraGen Secure. Dural Regeneration Matrix

DuraGen Secure. Dural Regeneration Matrix DuraGen Secure Dural Regeneration Matrix DESCRIPTION DuraGen Secure Dural Regeneration Matrix is an absorbable implant for the repair of dural defects. DuraGen Secure Dural Regeneration Matrix is an easy

More information

ISO INTERNATIONAL STANDARD. Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

ISO INTERNATIONAL STANDARD. Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process INTERNATIONAL STANDARD ISO 10993-1 Fourth edition 2009-10-15 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process Évaluation biologique des dispositifs

More information

MILITARY PHARMACY AND MEDICAL SUPPLY

MILITARY PHARMACY AND MEDICAL SUPPLY 6 MILITARY PHARMACY AND MEDICAL SUPPLY 289 6 MILITARY PHARMACY AND MEDICAL SUPPLY MILITARY PHARMACY AND MEDICAL SUPPLY APPLICATION OF INNOVATIVE TECHNOLOGIES FOR MANUFACTURING INFUSIVE SOLUTIONS IN DRUGSTORES

More information

Control Your Energy. with the Right Settings. A guide to monopolar energy with the ERBE VIO dv. PN US Rev A 04/17

Control Your Energy. with the Right Settings. A guide to monopolar energy with the ERBE VIO dv. PN US Rev A 04/17 Control Your Energy with the Right Settings A guide to monopolar energy with the ERBE VIO dv A Versatile Energy Source at your fingertips The VIO dv generator offers a variety of monopolar settings so

More information

External Defibrillator Improvement Initiative

External Defibrillator Improvement Initiative External Defibrillator Improvement Initiative November 2010 Center for Devices and Radiological Health U.S. Food and Drug Administration External Defibrillator Improvement Initiative Table of Contents

More information

Medical Devices INNOVATIVE SOLUTION FOR THE HEALTHCARE

Medical Devices INNOVATIVE SOLUTION FOR THE HEALTHCARE Medical Devices INNOVATIVE SOLUTION FOR THE HEALTHCARE Medical Devices The new Regulation 745/2017 defined as Medical Device any instrument, apparatus, appliance, software, implant, reagent, material or

More information

3M Tegaderm PICC/CVC Securement Device + I.V. Advanced Securement Dressing Product Description

3M Tegaderm PICC/CVC Securement Device + I.V. Advanced Securement Dressing Product Description 3M Tegaderm PICC/CVC Securement Device + I.V. Advanced Securement Dressing Product Description 3M Tegaderm PICC/CVC Securement Device + I.V. Advanced Securement Dressing ( Securement System ) is designed

More information

February 17, DSM Biomedical Ms. Brianna Jordan Regulatory Specialist 735 Pennsylvania Drive Exton, Pennsylvania 19341

February 17, DSM Biomedical Ms. Brianna Jordan Regulatory Specialist 735 Pennsylvania Drive Exton, Pennsylvania 19341 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 February 17, 2015 DSM

More information

The Lancet Publishes Results from the Landmark Phase III Rivaroxaban Study RECORD2

The Lancet Publishes Results from the Landmark Phase III Rivaroxaban Study RECORD2 News Release Bayer HealthCare AG Corporate Communications 51368 Leverkusen Germany Phone +49 214 30 1 www.news.bayer.com Venous Blood Clot Prevention after Hip Replacement Surgery: The Lancet Publishes

More information

Labelling, decanting and repackaging hazardous substances in the workplace

Labelling, decanting and repackaging hazardous substances in the workplace November 2017 H E A LT H & S A F E T Y AT WO R K HSWA AC T QUICK GUIDE Labelling, decanting and repackaging hazardous substances in the workplace KEY FACTS Make sure all containers in your workplace are

More information

BAXTER ANNOUNCES AGREEMENT TO BROADEN PORTFOLIO OF INNOVATIVE SURGICAL PRODUCTS

BAXTER ANNOUNCES AGREEMENT TO BROADEN PORTFOLIO OF INNOVATIVE SURGICAL PRODUCTS FOR IMMEDIATE RELEASE Media Contact: Beth Mueller, (224) 948-5353 media@baxter.com Investor Contact: Clare Trachtman, (224) 948-3085 BAXTER ANNOUNCES AGREEMENT TO BROADEN PORTFOLIO OF INNOVATIVE SURGICAL

More information

Say goodbye to bulky, toxic first aid. The future is just three ounces.

Say goodbye to bulky, toxic first aid. The future is just three ounces. First Aid Simplified Introducing the first multifunctional, non-toxic, skin and wound repair solution. Powered by the same molecule produced by our bodies in response to injury, this medical-grade, clinically

More information

EDUCATIONAL COMMENTARY MASSIVE TRANSFUSION PROTOCOL

EDUCATIONAL COMMENTARY MASSIVE TRANSFUSION PROTOCOL EDUCATIONAL COMMENTARY MASSIVE TRANSFUSION PROTOCOL Commentary provided by: Kathleen Trudell MLS (ASCP) CM SBBCM University of Nebraska Medical Center Division of Medical Laboratory Science College of

More information

Potassium Salt 5 to 20 Ion Exchange Resin 80 to 95

Potassium Salt 5 to 20 Ion Exchange Resin 80 to 95 MSDS Material Safety Data Sheet Effective Date: March 25, 2008 From: 1235 Tallevast Rd Sarasota, FL 34243 Phone: 941-360-1300 or Local Poison Control QR Powder (Packaged in individual packages) 1. Product

More information

ISO INTERNATIONAL STANDARD. Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process

ISO INTERNATIONAL STANDARD. Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process INTERNATIONAL STANDARD ISO 10993-1 Fourth edition 2009-10-15 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process Évaluation biologique des dispositifs

More information

Hydrogel and hemostatic dressings in body injuries

Hydrogel and hemostatic dressings in body injuries Military Pharmacy and Medicine 2012 1 43 49 Emergency Medicine Hydrogel and hemostatic dressings in body injuries Michał Starosolski Water Jel OLT for Poland, doctoral candidate of Medical University of

More information

Clotalyst. Autologous Activation Solution. Surgical Technique

Clotalyst. Autologous Activation Solution. Surgical Technique Clotalyst Autologous Activation Solution Surgical Technique Table of Contents Product Overview... 1-2 Processing Technique...3-9 Ordering Information... 10-13 Indication... 14 1 Clotalyst Autologous Activation

More information

Safety data sheet according to 1907/2006/EC, Article 31

Safety data sheet according to 1907/2006/EC, Article 31 Page 1/7 1 Identification of the substance/mixture and of the company/undertaking Product identifier Article number: 255771 Relevant identified uses of the substance or mixture and uses advised against

More information

SAFETY DATA SHEET. For research use only. Not intended for human or animal diagnostic or therapeutic uses.

SAFETY DATA SHEET. For research use only. Not intended for human or animal diagnostic or therapeutic uses. SAFETY DATA SHEET Date updated: 2016/1/14 SECTION 1: Identification of the substance/mixture and of the company/undertaking Identification of the substance or mixture Product code: CAC-NM-DND-001 Product

More information

D-Stat Dry Topical Hemostat Proven to Reduce Time-to-Hemostasis 1,2

D-Stat Dry Topical Hemostat Proven to Reduce Time-to-Hemostasis 1,2 D-Stat Dry Topical Hemostat Proven to Reduce Time-to-Hemostasis 1,2 Clinical Data to Support a True Hemostat Results are from a 376-patient, five-center, prospective randomized U.S. clinical study evaluating

More information

Medical Device Testing. Andrew Makin, MSc, ERT, MRSB Scientific Director CiToxLAB Scantox, Denmark

Medical Device Testing. Andrew Makin, MSc, ERT, MRSB Scientific Director CiToxLAB Scantox, Denmark Medical Device Testing Andrew Makin, MSc, ERT, MRSB Scientific Director CiToxLAB Scantox, Denmark Medical device Risk evaluation Efficacy Biocompatibility Clinical testing Pharmaceutical product Preclinical

More information

Celaire Non-Woven Materials A Natural Solution for Wound Care Copyright 2011 Celanese Corporation

Celaire Non-Woven Materials A Natural Solution for Wound Care Copyright 2011 Celanese Corporation Celaire Non-Woven Materials A Natural Solution for Wound Care 0 Concerns Heard in Wound Care Today From Practitioners From Manufacturers / Distributors Affordable wound care options often cause re-injury

More information

Hematology Emergencies: Problems with Platelets

Hematology Emergencies: Problems with Platelets Hematology Emergencies: Problems with Platelets Christian Cable, MD, FACP Associate Professor of Medicine Division of Hematology & Oncology Texas A&M HSC College of Medicine Scott & White Healthcare Fundamentals

More information

MEDICAL WASTE MANAGEMENT STUDY NOTES

MEDICAL WASTE MANAGEMENT STUDY NOTES MEDICAL WASTE MANAGEMENT STUDY NOTES UNIT 1 INTRODUCTION Hospital and other health care establishment has a duty of care for the environment and for public health and have particular responsibility in

More information

Safety data sheet according to 1907/2006/EC, Article 31

Safety data sheet according to 1907/2006/EC, Article 31 Page 1/7 Not classified as hazardous according to criteria of Australian Safety and Compensation Council 1 Identification of the substance/mixture and of the company/undertaking Product identifier Article

More information

Implementation of massive transfusion protocols to guide practice in severe bleeding- is your institution ready?

Implementation of massive transfusion protocols to guide practice in severe bleeding- is your institution ready? Implementation of massive transfusion protocols to guide practice in severe bleeding- is your institution ready? Ryan Zarychanski MD MSc University of Manitoba Sections of Hematology and Critical Care

More information

Use of Thromboelastography in the Management of the Trauma Patient Rio Grande Trauma Conference

Use of Thromboelastography in the Management of the Trauma Patient Rio Grande Trauma Conference Use of Thromboelastography in the Management of the Trauma Patient Rio Grande Trauma Conference John A. Aucar, MD, MSHI, FACS, CPE EmCare Acute Care Surgery Del Sol Medical Center Associate Professor,

More information

Lance Safety Heelstick

Lance Safety Heelstick Lancing Devices White Paper: Lance Safety Heelstick Defining, Translating and Validating Safety Features Abstract This white paper describes the redesigned babylance safety heelstick s safety features

More information

Guidance for FDA Reviewers

Guidance for FDA Reviewers Guidance for FDA Reviewers Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood Components Comments and suggestions regarding this document may be

More information

ADVANCED WOUND CARE MANAGEMENT

ADVANCED WOUND CARE MANAGEMENT POREX, FILTRATION GROUP ADVANCED WOUND CARE MANAGEMENT Innovative medical grade foams for acute and chronic wounds POREX Wound Care Foams The ideal wound care solution Our high performance medical grade

More information

Restore Foam Dressing Silver, Non-Adhesive with TRIACT Technology. Libertyville, Illinois USA

Restore Foam Dressing Silver, Non-Adhesive with TRIACT Technology. Libertyville, Illinois USA Section 1: Identification Product Name: Restore Foam Dressing Silver, Non-Adhesive with TRIACT Technology Product Code: 509345, 509346 SDS Manufacturer Number: 509345, 509346 Manufacturer Name: Address:

More information

The Role Of Point of Care Coagulation Testing (POCCT) in Patient Blood Management. Elham Khalaf Adeli

The Role Of Point of Care Coagulation Testing (POCCT) in Patient Blood Management. Elham Khalaf Adeli The Role Of Point of Care Coagulation Testing (POCCT) in Patient Blood Management Elham Khalaf Adeli Overview PBM, bleeding management, Coagulation POC Testing Review of laboratory conventional coagulation

More information

What do you think? Problems and solution. Mechanism of PolySTAT & evaluation. Schaub 17:00 R09

What do you think? Problems and solution. Mechanism of PolySTAT & evaluation. Schaub 17:00 R09 Schaub 17:00 R09 Disclaimer This paper partially fulfills a writing requirement for first year (freshman) engineering students at the University of Pittsburgh Swanson School of Engineering. This paper

More information

New factor concentrates on the way to the market

New factor concentrates on the way to the market New factor concentrates on the way to the market ISCB, Copenhagen, 1 September 2015 John R. Hess, MD, MPH, FACP, FAAAS Professor of Laboratory Medicine and Hematology Medical Director, Transfusion Service,

More information

Hemostatics CHITOGAUZE PRO Z-FOLDED HEMOSTATIC CHITOSAN DRESSING

Hemostatics CHITOGAUZE PRO Z-FOLDED HEMOSTATIC CHITOSAN DRESSING The Next Generation in Hemostatics CHITOGAUZE PRO Z-FOLDED HEMOSTATIC CHITOSAN DRESSING ChitoGauze PRO has greater success than Combat Gauze See in vivo study, pages 3-4 Antibacterial Properties Proven

More information

Deep dive into anticoagulant reversal In 20 minutes so we won t dive too deep. Mark Crowther on behalf many Some slides modified from other sources

Deep dive into anticoagulant reversal In 20 minutes so we won t dive too deep. Mark Crowther on behalf many Some slides modified from other sources Deep dive into anticoagulant reversal In 20 minutes so we won t dive too deep Mark Crowther on behalf many Some slides modified from other sources 1 Disclosures Major disclosure: Paid consulting with Portola,

More information

BAXTER UNVEILS DESIGN ENHANCEMENTS TO FLOSEAL AND TISSEEL HEMOSTATIC AGENTS AT AORN MEETING

BAXTER UNVEILS DESIGN ENHANCEMENTS TO FLOSEAL AND TISSEEL HEMOSTATIC AGENTS AT AORN MEETING FOR IMMEDIATE RELEASE Media Contact Beth Mueller, (224) 948-5353 media@baxter.com Investor Contact Clare Trachtman, (224) 948-3085 BAXTER UNVEILS DESIGN ENHANCEMENTS TO FLOSEAL AND TISSEEL HEMOSTATIC AGENTS

More information

How Pre-Validated Medical Device Packaging Complies with ISO Standards

How Pre-Validated Medical Device Packaging Complies with ISO Standards How Pre-Validated Medical Device Packaging Complies with ISO Standards Introduction There is a lot of excitement in the medical device packaging industry about pre-validated packaging. Using pre-validated

More information

Get the most out of Pure PRP

Get the most out of Pure PRP Get the most out of Pure PRP The Basic Science of PRP Platelets are small non-nucleated bodies in peripheral blood known for role in hemostasis Platelets contain proteins, cytokines & other bioactive factors

More information

SAFETY DATA SHEET. 1/10 Supersedes date: P/N-no.:

SAFETY DATA SHEET. 1/10 Supersedes date: P/N-no.: 1/10 SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING Product identifier Product name: Container size: 942-073 D8088+D8089 Crea membrane box A+B 943-833 S4921 Rinse Solution

More information

SELECTIVE LASER MELTED TUNGSTEN

SELECTIVE LASER MELTED TUNGSTEN January 2016 Page 1 of 5 1. Identification of the Substance/Mixture and of the Company/Undertaking 1.1 Product Identifier Material Name: Selective Laser Melted Tungsten. 1.2 Relevant identified uses of

More information

Material Safety Data Sheet LR 30 RESIN

Material Safety Data Sheet LR 30 RESIN Page 1 / 6 1 Identification of the substance/preparation and of the company/undertaking Product details Trade name: LR 30 RESIN Application of the substance / the preparation Epoxy resin Composition/information

More information

Guideline on the label design for Injections (Draft for Comments)

Guideline on the label design for Injections (Draft for Comments) Guideline on the label design for Injections (Draft for Comments) 2018.3 Content Foreword... 3 1. Scope... 4 2. Terms and definitions... 4 3. Basic requirements for labels... 4 4. Design principles of

More information

Precision. Proficiency. Proximity.

Precision. Proficiency. Proximity. Precision. Proficiency. Proximity. Precision Accuracy in testing is paramount to ensuring product safety and efficacy. And fast turnaround times are critical to keeping your project on schedule. With

More information

Safety data sheet according to 1907/2006/EC, Article 31

Safety data sheet according to 1907/2006/EC, Article 31 Page 1/7 1 Identification of the substance/mixture and of the company/undertaking Product identifier Part number: DRE-C10293000 CAS Number: 65710-07-8 EC number: 256-890-7 Relevant identified uses of the

More information

Guidelines for the use of blood warming devices(aabb) Reference: 2002 AABB

Guidelines for the use of blood warming devices(aabb) Reference: 2002 AABB Guidelines for the use of blood warming devices(aabb) Reference: 2002 AABB 1 Hypothermia Introduction Induced by rapid, large-volume transfusion of refrigerated blood components A potential source of serious

More information

Safety data sheet. according to 1907/2006/EC, Article 31. Printing date Revision:

Safety data sheet. according to 1907/2006/EC, Article 31. Printing date Revision: Page 1/5 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1 Product identifier 1.2 Relevant identified uses of the substance or mixture and uses advised against Application

More information

Material Safety Data Sheet According to EU Regulation 1907/2006

Material Safety Data Sheet According to EU Regulation 1907/2006 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1 Product Identifier Product Name Biological Definition INCI Name Lycium Barbarum Fruit Extract & Helianthus Annus Seed

More information

Artist Proof: Clotalyst. Autologous Serum Collection System

Artist Proof: Clotalyst. Autologous Serum Collection System Artist Proof: 01-15-10 Clotalyst Autologous Serum Collection System Clotalyst Autologous Serum The kit is designed for the preparation of autologous serum that is to be mixed with PRP and autograft or

More information

FINAL PUBLISHABLE SUMMARY REPORT

FINAL PUBLISHABLE SUMMARY REPORT FINAL PUBLISHABLE SUMMARY REPORT Grant Agreement number: 310389 Project acronym: BIP-UPY Project title: Bioactive Implantable Polymers based on Ureido-Pyrimidinone Funding Scheme: Large-scale integrating

More information

Safety data sheet according to 1907/2006/EC, Article 31

Safety data sheet according to 1907/2006/EC, Article 31 Page 1/6 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1 Product identifier Article number: 29036 1.2 Relevant identified uses of the substance or mixture and uses

More information

ESSENTIAL ENERGY FOR PROVEN PATIENT OUTCOMES

ESSENTIAL ENERGY FOR PROVEN PATIENT OUTCOMES ESSENTIAL ENERGY FOR PROVEN PATIENT OUTCOMES LigaSure Curved Jaw Device GRASP. SEAL. AND CUT. WITH ONE DEVICE. Let s move beyond mechanical ligation to a higher level of performance in open surgery The

More information

Platelet Concentrate in Total Knees BIOLOGICS. This brochure is for International use only. It is not for distribution in the United States.

Platelet Concentrate in Total Knees BIOLOGICS. This brochure is for International use only. It is not for distribution in the United States. Platelet Concentrate in Total Knees BIOLOGICS This brochure is for International use only. It is not for distribution in the United States. Platelet Concentrate in Total Knees Total Knee Arthroplasty Total

More information

Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices May 1, 1995 (G95-1)

Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices May 1, 1995 (G95-1) Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices May 1, 1995 (G95-1) This guidance was written prior to the February 27, 1997 implementation of FDA s Good Guidance

More information

INSTRUCTIONS FOR USE FOR:

INSTRUCTIONS FOR USE FOR: INSTRUCTIONS FOR USE FOR: B I O M A T E R I A L en English INSTRUCTIONS FOR USE FOR GORE SYNECOR INTRAPERITONEAL BIOMATERIAL INDICATIONS The GORE SYNECOR Intraperitoneal Biomaterial device is intended

More information

ASEAN Consultative Committee for Standards & Quality. Medical Device Product Working Group. Common Submission Dossier Template

ASEAN Consultative Committee for Standards & Quality. Medical Device Product Working Group. Common Submission Dossier Template ASEAN Consultative Committee for Standards & Quality Medical Device Product Working Group Common Submission Dossier Template 1.0 Introduction The document is intended to provide guidance for submission

More information

MATERIAL SAFETY DATA

MATERIAL SAFETY DATA MATERIAL SAFETY DATA 1. PRODUCT EDITION: 8 DATE: 17-Jan-07 NAME: weber.joint epoxy (fermapoxy) Chemical Nature A two-component paste adhesive based on a Bisphenol A/F epoxy resin, a modified aliphatic

More information

Printing date Revision:

Printing date Revision: Page 1/5 * 1 Identification of the substance/mixture and of the company/undertaking Product identifier Registration number 01-2119490412-42-0003 Relevant identified uses of the substance or mixture and

More information

MATERIAL SAFETY DATA SHEET SECTION 1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION SECTION 2. COMPOSITION, INFORMATION ON INGREDIENTS

MATERIAL SAFETY DATA SHEET SECTION 1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION SECTION 2. COMPOSITION, INFORMATION ON INGREDIENTS MATERIAL SAFETY DATA SHEET INDIUM In 111 CHLORIDE STERILE SOLUTION SECTION 1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION Product Name: Indium In 111 Chloride Sterile Solution Synonyms: In 111 Chloride

More information

Fire/Rescue Science Technology

Fire/Rescue Science Technology Fire/Rescue Science Technology Credentials: AAS Fire/Rescue Science Technology 61-64 Diploma Fire Chief 52-55 Certificate(s) Basic Firefighter 12 Advanced Firefighter 24 Fire Officer 13 Emergency Medical

More information

Safety Data Sheet Product No DMP-30, DMP-30 Kit Components Issue Date ( ) Review Date ( )

Safety Data Sheet Product No DMP-30, DMP-30 Kit Components Issue Date ( ) Review Date ( ) Safety Data Sheet Product No. 18042 DMP-30, DMP-30 Kit Components Issue Date (10-03-14) Review Date (08-31-17) Section 1: Product and Company Identification Product Name: DMP-30, DMP-30 Kit Components

More information

Hemophilia Care. Will there always be new people in the world with. Will hemophilia be treated more effectively and safely

Hemophilia Care. Will there always be new people in the world with. Will hemophilia be treated more effectively and safely Future of This chapter provides answers to these questions: Will there always be new people in the world with hemophilia? Will hemophilia be treated more effectively and safely in the future? Will the

More information

Acute Traumatic Coagulopathy

Acute Traumatic Coagulopathy Jean-Francois Pittet, M.D. Depts of Anesthesia and Surgery Cardiovascular Research Institute University of California San Francisco Acute Traumatic Coagulopathy Plan 1. Description of the coagulation system

More information

Certified Skin & Wound Specialist Examination

Certified Skin & Wound Specialist Examination Certified Skin & Wound Specialist Examination INSTRUCTIONS Please submit the following documents to the American Board of Wound Healing: 1. Signed Attestation Statement (See attached PDF) Confirming the

More information

Material Safety Data Sheet

Material Safety Data Sheet NON-Hazardous Substance, NON-Dangerous Goods 1. MATERIAL AND SUPPLY COMPANY IDENTIFICATION Manufacturer s Code: 505 Recommended use: Multipurpose cleaner. Spray onto surface rinse off with potable water.

More information

Material Safety Data Sheet acc. to ISO/DIS 11014

Material Safety Data Sheet acc. to ISO/DIS 11014 Page 1/6 1 Identification of the substance/mixture and of the company/undertaking Product Identifier Catalog Number: 225650 Details of the supplier of the safety data sheet Manufacturer/Supplier: BD Diagnostic

More information