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BIOSEAL ADVANCED Application

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Presentation on theme: "BIOSEAL ADVANCED Application"— Presentation transcript:

1 BIOSEAL ADVANCED Application
Welcome to the BIOSEAL ADVANCED Application Computer-Based Learning (CBL) Module Who should take this CBL? Any healthcare professional (physician, nurse or technician) involved in diagnostic or interventional procedures performed in a Cath Lab or Interventional Radiology (IR) setting, or the care of patients following such procedures.

2 Menu It will take approximately 20 minutes to navigate through this CBL and complete the post-test at the end. A score of 80% or higher is considered a passing score. Click the links below to jump to selected “chapters” in the course. Introduction What is BIOSEAL ADVANCED Powder? How does BIOSEAL ADVANCED Powder work? Instructions for Use Protocol Tips More Information on BIOSEAL ADVANCED Summary References

3 Introduction Course Objectives
Describe BIOSEAL ADVANCED Powder and how it is used Describe the mechanism of action of BIOSEAL ADVANCED Powder Discuss the benefits of BIOSEAL ADVANCED Powder Learn protocol for applying BIOSEAL ADVANCED Powder for vascular access procedures Learn BIOSEAL ADVANCED Powder application tips Learn how to find more information on the product and how to order BIOSEAL ADVANCED Powder

4 Introduction What is BIOSEAL ADVANCED Powder?
BIOSEAL ADVANCED Powder is a topical hemostatic powder that controls external bleeding from arterial access procedures, hemodialysis maintenance and other diagnostic or interventional procedures. When placed on an access site as an adjunct to manual pressure, BIOSEAL ADVANCED Powder quickly forms an occlusive seal and microbial barrier that covers the access site, stops blood flow and helps prevent infection. Once bleeding has stopped, natural clotting occurs below the seal, along the tract and at the arteriotomy. BioSeal drastically reduces hold times regardless of anticoagulation level. The ingredients are a mixture of a hydrophilic polymer and potassium ferrate.

5 Introduction Target Applications Cardiac Cath Labs
Sheath removal from interventional and diagnostic procedures Bleeding/oozing following closure device deployment Interventional Radiology Sheath removal from vascular access procedures Hemodialysis access maintenance (AV fistula/graft) Bleeding oozing from temporary dialysis catheters Other diagnostic or interventional procedures resulting in external bleeding

6 Introduction Consistent 5-Minute Hold Times For Fistula Declots & Other Challenging AVDA Procedures BioSeal ADVANCED is efficacious for: Challenging declots, fistulagrams, fistulaplasties and other access procedures Patients with low platelet counts or anticoagulated patients (i.e., on blood thinners) “I routinely use BioSeal in access procedures. I tell people I call it “magic dust” ... and to try it, they will love it.” Scott O. Trerotola, MD Professor of Radiology and Surgery Associate Chair and Chief, Interventional Radiology University of Pennsylvania School of Medicine

7 Introduction Review Question
The ingredients of BIOSEAL ADVANCED Powder are: A. An oxidized cellulose gauze B. A hydrophilic polymer and potassium ferrate C. A calcium alginate wound dressing D. Chitosan and potassium Place the pointer over the desired answer and click the left mouse button for immediate feedback.

8 How Does It Work? Mechanism of Action
BIOSEAL ADVANCED Powder creates a seal or barrier to stop the flow of blood or control exudate. The mechanism of action is a simultaneous two step action: 1. The polymer rapidly dehydrates the blood, stacking up the solid components. 2. The ferrate component agglomerates the solid components creating an occlusive barrier. BIOSEAL ADVANCED Powder Actual electron microscopy image

9 How Does It Work? The Science of the “BIOSEAL”
The Powder + Pressure = Seal that works as an occlusive dressing to: Provide a barrier that stops the flow of blood or exudate OUT of the wound and prevents microbes from coming IN to the wound. Create a hostile environment to inhibit microbial activity (pH above the seal is ~2 and neutral below the seal). Bacteria H20, Ca++, Na+, K+ Desiccation H+ BioSeal Powder above seal The Seal

10 The seal following dressing removal
How Does It Work? Product Benefits Quickly creates a microbial barrier/seal that allows nothing in/nothing out of the vascular access site Drastically reduces hold times regardless of anticoagulation level Proven to achieve hemostasis in less than two minutes for venous access procedures and four minutes for arterial procedures, based on a single-institution retrospective review (mean times) Seal remains in place until wound healing is complete and it falls off naturally (seal travels home with the patient) The seal following dressing removal

11 How Does It Work? More Product Benefits
Works independently of the clotting cascade - works for patients on anticoagulants/problem bleeders Increases patient comfort (through reduction of hold times) Easy to use More cost-effective than vascular closure devices or hemostatic pads 11

12 How Does It Work? Review Question
A characteristic or benefit of the “BIOSEAL” is: A. It stops the flow of blood. B. It provides a barrier that allows "nothing in, nothing out." C. It creates a hostile environment to inhibit microbial activity. D. All of the above. Place the pointer over the desired answer and click the left mouse button for immediate feedback.

13 How Does It Work? Review Question
BIOSEAL is dependent on the natural clotting cascade. True False Place the pointer over the desired answer and click the left mouse button for immediate feedback. 13

14 Instructions for Use Femoral Sheath Pulls
Clean and dry the area around the site. Withdraw sheath leaving at least 3 to 4 centimeters under the skin. Remove PCD from package, peel paper backing and center (PCD) around sheath. Pour powder into PCD - lift sheath gently to ensure powder gets under sheath, then create a pile of powder around the sheath and completely fill the PCD. Place PCD center (foam insert) over the powder. Pull sheath slowly while applying pressure over the arteriotomy and the insertion site.

15 Instructions for Use (continued)
BioSeal Advanced is a manual pressure adjunct. For initial uses, start at current manual pressure hold times then gradually adjust downward. Extend hold times as necessary for hypertensive patients, anticoagulated patients, e.g. - low platelets, high ACT levels – or larger sheath sizes. Release pressure slowly; Roll fingers off PCD*. Place transparent dressing per protocol; Apply product description label on top of dressing to identify powder. Provide discharge instructions to patient or caregiver. Follow your normal ambulation protocol. *If bleeding continues, apply more powder as necessary with manual compression until bleeding stops.

16 Instructions for Use Sheath Removal Following Fistula/Graft Access
The protocol for BioSeal ADVANCED application for sheath removal from fistula/graft access is similar to that of femoral sheath removal with these differences: After 5 minutes* of continuous pressure, relieve pressure slightly without removing the PCD center (foam insert); then roll fingers away to assess site. If bleeding/oozing is visible through PCD, continue to apply additional pressure for 2 minutes and re-assess; if necessary, you can apply more BioSeal ADVANCED powder and resume holding. If no bleeding/oozing is visible, carefully clean PCD with clean gauze if necessary. Follow your normal ambulation protocol. Instruct patient to minimize arm flexion for at least 30 minutes and to leave seal in place once dressing is removed. Avoid needle punctures through seal. *Extend hold times as necessary for larger sheaths, hypertensive patients or anticoagulated patients

17 Instructions for Use Review Question
When applying BIOSEAL ADVANCED following femoral sheath removal you should do which of the following: A. Pull sheath quickly. B. Do not use for anti-coagulated patients. C. Start with current hold times then gradually adjust downward. D. Place gauze over site. Place the pointer over the desired answer and click the left mouse button for immediate feedback.

18 Protocol Tips When placing the PCD, try to make the application area as flat as possible (less vertical). Make sure gloves are completely dry. When removing the sheath, pull slowly to reduce surge of blood/pressure and minimize displacement of powder. Avoid using gauze to hold pressure as it may adhere to the powder and disrupt the seal when removed. Apply continuous pressure over the arteriotomy and over the insertion site (don’t peek for at least 5 minutes). Remind patients not to remove the seal. 18

19 Review Question When holding pressure following sheath removal and application of BIOSEAL ADVANCED, it is not necessary to extend holding times based on anti-coagulation levels, platelet levels, ACT levels or larger sheath sizes. True False Place the pointer over the desired answer and click the left mouse button for immediate feedback.

20 More Information on BIOSEAL ADVANCED
Educational Tools There are resources available to educate both patients and clinicians about BIOSEAL ADVANCED. These resources include: Brochures for Medical Staff Posters Protocol sheets Patient Discharge Instructions – included in every package of BIOSEAL ADVANCED These resources are available at

21 More Information on BIOSEAL ADVANCED
Ordering Information BIOSEAL ADVANCED Powder is available as follows: 6 Sterile Bottles per Box – LP607 24 Sterile Bottles per Case – LP637 Each unit includes bottle, PCD, foam insert, identification sticker and Patient Discharge Information. Contact your local Biolife Sales Representative or call Biolife at to place your order.

22 More Information on BIOSEAL ADVANCED
Review Question Educational tools for BIOSEAL ADVANCED Powder must be special ordered from Biolife. True False Place the pointer over the desired answer and click the left mouse button for immediate feedback.

23 Summary This CBL course has focused on:
The components and mechanism of action of BIOSEAL ADVANCED Powder How and where BIOSEAL ADVANCED is used The benefits of BIOSEAL ADVANCED BIOSEAL ADVANCED Instructions for Use BIOSEAL ADVANCED protocol tips How to find more information on the product and how to order BIOSEAL ADVANCED

24 References/Credits Wang DS, Chu LF, Olson SE, Miller FJ,  Valji K, Wong WH, Rose SC, Austin M, Kuo MD. Comparative Evaluation of Noninvasive Compression Adjuncts for Hemostasis in Percutaneous Arterial, Venous, and Arteriovenous Dialysis Access Procedures.  J Vasc Interv Radiol 2008; 19: Photos are the property of Biolife, LLC.

25 Exit We hope this Computer Based Learning course has been both informative and helpful. Feel free to review the screens of this course until you are confident about your knowledge of the material presented. Press Esc key to exit presentation and then close PowerPoint® application.* (*this screen can be customized to interface with each institution’s learning management system).

26 Review Question Feedback
Correct Your answer is correct! BIOSEAL ADVANCED Powder is made of a hydrophilic polymer and a potassium ferrate. Return to Course

27 Review Question Feedback
Incorrect Your answer is incorrect! BIOSEAL ADVANCED Powder is made of a hydrophilic polymer and a potassium ferrate. Return to Course

28 Review Question Feedback
Correct Your answer is correct! The “BIOSEAL” stops the flow of blood, provides a barrier that allows nothing in/nothing out, and creates a hostile environment to inhibit microbial activity. Return to Course

29 Review Question Feedback
Incorrect Your answer is incorrect! All of the above is the correct answer. The “BIOSEAL” stops the flow of blood, provides a barrier that allows nothing in/ nothing out, and creates a hostile environment to inhibit microbial activity. Return to Course

30 Review Question Feedback
Incorrect Your answer is incorrect! BIOSEAL ADVANCED Powder functions independently of the clotting cascade (works for “problem bleeders.”) Return to Course 30

31 Review Question Feedback
Correct Your answer is correct! BIOSEAL ADVANCED Powder functions independently of the clotting cascade (works for “problem bleeders.”) Return to Course 31

32 Review Question Feedback
Incorrect Your answer is incorrect! The correct answer is C. Following femoral sheath removal, start with current hold times, then gradually adjust downward. Return to Course 32

33 Review Question Feedback
Correct Your answer is correct! When applying BIOSEAL ADVANCED following femoral sheath removal, start with current hold times, then gradually adjust downward. Return to Course

34 Review Question Feedback
Incorrect Your answer is incorrect. It may be necessary to extend holding times based on anti-coagulation levels, platelet levels, ACT levels or larger sheath sizes. Return to Course

35 Review Question Feedback
Correct Your answer is correct! It may be necessary to extend holding times based on anti-coagulation levels, platelet levels, ACT levels or larger sheath sizes. Return to Course

36 Review Question Feedback
Correct Your answer is correct! Educational tools for BIOSEAL ADVANCED are available online at Patient Discharge Instructions come in each product package. Return to Course

37 Review Question Feedback
Incorrect Your answer is incorrect! Educational tools for BIOSEAL ADVANCED are available online at Patient Discharge Instructions come in each product package. Return to Course


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