StatLock® Universal Plus Stabilization Device
- The StatLock® Universal Plus Stabilization Device sets the new standard of excellence for suture-free stabilization of biliary and nephrostomy percutaneous drainage, and peritoneal lavage catheters.
- Advanced technologies now combine with the StatLock® Stabilization Device design sophistication to deliver skin-safe, suture-free, releasable stabilization of even the most lubricious catheters.
- The StatLock® Universal Plus Stabilization Device comes in four sizes, to fit virtually all percutaneous drainage catheters:
- small (6-8.5 Fr)
- medium (10-12 Fr)
- large (12-14 Fr)
- extra large (14-16 Fr) -The extra large size is especially adapted to secure 14-16 Fr. peritoneal lavage catheters.
StatLock® Stabilization Devices are a more effective alternative to tape in helping improve clinical outcomes, quality of care and economic efficiencies. The StatLock® Universal Plus Stabilization Device is a suture-free stabilization device for biliary and nephrostomy drainage and peritoneal lavage catheters. It comes in four sizes: small (6-8.5 Fr), medium (10-12 Fr), large (12-14 Fr) and extra-large (14-16 Fr) .
Please consult product labels, IFU, and package inserts for any indications, contraindications, hazards, warnings, cautions, and instructions for use.
|Stand Alone/Kit||Size||Description||Item |
Specifications subject to change without notice.
Please refer below to the Instructions for Use (IFUs) for any indications, contraindications, hazards, warnings, and cautions.
INDICATIONS FOR USE: The StatLock® stabilization device is compatible for medical tubes and catheters.
CONTRAINDICATIONS: Known tape or adhesive allergies. Known sensitivity to benzoin. (Zinc Oxide PICC Neonatal Universal)
WARNINGS AND PRECAUTIONS
- Do not use the StatLock® stabilization device where loss of adherence could occur, such as with a confused patient, unattended access device, diaphoretic or non-adherent skin, or when the access device is not monitored daily.
- Observe universal blood and body fluid precautions and infection control procedures, during the StatLock® stabilization device application and removal.
- Suture the StatLock® stabilization device pad to skin if necessary or deemed necessary.
- Avoid the StatLock® stabilization device contact with alcohol or acetone, both can weaken bonding of components and the StatLock® stabilization device pad adherence.
- Minimize catheter manipulation during StatLock® stabilization device application and removal.
- Remove oil and moisturizer from targeted skin area.
- The StatLock® stabilization device pad adherence and catheter/tube position should be routinely inspected.
- Orient the StatLock® stabilization device so arrows point toward the catheter tip.
- The StatLock® stabilization device should be replaced every 7 days.
- A StatLock® stabilization device luer-lock connector must be used to secure venous and arterial catheters.
- Always apply the adhesive strip to central venous and arterial catheters at or near the insertion site when using a StatLock® stabilization device.
- This is a single use device. Reuse/and or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patent.
- Do not re-sterilize. The sterility of the single use device is not guaranteed following re-sterilization because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infection complications. Re-sterilization may compromise the structural integrity, essential material and/or design characteristics and may lead to an unpredictable loss of functionality and/or device failure.
- Special Patient Population
- Do not use alcohol or acetone containing products on pre-term infants
Quality of Care
The Unrivaled Evidence You Need To Proceed
Clinical studies comparing the stabilization of catheter using tape versus StatLock® stabilization devices demonstrate that the StatLock® stabilization devices are unrivaled in helping to improve patient outcomes, quality of care and economic efficiencies. 5,2,11
The results demonstrate that the innovative designs of StatLock® stabilization devices provide superlative results in promoting healthcare worker safety and patient satisfaction. The comparative data makes a persuasive case as to why StatLock® stabilization devices are more effective than traditional forms of tape and suture stabilization to achieve the positive outcomes you seek.
Enhances Patient Care
StatLock® stabilization device for Peripheral IV Catheter:
- Meets the 2006 INS Standards that state "whenever feasible, using a manufactured catheter stabilization device is preferred."31
- Increases IV catheter dwell times from 44 hours to 98 hours 4,27
- Decreases unscheduled IV catheter restarts from approximately 71% to 17% 5
- Eliminates the use of non-sterile tape which has a 74% contamination rate StatLock® stabilization device for PICC Catheter 13
StatLock® stabilization device for PICC Catheter:
- Meets the 2006 INS Standards that state "Whenever feasible, using a manufactured catheter stabilization device is preferred." 31
- Eliminates suture related needlesticks 18,29,30
StatLock® stabilization device for Arterial Catheter:
- Meets the 2006 INS Standards that state "Whenever feasible, using a manufactured catheter stabilization device is preferred." (31)
For references, click here
StatLock® STABILIZATION DEVICES DELIVER PROVEN PERFORMANCE
The StatLock® stabilization device portfolio is a family of proprietary, mechanical, IV catheter stabilization devices with the proven ability to reduce IV therapy complications, improve nursing efficiency, and decrease the costs of complications.5,11
StatLock® stabilization devices are designed to minimize complications resulting from movement of a catheter and may help to reduce vessel trauma.2,3,27
StatLock® stabilization devices have demonstrated many significant advantages, for both patients and healthcare providers, compared to conventional methods of catheter securement.27
StatLock® STABILIZATION DEVICES DELIVER PROVEN CLINICAL BENEFITS
StatLock® IV stabilization devices reduce catheter tip micromotion better than tape and provide greater stability over time
(data on file)
StatLock® IV stabilization devices maintain IV catheter placement better than other devices currently on the market(data on file)
StatLock® IV stabilization devices maintain IV catheter placement better than other devices currently on the market
(data on file)
StatLock® IV stabilization devices provide up to 32.7% greater pull strength compared to other devices currently on the market
Skin Pull Test
N=6 per Device, Bench Testing on File
For references, click here
Why Mechanical Stabilization
Preventing IV therapy complications and the resulting unplanned IV restarts can improve patient care, while decreasing nurse intervention time and related patient care costs.
Tape Secured IV Catheters May Cause Complications
Macro and micro-motion or "pistoning" of an IV within a vessel is considered the cause of these complication2,3,4,27
Phlebitis, infiltration, extravasation, occlusion, and dislodgement are common complications5
COMPLICATIONS CAUSE IV THERAPY RESTARTS, WHICH CAN IMPACT THE SAFETY AND COMFORT OF PATIENTS
Movement of an IV within a vein may cause damage to the vessel wall, resulting in complications3
The average taped secured catheter dwell time is just 44 hours –one-third to one-half the 72 to 96 hours per Centers for Disease Control and Prevention guidelines27
Tape Secured Catheter Dwell Times
IV THERAPY INTERRUPTIONS COST TIME AND MONEY
Catheter restarts require nurse intervention and restart costs11
Medicare and other third-party payors will no longer pay the cost of treating preventable errors28
For references, click here
Frequently Asked Questions
Is the StatLock® IV stabilization device appropriate for all patients with PIV's?
Nearly. The StatLock® stabilization device is contraindicated in patients with known allergies to adhesives or tapes. While the StatLock® stabilization device is probably appropriate for more than 99% of your patients; some people have skin that simply will not accept an adhesive-based product – their skin is too flaky, too greasy, or too diaphoretic. Use clinical judgment. Just know that where you can use StatLock® stabilization device, your clinical and cost outcomes will be dramatically improved.
Do I have to use a special skin prep for StatLock® stabilization device IV products?
You do need to extend your insertion site alcohol prep or chlorhexidine prep widely to both sides to cover the securement site. This is a necessary step to cleanse the skin before the StatLock® stabilization device application. Bard Medical recommends the use of the skin prep pad included with the StatLock® stabilization device. The skin prep provides an acrylic layer that protects the skin and enhances adherence of the anchor pad. Performing both of these steps will maximize product performance. When you use the skin prep you'll need to allow it to dry for 10 to 15 seconds and make certain it is dry, meaning smooth to the touch – not tacky. Use your clinical judgment based on assessment of the patient's skin. Just remember, when skin prep is not used the StatLock® stabilization devices may prematurely lift.
Any special tips or instructions for actually snap fitting the StatLock® IV Ultra Stabilization device onto the catheter?
- Always orient the push-tab straight up.
- Always connect the StatLock® stabilization retainer device to the PIV - - -- BEFORE placing the StatLock® stabilization device onto skin.
The blue StatLock® stabilization device retainer clip is like an upside-down "V". Therefore, do not inadvertently squeeze it closed by compressing both sides. Instead, just hold one side and snap it over the hub of the catheter.
What do I use the sterile StatLock® stabilization device adhesive foam strips for?
You can use them to:
- Stabilize the catheter while prepping and securing with the StatLock® stabilization device by applying the foam strips over the catheter hub
- Fashion a J-loop with the IV tubing
- Form a cushion under your luer lock spin nut
- For extension sets without luer locks, wrap them around the catheter and the extension set connection for added security
- Reinforce the StatLock® stabilization devices. They are sterile, tape is not.
What if I need to change the IV tubing, do I have to remove the StatLock® stabilization device first?
If you had a tape-secured PIV, then you would have to remove the tape to change the tubing.
With the StatLock® IV Ultra stabilization device you can keep the stabilization device in place while you change tubing. Simply steady the retainer with the thumb and index finger of one hand while unscrewing the extension set. Remove the set. Then, while continuing to brace the retainer, press-fit and screw in your replacement extension set. For StatLock® IV Select stabilization device, you will need to replace the StatLock® stabilization devices when you remove and replace the tubing – just as you would with tape securement; but this is a rare event offset by StatLock® stabilization device advantages.
We have provided an easy reference to these relevant articles, fact sheets, clinical reviews and clinical studies that examine the clinical, quality and economic outcomes from utilizing a mechanical stabilization device.
Prints of the following clinical studies can be provided by your local representative or by calling customer service at 1-800-545-0890.
- 1. A Prospective Study of Two Intravenous Catheter Securement Techniques in a Skilled Nursing Facility
Kathy Sheppard, Journal of Intravenous Nursing, Vol. 22, No. 3, May/June 1999.
- 2. Improving Short Peripheral IV Outcomes: A Clinical Trial of Two Securement Methods
Timothy Royer, The Journal of the Association for Vascular Access (JAVA), 2003, Vol. 8, No. 4.
- 3. Peripheral Intravenous Catheter Dwell Times: A Comparison of 3 Securement Methods for Implementation of a 96–Hour Scheduled Change Protocol
Bonnie Smith, Journal of Infusion Nursing, Vol. 29, No. 1, January/February 2006.
- 4. Summary of Product Trials for 10,164 Patients: Comparing an Intravenous Stabilizing Device to Tape
Gregory J. Schears, Journal of Infusion Nursing, Vol. 29, No. 4, July/August 2006.
- 5. New Standards for Improving Peripheral IV Catheter Securement
Bonnie Smith and Timothy Royer, Nursing 2007, Vol. 37, No. 3.
- 6. Evaluation of a Visual Infusion Phlebitis Scale for Determining Appropriate Discontinuation of Peripheral Intravenous Catheters
Paulette Gallant, Journal of Infusion Nursing, Vol. 29, No. 6, November/December 2006, 338-345.
- 7. How to Secure a Peripheral IV Catheter
Bonnie Trottier, Infection Control Today, February 2005, Vol. 9, No. 2.
- 8. Caring for a Nontunneled CVC Site
Lynn Hadaway, Nursing 2005, December, Vol. 35, No. 12.
- 9. Catheter stabilization devices Are Becoming Standard of Care
Gregory Schears, American Society of Anesthesiologists, June 2007, Vol. 71 No. 6.
- 10. A Comparative Retrospective Analysis of Two Securement Techniques for Peripherally Inserted Central Catheters (PICC) and Midlines in the Homecare Setting
Diana Wood and Leigh Ann Bowe-Geddes, Journal of Vascular Access Devices, Vol. 2, No. 3, Fall 1997.
- 11. The Advantages of a Precision-Engineered Securement Device for Fixation of Arterial Pressure-Monitoring Catheters
Catharine Stephenson, The Journal of the Association for Vascular Access "JAVA", 2005, Vol. 10, No. 3.
- 12. Infiltration and Extravasation: Preventing a Complication of IV Catheterization
Lynn Hadaway, American Journal of Nursing, Vol. 107, No. 8, pp. 64-72, August 2007.
- 13. Needlestick Injuries Among Surgeons in Training
M.A. Makary, NEJM, Vol. 356, No. 26.
- 14. Optimizing IV Therapy In The Elderly: Manufactured catheter stabilization devices make their case in multiple studies
Bonnie Smith, R.N., C.R.N.I. and Frances Hannum, B.A., B.S., Advance For Nurses, August 25, 2008.
- 15. Suture-Free Alternati.v.es: New approaches to reduce the risk of suture needle injuries
Jaime Ritter, MPH, CIC, Managing Infection Control, December 2008.
- 16. Influencing Product Evaluation With Hard-Hitting Evidence
Jeannie Akridge, Healthcare Purchasing News, July 2007, Vol. 31, No. 7.
- 17. OSHA Fact Sheet – Securing Medical Catheters
OSHA, U.S. Department of Labor, August 2004.
Link to OSHA
- 18. CDC's Seven Healthcare Safety Challenges
CDC, July 11, 2003.
Link to CDC
- 19. The 4-1-1 on New Infusion Nursing Standards of Practice
Lynn Hadaway, Infection Control Today, June 2006.
- 20. ECRI: OSHA Requires Annual Review of Catheter-Securement Devices
October 1, 2004.
- 21. Techniques for Stabilizing Urinary Catheters
Marilyn Hanchett, M.A., R.N., C.P.H.Q.. American Journal of Nursing, March 2002, Vol. 102, No. 3.
- 22. Catheter Securement Device Provides Substantial Cost Savings
Robert Inbornone, Healthcare Purchasing News, June 2005.
- 23. Catheter stabilization devices Are Becoming Standard of Care
Gregory Schears, American Society of Anesthesiologists, June 2007, Vol. 71, No. 6.
- 24. Securing Quality and Safety Without Tape; Holmes Regional Medical Center
Susan Birk, Materials Management in Health Care, June 2007, Vol. 16, No. 6.
- 25. Cost Containment and Infusion Services
Kathy Kokotis, Supplement to Journal of Infusion Nursing, Vol. 28, No. 3S, May/June 2005, S22:S32.
- 26. Summary of Product Trials for 10,164 Patients: Comparing an Intravenous Stabilizing Device to Tape
Gregory J. Schears, Journal of Infusion Nursing, Vol. 29, No. 4, July/August 2006