Clinical Information

What the experts are saying:

Centers for Disease Control and Prevention

Catheter Securement Devices Recommendation:

“Use a suture-less securement device to reduce the risk of infection for intravascular catheters.” Category II (Suggested for implementation and supported by suggestive clinical or epidemiologic studies or theoretical rationale)

Background

“Catheter stabilization is recognized as an intervention to decrease the risk for phlebitis, catheter migration and dislodgement, and may be advantageous in preventing catheter related bloodstream infections (CRBSIs). Pathogenesis of CRBSI occurs via migration of skin flora through the percutaneous entry site. Sutureless securement devices avoid disruption around the catheter entry site and may decrease the degree of bacterial colonization. Using a sutureless securement device also mitigates the risk of sharps injury to the healthcare provider from inadvertent needlestick injury.”

Source: Naomi P. O'Grady, M.D.; Mary Alexander, R.N.; Lillian A. Burns, M.T., M.P.H., C.I.C.; E. Patchen Dellinger, M.D.; Jeffery Garland, M.D., S.M.; Stephen O. Heard, M.D.; Pamela A. Lipsett, M.D.; Henry Masur, M.D.; Leonard A. Mermel, D.O., Sc.M.; Michele L. Pearson, M.D.; Issam I. Raad, M.D.; Adrienne Randolph, M.D., M.Sc.; Mark E. Rupp, M.D.; Sanjay Saint, M.D., M.P.H.; and the Healthcare Infection Control Practices Advisory Committee (HICPAC). "Guidelines for the Prevention of Intravascular Catheter-related Infections." The Centers for Disease Control, April 2011

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Infusion Nurses Society:

36.1. “Vascular Access Device (VAD) stabilization shall be used to preserve the integrity of the access device, minimize catheter movement at the hub, and prevent catheter dislodgment and loss of access.”

36.B “Transparent semi-permeable membrane dressings or other dressings are often cited as helpful in stabilizing the catheter; however, there is insufficient evidence supporting their benefits in stabilization at the intravenous catheter hub alone.”

Source: “Infusion Nursing Standards of Practice.” The Journal of Infusion Nursing. Vol. 34. No.1S. January/February 2011

Clinical Studies
Reference / What the study determined
Bonnie Smith and Timothy Royer. “New standards for Improving Peripheral IV Catheter Securement.” Nursing 2007, Vol. 37, No. 3, pg 72-73
/ •Nonrandomized observational study of tape, HubGuard, and StatLock stabilization device
•Outcome measure: percent of IVs remaining in place 96 hours
•Observed rates
-8% peripheral IVs with tape
-9% peripheral IVswith HubGuard
-52% peripheral IVs with StatLock IV Ultra Stabilization device
•P <0.001 StatLock device vs. tape or HubGuard
Diana Wood and Leigh Ann Bowe-Geddes. “A Comparative Retrospective Analysis of Two Securement Techniques for Peripherally Inserted Central Catheters (PICC) and Midlines in the Homecare Setting.” Journal of Vascular Access Devices, Fall 1997, Vol. 2, No. 3, pg.1-6. / •StatLock PICC Plus Stabilization Device, Steri-Strips® and tape
•10.7/1,000 catheter days therapy discontinuation due to complications in control group
•2.18/1,000 catheter days therapy discontinuation due to complications in study group (StatLock PICC Plus Stabilization Device)
•14.86/1,000 catheter days unscheduled nursing visits in the control group
•3.55/1,000 catheter days unscheduled nursing visits in the study group (StatLock PICC Plus Stabilization Device)
•Three-fold decrease in dislodgement with StatLock PICC Plus Stabilization Device
•Reduction in overall incidence of complications P <0.05
Catherine Stephenson. “The Advantages of a Precision-Engineered Securement Device for Fixation of Arterial Pressure-Monitoring Catheters.” The Journal for the Association of Vascular Access (JAVA), 2005, Vol. 10, No. 3, pg. 1-3. / •Prospective, nonrandomized, sequential, observational study
•468 arterial catheters secured with StatLock Arterial Select Stabilization Device
•995 arterial catheters secured with protocol during control period
•25% restart rate with tape and transparent membrane dressing
•12.8% restart rate with study device (StatLock Arterial Select Stabilization Device) representing 48.8% reduction in unscheduled arterial catheter restarts
•P <0.001
•StatLock Arterial Select Stabilization Device was essentially cost neutral
Premier’s product planning process: A Retrospective StatLock Value Analysis / •Use of StatLock IVresulted in an 87% success rate in achieving a 96 hour dwellperiod for the IVs secured withStatlock
•Patient satisfaction was improved by 76% with the use of a securement device over tape as a method to secure PIV catheters
•Patient satisfaction data, measured on a Likert scale of 1 to 5, was 4.4 with StatLock, compared to the national average of 2.5 with tape

The use of StatLock as a securement device increases patient satisfaction and reduces the amount of time needed for staff to restart IVs.

Product Information

The StatLock® line includes products that secure or stabilize vascular access devices, continuous nerve block (CNB) catheters, nasogastric (NG) tubes, epidural catheters,foley catheters,PICCs, midlines, CVCs, and hemodialysis catheters. There are also universal and multi-purpose StatLock devices.

Bard StatLock applications
StatLockArterial Plus Stabilization Device /
StatLockCV Plus Stabilization Device /
StatLockDialysis Stabilization Device /
StatLock Epidural Stabilization Device /
StatLockHuber Plus Stabilization Device /
StatLockIV Ultra Stabilization Device /
StatLock Nasogastric Stabilization Device /
StatLockPICC Plus Stabilization Device /
StatLockUniversal Plus Stabilization Device /

Critical Criteria

Bard
Latex-free packaging / 
Latex-free products / 
Company's catheter securement meet OSHA 29 CFR 1910.1030 standards / 
Products in the stabilization and securement product lines meet or exceed INS Standard 43 / 
Staff education / Learn more
Company will provide, at no charge to the participating member, clinical and/or in service training for all shifts / 
Company program to work with the Premier members to improve their supply chain capabilities for this category / 
Products specifically designed for the pediatric population in this category / 
Shelf life / 1 to 2 years
Clinical studies / Learn more
Company will provide, at no charge to the participating member, samples for product evaluation / Amount of samples will be determined by the territory manager and the member.

Product Review

Product factors influencing the Nursing Committee decision to move suppliers through the contracting process focused on committee member discussions and critical criteria.

When conducting a product review in your facility, consider:

•Adhesive

•Application type(arterial catheter, IV catheter, PICC, CVA, epidural, NG tube)

•Bore size(macrobore,small bore, microbore, standard bore)

•Connector type (luer lock)

•Material(tricot)

•Patient size(pediatric, neonatal, infant)

•Post adjustability (fixed or movable)

•Securement pad shape(crescent or butterfly)

•Sterile product packaging

•Tubing size(6in, 12in)

•Valve type (smartsite, ultrasite, valve, y-valve, stopcock)

To review Bard products in your facility, contact:Bob Anderson, 770.784.6164,

Supplier Tiers

Bard expiring tiers (PP-NS-528) / Bard new tiers (PP-NS-683)
Distributor / Distributor
Tier 1 / < 80% participation / Tier 1 / < 80%participation
Tier 2 / 80% participation / Tier 2 / 80% participation
Direct /  / Tier 3 / $1,200,000AND
70% participation
Tier 3 / < 80% participation / Direct
Tier 4 / 80% participation / Tier 4 / < 80%participation
Note: StatLock kit volumes bought from distributors on other Premier contracts will be included in participation measurements for the sole purpose of achieving tier requirements. / Tier 5 / 80%participation
Tier 6 / $1,200,000AND
70% participation

Financial Analysis

Thefinancial analysis is a comparison of the incumbent’s expiring pricing compared to incumbent’s new pricing.

Financial analysis based on market basket representing 72 percentof spend.

Cross-reference performed by product planning staff and validated by suppliers.

Calculations are based upon overall Premier utilization. Individual savings will vary.

Bard new pricing vs. Bard expiringpricing (weighted)
Distributor* / Direct / Number items analyzed
T1/1 / T2/2 / T2/T3 / Overall impact / T3/T4 / T4/T5 / T4/T6 / Overall impact
17%
savings / 4%
savings / 8%
savings / 10%
savings / 17%
savings / 4%
savings / 5%
savings / 9%
savings / 141 of 168
*Currently, 97 percent of members purchase Bard products through distribution.
Note: Bard’s distributor pricing is 8.5 percent less, in aggregate, when compared to their direct pricing.

Portfolio Summary

Bard

Diversity supplier

/ N/A

Electronic PA / PMDF required

/ Tiers 2, 3, 5 and 6

Aggregation

/ Yes

Continuum of Care

/ Yes

Local negotiation

/ Yes

Distribution

/ Direct and distribution

Price protection

/ Firm for the term

Payment terms*

/ Net 30 days

Early payment discount*

/ None

Minimum order*

/ None

Shipping terms*

/ FOB Origin, paid by seller within U.S., title and risk of loss transfer at origin

Large dollar threshold*

/ None

Reimbursement of substitute products*

/ 100% of difference; exclusive of freight and insurance; price must not exceed list price; will not pay on the lesser of orders over what was not delivered or over normal use

Acceptance of purchase cards or credit cards at no additional charge

/ Yes

Manufacturing locations

/ Mexico

Representatives

/ 41 – 60 FTEs

Clinical representatives

/ > 30 FTEs

Telephone customer service support

/ Clinical support is available 24hours a day through the Medical Support Services department 800.227.3357
*For orders through distributors, payment and shipping terms are negotiated between authorized distributor and member.

Market Highlights


Supplier reported spend FY 2010 / Supplier reported spend FY 2010 - Bard
Supplier / Volume / Percent spend / Application / Volume / Percent
Bard / $14,114,407 / 97% / IV Catheters / $10,428,364 / 73%
Centurion / $499,802 / 3% / PICC / $2,953,594 / 21%
Total / $14,614,209 / 100% / Universal / $252,967 / 2%
Central Line Catheters / $231,433 / 2%
Arterial Catheters / $136,045 / 1%
NG Tubes / $99,499 / 1%
Dialysis Catheters / $12,229 / 0%
Epidural Catheters / $276 / 0%
Total / $14,114,407 / 100%
Note: Centurion was unable to provide a product break down by application due to their universal application.

Sourcing Summary

Catheter Tube Securement and Stabilization Products
Committee / Nursing
Request for information (RFI) sent to: / •ACMI
•B. Braun
•Bard
•Baxter
•Cardinal
•Centurion / •Dale Medical
•Datascope
•DeRoyal
•Hollister
•Lapyx Medical
•Marpac / •Medline
•Merit Medical
•Owens & Minor
•Smiths Medical
•Valmed Medical
•Zefon
Awarded supplier / •Bard

About the Nursing Committee:

The 18 voting members of the Nursing Committee come from all geographic regions of the United States and represent the full diversity of Premier entities: from a 74-bed rural Midwestern hospital to a 3,000-bed West Coast IDN to a 300-facility Northeastern system. Facilities are urban and rural, teaching and non-teaching, acute and non-acute. Individually, the committee members’ years of healthcare experience range from six to 42, with a median 25 years in the industry. Clinical backgrounds include pediatric and adult nursing, infection control, respiratory therapy,clinical engineering and clinical education. The committee is rounded out with professionals from positions in administration and materials management.

  • Product considerations were used to determine suppliers who participated in the final negotiation process.Final awards were based on offering members supplier choice and savings opportunities.

Questions

For questions about these agreements, please contact your local Premier representative or the Premier Solution Center at 877.777.1552 or . Pricing and other contract information may be accessed through Premier’s Supply Chain Advisor catalog at

*Value analysis toolkits: The Premier performance improvement alliance, with the aid of members, has been building out new value analysis toolkits for our contracted categories. The goal of these toolkits is to expedite value analysis processes of Premier supplier offerings within member facilities by leveraging the existing work already completed by the Premier member committees as part of the standard negotiations process. Certain contracted products and/or services may still require a trial within your IDN, regional collaborative or facility. While some members may still choose to complete ad hoc value analysis work at their facility, it is our hope that these enhanced documents will give you the critical information gathered in our in-depth sourcing process as well as related resources to move you to trial more efficiently.

As in your own facilities, depth of material will depend on who was awarded, their market share, healthcare-associated conditions and concerns commonly associated with procedures in which the product/service is used, and the ability to share member conversion/usage experiences. Where these documents are available, they will take the place of contract launch summaries.