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BD ChloraPrep™ ChloraPrep™ patient preoperative skin preparation products ChloraPrep™ applicators

BD ChloraPrep™ Clear 26-mL applicator with Sterile Solution 

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Overview

BD ChloraPrep™ patient preoperative skin preparation with sterile solution delivers standardized, powerful, persistent antimicrobial protection that is backed by more than 60 clinical studies and trusted by healthcare providers for more than 21 years. In a recent clinical study, BD ChloraPrep™ preoperative skin antiseptic demonstrated antimicrobial persistence for at least 7 days.¹

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Features and Benefits
Promotional Story
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References
  1. Beausoleil C, Comstock SL, Werner D, Li L, Eby JM, Zook EC. Antimicrobial persistence of two alcoholic preoperative skin preparation solutions. J Hosp Infect. 2022 Nov;129:8-16.
true
Specification

GTIN - Each

00354365400372

1

GTIN - Case

50354365400377

25


Quantity

25 app/case

GTIN

GTIN - Each 00354365400372 1
GTIN - Case 50354365400377 25

Packaging

Quantity 25 app/case
References
false
Electronic Instructions for Use (eIFUs)
Resources
References
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Frequently Asked Questions

BD ChloraPrep™ Overview

BD ChloraPrep™ is a rapid-acting and persistent preoperative skin preparation. Its proven formulation is available in six unique applicators designed for the right amount of solution for the right procedural area.

Advantages of BD ChloraPrep™ preoperative skin preparation include its broad spectrum, rapid-acting and persistent antimicrobial activity (at least 7 days¹), and effectiveness in the presence of blood and organic matter. These advantages are a result of the unique 2% CHG/70% IPA formulation of BD ChloraPrep™ preoperative skin preparation. Chlorhexidine gluconate, a cationic bisbiguanide, works by destroying the bacterial cell membrane and precipitating cell contents. Alcohol denatures cell proteins. As a result, BD ChloraPrep™ preoperative skin preparation provides better broad spectrum, immediate, cumulative and residual antibacterial activity compared to traditional iodophors. ² ³

2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)

Yes. After submitting a new drug application (NDA) to the Food and Drug Administration (FDA), BD ChloraPrep™ preoperative skin preparation received FDA approval in 2000.

When seeking Food and Drug Administration (FDA) approval for an over-the-counter antiseptic, all manufacturers of chlorhexidine-based solutions are required to submit a new drug application (NDA). The review of a NDA by the FDA includes evaluation of clinical, manufacturing and labeling information to assure the product is safe and effective.

Alcohol and iodophors were identified by the FDA as "generally recognized as safe and effective" (GRASE) and are included in the tentative final monograph from the FDA. As a result, manufacturers of alcohol, iodophors and iodine-based solutions can market products without submitting efficacy and safety data and product labeling to the FDA for review prior to marketing and selling their products.

Getting Started with BD ChloraPrep™ preoperative skin preparation

Prepping time varies by the location and size of the prep site and applicator used.

Pinch

• Hold the applicator with the sponge down.

• Pinch the lever only once to activate the ampules and release the antiseptic.

Apply

Wet the sponge by pressing and releasing the sponge against the treatment/incision area until liquid is visible on the skin.

• Completely wet the treatment area with antiseptic.

Dry surgical sites (e.g., abdomen or arm)

– Use gentle, repeated back-and-forth strokes for 30 seconds.

Moist surgical sites (e.g., inguinal fold)

– Use gentle, repeated back-and-forth strokes for 2 minutes.

• Do not allow the solution to pool; tuck prep towels to absorb solution, and then remove.

Dry

• For safety and efficacy, allow the solution to completely dry.  Follow labeled instructions per applicator package.

Prepping time varies by the location and size of the prep site and applicator. Prepping with BD ChloraPrep™ preoperative skin preparation is a procedure that, compared to the "scrub and paint technique," greatly reduces the amount of time required for patient preoperative skin preparation.

BD ChloraPrep™ Use FAQs

BD ChloraPrep™ preoperative skin preparation is for external use only.

Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

BD ChloraPrep™ should not be used:

  • On patients with known allergies to chlorhexidine gluconate or isopropyl alcohol
  • For lumbar puncture or in contact with the meninges
  • On open skin wounds or as a general skin cleanser
  • In or around eyes, ears, and mouth. It may cause serious or permanent injury if it is permitted to enter and remain.

Additional labeled warnings of BD ChloraPrep™ preoperative skin preparation include:

  • Solution contains alcohol and gives off flammable vapors—allow it to dry for three minutes on hairless skin.
  • Do not drape or use an ignition source (e.g., cautery, laser) until the solution is completely dry (allow it to dry for a minimum of three minutes on hairless skin; up to one hour in hair).
  • Avoid getting solution into hairy areas, as wet hair is flammable. Hair may take up to one hour to dry. Reduced dry time for smaller applicators.
  • Do not allow the solution to pool.
  • Remove any soaked materials, drapes and gowns before using ignition sources.
  • Whenever prepping the neck area, place towels under each side to absorb excess solution and then remove.

Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

BD ChloraPrep™ 

applicators and tints

Each BD ChloraPrep™ applicator is appropriate for a variety of procedures, depending on the size of the area that needs to be prepped.

26 mL BD ChloraPrep™ applicator (~13.2 in x ~13.2 in)

10.5 mL BD ChloraPrep™ applicator (~8.4 in x ~8.4 in)

3 mL BD ChloraPrep™ applicator (~4 in x ~5 in)

1 mL and FREPP™ 1.5 mL BD ChloraPrep™ applicators and ChloraPrep™ swabstick (~2.5 in x ~2.5 in)

BD ChloraPrep™ applicators have been designed as convenient single-use, latex-free, hands-off applicators. Designed for a smooth delivery of the appropriate amount of solution for each respective procedure, the packaging for the BD ChloraPrep™ swabstick and the patented glass ampule in the Frepp™3 mL, 10.5 mL and 26 mL applicators eliminate the risk of contaminated solution and protect the chlorhexidine gluconate (CHG) molecule from degradation.

Furthermore, BD ChloraPrep™ Frepp™3 mL, 10.5 mL and 26 mL applicators each use a patented "wing" design to minimize instances where aseptic technique is compromised.

The tint process for BD ChloraPrep™ Scrub Teal™ and Hi-Lite Orange™ tints is a patented technology that adds color to the solution as it enters the sponge pad. When applied to the skin, each tint allows for easy visualization of the prepped area. Unlike iodine-based preps, which are brown, Scrub Teal™ and Hi-Lite Orange™ tints are easy to see when applied to a variety of skin tones. The dyes in Scrub Teal™ and Hi-Lite Orang™e tints are Food, Drug and Cosmetic (FD&C) Green #3 and Yellow #6 dyes, and have been "generally recognized as safe" (GRAS) by the Food and Drug Administration (FDA). For an ingredient to be listed as GRAS, extensive safety testing is conducted, reviewed and accepted. FD&C Green #3 is a common colorant used in many applications throughout the healthcare field (e.g., eye angiography and screening for ocular dryness, routine lab testing, dye injections, histological/cytological stains for cancer screening of tissues). FD&C Green #3 and Yellow #6 were found to be stable when combined with the 2% chlorhexidine gluconate/70% isopropyl alcohol BD ChloraPrep™ formulation, which offers proven, stable and uncompromised chlorhexidine-based solutions.

It is recommended that BD ChloraPrep™ preoperative skin preparation with tint remain on the skin, especially at the incision site, post-procedure to provide maximum antimicrobial activity. The tints will slowly fade from the skin. If your facility's policies or procedures require clean-up and/or removal of the BD ChloraPrep™ tints, they can be removed with a BD ChloraPrep™ clear applicator, alcohol, or soap and water.

The coverage area is specific to each applicator.

26 mL BD BD ChloraPrep™ applicator: ~13.2 inches x ~13.2 inches

10.5 mL BD BD ChloraPrep™ applicator: ~8.4 inches x ~8.4 inches

3 mL BD BD ChloraPrep™ applicator: ~4 inches x ~5 inches

1mL and FREPP 1.5 mL BD BD ChloraPrep™ applicators and BD ChloraPrep™ swabstick: ~2.5 inches x ~2.5 inches

BD ChloraPrep™ products are labeled with a three-year shelf life from the date of production.

Customer support

Yes. The full line of BD ChloraPrep™ applicators is available in a wide range of kits and trays. Our trained customer support representatives can work with your facility kit manufacturers to include BD ChloraPrep™ preoperative skin preparation in your current SPT/CPT kits.

Yes. To request samples, contact BD ChloraPrep™ Customer Support at 1.844.8.BD.LIFE (844.823.5433)

Surgical Skin Preparation

Preoperative skin preparation is necessary to limit microorganisms on the skin and help minimize their entry into an incision or device-insertion site after application. Normal skin flora and suboptimal skin antisepsis are the primary drivers of healthcare-associated infections (HAIs).¹

For most SSIs, the source of pathogens is the endogenous flora of the patient’s skin, mucous membranes, or hollow viscera. When mucous membranes or skin is incised, the exposed tissues are at risk for contamination with endogenous flora.⁴ The goal of preoperative patient skin antisepsis is to reduce the patient's risk of developing a surgical site infection by removing soil and transient microorganisms at the surgical site. Reducing the amount of bacteria on the skin near the surgical Incision lowers the risk of contaminating the surgical incision site. Effective skin antiseptics rapidly and persistently remove transient microorganisms and reduce resident microorganisms to sub-pathogenic levels with minimal skin and tissue irritation.⁵

Surgical skin preparation aims to reduce the bacteria on the skin that may cause infection through the cleaning of the patient’s skin.⁶

How to prepare the skin for surgery

Clipping hair before surgery isn’t just messy—the loose hair can increase the potential risk of contamination to your patients. Potentially contaminated hair on linens, wheels and the floor can migrate into the OR and elsewhere in the facility.

Cleaning the skin before surgery reduces the amount of bacteria and microorganisms present that may cause surgical site infections. Follow antiseptic package inserts for optimal efficacy with regards to following prep time, application process, dry time, and warnings/contraindications.

Alcohol-based preoperative skin antiseptics are recommended in the evidence-based infection prevention guidelines published by preeminent health organizations:

● American College of Surgeons/Surgical Infection Society (ACS/SIS): Alcohol-containing preoperative skin preparatory agents should be used unless contraindication exists. (2016)⁷

● Centers for Disease Control and Prevention (CDC): Perform intraoperative skin preparation with an alcohol-based antiseptic agent unless contraindicated. (2017)⁸

● World Health Organization (WHO): The panel recommends alcohol-based antiseptic solutions based on CHG for surgical skin site preparation.⁶

● Society for Healthcare Epidemiology of America (SHEA): Use an alcohol based antiseptic for skin preparation.⁹

A comparison of patient preoperative skin antiseptics

 AlcoholIodophors
(iodine-based)
CHGIodine+ alcoholBD PurPrep™
patient
preoperative
skin
preparation
with sterile solution
CHG+ alcoholBD ChloraPrep™
patient
preoperative
skin
preparation
with sterile solution
Broad spectrum9-12XXXXXXX
Fast acting9-12X  XXXX
Persistent9-12  XXXXX
Acting in the presence or organic matter 9-12  X  XX
Minimizes the risk of Intrinsic contamination1B    X X

 

Types of Alcohol-Based Antiseptics

○ PVP-I allows for the free iodine to be released, which destroys proteins and DNA of microorganisms.

○ This solution is often used, since it is safe to use on most skin regardless of age.

○ CHG breaks down bacteria cell membranes to disinfect the skin.

○ The combination of fast-acting and persistent antimicrobial activity is the key to an effective preoperative skin preparation. IPA alone provides a 99.99% reduction in bacteria, but it does not provide long-lasting microbial kill. BD ChloraPrep™ maintains antimicrobial activity, demonstrating persistence for at least 7 days¹ compared to two hours for free iodine. Because BD ChloraPrep™ preoperative skin preparation contains the combination of isopropyl alcohol and chlorhexidine, it is more effective than isopropyl alcohol alone.

○ The chlorhexidine bisbiguanide groupings associate strongly to exposed anionic sites on the cell wall and cell membrane, particularly acidic phospholipids and proteins, causing displacement of divalent cations (Ca2+ and Mg2+). Bridging adjacent phospholipids in the cell membrane will cause a loss of structural integrity, reduce membrane fluidity and allow leakage of cellular materials. ¹³

○ Bacterial cells are negatively charged, but in the presence of chlorhexidine, the bacterial cell is neutralized and the charge is reversed. The attraction of the cationic chlorhexidine molecule and the negatively charged bacterial cell contributes to a rapid rate of bacterial kill; surface charge reversal is secondary to cell death. ³

○ In contrast, traditional iodophors can take two to three minutes until the free release of iodine can occur. While the iodophor dries, free iodine becomes available. The iodine then attacks the bacterial cell and the oxidation of two sulfhydryl groups, resulting in the formation of a disulfide bond. The effectiveness of iodophors is ≤ three hours. Lastly, iodophors are neutralized in the presence of blood and organic matter and have greater irritation than the CHG solution. ¹⁴

○ Chlorhexidine-based antiseptics have been used globally for more than 50 years and have been widely used in the US, Europe, Canada and Japan for more than 30 years. In the United States alone, more than 100 studies (excluding those focused on hand hygiene data) have been published, revealing positive outcomes related to the use of chlorhexidine gluconate (CHG)-based antiseptics. There are over 60+ published studies specifically for BD ChloraPrep™ preoperative skin preparation.

The combination of fast-acting and long-lasting antimicrobial activity is the key to an effective preoperative skin preparation. IPA alone provides a 99.99% reduction in bacteria, but it does not provide long-lasting microbial kill. BD ChloraPrep™ maintains antimicrobial activity for at least 7 days¹ compared to two hours for free iodine.³ Because BD ChloraPrep™ preoperative skin preparation contains the combination of isopropyl alcohol and chlorhexidine, it is more effective than isopropyl alcohol alone.

Why skin preparation matters

There are a number of reasons why skin preparation prior to surgery matters. Effectively preparing the skin can reduce the microorganisms on the skin that may cause surgical site infections. Below are some of the risk factors:

● On a single square centimeter of skin, there can be as many as 10 million aerobic bacteria¹⁵

● 80% of microorganisms reside in the first five cell layers of the epidermis¹⁶

● Infection prevention measures have focused on asepsis of healthcare providers and the environment, but there is evidence about the role played by the patient's own skin⁸

Skin preparation solutions designed to reduce microorganisms on the skin before surgical procedures may contribute to contamination when nonsterile antiseptic solutions are used. According to the FDA, intrinsic contamination “may occur during the manufacturing process”.¹⁷ Infections from intrinsic contamination of antiseptics have been well documented.¹⁸ ¹⁹ Because of intrinsic contamination risks, the FDA requested that manufacturers label topical antiseptic solutions as sterile or nonsterile.¹⁷ Sterilizing the antiseptic solution during production can minimize potential intrinsic bacterial threats. However, most U.S. manufacturers of commercially available antiseptic skin preparations have not adopted this technologically challenging process. BD overcame this challenge, developing a patented process to sterilize antiseptic solutions within sealed containers to provide sterility assurance. In summary:

● Antiseptics do not self-sterilize²º

● All commonly used antiseptic agents have been linked to infection-causing contamination.¹⁹

● Outcomes associated with contaminated antiseptics may be underreported for a range of reasons. ○ Disposal of the contaminated product before infection is discovered¹⁸

    ○ Inconsistent contamination within the same product lot¹⁸

BD  offers an exclusive portfolio of fully sterile skin prep applicator products.

How BD can help you prepare for surgery

BD has a number of tools and products aimed at helping reduce bacteria on the skin that may cause infections.

○ One study compared the removal of dispersed hair using standard surgical clippers with surgical tape vs clippers fitted with the ClipVac™ Hair Removal System. The study assessed clipping duration and the amount of loose hair and microbial contamination following clipping.²¹

■ Faster clipping and cleanup time: Using BD clippers with the ClipVac™ System resulted in an average of 40% faster clipping and cleanup time compared to clippers and adhesive tape.

■ Reduced contamination: Using clippers and the ClipVac™ System significantly reduced the amount of microbial contamination, by an average of 85%, compared to clipping and tape cleanup.

■ Less residual loose hair: Clipping with the ClipVac™ System was highly effective in reducing the dispersion of contaminated hair fibers within areas adjacent to the skin-prep site vs clipping followed by tape cleanup.

Skin preparation solutions designed to reduce microorganisms on the skin before surgical procedures may contribute to contamination when nonsterile antiseptic solutions are used. According to the FDA, intrinsic contamination “may occur during the manufacturing process”.¹⁷ Infections from intrinsic contamination of antiseptics have been well documented.¹⁸ ¹⁹ Because of intrinsic contamination risks, the FDA requested that manufacturers label topical antiseptic solutions as sterile or nonsterile.¹⁷ Sterilizing the antiseptic solution during production can minimize potential intrinsic bacterial threats. However, most U.S. manufacturers of commercially available antiseptic skin preparations have not adopted this technologically challenging process. BD overcame this challenge, developing a patented process to sterilize antiseptic solutions within sealed containers to provide sterility assurance. In summary:

● Antiseptics do not self-sterilize²º

● All commonly used antiseptic agents have been linked to infection-causing contamination.¹⁹

● Outcomes associated with contaminated antiseptics may be underreported for a range of reasons. ○ Disposal of the contaminated product before infection is discovered¹⁸

    ○ Inconsistent contamination within the same product lot¹⁸

BD  offers an exclusive portfolio of fully sterile skin prep applicator products.

○ BD’s durable, efficient clippers support patient preoperative hair removal in a single pass and minimize the risk of compromising the skin. Our clippers remove more hair per second than 3M™, Cardinal Health™, and Medline™ in internal laboratory tests ²⁴, saving valuable OR patient-prep time. They also offer the following benefits:

■ A close cut while maintaining skin integrity

■ A 40° angled, ergonomic handle, allowing seamless preoperative hair removal

■ Usability in either wet or dry clipping conditions

■ The only IXP-7 waterproof-rated clippers for submersibility, to support thorough cleaning and disinfecting

■ Lithium-ion battery technology to facilitate longer runtime and improve energy efficiency

■ Battery-life and charging indicators that alert clinicians to charge level

■ Choice of three blades for a variety of procedures

○ BD ChloraPrep™ is a rapid-acting and persistent preoperative skin preparation. Its proven formulation is available in six unique applicators designed for the right amount of solution for the right procedural area.

○ Advantages of BD ChloraPrep™ preoperative skin preparation include its broad spectrum, rapid-acting and persistent antimicrobial activity (7 days¹) and effectiveness in the presence of blood and organic matter. These advantages are a result of the unique 2% CHG/70% IPA formulation of BD ChloraPrep™ preoperative skin preparation. Chlorhexidine gluconate, a cationic bisbiguanide, works by destroying the bacterial cell membrane and precipitating cell contents. Alcohol denatures cell proteins. As a result, BD ChloraPrep™ preoperative skin preparation provides better broad spectrum, immediate, cumulative and residual antibacterial activity compared to traditional iodophors.² ³

BD PurPrep™ Patient Preoperative Skin Preparation with Sterile Solution is the first and only fully sterile povidone-iodine (PVP-I) plus isopropyl alcohol (IPA) in applicator form available in the United States.

BD E-Z Scrub™ preoperative surgical scrub brushes are single-packaged brushes impregnated with a wide range of antimicrobial formulations. These formulations include chlorhexidine gluconate (CHG), chloroxylenol (PCMX), and povidone-iodine (PVP-I)

These unique sponges are not only designed to be comfortable and gentle on the skin, they are uniquely formulated to help meet CDC and WHO guidelines for cleaning hands before putting on gloves or contacting patients.²⁵

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References
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