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Winged infusion set

A winged infusion set, also known as a butterfly needle or scalp vein set, is a single-use, sterile, FDA Class II medical device consisting of a small hypodermic needle attached to flexible plastic wings, transparent tubing, and a Luer connector, designed for accessing superficial veins to facilitate short-term intravenous infusions, medication administration, or blood collection.^[1]^[2]^[3] These devices are particularly suited for patients with fragile, thin, or rolling veins, such as infants, the elderly, or those with difficult venous access, due to their small size (typically 18G to 27G needles, ½" to 1⅛" lengths) and shallow insertion angle, which minimize pain and tissue trauma.^[2]^[3]^[4] The flexible wings allow for secure grip and positioning against the skin, while the thin-wall needle design ensures easy penetration and sustained flow with a single insertion.^[1]^[4] Common applications include phlebotomy for laboratory testing or blood donation, intravenous hydration to treat dehydration, and delivery of medications such as antibiotics, chemotherapy, or pain relief, often in outpatient or short-procedure settings.^[2]^[3] They are indicated for infusions lasting up to 2 hours and venous blood draws, with transparent tubing enabling visual confirmation of blood flashback to verify proper vein placement.^[1]^[2] Modern variants incorporate safety mechanisms, such as retractable sheaths or sliding shields, to reduce needlestick injury risks for healthcare providers, and are available with tubing lengths of 3½" to 12" for varied procedural needs.^[1]^[3] Compared to indwelling catheters, winged infusion sets offer advantages like lower rates of hemolysis, decreased risk of vein collapse or bleeding, and suitability for patients with conditions like hemophilia.^[3]^[5] They must be used by trained professionals and disposed of properly after single use to maintain sterility and prevent infection.^[1]

Overview

Definition and purpose

A winged infusion set is a specialized venipuncture device consisting of a hypodermic needle with two bilateral flexible wings for grip, attached to a short segment of flexible tubing and a connector, typically a Luer lock or slip, for interfacing with syringes or intravenous lines.^[6] This configuration facilitates controlled insertion into superficial veins, minimizing trauma during access.^[7] The primary purpose of a winged infusion set is to provide short-term venous access for procedures such as blood collection or the administration of fluids and medications, particularly in clinical settings where standard hypodermic needles may be unsuitable due to vein fragility or patient mobility.^[8] It enables healthcare providers to stabilize the needle during puncture and withdrawal, reducing the risk of vein damage or patient discomfort.^[9] Historically specialized for challenging venipuncture scenarios, the device is commonly employed in pediatrics and geriatrics, where patients often have small, narrow, or fragile veins that are harder to access with conventional tools.^[8] It is also referred to by alternative names such as butterfly needle or scalp vein set.^[7]

Alternative names

The winged infusion set is commonly referred to by several alternative names in medical literature and practice, reflecting its design and historical applications in venipuncture procedures.^[8]^[7] The most prevalent synonym is "butterfly needle," derived from the pair of flexible, wing-like plastic flaps attached to the needle hub, which resemble the wings of a butterfly and aid in precise insertion and stabilization during blood draws or infusions.^[8]^[7] Another primary term is "scalp vein set," originating from its early 20th-century use for accessing fragile scalp veins in infants and neonates, where standard needles posed higher risks of complications.^[2]^[10] In contemporary contexts emphasizing needlestick prevention, variants are often called "safety winged sets" or "safety winged infusion sets," incorporating mechanisms like retractable needles or shielding to reduce injury risks for healthcare providers.^[11]^[12]

History

Early development

The winged infusion set, commonly known as the butterfly needle or scalp vein set, emerged in the late 1950s as an advancement over earlier hypodermic needle designs originating in the 19th century. The foundational hypodermic needle was invented by Irish physician Francis Rynd in 1844, who developed a hollow steel needle for subcutaneous injections, followed by Scottish surgeon Alexander Wood's refinements in 1853 that enabled hypodermic syringe use for administering drugs directly into veins.^[13] These early straight needles, while revolutionary, proved challenging for precise venipuncture in delicate areas due to their rigidity and lack of stabilizing features. Building on this legacy, the winged design introduced flexible wings for better grip and control, addressing the need for safer access to superficial veins. The device was pioneered by Dr. John Court, a physician at the Royal Children's Hospital in Melbourne, Australia, specifically to facilitate intravenous access in pediatric patients, including neonates whose scalp veins were often the most accessible.^[14] Prior to this innovation, straight needles frequently caused trauma to fragile infant veins, leading to complications like bruising, infiltration, or failed insertions during blood draws or infusions. Court's prototypes, developed in the late 1950s, featured a stainless steel needle attached to soft plastic wings shaped like butterfly flaps, connected via a plastic hub to standard IV tubing, allowing for more stable and less painful procedures.^[15] This design was initially handmade, with iterative improvements to the hub and wing materials to enhance maneuverability and reduce vein damage. Commercial production began shortly after, in the late 1950s, when Plastalon—an Australian company originally manufacturing plastic raincoats—adapted its expertise to fabricate the first sterile, disposable versions using gamma irradiation for sterilization.^[16] Dubbed the "Court needle" or butterfly needle, it gained rapid adoption in hospitals worldwide for infant blood collection and short-term IV therapy, marking a key milestone in pediatric care by minimizing procedural discomfort and improving success rates in venipuncture.^[17] Medical device firms, including Becton Dickinson, later incorporated similar winged designs into their product lines, building on this foundational work to standardize the tool for broader clinical use.

Modern advancements

In the late 20th century, the development of safety-engineered winged infusion sets gained momentum in response to rising concerns over needlestick injuries among healthcare workers. The U.S. Occupational Safety and Health Administration (OSHA) issued its Bloodborne Pathogens Standard in 1991, mandating employers to evaluate and implement safer medical devices to reduce exposure risks, which spurred innovations like re-sheathable and retractable needle mechanisms in winged sets during the 1990s.^[18] These features, such as sliding shields that cover the needle post-use, were further reinforced by the Needlestick Safety and Prevention Act of 2000, which amended the standard to explicitly require engineering controls for hollow-bore needles, including those in butterfly-style infusion sets.^[19] By the early 2000s, retractable winged steel needles became a focus of performance improvement projects to comply with OSHA enforcement, significantly lowering injury rates associated with these devices.^[20] Advancements in the 2000s emphasized enhanced materials and manufacturing precision to improve patient comfort and device reliability. Needles in modern winged infusion sets are often coated with medical-grade silicone lubricants, which facilitate smoother tissue penetration and reduce vein trauma during insertion.^[21] This biocompatible coating minimizes friction and irritation, contributing to lower complication rates in venipuncture procedures. Manufacturing techniques evolved with precision honing of needle tips and injection molding for wings, enabling thinner walls for better flow while maintaining structural integrity; flexible, interlocking wings now conform more effectively to the body's contours, aiding precise placement without altering insertion techniques.^[4] These improvements, exemplified in products like Terumo's SURFLO sets, reflect a shift toward user-friendly designs that balance safety and efficacy.^[11]

Design and components

Needle structure

The needle of a winged infusion set is a hypodermic needle constructed from stainless steel, providing durability and biocompatibility for vascular access.^[4]^[22] It features a beveled tip, typically with a triple-bevel or honed lancet design, which facilitates smooth penetration into the skin and vein wall while minimizing tissue trauma.^[4]^[23] These needles are engineered with a thin-wall configuration to enhance flow rates despite their small diameters, making them suitable for superficial venipuncture.^[4]^[24] Lengths of these needles generally range from ½ to 1⅛ inches (12.7 to 28.6 mm), optimized for accessing shallow veins without excessive depth that could risk deeper structures.^[4]^[22]^[1] This short length supports precise control during insertion into fragile or small-caliber vessels, such as those in pediatric or geriatric patients.^[25] The needle's thin gauge further reduces vessel trauma by limiting the puncture size, promoting quicker hemostasis post-procedure.^[26] In terms of integration, the needle is securely attached to the device's hub, which connects to the wings and tubing assembly, allowing for stable positioning during use.^[4] Variations in bevel angles, such as shorter or more acute bevels in some designs, aid easier insertion into delicate veins by reducing the force required and the risk of vein wall perforation.^[24]^[27] These adaptations ensure the needle's primary function as a low-trauma entry point within the overall infusion set.^[28]

Wings and grip mechanism

The wings of a winged infusion set consist of bilateral flexible plastic extensions molded directly onto the needle hub, enabling users to pinch and manipulate the device for enhanced control during venipuncture. These wings are engineered to facilitate stable handling, with their interlocking design allowing for secure fingertip grasp that supports accurate needle positioning.^[4] The wings are typically color-coded according to the needle gauge for easy identification.^[4] Ergonomically, the wings promote precise angle control by providing a textured surface for grip, which helps minimize inadvertent movements and reduces the risk of vein trauma during insertion. This design ensures a secure hold that distributes pressure evenly, avoiding direct compression on the surrounding tissue or vessel. The angled orientation of the wings further aids in maintaining optimal needle trajectory, contributing to overall procedural stability without compromising patient comfort.^[4]^[28] Constructed from soft, deformable polyvinyl chloride, the wings conform readily to the patient's skin contours, enhancing adherence and reducing discomfort from rigid contact. This material property allows the wings to flex under light pressure while retaining structural integrity for reliable manipulation, thereby supporting the device's attachment to the needle hub for sustained stability throughout use.^[29]

Tubing and connector

The tubing in a winged infusion set is typically constructed from transparent medical-grade polyvinyl chloride (PVC) or DEHP-free alternatives, such as PVC plasticized with TOTM, allowing visual monitoring of fluid flow while ensuring biocompatibility and flexibility for patient comfort.^[30] These tubes feature a small-bore inner diameter equivalent to 19-25 gauge, ranging from approximately 1.1 to 1.2 mm, which supports adequate flow rates for blood collection and short-term infusions without excessive volume retention.^[30] Standard lengths vary from 3½ to 12 inches (9 to 30 cm), with common options at 8 inches (20 cm) or 12 inches (30 cm), designed to minimize dead space and facilitate precise handling during procedures.^[4] This compact design connects the tubing proximally to the winged hub and needle assembly, forming an integrated pathway for fluid transfer.^[6] At the distal end, the tubing terminates in a female Luer connector, which may be either a slip or lock type, enabling secure attachment to syringes, vacuum tubes (such as Vacutainers), or intravenous lines for versatile clinical use.^[30] The Luer lock variant provides threaded engagement for enhanced stability during infusion, while the slip type allows quick, friction-based connection, both adhering to ISO 80369-7 standards for interoperability. Flow dynamics in the tubing are optimized for efficiency, with priming volumes typically ranging from 0.19 to 0.45 mL depending on length and diameter, which reduces medication waste and ensures rapid priming in low-volume applications like pediatric or geriatric care.^[30] This low dead volume contributes to accurate dosing and minimizes residual fluid, particularly beneficial for costly or viscous infusates.^[31]

Clinical applications

Blood collection

Winged infusion sets, also known as butterfly needles, are widely employed in phlebotomy for venipuncture to collect blood samples, especially when veins are superficial, small, or difficult to access. The procedure commences with verifying patient identity using two forms of identification and explaining the process to alleviate anxiety. The phlebotomist performs hand hygiene, dons gloves, and gathers supplies including the winged set (typically 21-25 gauge), alcohol swabs, tourniquet, collection tubes, and a sharps container. A suitable venipuncture site is selected, such as veins on the back of the hand or forearm in patients with fragile vasculature, to minimize discomfort and complications. The site is cleansed with a 70% isopropyl alcohol pad in a circular motion from center outward, allowing it to air dry for 30-60 seconds to ensure effective disinfection. A tourniquet is applied 2-4 inches proximal to the site and the patient is asked to clench their fist to distend the vein.^[32]^[33]^[8] The phlebotomist then grips the winged infusion set by its stabilizing wings between the thumb and index finger, inserting the short bevel needle into the vein at a shallow 10-15 degree angle for precise control and reduced tissue trauma. Successful placement is confirmed by a "flash" of blood appearing in the transparent tubing, after which the tourniquet is promptly released to avoid hemoconcentration. The flexible tubing is attached to the first evacuated collection tube, which is gently inverted to mix additives if required, and subsequent tubes are filled in the standard order of draw to prevent cross-contamination between additives. For coagulation studies as the first tube when using a winged set, a discard tube (plain red or light blue top) must be drawn initially and partially filled to account for potential clotting factor activation in the tubing. Once collection is complete, the final tube is removed, the needle is withdrawn steadily while applying pressure with gauze to the site, and direct pressure is held for 1-2 minutes to achieve hemostasis. The device is activated for safety if equipped and disposed of intact in a sharps container without recapping.^[32]^[33]^[9] These devices offer significant advantages in blood collection for challenging patient populations, including pediatrics, the elderly, and oncology patients with compromised or fragile veins, where traditional straight needles may cause vein collapse or excessive trauma. The winged design enables better grip and a shallower insertion angle, facilitating access to narrow or rolling veins while minimizing pain and patient movement, which is particularly beneficial for needle-phobic individuals or those with bleeding disorders common in oncology. Clinical studies have demonstrated that winged infusion sets reduce hemolysis rates by up to 50% compared to drawing blood from intravenous catheters. However, compared to standard straight needles, winged sets may have higher hemolysis rates due to the tubing and smaller gauge, making straight needles preferable for routine collections where access is not challenging.^[7]^[9]^[8]^[34] In blood banking, they support efficient donor screening and therapeutic phlebotomy by allowing controlled draws from superficial sites, while in routine lab testing, they ensure reliable sample quality for hematology, chemistry, and coagulation panels.^[7] Specific protocols emphasize single-use to prevent infection transmission, with the entire set discarded as biohazardous waste immediately post-procedure per OSHA and CDC guidelines. Gloves are changed between patients, and surfaces are decontaminated with 10% bleach solution. In blood banking settings, winged sets are integral to whole blood donation protocols, where they help maintain sterility during collection into citrate bags, reducing contamination risks. For laboratory testing, adherence to these protocols ensures samples are viable for automated analyzers, with post-collection labeling and transport in temperature-controlled conditions to uphold chain-of-custody standards.^[33]^[32]

Intravenous therapy

Winged infusion sets, also known as butterfly needles, are commonly employed for short-term intravenous (IV) access to administer fluids and medications directly into a vein. These devices connect via their flexible tubing to IV bags, syringes, or infusion pumps, facilitating the delivery of therapies such as hydration fluids, antibiotics, chemotherapy agents, or pain relievers. They are particularly suited for brief infusions lasting up to a few hours, though some models support administration for up to 24 hours when used with compatible disposable infusion devices.^[8]^[30]^[9] Post-insertion, the wings of the device are typically secured with adhesive tape or a stabilization device to prevent dislodgement, ensuring stable access during infusion. In sensitive insertion sites like the antecubital fossa, close monitoring is essential to detect signs of infiltration, such as swelling or pain, due to the area's flexion and higher risk of complications. This adaptation allows for precise control and minimizes patient discomfort during the procedure.^[35]^[36]^[37] Clinically, winged infusion sets find application in outpatient settings for routine short-term therapies, emergency scenarios requiring rapid fluid or medication delivery including blood transfusions, and neonatal care where fragile or small veins preclude the use of longer catheters. Their design supports multi-purpose access, overlapping briefly with venipuncture techniques for combined blood sampling and infusion when needed. In these contexts, the sets provide reliable, low-trauma entry for patients with difficult venous access, such as infants or the elderly.^[8]^[38]^[39]

Specifications and variations

Needle gauge and length

Winged infusion sets feature needles in gauges ranging from 18 to 27, with higher gauge numbers indicating thinner diameters that reduce patient discomfort and vessel trauma, particularly in pediatric or fragile-vein cases, while lower gauges provide larger lumens for faster flow rates in adult applications.^[8] The thinnest options, such as 27 gauge, are reserved for neonates or patients with very small veins to minimize pain and complications like infiltration.^[4] The most commonly used gauges are 21 and 23, striking an optimal balance between ease of insertion, patient comfort, and sufficient flow for routine blood collection or short-term infusions without causing hemolysis from excessive shear stress on blood cells.^[40] Needle lengths typically measure 1/2 inch (12 mm) as standard for superficial veins, extending to 1 1/8 inch (29 mm) for accessing deeper vessels while maintaining control during insertion.^[1]^[40] Selection of gauge and length is guided by patient-specific factors including vein size and condition, age, and procedural needs; for instance, 25-gauge needles with shorter lengths are ideal for neonates to limit tissue damage, whereas 18-gauge options with standard lengths support rapid infusions or transfusions requiring high-volume flow in adults with robust veins.^[41]^[42] Oversized needles risk vein tears and hematomas, while undersized ones may lead to slow flow or sample contamination, emphasizing the need for vein assessment prior to choice.^[43]

Safety features

Winged infusion sets feature built-in needlestick prevention mechanisms to protect healthcare workers from accidental injuries after needle withdrawal. These typically include hinged or sliding shields that cover the exposed needle tip once activated, often with an audible click for confirmation of engagement, ensuring the needle remains securely encased. Activation can be performed using one-handed techniques, such as those in the Surshield® system, allowing safe disposal without recapping. Such designs comply with the Needlestick Safety and Prevention Act of 2000, which requires employers to use engineering controls like safety-engineered sharps to minimize occupational exposure to bloodborne pathogens.^[44]^[11]^[45] Additional safety enhancements include color-coded wings for rapid gauge identification, which helps prevent procedural errors by enabling quick visual recognition of the device specifications. Low-profile wing configurations reduce the likelihood of accidental pulls or dislodgement during patient movement, promoting secure placement and minimizing disruption to the infusion site. These elements integrate directly with standard low-pressure tubing connectors, maintaining compatibility for routine clinical workflows.^[2]^[46] The efficacy of these safety features is supported by epidemiological data showing substantial reductions in injury rates. According to the Centers for Disease Control and Prevention (CDC), as estimated in the early 2000s, safety-engineered devices can prevent 62% to 88% of sharps injuries in healthcare settings.^[47]

Advantages and considerations

Benefits in use

The wings of a winged infusion set provide enhanced grip and stability during insertion, allowing for better vein visualization and more precise needle placement, particularly in patients with small or fragile veins. This design facilitates a shallower insertion angle and reduces the need for repositioning, contributing to higher first-attempt cannulation success rates compared to non-winged alternatives. Such precision is especially beneficial in challenging vascular access scenarios, where the wings enable clinicians to maintain control even if the patient moves slightly.^[8]^[9] Winged infusion sets promote greater patient comfort through their smaller needle sizes, typically ranging from 21 to 25 gauge, and flexible tubing, which minimize tissue trauma and pain during venipuncture. Compared to straight needles or indwelling catheters, this configuration results in less bruising and hematoma formation by limiting vein wall perforation and allowing for gentler entry.^[9] Patients, including those with needle phobia or sensitive veins, often report reduced discomfort, as the device's design supports a more controlled and less intimidating procedure.^[8] The versatility of winged infusion sets extends their utility across diverse clinical environments, including hospital laboratories for blood collection, short-term intravenous therapy in outpatient settings, and home care for intermittent infusions. Their compact, easy-to-handle format reduces the likelihood of multiple insertion attempts, streamlining procedures and making them ideal for pediatrics, geriatrics, or patients with limited venous access.^[9] This adaptability supports efficient use in both routine phlebotomy and brief therapeutic applications without requiring specialized equipment.^[8]

Potential drawbacks

Winged infusion sets, also known as butterfly needles, incur higher costs compared to standard straight needles due to the inclusion of stabilizing wings and attached tubing, which can strain budgets in high-volume phlebotomy or infusion settings.^[48]^[8] This added expense is attributed to the specialized components that enhance precision but increase manufacturing complexity.^[34] Key risk factors associated with their use include the potential for tubing kinking, which may interrupt fluid flow and require repositioning, as well as elevated occlusion rates during extended applications beyond recommended short-term durations (up to 2 hours).^[8]^[1] Prolonged indwelling can lead to vein irritation or collapse, exacerbating occlusion risks.^[9] Additionally, effective deployment demands trained personnel to mitigate complications such as percutaneous injuries, which occur at rates up to four times higher than with vacutainer systems if mishandled.^[34] These devices are contraindicated for high-flow infusions owing to their narrow tubing and needle gauge, which restrict flow rates and hinder rapid fluid or blood delivery.^[8] They are also unsuitable for patients with deep veins, such as those in obese individuals, as the short needle length limits access to superficial vessels only.^[8] Furthermore, reusing non-single-use sets heightens infection risks through potential contamination.^[9] While these limitations exist, the sets' design can offset certain risks for populations with fragile or small veins.^[8]

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