The Journal of Bone & Joint Surgery

The Journal of Bone & Joint Surgery, Volume 93, Issue 17

Scientific Articles | September 07, 2011

Safety Syringes and Anti-Needlestick Devices in Orthopaedic Surgery

Wilmer L. Sibbitt, Jr, MD¹; Philip A. Band, PhD²; Lawrence G. Kettwich, BS¹; Cristina R. Sibbitt, BS³; Lori J. Sibbitt, BS⁴; Arthur D. Bankhurst, MD¹

¹ Department of Internal Medicine, University of New Mexico Health Sciences Center, Fifth Floor ACC, Mail Stop: MSC10-5550, Albuquerque, NM 87131. E-mail address for W.L. Sibbitt Jr.: wsibbitt@salud.unm.edu. E-mail address for L.G. Kettwich: lkettwich@salud.unm.edu. E-mail address for A.D. Bankhurst: abankhurst@salud.unm.edu
² Departments of Orthopaedic Surgery and Pharmacology, New York University Hospital for Special Surgery, 301 East 17th Street, New York, NY 10003. E-mail address: Philip.band@nyumc.org
³ 710 A Skylark Court, Missoula, MT 59801. E-mail address: BuBukity15@aol.com
⁴ 702 Madison Avenue, Helena, MT 59601. E-mail address: superdog182@aol.com

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Disclosure: None of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of any aspect of this work. One or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. No author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

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Investigation performed at the Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, and the Department of Orthopaedic Surgery, New York University School of Medicine, New York, NY

J Bone Joint Surg Am, 2011 Sep 07;93(17):1641-1649. doi: 10.2106/JBJS.J.01255

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Abstract

Background:

The American Academy of Orthopaedic Surgery (AAOS), The Joint Commission, the Occupational Safety and Health Administration (OSHA), and the Needlestick Safety and Prevention Act encourage the integration of safety-engineered devices to prevent needlestick injuries to health-care workers and patients. We hypothesized that safety syringes and needles could be used in outpatient orthopaedic injection and aspiration procedures.

Methods:

The study investigated the orthopaedic uses and procedural idiosyncrasies of safety-engineered devices, including (1) four safety needles (Eclipse, SafetyGlide, SurGuard, and Magellan), (2) a mechanical safety syringe (RPD), (3) two automatic retractable syringes (Integra, VanishPoint), (4) three manual retractable syringes (Procedur-SF, Baksnap, Invirosnap), and (5) three shielded syringes (Safety-Lok, Monoject, and Digitally Activated Shielded [DAS] Syringe). The devices were first tested ex vivo, and then 1300 devices were used for 425 subjects undergoing outpatient arthrocentesis, intra-articular injections, local anesthesia, aspiration biopsy, and ultrasound-guided procedures.

Results:

During the clinical observation, there were no accidental needlesticks (0 needlesticks per 1300 devices). Safety needles could be successfully used on a Luer syringe but were limited to ≤1.5 in (≤3.81 cm) in length and the shield could interfere with sonography. The mechanical safety syringes functioned well in all orthopaedic procedures. Automatic retractable syringes were too small for arthrocentesis of the knee, and the plunger blew out and prematurely collapsed with high-pressure injections. The manual retractable syringes and shielded syringes could be used with conventional needles for most orthopaedic procedures.

Conclusions:

The most effective and reliable safety devices for orthopaedic syringe procedures are shielded safety needles, mechanical syringes, manual retractable syringes, and shielded syringes, but not automatic retractable syringes. Even when adopting safety-engineered devices for an orthopaedic clinic, conventional syringes larger than 20 mL and conventional needles longer than 1.5 in (3.8 cm) are necessary.

Level of Evidence:

Therapeutic Level III. See Instructions to Authors for a complete description of levels of evidence.

Figures in this Article

Introduction

Orthopaedic surgeons are compliant in implementing safety measures, yet the risk of an injury from a sharp object to an orthopaedic surgeon over a ten-year period remains 80% to 90%, with glove penetrations (90%), self-puncture of the finger with the suture needle (43%), scalpel blade injuries (17%), needlestick from a syringe (12%), and injury by bone fragments (2%) being the most common^1-8. Similarly, avoidable patient injuries are of concern in orthopaedics but are challenging to prevent^9-13. The American Academy of Orthopaedic Surgeons, The Joint Commission, the Needlestick Safety and Prevention Act, and the Occupational Safety and Health Administration (OSHA) all encourage health-care entities, including orthopaedic services, to develop formal mechanisms to improve patient and health-care worker safety that include the integration of new safety technologies^14-18.

The identification, evaluation, validation, and introduction of new safety technologies are not always straightforward and require considerable research and validation^19-34. Before a safety device is adopted by an institution, knowledge concerning the performance of that safety device in common orthopaedic procedures is critical because once the device is adopted it is often the only device of that class readily available to the surgeon^33,34. We hypothesized that safety syringes and safety needles could be used in typical outpatient orthopaedic injection and aspiration procedures.

Materials and Methods

Description of Study

This project was in compliance with the Declaration of Helsinki. The Safety and Quality Improvement Committee of our division performed a survey and assessment of potential safety devices for integration into our outpatient procedural activities. The candidate safety technologies were identified through a review of the literature and educational safety resources^22-31. Candidate technologies included safety needles, retractable syringes, shielded syringes, and mechanical syringes^27-38. The devices initially were tested ex vivo and were used in clinical practice to obtain experience with the idiosyncrasies of each device. Approved devices were cleared by the United States Food and Drug Administration (FDA) by the 510(k) pathway³⁸. Devices that were not yet FDA-approved were studied in a safety-syringe study registered at ClinicalTrials.gov (Clinical Trial Identifier NCT00651625).

Clinical Experience with Safety Devices

The devices were sequentially used in clinical practice to obtain experience in their use and to determine their suitability for integration into our patient safety and health-care worker safety program. One hundred of each device were used. Procedures that were performed with the devices in the usual performance of our clinical activities included (1) aspiration of medication out of a vial, (2) administration of local anesthesia, (3) arthrocentesis, (4) intra-articular injections (using either direct injection or the one-needle two-syringe technique), (5) injection of bursae, (6) ultrasound-guided procedures, (7) aspiration biopsy (of fat, synovial membrane, or muscle), and (8) high-pressure hydrodissection and injection of dense connective-tissue lesions, including rheumatoid nodules, nodules of Dupuytren contracture, and trigger finger. At the end of the quality-improvement and safety process, 425 patients had undergone procedures with these safety devices.

Safety Needles

Safety needles are needles that are inactivated with a movable shield that is part of the needle assembly (Figs. 1 and 2) (see Appendix)^27-31,35. The safety needles that were tested included the Eclipse Safety Needle (305783; BD, Franklin Lakes, New Jersey), SafetyGlide Safety Needle (305900; BD), SurGuard2 Safety Needle (SG2-2238; Terumo Medical Corporation, Somerset, New Jersey), and Monoject Magellan Safety Needle (8881850215; Kendall [Covidien], Mansfield, Massachusetts).

Fig. 1

Photograph showing shielded safety needles, including the BD Eclipse Safety Needle (A), Terumo SurGuard2 Safety Needle (B), Kendall Monoject Magellan Safety Needle (C), and BD SafetyGlide Safety Needle (D). Each needle is shown in its active utility form (left) and in its inactivated form (right).

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Fig. 2

Photograph showing a mechanical patient-safety syringe (Avanca RPD) fitted with a safety needle with a rotating sheath (Eclipse). Here, the mechanical syringe is being used for aspiration of a popliteal cyst with use of sonographic guidance.

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Retractable Safety Syringes

Retractable syringes inactivate the needle by retracting the needle into the barrel or the plunger (Fig. 3) (see Appendix)^31,36. The retractable safety syringes that were tested included the BD Integra Syringe (305274; BD), Avanca Procedur-SF Safety Syringe (Avanca Medical Devices, Albuquerque, New Mexico), Baksnap Retractable Safety Syringe (97203351; Duopross Meditech Corporation, Farmingdale, New York), Safepro Invirosnap Retractable Syringe (100076; Inviro Medical, Duluth, Georgia), and RTI VanishPoint Syringe (10341; Retractable Technologies, Little Elm, Texas).

Fig. 3

Photograph showing retractable safety syringes, including the BD Integra Syringe (automatic retraction) (A), RTI VanishPoint Syringe (automatic retraction) (B), Baksnap Retractable Safety Syringe (manual retraction) (C), and Avanca Procedur-SF Safety Syringe (digital retraction) (D1 and D2). Each syringe is shown in its active utility form (left) and in its retractable inactivated form (right). The Safepro Invirosnap Retractable Syringe is similar to the Baksnap and is not shown.

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Shielded Safety Syringes

Shielded safety syringes have a barrel-based shield that slides to cover and inactivate the needle (Figs. 4 and 5)^31,37. The shielded safety syringes that were tested included the BD Safety-Lok Syringe (309593; BD), Monoject Safety Syringe (8881; Covidien), and DAS Safety Syringe (Digitally Activated Shielded Syringe; Science & Technology Corporation @ UNM, Albuquerque, New Mexico).

Fig. 4

Photograph showing shielded safety syringes, including the BD Safety-Lok Syringe (A), Kendall Monoject Safety Syringe (B), and DAS Shielded Syringe (C). Each needle is shown in its active utility form (left) and in its inactivated form (right).

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Fig. 5

Photographs showing the DAS Safety Syringe. The Digitally Activated (DAS) Safety Syringe is similar to both BD Safety-Lok Syringe and Kendall Monoject Safety Syringe but can be inactivated with one hand. After completing injection (A), the thumb is moved from the syringe plunger to the shield plunger (B) and the shield plunger is then depressed, locking the contaminated needle within the shield (C).

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Composite Safety Syringe

Composite safety syringes combine both patient safety technologies and anti-needlestick technologies (Fig. 2) (see Appendix)³⁴. The composite safety syringe that was tested was the RPD mechanical syringe (Avanca Medical Devices) combined with a safety needle with an off-axis rotating safety sheath (BD Eclipse Needle, 305783; BD).

Ex Vivo Testing of Safety Devices

The devices were assessed for technical aspects with a review of the literature and product specifications as well as with a hands-on evaluation to determine the available needle length and gauge, the ability to change needles on the same syringe, the ability to attach specialty needles such as spinal needles, the maximum length of needle that can be inactivated, the ability to inactivate the needle with one or two hands, the ability to generate pressure without inactivating the device, aerosolization or spray from the device during inactivation, the bulkiness of the device, the ability to aspirate and inject with one hand, and patient safety characteristics.

Source of Funding

There was no funding source or industry support for this study.

Results

During the evaluation of the 1300 safety-engineered devices, no needlesticks occurred to any operator. Safety devices could be used for most aspiration and injection procedures, with only minor modifications in technique. However, certain safety devices interfered to some degree with specific types of musculoskeletal procedures. In addition, certain safety syringes failed during high-pressure injections. The summary of safety device characteristics and performance are shown in tables in the Appendix.

Safety Needles

The BD Eclipse (Fig. 1, A) and the Terumo SurGuard2 (Fig. 1, B) needles each have a rotating sheath that encloses and inactivates the used needle, whereas the Kendall Monoject Magellan Safety (Fig. 1, C) and the BD SafetyGlide Safety (1, D) needles each have an elbow-like extendable sheath. Needles are available in 18 to 30-gauge sizes and 0.5 to 1.5-in (1.3 to 3.8-cm) lengths. Both direct injection and the one-needle two-syringe technique can be used with any of these devices. For ultrasound-directed procedures, the shield of each device may physically interfere with the ultrasound probe. These safety needles can be used for most orthopaedic procedures, but needle lengths of >1.5 in (>3.8 cm) are not available.

Composite Safety Syringes

The Avanca RPD syringe is a mechanical syringe that is fitted with a 1.5-in (3.8-cm) 22-gauge needle with a rotating sheath (see Appendix). The RPD syringe is formed around the core of a conventional syringe barrel and plunger but has a parallel aspiration plunger and an accessory barrel (see Appendix). The two plungers are mechanically linked by a pulley, resulting in a set of reciprocating plungers (see Appendix). When the aspiration plunger is depressed with the thumb, the syringe aspirates (see Appendix), and when the injection plunger is depressed, the syringe injects (see Appendix). The index and middle fingers remain in one position during both aspiration and injection, and the thumb moves to the alternative plunger to change from aspiration to injection. This permits greater needle control, one-handed operation, and more precise aspiration and injection during both palpation-guided and ultrasound-guided procedures (Fig. 2)^39,40. Although the RPD syringe permits facile one-handed aspiration and injection with enhanced needle control, this mechanical syringe is not an integrated two-step aspiration-injection device. Mechanical syringes are a patient-safety technology and have been demonstrated to enhance needle control, to permit controlled aspiration and injection, and to improve outcomes while reducing procedural pain and complications, including hemorrhage^34,41-49.

The RPD syringe is available in 1, 3, 10, and 25-mL sizes. The RPD syringe has larger syringe profile and operates by means of a "push-push" as opposed to the "push-pull" of a conventional syringe (see Appendix). Large-volume arthrocentesis in the knee can be accomplished with the 25-mL RPD. The RPD can be used with needleless Luer connectors. The RPD syringe can be used both for simple injection and for orthopaedic procedures^41-49.

Automatic Retractable Syringes

The BD Integra (Fig. 3, A) and RTI VanishPoint (Fig. 3, B) are spring-loaded automatic retractable syringes; the Integra has a nonfrictional mechanical retaining member, and the VanishPoint has purely a frictionally held retaining member. Automatic syringes are used like conventional syringes, and, after use, the plunger is forcefully depressed, triggering the retraction mechanism (a coiled spring) that retracts the needle into a hollow plunger. The Integra uses proprietary interchangeable non-Luer needles. Needles are available in 25 to 22-gauge sizes and 5/8 to 1.5-in (1.6 to 3.8-cm) lengths. The Integra syringe is only available in a 3-mL size. If the Integra is inverted with the needle off, the medication can drip out of the syringe by gravity; thus, the syringe must be held up at an angle during needle exchanges.

The VanishPoint has a fixed needle; thus, there is no possibility of changing needles. VanishPoint syringes are available in 1, 3, 5, and 10-mL sizes, and needles are available in 30 to 20-gauge sizes and 0.5 to 1.5-in (1.3 to 3.8-cm) lengths. The one-needle two-syringe technique cannot be used with the VanishPoint. When the Integra and VanishPoint are activated, the spring is not powerful enough to retract the needle from the joint capsule; thus, the needle must be pulled back to the subcutaneous tissues before automatic retraction occurs. The Integra and VanishPoint cannot be used with needleless Luer connectors. Both automatic syringes are inappropriate for aspiration biopsy and high-pressure procedures, including hydrodissection and injection of dense connective-tissue lesions, because the high pressure results in premature plunger collapse and failure of the procedure. Needles longer than 1.5 in (3.8 cm) are not available.

Manual Retractable Syringes

The Duopross MediTech Baksnap (Fig. 3, C) and Inviro Safepro Invirosnap are manual retractable syringes that have a fitting on the plunger that locks into the Luer-lock needle fitting; pulling on the plunger causes the needle to be manually retracted into the syringe barrel. After the plunger is locked in place, the plunger is broken ("snapped off") to prevent reuse. The Baksnap and Invirosnap have a Luer-lock fitting and thus can accommodate any Luer device, including any length of needle, but, with needles longer than 1.5 in (3.8 cm), the contaminated needle tip protrudes from the barrel after retraction. The Baksnap syringe is available in 1, 3, 5, 10, and 20-mL sizes, and the Invirosnap syringe is available in 3, 5, and 10-mL sizes.

The Procedur-SF is a retractable syringe with plunger-needle locking mechanism similar to that of the Baksnap (Fig. 3, D) (see Appendix). However, the needle is retracted not by pulling, but rather by depressing the aspiration plunger (see Appendix). The Procedur-SF syringe is a mechanical syringe that permits greater needle control, one-handed operation, and more precise aspiration and injection^34,41-49.

All three manual retractable syringes can be used with needleless Luer connectors. Manual retractable syringes can be used for simple injections and most orthopaedic procedures; however, at the end of a plunger stroke, the plunger can be unintentionally locked to the needle fitting, prematurely ending the procedure.

Manually Shielded Syringes

The BD Safety-Lok (Fig. 4, A) and Kendall Monoject (Fig. 4, B) have an exterior shield that resides on the outside of the barrel. After using the syringe, the shield is pulled forward to lock and shield the contaminated needle. The DAS safety syringe (Fig. 4, C) is similar but has a shield with its own plunger and, thus, can be inactivated with one hand. After injection (Fig. 5, A), the thumb moves from the syringe plunger to the shield plunger (Fig. 5, B); depression of the shield plunger (Fig. 5, B) extends and locks the shield over the needle (Fig. 5, C).

Manual retractable syringes have a Luer-lock fitting and thus can accommodate any Luer device, including any length of needle. With needles longer than 1.5 in (3.8 cm), the contaminated needle protrudes from the shield. Syringes are available in 1, 3, 5, and 10-mL (or 12-mL) sizes. These syringes can be used with needleless Luer connectors. Manual retractable syringes function well both for simple injection and for orthopaedic procedures, but the shield makes them bulkier and more awkward.

Discussion

Orthopaedic surgeons are the most compliant of surgical specialists in terms of the use of safety procedures and safety technologies¹. However, the orthopaedic surgeon's ten-year risk for body fluid contact exposure and injury by sharp medical objects remains one of the highest among all health-care workers^1-8. Avoiding needlesticks remains especially important because a needlestick can be effectively prevented by safety engineering whereas other injuries by sharp medical devices are more difficult to prevent^1-8,50-57.

Education concerning universal precautions is critical to reduce injuries by sharp medical devices, but education alone has proved to be inadequate for preventing needlestick injuries^28,35,52. Safety engineering of medical devices is one of the most robust methods to improve safety and has been shown to reduce iatrogenic injuries to patients and needlesticks to health-care workers^19-26,35,52. Multiple groups have reported a 70% to 100% reduction in needlesticks after conversion to safety-engineered devices^35,54-56. At least 20,000 devices are necessary for statistical power to demonstrate a significant reduction in needlesticks^35,54-56. However, as the present study demonstrates, the failure rates of devices (premature inactivation, plunger blowout, inadequate needle length, interference with sonography) in specific orthopaedic procedures can be determined with far fewer devices.

Tosini et al. reported that passive safety devices are the most effective, followed by automatic retractable syringes, shielded needles, shielded syringes, and manually retractable syringes⁵⁷. Passive devices include needle-free connectors, puncture-resistant gloves, double gloves, and blunt needles⁵⁷. Blunt needles do not puncture the skin well for intra-articular procedures, tend to tear the skin, are painful for the patient, and are thus contraindicated for outpatient orthopaedic procedures^57,58.

Automatic retractable syringes functioned well for subcutaneous or intramuscular injections but failed in many orthopaedic procedures. Automatic retractable syringes cannot be used in association with conventional Luer needles, cannot accommodate a needle longer than 1.5 in (3.8 cm), are too small in volume for knee arthrocentesis, do not function well for suction biopsy, and fail during high-pressure injections as a result of premature plunger blowout and plunger collapse. Furthermore, the VanishPoint has a fixed needle and cannot be used for the one-needle two-syringe technique. Thus, except for low-pressure superficial injections, automatic retractable syringes are inadequate for orthopaedic injection and aspiration procedures and therefore should not replace conventional devices in an orthopaedic clinic.

Rotating or toppling shielded needles are the next most effective technology to prevent needlestick⁵⁷. The present study demonstrated that shielded needles could be used for orthopaedic procedures, with only minor adjustments in technique. The greatest limitation of these devices is needle length, which is restricted to 1.5 in (3.8 cm) and is too short for many orthopaedic procedures. Also, the shield can interfere with certain ultrasound-guided procedures. Thus, shielded needles can replace conventional needles in an orthopaedic clinic; however, conventional 2-in (5.1-cm)-long needles and spinal needles must also be available for many procedures.

Sliding shield devices are the next most effective anti-needlestick devices and include both manual retractable syringes and shielded syringes⁵⁷. Manual retractable syringes were effective for almost all orthopaedic procedures but were not optimal for suction biopsy. Also, care must be taken not to accidently lock the plunger into the needle fitting at the end of the plunger stroke. The Baksnap was more favorable than the Invirosnap because the 20-mL Baksnap could be used for knee effusions whereas Invirosnap was not available with this larger syringe size.

Shielded syringes could also be used for orthopaedic procedures but were limited because 10 mL was the largest size. They were also more awkward to operate because of the increased syringe diameter. Unlike the Safety-Lok and Monoject Safety Syringe, the DAS shielded syringe could be inactivated with one hand, which has potential safety advantages (Figs. 4 and 5). Thus, manually retractable syringes and shielded syringes can be used in orthopaedic procedures with minimal change in technique, but 20-mL and larger sizes of conventional syringes must also be stocked because of the restricted sizes of shielded safety syringes.

Patient safety devices reduce procedural pain, procedural complications, and patient injuries^{10-15,17,19,21-26,34,39,40,46-49}. In the present study, only two patient safety devices, the RPD and the Procedur-SF mechanical syringes, were used; these devices have been demonstrated to enhance needle control, to permit controlled aspiration and injection, and to improve injection outcomes while reducing procedural pain and needle complications, including hemorrhage^{34,41-49,59-63} (Figs. 1 through 3) (see Appendix). Although both mechanical syringes functioned well for orthopaedic procedures, the RPD syringe was more robust than the Procedur-SF because there was no danger of prematurely locking the plunger.

Safety-engineered devices cost more than conventional alternatives (see Appendix). The cost-effectiveness of safety devices are judged on the lesser costs associated with the prevention of injuries by sharp medical devices, chronic illnesses, and premature death to health-care workers and the induction of better outcomes and fewer injuries to patients as compared with the additional costs of safety devices^64-70. A 10-mL conventional syringe costs $0.08 to $0.25 (United States dollars) per syringe, whereas a 10-mL safety syringe cost $1.00 to $1.60 per syringe, increasing the absolute cost of an intra-articular injection ($84) by $0.75 to $1.52 per procedure (representing a 0.1% to 1.8% increase in total cost for an intra-articular injection)⁷¹. Similarly, a 1.5-in (3.8-cm) conventional needle costs $0.04 to $0.10 per needle, whereas a 1.5-in (3.8-cm) safety needle costs $0.20 to $0.40 per needle, increasing the absolute cost by $0.10 to $0.36 per procedure (representing a 0.1% to 0.4% increase in total cost for an intra-articular injection)⁷¹.

Safety needles and syringes, although highly effective and saving $365 to $800 US per needlestick injury prevented, are more expensive in terms of total acquisition costs. Despite fewer needlesticks and infectious illnesses, it is unclear whether anti-needlestick devices are globally cost-effective^64-70. Mechanical syringes (double-barrel syringes) are also more costly per procedure but have been demonstrated to be cost-effective by decreasing procedural complications, reducing costs per responder, and decreasing total costs per patient per year^46,49,72-74. However, both federal law and the certifying authorities increasingly mandate the use of safety devices, so, regardless of costs, the integration of safety devices is an issue that must be addressed by each department and institution^12-32.

In summary, safety-engineered devices to prevent needlesticks to health-care workers and to enhance patient safety can be successfully evaluated, integrated, and used in outpatient orthopaedic procedures in which syringes are used. The most appropriate safety devices for orthopaedic procedures are shielded safety needles, mechanical syringes, manual retractable syringes, and shielded syringes. Automatic retractable syringes are less robust and are inappropriate for many orthopaedic procedures. Even when adopting safety-engineered injection devices for an orthopaedic clinic, conventional syringes that are 20 mL and larger and conventional needles that are longer than 1.5 in (3.8 cm) are necessary for many procedures.

Appendix

Figures showing a mechanical safety syringe and a digital retractable syringe and tables summarizing the data on all safety devices are available with the online version of this article as a data supplement at jbjs.org.

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Topics

needle device ; needlestick injuries ; protective devices ; safety ; syringes

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Wilmer L. Sibbitt, Jr, Philip A. Band, Lawrence G. Kettwich, Cristina R. Sibbitt, Lori J. Sibbitt, Arthur D. Bankhurst; Safety Syringes and Anti-Needlestick Devices in Orthopaedic Surgery. The Journal of Bone & Joint Surgery. 2011 Sep;93(17):1641-1649.

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