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Workbook for Designing, Implementing, and Evaluating a Sharps Injury Prevention Program


Contents:

APPENDIX B - Devices with Engineered Sharps Injury Prevention Features

Devices with Engineered Sharps Injury Prevention Features

 

Introduction

This section describes various ways safety features have been incorporated into the most commonly used conventional needles and other sharp devices to protect healthcare workers from injury. Factors to consider during device selection, including concerns for patient safety, are provided to help guide the decision-making process. Information provided in this section is intended to help healthcare organizations make informed product choices and does not reflect CDC endorsement or disapproval of any product. Healthcare organizations are also encouraged to look to other literature on these devices.


Definition of an "Engineered Sharps Injury Prevention Device"
This term has been defined by the OSHA and refers to:

 

  • "A physical attribute built into a needle device used for withdrawing body fluids, accessing a vein or artery, or administering medications or other fluids, which effectively reduces the risk of an exposure incident by a mechanism such as barrier creation, blunting, encapsulation, withdrawal or other effective mechanisms;
  • Or

  • A physical attribute built into any other type of needle device or into a non-needle sharp, which effectively reduces the risk of an exposure incident."
  • These engineering modifications generally involve one of the following strategies:

  • Eliminate the need for a needle (substitution);
  • Permanently isolate the needle so that it is never poses a hazard; or
  • Provide a means to isolate or encase a needle after use.

Another type of engineering control is the rigid sharps disposal container that comes in a variety of shapes and sizes. Although not discussed in this workbook, these containers are an important strategy for reducing the risk of sharps injuries and an essential element in a comprehensive sharps injury prevention program. The National Institute for Occupational Safety and Health has published guidance on the selection of sharps containers (116) (www.cdc.gov/niosh/sharps1.html)

Other products have also been developed to promote safer work practices, such as needle recapping devices and IV line stabilizers. These products can have an important role in prevention. For example, fixed needle recappers (i.e., permanently or temporarily attached to a surface) that facilitate safe recapping when a needle must be reused on the same patient during a procedure (e.g., providing local anesthesia) might be considered when no acceptable alternative is available. Also, devices used to stabilize an intravenous or arterial line that provide an alternative to suturing are likely to reduce percutaneous injuries to healthcare providers as well as improve patient care by reducing site trauma and inadvertent line removal and the need to reinsert another catheter. Information on these products is not included in this workbook.

Concept of "Active and Passive" Safety Features

The majority of safety features integrated into devices are active, i.e., they require some action on the part of the user to ensure that the needle or sharp is isolated after use. With some devices, activation of the safety feature can be done before the needle is removed from the patient. However, for most devices, activation of the safety feature is performed following the procedure. The timing of activation has implications for needlestick prevention; the sooner the needle is permanently isolated, the less likely a subsequent needlestick will occur.

A passive safety feature is one that requires no action by the user. A good example of such a device is a protected needle used to access parts of an IV delivery system; although a needle is used, it is never exposed (i.e., unprotected) and does not rely on the user to do render it safe.

Few devices with passive safety features are currently available. Many devices currently marketed as self-blunting, self-resheathing, or self-retracting imply that the safety feature is passive. However, devices that use these strategies generally require that the user engage the safety feature.

Although devices with passive safety features are intuitively more desirable, this does not mean that a safety feature that requires activation is poorly designed or not desirable. In certain situations it is not practical or feasible for the device or for the procedure to have a passive control. Therefore, whether a safety feature is active or passive should not take priority in deciding the merits of a particular device. The relevance of this information is most important for the training of healthcare personnel in the correct use of a modified device and motivating compliance in using the safety feature.

The following Websites provide information on the various safety devices that are currently available. (Need to add the CDC disclaimer)

List of Devices Designed to Prevent Percutaneous Injury and Exposures to Bloodborne Pathogens in the Health Care Setting (Developed by the University of Virginia's International Health Care Worker Safety Center.) www.med.virginia.edu/epinet/

The California List of Needlesless Systems and Needles with Engineered Sharps Injury Protection (Developed in accordance with California Labor Code section 144.7 by the California Department of Health Services (DHS) and the Division of Occupational Safety and Health (Cal/OSHA).) www.dhs.ca.gov/ohb/SHARPS/disclaim.html

The National Alliance for the Primary Prevention of Sharps Injuries (NAPPSI) is a group of health organizations, medical device manufacturers, healthcare professionals, and others working cooperatively to reduce sharps injuries by reducing the number of sharps in the workplace. This Website has links to several manufacturers that include pictures of the various devices available.

http://www.nappsi.org

The Premier Safety Institute has information on the evaluation of several safety devices products by organization members. www.premierinc.com Needlestick Prevention Device Selection Guide is sponsored by ECRI, an independent non-profit health services research agency.

www.ecri.org

 

Devices with Sharps Injury Prevention Features
Conventional Device
Device with Engineered Sharps Injury Protection
Comment
IV delivery systems that use hypodermic needles to connect and access system components Valved access ports and connectors. Needles generally cannot be used with valved ports. Needles can be used with pre-pierced septa systems and may be necessary in some situations. Assessment for compatibility with existing IV delivery systems in use in a facility, including IV pumps, is necessary before selecting a device. The number of parts can influence effective use of a system; fewer parts promote simplicity and safety.
Pre-pierced septa for use with blunted cannulas.
Recessed/protected needle connectors.
Hypodermic needle with attached syringe Syringe or needle with sliding sheath that covers needle after use. Scope of needle/syringe use is not limited. No forcing function requires user to activate safety feature. Increases in waste volume should be considered.
Hinged needle guard/shield attached to needle hub is manually folded over needle after use; hinged guards also can be purchased separately. Scope of needle/syringe use is not limited. Ability to permanently lock hinge in place over needle varies among devices with this feature. Compliance may be compromised if purchased as an add-on feature rather than being pre-attached at the time of manufacture. Hinge shield may promote compliance with safety feature activation; needle disposal is difficult if shield is not in place. Some interference with the procedure is possible if working in a confined area.
Sliding shield needle guard attached to needle hub is manually moved forward to cover needle after use. Scope of needle/syringe use is not limited. No forcing function requires user to activate safety feature.
Syringe with mechanical needle- retraction feature isolates needle inside syringe; placing additional pressure on plunger upon completing injection activates retraction feature. Needle is completely isolated after use. Device can only be used for performing injections; fixed needle does not permit change of needle if needed; potential exists for creating aerosols if needle is retracted outside the body. Waste volume is reduced.
Needleless jet injection devices. Eliminates needle hazard. Scope of use is currently limited to giving injections and only with certain drugs.
Intravenous (IV) insertion devices (catheters) IV catheters (peripheral and midline) with sliding needle guard/shields. The stylet is permanently protected as it is withdrawn from the catheter. Some devices encase the entire stylet while others protect only the tip. Differences exist in the mode of safety feature activation (i.e., active versus passive). No device with engineered sharps protection feature is currently available for central or arterial line catheters. However, there are midline (PICC) devices with safety features.
IV catheters with button or slide activated rigid needle encasement feature.
Blood collection tube/phlebotomy needle assembly Bluntable phlebotomy needle for use with reusable or single use tube holder. Looks like a conventional phlebotomy needle. An internal cannula, advanced forward by pressing on the end of the blood tube, blunts the needle by extending beyond the tip. The safety feature can be activated while needle is still in the vein. No forcing function requires the user to activate the blunting feature. A sharps disposal container is sold with the device.
Hinged shield attached to needle for use with reusable or single use tube holder. Hinged shield may promote compliance with safety feature activation; needle disposal is difficult if shield is not in place.
Single use blood tube holder into which needle is manually retracted after use; hinged end at bottom of tube holder closes to encase needle. Completely protects both ends of needle, i.e. venipunture needle and needle that punctures blood tube. No forcing function requires the user to activate the safety feature; increases in waste volume should be anticipated if changing from multiple- to single-use tube holders.
Single use blood tube holder into which needle mechanically retracts after use; hinged cover at bottom of holder triggers retraction feature when closed.
Single use vacuum tube holder with attached sliding shield that protects needle after use.
Winged steel (butterfly-type) needles for phlebotomy Needle sheath that slides forward to cover the entire needle after use. All devices require activation of the safety feature. No protection for boot end needle (tip that punctures the blood tube) is provided unless a single-use tube holder is used. Waste volume should not be affected with these devices.
Needle sheath into which the needle is withdrawn to cover the entire needle after use.
Stainless steel needle tip guard that slides forward to cover the needle tip after use.
Hemodialysis fistula needles Needle is encased in protective housing as it is withdrawn from the fistula. No comments due to limited information on use of these devices.
A protective case is folded over the needle after withdrawal from the fistula.
Finger/heel stick lancets Single-use lancets with trigger that automatically protracts and retracts lancet. With some devices, the lancet is not locked in place after use. The method of activation also varies.
Reusable pen-like lancets with disposable end caps and lancets (available as separate components or as a combined unit). Pen-like devices should be assigned to individual patients to reduce the risk for cross-transmission of bloodborne pathogens.
Curved, pointed suture needles Curved, blunted suture needles. Limited to use on certain types of tissue (e.g., muscle, fascia).
Surgical scalpels Single-use disposable scalpels with shields to cover the scalpel blade. No comments due to limited information on use of these devices.
Reusable scalpels with lock/release to allow mechanical removal of blade.

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Publish date: February 12, 2004
This page last reviewed February 12, 2004