Cause of Device-Related Incident
Device factors; Support system failures; User errors

Clinical Specialty or Hospital Department
CCU / ICU / NICU; CSR / Materials Management; Infection Control; Nursing; Pharmacy / IV therapy

Device Factors
Design / labeling error

Document Type
Hazard Reports

External Factors
*Not stated

Mechanism of Injury or Death
Embolism (gaseous or particulate); Exposure to bloodborne pathogens; Exsanguination; Infection

Support System Failures
Poor prepurchase evaluation; Use of inappropriate devices

Tampering and/or Sabotage
*Not stated

User Errors
Incorrect clinical use

UMDNS
Catheter Injector Ports [16-858]; Catheters, Central Venous [10-729]; Intravenous Administration Sets [12-157]; Infusion Pump Administration Sets [16-579]; Infusion Pumps, General-Purpose [13-215]

Risks of Using Intravenous Administration Sets with Non-Self-Sealing Injection Sites



Hazard [Health Devices Dec 1995;24(12):515]

Problem

A member hospital reported a case of blood loss through a Luer-fitting injection site that was not capped (i.e., was unsealed). The injection site was near the patient end of an infusion pump administration set, which was connected to a peripheral catheter. The administration set was provided by an infusion pump manufacturer to satisfy the hospital's request for a needleless connection set. Similar products are available from other suppliers. This incident raises a concern about the risk of air embolism, exsanguination, and contamination with the use of non-self-sealing injection sites.

Discussion

The Development of Needleless Systems

In the past, all injection sites (also called side ports or Y-sites) were sealed with nonremovable rubber septums. These sites were used by piercing the septum with a needle connected to a syringe or secondary tubing set. When the needle was removed, the septum would reseal. However, the need to use hypodermic-type injection needles with these sites posed a risk of needlestick injuries—a hazard that has lead to the development and implementation of needleless infusion administration systems. In general, these systems use components such as recessed needles, valved connectors, or capped Luer fittings to reduce or eliminate the needlestick hazard.

Not all infusion pump manufacturers offer needleless systems at this time; however, when considering new infusion pump purchases, many hospitals now specify that needleless systems be available. As an interim measure, some manufacturers may offer sets with capped Luer-fitting injection sites, which can be developed quickly and sold as an inexpensive needleless product. (More than one manufacturer has already done so.) However, these sites are not self-sealing and require the user to manually close the site (e.g., by closing a clamp) after each use. This approach to preventing needlestick injuries introduces the new hazards explained below. We are concerned that, in the current environment of heightened concern about needlestick injuries and cost containment, additional manufacturers of administration sets may start offering sets with Luer-fitting injection sites.

The Risks of Using Non-Self-Sealing Injection Sites

Patients and personnel are placed at risk when Luer-fitting injection sites are not properly sealed, such as when sites are left uncapped and/or unclamped or possibly when caps are inadvertently removed or loosened during use (which may not be obvious). The consequences of an injection site being left open on an administration set, especially one connected to a central venous catheter, are potentially fatal. An open injection site could result in the following:

  • Gas embolism. This is likely to occur only when the set is connected to a central venous catheter. (See "Air Embolism through Central Venous Catheters" in Health Devices 14(14):436-7, Dec 1985. Subatmospheric pressure sometimes develops at the tip of a central venous catheter positioned in the superior vena cava, especially during inhalation and when the patient is in a sitting or standing position. A subatmospheric pressure of as little as 5 mm Hg can draw air into the superior vena cava through the open injection site and catheter.
  • Blood loss. This could occur from any vascular access device if the injection site is open and blood pressure at the vascular access site is greater than atmospheric pressure.
  • Contamination. If blood leakage does occur from an open injection site, hospital personnel, equipment, and the room in which the leakage occurs may be at an increased risk of contamination.

Manual clamping of the set between the injection site and the catheter or clamping of the catheter itself before removing the cap on the Luer-fitting injection site will prevent both gas embolism and blood loss. However, manual clamping is subject to human error.

Alternatives

Hospitals should consider implementing one of the following alternatives to the use of administration sets with Luer-fitting injection sites:

  • Whenever possible, use sets with nonremovable, needleless, self-sealing injection sites that can be accessed with either a blunt cannula or a male Luer fitting, such as those on standard syringes. This type of set, which includes sets with prepierced septums or valved injection sites, is preferred. However, systems using nonremovable prepierced septums and valved injection sites are not available for all infusion pumps, and they may be cost prohibitive for some institutions.The following approaches are equally acceptable in reducing the risk of gas embolism and bleeding:

Using an extension set with a valved connector Y-site connected between the catheter and the administration set. This configuration allows for manual injections directly through the second port of the extension set and eliminates the need for injection sites on the administration set below the pump.

Using recessed needle systems on administration sets with traditional rubber septum injection sites. These adapters can be added as needed and, therefore, need only be applied at injection sites when in use.

  • When the sets described in the first item above are not available, the next best alternative is to use self-sealing IV connectors on sets with standard Luer-fitting injection sites. These connectors must be securely attached to each injection site to which access is required before the set is connected to the patient. After each injection through these connectors, clinicians should verify that the IV connector is securely attached to the injection site. One drawback to this alternative is that it does not protect against inadvertent disconnection of the self-sealing IV connector from the injection site.

While the above alternatives are preferred, Luer-fitting injection sites can be used with clamps and traditional male Luer caps, provided that each site is kept clamped whenever it is not being used for an injection or secondary infusion (see figure) However, we do not recommend this approach because it is most subject to human error.

NOTE: When selecting the type of injection site to be used as part of a needlestick-prevention program, many issues need to be considered. In addition to those discussed in our Evaluation of needlestick-prevention devices (NPDs), which was published in the August-September 1994 issue of Health Devices (23[8-9]) and which has been updated in 1995, hospitals should consider 1) that the retained volume of injection sites and adapters will vary among products; thus, users may need to flush the injection site after small-volume injections with some systems and 2) that increasing the number of components connected to an administration set increases labor and the likelihood of both contamination and disconnection.

Recommendations

To avoid the risks of air embolism, blood loss, and contamination, ECRI recommends against the use of IV administration sets that feature Luer-fitting injection sites. Instead, use one of the following alternatives, as described above:

  • Sets with nonremovable, needleless, self-sealing injection sites that can be accessed with either a blunt cannula or a male Luer fitting.
  • Extension sets with a valved connector Y-site connected between the catheter and the administration set.
  • Recessed needle systems for use on administration sets with traditional rubber septum injection sites.

If such sets are not available, use self-sealing IV connectors on sets with standard Luer-fitting injection sites. (Note that these recommendations go beyond those made in our August-September 1994 Evaluation of NPDs.)

UMDNS Terms

  • Catheter Injector Ports [16-858]
  • Catheters, Central Venous [10-729]
  • Intravenous Administration Sets [12-157]
  • Infusion Pump Administration Sets [16-579]
  • Infusion Pumps, General-Purpose [13-215]

Cause of Device-Related Incident

Device factor: Design/labeling error

User error: Incorrect clinical use

Support system failures: Poor prepurchase evaluation; Use of inappropriate devices

Mechanism of Injury or Death

Embolism (gaseous); Exposure to bloodborne pathogens; Exsanguination; Infection


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