“USP <800> requires three effective protection mechanisms for the nurse – closed system transfer devices, personal protective equipment, and administrative controls.”

Seth Eisenberg, RN, ASN, OCN®, BMTCN™

While the majority of USP <800> deals with pharmacy-related activities such as compounding and its associated activities, sections of the standard dictate practices specific to the administration of hazardous drugs (HDs) and training requirements. USP <800> mandates the use of a closed system transfer device (CSTD) for administration of HDs when the dosage form allows. For nurses not already using a CSTD, incorporating these devices into administration will require a significant change in practice. In addition, USP <800> requires wearing two pairs of chemotherapy gloves tested to the ASTM D6978 standard or its successor, as well as the use of an appropriate disposable, back-closing gown.

Administering HDs and the Necessary PPE.

Use of a Closed System Transfer Device (CSTD):

It has been well established that HD contamination can occur at multiple points during the administration process. Examples include the use of Luer fittings or open system connections, spiking the bag at the bedside, priming IV tubing, connecting and disconnecting tubing and syringes, leaking connections, and un-spiking an IV bag when the infusion is complete.

CSTDs work by preventing the release of aerosols, vapors, and droplets that can occur during compounding, due to pressure inside drug vials and repeated transfer of the drug from the vial to an IV bag. CSTDs protect nurses during administration and after completion, by not allowing fluid to pass between connection points unless the device is fully engaged, preventing drips that typically occur when tubing has been disconnected.

For nurses not already using a CSTD, incorporating these devices into administration will require a significant change in practice. There are a number of different, possible CSTD combinations depending on the device and tubing configuration.

The key to success is ensuring all staff who administer an HD are completely familiar with the correct use of the device, and creating a workplace culture that places the safety of the nurse at the forefront. It is important to ask each CSTD manufacturer to supply educators who can assist in training staff and CSTD roll-out. It is also recommended that each nursing unit involve designated “super-users” who are not only familiar with the device, but are also experts in the nuances of patient care workflow and the equipment used for administration. These in-house experts provide a link between USP <800> and the real world.

Ideally, CSTD components required for administration should be stocked at the bedside. For facilities that do not have this ability, sending the requisite components along with the HD bag is another possible option. Failure to provide the necessary components where they are needed will likely result in noncompliance.

If the current practice allows for spiking IV HD bags or priming tubing with HD at the bedside, a radical change will be required as both of these activities are prohibited by USP <800>. A number of alternatives for priming and administration are available and will depend on pharmacy workflow, the brand of IV pump being used, and the CSTD selected. The department’s super-users will play a crucial role in helping to design workflow that is compliant with USP <800> and for helping to change current practice.

Using proper personal protective equipment:

Historically, nurses have relied upon PPE as their sole source of protection. While prior to the development of CSTDs, this reliance was properly placed, even when CSTDs are in use, proper PPE is still essential. Research shows that when PPE is not conveniently located near patient care areas, it is less likely to be used by nurses.

Wearing two pairs of chemotherapy-tested gloves will usually necessitate a culture change within the organization. Correct donning and doffing typically requires hands-on education, making sure the inner pair is under the sleeve of the gown while the outer pair covers the sleeve. Similarly, removing the outer pair without disturbing the inner pair may also require practice. During patient care, extra time will be required for donning the outer pair over the inner gloves, and nurses will need to plan accordingly.

USP <800> requires that disposable gowns be worn for administration of HDs. All gowns must be resistant to HDs. Gowns must be back-closing, and have long sleeves with elastic cuffs. The gowns must be seamless or have taped seams. Gowns that are coated are preferred, as they have demonstrated superior performance to non-coated gowns. Gowns must be changed per the manufacturer’s information for permeation of the gown. If no permeation information is available for the gowns used, the recommendation is to change them every 2–3 hours or immediately after a spill or splash. Gowns worn in HD handling areas must not be worn to other areas.

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