This article (Part 1) discusses appropriate hazardous drug (HD) personal protective equipment (PPE) for USP <800> compliance, including gloves, gowns, shoe covers, sleeve covers, donning and doffing, and PPE disposal. A future article (Part 2) will discuss appropriate respiratory protection, eye and face protection, and hair covers.
While the purpose of USP <797> is to protect patients, USP <800> provides standards for safe HD handling to minimize the risk of exposure to health care personnel, patients, and the environment. Moreover, USP <800> personalizes the concept of protecting health care providers with guidance regarding use of appropriate PPE. PPE provides an active barrier to protect staff from direct contact with hazards; thus, appropriate PPE use is a critical component of ensuring staff safety, as well as USP compliance.
To maintain the integrity of sterile products, USP <797> and <800> require specific processes be addressed in a formal garbing program. The first step in establishing an effective garbing program is to review USP <797>, USP <800>, and ASTM testing standards. Note that prior to implementing any garbing program, sites must conduct an overall risk assessment for each HD handling contact point and define the requirements for specific PPE to protect health care personnel. The following topics should be included in comprehensive garbing policies and procedures:
- Compounding personnel clothing requirements for entry into compounding spaces
- Clean shoe requirements for compounding personnel entering compounding spaces
- Personnel policies should state that staff with rashes, sunburn, weeping sores, conjunctivitis, active respiratory infection, and staff wearing cosmetics are prohibited from preparing compounded sterile preparations (CSPs)
- Compounding personnel must remove outer garments; cosmetics; artificial nails; hand, wrist, and body jewelry that can interfere with the fit of gowns and gloves; and visible body piercings above the neck
Once a formal garbing competency program has been established, it is critical for each health care team member to have competencies documented prior to handling any hazards, annually, or more frequently, in the event of a change at the facility in any item of garb. The goal of the competency program should be to educate and validate that staff members understand the purpose of garb.
Employee protection and comfort should be the primary considerations when choosing PPE, with cost a secondary consideration. Sites should stock a variety of sizes and styles of PPE to meet all staff needs. Involving staff with selecting predefined options of available PPE will optimize employee protection and comfort with the goal of ensuring compliant garbing.
PPE Testing Standards
PPE is considered protective when it receives approval by testing standards agencies, such as American Standards and Testing Measures (ASTM), as the organization’s sole purpose is to set standards for the testing, tolerance, and specifications of materials and processes. Only PPE tested to ASTM’s standards can be labelled as meeting these requirements. Each PPE component should be tested to standards that replicate mechanical and clinical practice. Do not assume that any item of PPE is HD-protective; always ask for a copy of the testing standard of a particular item of PPE and review the limitations of the PPE as defined by the test. A thorough understanding of the testing requirements is critical to choosing the correct PPE. For example, if a tested glove has a break-through time of 1.06 minutes when handling carmustine at a concentration of 3.3 mg/mL, the glove is not appropriate for handling this drug.
Staff should clearly understand the occupational hazard of handling HD packaging, package inserts, and the exterior of vials, as these items may contain measurable HD concentrations; thus, the corresponding PPE is required for safe handling.1 Currently, there are no regulatory standards that require HD manufacturers to provide health care workers with “clean” packaging, package inserts, and vials; until such regulations are in place, sites must always operate under the assumption that these components are contaminated.
Sites should conduct a tracer to identify points of potential contamination from the time HDs arrive at the facility and throughout the medication-use process up to the point of disposal. Identify each employee who may come into contact with HDs and define the PPE required within the job description for each task. Consider the risks associated with HD receipt, storage, transport, non-sterile compounding, sterile compounding, drug administration, cleaning, spill cleanup, and waste disposal, and the corresponding PPE required to ensure proper protection.
Choosing the Right Equipment
Not all PPE is appropriate for HD handling; understanding the differences among various types of PPE, and how to use them correctly, is a prerequisite to achieving proper protection. Consider the following points when selecting the appropriate PPE for health care staff.
Gloves provide the health care provider with protection while preserving tactile sensation in the hands. Gloves must be worn when handling HDs during every step of the handling process: receipt, storage, transport, sterile compounding, non-sterile compounding, drug administration, cleaning, spill cleanup, and waste disposal. Per USP <800>, gloves must be powder-free and tested to ASTM D 6978 or newer standards. The terminal (outer) glove used for compounding sterile products must be sterile and rated to the ASTM standard. A glove that has been tested to the ASTM standard will state this clearly on the packaging material or in an accompanying document. If a supplier is unable to provide the ASTM D 6978 (or newer testing standard) results for a product, the gloves may not meet the USP <800> requirement. An example of glove labelling with supporting ASTM D 6978 testing information is shown in the FIGURE.
Gloves are made from multiple materials, including natural rubber latex, acrylonitrile-butadiene (Nitrile), and polyvinyl chloride (vinyl, PVC). Note that labeling a glove as made from a specific material, such as Nitrile, is not equivalent to having been tested to the ASTM D 6978 standard. When choosing a glove, a best practice is to check the specifics of the glove in reference to thiotepa and carmustine permeation; these two drugs represent a true challenge to gloves’ ability to act as a protective barrier.
Double gloving is required for higher risk procedures, such as HD compounding and administration. When double gloving in combination with a protective barrier gown/garb, the inner glove should be worn under the gown cuff and the outer glove over the gown cuff. Change gloves every 30 minutes, or immediately when damaged, or when HD contamination is known or suspected. If gloves leave the ISO 5 compounding space, they should be disinfected with an agent such as sterile isopropyl alcohol prior to re-entry into the ISO 5 space.
When gloves are used with isolator gauntlets/sleeves for compounding, double gloving is still required. The terminal glove must be sterile and rated to ASTM D 6978 standards. Prior to compounding, pay particular attention to the gauntlet/sleeve-to-glove interface to ensure this junction is closed and that no tears occurred during changing. As noted, gloves should be changed every 30 minutes or immediately when damaged or when contamination by an HD is known or suspected. Additional inspection of the integrity of the gauntlets/sleeves should occur while inspecting gloves. Although not stated within USP <800>, gauntlets/sleeves should be placed on a routine inspection and replacement schedule based on the manufacturer’s recommendations. Protection is compromised when pinholes or cuts are present, or when worn-out gauntlets/sleeves are used during compounding.
USP reiterates that washing hands with soap and water after removing gloves is an important step in minimizing contamination.
Unlike gloves, gowns are not tested to a specific standard. However, the general ASTM F 739 standard (Testing Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact) can be applied. Gowns should not be constructed of cloth but made of polyethylene-coated polypropylene or another non-absorbent, non-linting, disposable laminate. Specific design attributes should include tight cuffs (either knit or elastic), long sleeves, back closure, with no seams, openings, or closures that allow the worker to be exposed. USP does not differentiate between smock-system and full-suit gowns; however, full-suit options may provide increased overall coverage.
Sites may consider adopting coverall-style gowns (ie, bunny suits) for staff. Although not listed within USP <800>, a full assessment of the use of bunny suits should include the overall protection to the donned person and the minimization of cross-contamination to adjacent locations and colleagues. Many varieties of coveralls are available; features to consider include ease of donning/doffing; integrated shoe covers, thumb loops, and a head cover hood; breathability and permeability of the material; fastening and securing mechanisms; and whether the coveralls meet testing standards. If the coverall has not been tested to impermeability standards for HDs (eg, ASTM 739), the use of the aforementioned PPE, such as a rated gown, is required, in addition to a second set of shoe covers when entering the HD compounding room. Note that if the coverall becomes contaminated, it must be doffed prior to exiting the compounding room and disposed of properly.
USP highlights the importance of not taking home clothing that is known to be contaminated; all personnel who handle HDs must be educated regarding this key point. Sites should have options in place for dealing with contaminated clothing (eg, alternative clothing, compensation for damaged garments, etc). Gowns must be changed immediately after an overt or suspected contamination or when changing the inner pair of gloves. Otherwise, if the manufacturer provides no permeation information, gowns should be changed every 2 to 3 hours. Because the outer gown can become contaminated if it was worn for compounding, it should not be worn outside of the HD compounding designated area.
It is important to establish guidelines that detail the type of shoes that are acceptable for use in compounding and ISO-rated spaces; for example, the shoe should cover the entirety of the foot (ie, no sandals or spiked heels that can poke through paper-based shoe covers). Shoes must be visibly clean and dry prior to donning the covers. Measures must be taken for rainy or snowy days to ensure shoes are not wet when shoe covers are donned, which could impact the integrity of the shoe covers. If visible dirt and debris is a continual issue in compounding spaces, the use of devoted shoeware should be considered in addition to the required shoe covers. Low-linting socks or hosiery should be worn to minimize exposed skin in the ISO-rated spaces.
Donning shoe covers can be a challenge for some staff; consider including a bench or lean-to stand in the garbing area for support. In addition, commercially available, hands-free, automated shoe cover dispensing units may be used. These units, which are available with and without stabilizing bars, may require the use of proprietary shoe cover bundles. Hands-free shoe cover removers, which use a vacuum to remove the cover, are also available. Automated shoe cover machines may increase efficiency for sites with numerous staff in the compounding areas or sites that compound a high volume of sterile drugs.
The role of shoe covers is to encase the entirety of the shoe and prevent any particulate matter from coming off the shoes and into contact with ISO-rated and compounding spaces. Shoe covers come in a variety of sizes and lengths (eg, shoe-only, shoe and ankle, and shoe knee-high boot cover). USP <800> requires the use of a second pair to cover the first pair of shoe covers when crossing over the line of demarcation into the HD compounding space. The outer pair must be removed prior to exiting that space, leaving the inner booties in place. This process minimizes the migration of any HD residue from the compounding location to outside the designated spaces.
Some shoe covers that have a polycoated, non-skid, or foam-strip anti-skid feature may have a tendency to flake off the anti-skid coating over time. Shoe covers that have poly-coated material and are tested against blood and bodily fluids per ASTM 1670 may be more durable. It is important to educate staff that most disposable shoe covers are made of thin polypropylene or polyethylene and have a tendency to wear, thus exposing the shoe. Staff should continually examine the integrity of shoe covers to ensure they are intact. If the shoe covers get wet, they should be replaced as soon as possible, given the increased tearability of wet covers and the potential for any residues on the bottom of the shoe to be liquified.
Staff should be educated to never leave ISO-rated spaces with shoe covers on and then enter those spaces or other ISO-rated spaces (ie, operating suites) while wearing the same pair. A new pair of booties must always be donned when entering an ISO-rated space.
The concept of the use of sleeve covers is introduced in USP <800> as an additional protectant for areas of the arm that may come into contact with HDs. Ancillary sleeves should not be considered an alternative to the gowns required for compounding. Rather, consider using sleeve covers for unpacking or stocking shelves and for minor manipulations or transfers of oral, non-antineoplastic and/or reproductive-risk HDs. Sites must conduct a formal risk assessment for the use of sleeves versus the need for a protective gown, noting that sleeves are not a replacement for gowns.
Donning and Doffing Procedures
Donning PPE in the correct sequence is critical to minimize bioburden contamination and ensure maximum protection. Doffing PPE properly is equally important. Oftentimes little thought is given to this process; however, it is a potential exposure point for staff members, and as such, is crucially important.
Given that the PPE has been exposed to HDs and their residues, it should be assumed the protective barrier of the PPE is contaminated on the outside. As such, employees should take a methodical approach to doffing PPE to prevent exposure to the skin or mucous membranes. To assist staff, developing pictograms of the correct donning and doffing processes may be useful.
For more information about proper donning and doffing of PPE, see PP&P’s November 2016 article, Best Practices for Garbing in HD Sterile Compounding, and the January 2017 article, Best Practices for Garbing in HD Sterile Compounding: Part 2—Doffing.
Appropriate PPE disposal is required to prevent cross contamination of HD residue to other areas or to other individuals. USP <800> notes that all used PPE should be considered contaminated. Best practice is to not store or reuse worn gowns. However, if your site’s policy permits reuse of gowns, a process should be in place to handle the safe interim storage of worn gowns.
Because worn PPE is suspected of being contaminated, it should be disposed of according to state and federal waste standards. Most facilities use a commercial waste vendor, which should be able to assist with the appropriate waste stream strategy.
Proper use of PPE is not only a USP requirement; it should be considered a cost of doing business in order to protect health care providers from HD exposure. Given that the new official implementation date for USP <800> is December 1, 2019, there is ample opportunity to achieve PPE compliance by the deadline. Now is the time to review USP’s newest chapter, while keeping abreast of changes to USP <797>.
- Power LA, Sessink PJM, Gesy K, et al. Hazardous drug residue on exterior vial surfaces: evaluation of a commercial manufacturing process. Hosp Pharm. 2014;49(4);355-362.
Fred Massoomi, RPh, PharmD, FASHP, is a senior director of hospital and health-system pharmacy for Visante, Inc. He received his doctorate from the University of Kansas School of Pharmacy. Fred is a member of PP&P’s Editorial Board.
Part 1 of a 2-Part Series: Elements of a USP <800> Compliant Cleaning Program
Conduct a Drug Diversion Investigation
Special PP&P Buyer's Guide: Temperature Monitoring
Develop a Pneumococcal Vaccination Program
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