Section 7 Personal Protective Equipment
Sections 1 through 6 of United States Pharmacopeia (USP) Chapter 800: Hazardous Drugs—Handling in Healthcare Settings is the blueprint and engineering structures with checks and balances for quality control on our road to compliance.
Section 7 of USP 800 personalizes the concept of protecting the healthcare provider with guidance regarding the proper personal protective equipment (PPE). The PPE provides the active barrier to protect healthcare providers from direct contact with hazards.
It is important to note that each component of PPE must be tested to standards that replicate mechanical and clinical practice. It MUST NOT be assumed that any piece of the PPE armor is hazardous drug protective. International standards exist within ISO and ASTM standards and PPE tested to these standards are allowed to label their respective PPE components with standard. Interpretations of the testing is critical to better understand the limitation of the PPE. For example, if a tested glove has a break through time of 1.06 minutes when handling carmustine at a concentration of 3.3mg/mL, this glove is not appropriate for handling this drug.
The PPE required for handling hazardous drugs and the corresponding residue of the drugs must be defined. Sites should conduct a tracer from the dock to the disposal process of hazardous drugs. Within the tracer, identify each job code that may come in contact with hazardous drugs and define personal protective equipment within the job description for each job code. Consideration should be given to the receipt; storage; transport; non-sterile compounding; sterile compounding; drug administration; cleaning; spill cleanup; and waste disposal personnel and the risks associated with their positions and corresponding PPE for protection.
Choosing the Right Equipment
Gloves represent one of the most intimate pieces of the PPE and are often a very emotional topic of discussion at facilities when looking for consolidation for savings. It is important to highlight that gloves should be worn whenever handling hazardous drugs in any step of the process: receipt; storage; transport; non-sterile compounding; sterile compounding; drug administration; cleaning; spill cleanup; and waste disposal. Gloves must be powder free, tested to ASTM D 6978 or newer standards. The terminal glove used for compounding sterile products must be sterile and must be rated to the ASTM standard. The glove provides the healthcare provider with a protective yet tactile sensation that assists the healthcare professional to make decisions while providing protection. The key standard listed within USP 800 for gloves is ASTM D 6978. For a glove to have been tested to this specific standard, it must state it on the glove packaging material or an accompanying document. If a supplier is unable to provide the ASTM D 6978 testing standard results for a specific product, then it would not meet the recommendation listed within USP 800. Here is an example glove with supporting ASTM D 6978 testing listed.
Gloves can be made out of many materials such as natural rubber latex, acrylonitrile-butadiene (Nitrile), polyvinyl chloride (vinyl, PVC). It’s important to note that labeling a glove as being made from a specific material, for example ‘nitrile’, does not equate it to being tested the ASTM D 6978 standard. 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 their abilities to act as protective barriers.
The use of double gloving for higher risk procedures such as compounding and administration of the hazardous drugs is a requirement. When using double gloving with a protective barrier gown/garb, the inner glove should go under the gown cuff and the outer glove over the gown cuff. Gloves should be changed every 30 minutes or immediately when damaged or when contamination by a hazardous drug is known or suspected. If gloves leave the ISO-5 compounding space they should be disinfected with an agent like sterile isopropyl alcohol prior to re-entry into the ISO-5 space.
When gloves are used with gauntlets/sleeves for isolators for compounding, double gloving must still take place. The terminal glove (outer glove) must be sterile and rated to ASTM D 6978 standards. Prior to compounding, particular attention should be directed towards the gauntlet/sleeve-to-glove interface to assure this junction is closed and no tears occurred during changing. As noted, gloves should be changed every 30 minutes or immediately when damaged or when contamination by a hazardous drug is known or suspected. Additional inspection of the integrity of the gauntlets/sleeves should take place while inspecting gloves. Although not listed within USP 800, gauntlets/sleeves should be placed on a routine inspection and replacement program based on the manufacturer’s recommendations. Protection is lost when pinholes, cuts or worn-through gauntlets/sleeves are used during compounding.
USP reminds us that washing hands with soap and water after removing gloves is an important step in minimizing contamination.
Unlike gloves, gowns do not have a testing standard specific to this PPE. However, the general ASTM F 739 standard can be applied: Testing Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact. Gowns should not be cloth, but made of a material such as polyethylene-coated polypropylene or other laminate, non-absorbent, non-linting, and disposable. Specific design attributes should include tight cuffs (either knit or elastic), long sleeved, back closure, and no seams, openings or closures that allow for the worker to be exposed. USP does not differentiate between smock-system versus full-suited gowns, however full-suited options may provide better overall coverage. USP highlights the concern of not taking home known contaminated clothing if an exposure takes place. Sites should have options available for when clothing becomes contaminated (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, gowns should be changed every two to three hours if the manufacturer provides no permeation information. Since the outer gown can become contaminated, it should not be worn outside of the hazardous compounding area if it was worn for compounding hazardous drugs.
Hair covers and facial hair covers have the distinct function of preventing hair from entering the ISO rated spaces. Head hair covers should be worn regardless of the quantity of hair on the head. To work properly, the hair cover must cover and contain all hair. If a site struggles with hair (look on the floors, in corners, in the vents), it may want to consider best practice of a hood-type hair cover. Facial hair covers must cover the entire facial hair (excluding eyebrows and eyelashes!). If sites struggle with finding a satisfactory facial hair cover, sites can combine the hooded head covers with facial hair covers to maximize the coverage. If you can see the hair of your staff working in the ISO areas, they are actively contaminating those areas.
Shoe covers or booties are pretty self-explanatory. Their primary role is to cover the entirety of the shoe and prevent any particulate matter from coming off the shoes and into contact with ISO rated spaces. USP 800 requires the use of a second pair to cover the first pair of shoe covers when crossing into the line of demarcation for the hazardous drug compounding space. The outer pair must be removed prior to exiting that space, leaving the inner booties in place. Following this process will minimize the migration of any hazardous drug residue from the compounding location to outside of the designated spaces.
An education point for staff is to never leave ISO rated spaces with shoe covers on and then enter those spaces or other ISO rated spaces (i.e., operating suites) with the same pair. A new pair of booties must always be donned with entering an ISO rated space.
A note on shoes worn into ISO rated spaces: sites should have in place guidelines on the type of shoes (fully covers the entirety of the foot, i.e., no sandals; spiked heels can poke through paper-based shoe covers). Shoes must be visibly clean and dry prior to donning the covers. Think about rainy days or winter where shoes may be wet only to have them covered by paper-based covers that will eventually be soaked through to the floor of the ISO space. A note on socks or hosiery: they should be worn and should be low-linting to minimize exposed skin to the ISO rated spaces.
Sleeve covers are introduced in USP 800 as an additional protectant for areas of the arm that may come into contact with hazardous drugs. Since the section talks about residue, the ancillary sleeves should not be considered as an alternative to the required gowns for compounding. Consider their use for the unpacking or stocking shelves.
Eye and Face Protection are required when there is a potential for exposure to hazardous drugs resulting from spills or splashes. Example exposure scenarios include, but not limited to: the cleaning of primary engineering controls underpans, accessing primary engineering control plenums, addressing spills, and removing large quantities of wastes of hazardous materials that are not in sealed containers. Consideration should be given to nursing and housekeeping where linen changes with noticeable contaminated body fluids present. If sites are looking into various types of eye protection, they should consider goggles that are anti-fogging and fit tight to the face versus safety glasses. Safety glasses do not offer adequate protection from splashes or sprays. The goal of the eye and face protection is minimizing dermal and mucosal exposure.
Respiratory Protection represents a multifactorial and critical piece of PPE. The most important comment within USP 800 with regards to respiratory protection is the note that ‘surgical masks do not provide respiratory protection from drug exposure,’ and thus, should not be used when respiratory protection is required to protect the person. Respiratory protection should be strongly considered when the risk of exposure is high such as in attending to large spills; conducting the USP 800 4-step cleaning process to underpans or accessing plenums of PEC’s; or there is a known or suspected aerosolization of powders or vapors from drugs. USP 800 clearly defines when this level of protection requires a full-face mask with a chemical cartridge-type respiratory or a powered air-purifying respirator (PAPR) be worn. A PAPR cannot protect if worn improperly; cannot protect if the battery is not charged; cannot protect if filters are saturated or loaded; cannot protect you if head cover is damaged; and, PAPR’s should not be used in an oxygen depleted environment. Sites should strongly consider the best practice of having one of the noted units available for staff in the event of a large spill.
USP points to fit-tested, N-95 respirators as means to addressing most activities surrounding the handling of hazardous drugs. Paper surgical mask provides minimal protection with regards to splashes, droplets and sprays and thus it can be interpreted that an N-95 mask for use is best practice. With these types of respirators, each employee must be annually fit tested and trained on how to properly use the respirator. If the employee has any change in facial hair after being fit-tested, they will need to be re-fit tested to assure the sizing and seal is appropriate. N-95 respirators are limited in the ability to protect the employee. N-95 cannot protect if worn improperly or does not fit; cannot protect if folded, damaged or altered; cannot protect from chemicals or drugs especially gases or vapors; cannot be used in an oxygen depleted environment; will not work if it becomes wet (think of sweat and perspiration); and, does not protect eyes or the face. An alternative to N-95 is the R-95 with the major difference of the R-95 mask incorporating the use of carbon/charcoal. The main benefit to the use of the R-95 is the ability to help filter out smells, especially those associated with cleaning solutions.
USP encourages sites to follow all the requirements noted within the Occupational Safety and Health Administration (OSHA)’s respiratory protection standard (29 CFR 1910.134) when choosing the appropriate protection device(s).
Donning and Doffing Procedures should be a formal and competency requirement, although not called out within USP 800. The sequence of putting on the PPE is important to minimize bioburden contamination and to assure maximum protection from the equipment. Equally important is the doffing, or taking off, of the PPE. Little thought is given to this process, however it is a potential exposure point for the staff member. Since the PPE has been in and around the hazardous drugs 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 taking off the PPE as to prevent exposure to the skin or mucous membranes. To assist staff, sites should develop pictograms of the donning and doffing processes. Here is an example.
Appropriate Disposal of Personal Protective Equipment is a must to prevent cross contamination of hazardous drug residue to other areas or to other people. USP 800 notes that all used PPE should be considered contaminated. With this, examine how staff handles the garb in between uses. Are they draping gowns over chairs or over cloth lab coats for latter use? Have a process in place to handle the safe interim storage of worn gowns, if this is the policy for the site (best practice is to not store worn gowns).
Since the PPE is suspected of being contaminated, they should be disposed of according to your state and federal waste standards. Most facilities use a commercial waste vendor and the vendor should be able to assist with the appropriate waste stream strategy.
As the NEW official implementation date of December 1, 2019, for USP Chapter 800 Hazardous Drugs—Handling in Healthcare Settings compliance allows time for compliance, the time for review of USP’s newest chapter in combination with keeping up with USP’s website for revisions to USP 797. www.USP.org/797
Don’t know where to start with a hazardous drug safety program? Visante, Inc. offers a full line of consulting activities to clients just starting down the road to compliance to practice sites on the journey and wanting to go beyond minimal practice standards. Contact us today to get started.
 USP General Chapter 800 Hazardous Drugs—Handling in Healthcare Settings
 NIOSH . NIOSH alert: preventing occupational exposure to antineoplastic and other hazardous drugs in health care settings. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165. http://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf Accessed May 10, 2017.