Personal Protective Equipment
Hazardous drug PPE has been "recommended" since the discovery in the early 1980s that nurses and pharmacists were being exposed. It's been a fundamental component of HD safety since the first ONS guidelines and has been included in every other HD guideline from NIOSH, OSHA, ASHP and INS, and an integral part of USP <800>.
PPE is the first line of defense against exposure, although based on the NIOSH hierarchy of exposure prevention, it is the least effective. By the time the HD comes in contact
with the gown and gloves, it's too late. Contamination is already in the environment.
On a basic level, PPE consists of gloves and a gown, and must be worn for during all phases of HD contact: receiving HDs from the distributor, compounding, administration, discontinuing, disposal, and handling of excreta. It should be noted that compounding has additional specific requirements based on USP <797> and is not discussed here.
One important concept with PPE is that it should never be worn outside of the immediate area where HDs are being administered. All PPE is presumed to be contaminated and wearing it to other areas can lead to widespread workplace contamination. NIOSH and ONS state that gowns are to be single use, which means once removed it cannot be put back on. This is to avoid self-contamination when donning, and to prevent other personnel from inadvertently coming in contact with a potentially contaminated gown.
Double-gloving has been recommended since the 2004 NIOSH Alert, although NIOSH did not provide the rationale. Much confusion (and not coincidentally, lack of compliance) associated with double-gloving arose from not having a clear understandings of the implications of using a single pair of gloves.
The incorrect (but seemingly obvious) reason for two pairs of gloves is to provide twice the barrier thickness should one glove break. However, that is not the intent. Instead, the reasons stemmed from potential self-contamination associated with removing the single glove, particularly contact with the forearm and wrist area. A secondary reason is the tendency for nurses to touch items in the room (particularly the IV pump) with the single (likely contaminated) gloves.
A large study by Boiano, Steege & Sweeney in 2014 showed that nurses routinely touched the IV pump while wearing gloves (61%). If we assume that the glove could have HD residue, it explains why other studies have demonstrate HD contamination on keyboards, computer mice and pens. Recent surveys continue to show that double-gloving has not been universally adopted, although it has improved significantly over the past 20 years. USP <800> will make this a requirement as of December 1, 2019. In addition, USP has intelligently added that both gloves need to be meet the ASTM 6978-05 standard. Because this standard has been identified, it's worth looking at what that means.
A Tale of Two Tests
ASTM has two standards for glove testing: ASTM F739, which is the Standard Test Method for Resistance of Protective Clothing Materials to Permeation by Liquid or Gases, and ASTM D6978 which is the Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy. Some manufacturers market “Chemotherapy Gloves” and say they're ASTM tested, but cite the older F739 standard. This is misleading and unsafe.
In 2015, Tom Connor, former Research Biologist for NIOSH, along with ASHP HD Guideline creator and pharmacy consultant Luci Power, pharmacist and HD advocate Fred Massoomi, and ONS HD leader Marty Polovich published an article discussing the differences in testing methods for gloves. The article provided examples of confusing packaging and urged healthcare professionals to remain vigilant and stay informed. The issue of glove safety was raised by the Joint Commission who published an article on this topic in the ECNews (March 2015, 18(3).
All gloves are subject to breakage. And while different materials influence the ability of a glove to stretch without breaking, nearly all chemotherapy gloves are nitrile. But not all nitrile chemotherapy gloves are equal. Thickness plays an important role in how easily the glove will tear.
For example, the Kimberly Clark KC500 purple nitrile glove (tested against 29 HDs) has a finger thickness of 5.9mil. The Medline SensiCare Ice Blue chemotherapy glove is 3.6mil thick. Personal experience with both gloves has shown that the thinner glove tears more frequently. Yet both are considered "chemotherapy gloves."
Aside from meeting the ASTM D6978-05 standard, chemotherapy gloves must have a sufficiently long cuff to go under the gown sleeve.
As nurses, we may not have the ability to pick and choose our gloves, but we do have the right to ensure that the gloves we rely upon are going to protect us.
ASTM does not currently have a standard for testing chemotherapy gowns. [Jan 17 update: A draft of an HD gown standard has been written and is scheduled to be reviewed in February 2020.] This makes choosing a gown even more difficult, as manufacturers can make claims without providing evidence, or without using the same testing criteria.
Over the years, many types and styles of gowns have been sold as a chemotherapy gown. Some have had "thumb holes" without requisite elastic or knit cuffs. Others have had snaps down the front instead of being fully closed. Still others were "front only" gowns, leaving the posterior of the nurse completely exposed.
Even more than gloves, gown materials and construction influence both protection and comfort. In a landmark 1999 publication, Harrison and Kloos published information on penetration of 6 gown materials, tested against 15 HDs. They found that composite gowns made with polypropylene coatings and polyethylene were superior. Unfortunately, virtually nothing has been published in the 20 years, leaving little or no independent reports of currently manufactured gowns.
The ChemoPlus gown, (originally made by Sage Products and now marketed by Cardinal) was one of the top performing gowns in the Harrison & Kloos test, and is still available. To their credit, Cardinal posts the drug tests, and that information is available here.
Despite the requirements of using a CSTD for HD administration, PPE remains the fundamental physical barrier between hazardous drugs and the nurse. You may not be directly involved in choosing your PPE, but you should ensure that the equipment you are using is filling its intended purpose.
ONS HD guidelines (2018), along with NIOSH (2004) state that gowns are "single use", meaning once removed they need to be properly disposed of. This continues to be a source of controversy, particularly in common situations where the nurse may need to interact with the same patient for multiple bags of chemotherapy, and for Infusion departments that are set up with groups of patients in close proximity. Gowns must also not be taken outside of the immediate areas where HDs are being administered.
There are several reasons for these guidelines.
First, since it is impossible to determine if any trace amounts of HD has contaminated the PPE, we must assume that it could be contaminated. It is the reason we place PPE into specialized containers after use, rather than tossing them into normal trash. Once a gown has been removed, there is a potential for self-contamination when putting it back on. In addition, other staff who could inadvertently come in contact with the gown might become contaminated.
Bringing a potentially contaminated piece of PPE into another area of the health-care facility can easily spread HD to those areas. In a landmark study by Hon and colleagues, traces of chemotherapy were found at the nursing stations on objects such as pens and printers were found to have measurable HD levels (Hon C-Y, 2013). A subsequent study by the same author showed that after performing wipe sample testing on the hands of employees, the unit clerks had the highest level of HD, even though they were never involved with directly handling the medications (Hon, CY et al, 2015). Thus, we must remain diligent in preventing the spread of HD outside of the immediate areas where they are administered.