By Ronak Kadakia
The National Institute for Occupational Safety and Health (NIOSH) estimates that about 8 million U.S. healthcare workers are potentially exposed to hazardous drugs in the workplace. This figure includes pharmacy and nursing personnel, physicians, operating room personnel, environmental services workers, workers in research laboratories, veterinary care workers, and shipping and receiving personnel.
NIOSH has shown that these drugs can produce several adverse health outcomes such as abdominal pain, nausea, vomiting, diarrhea, coughing, facial flushing, hair thinning, hair loss, dermatitis, irritation of skin and eyes, irritation of mucous membranes, menstrual cycle disruption, fetal loss, and even some forms of cancer.
As a result, NIOSH recommends that in tandem with other safety measures, healthcare workers use a Closed System Transfer Device (CSTD) throughout the hazardous drug-handling process [NIOSH 2004]. Although all CSTDs may not be equally protective, a study by Vyas in 2013 shows that CSTD-use can reduce hazardous drug contamination.
As is the case with all protective devices, not all CSTDs are created equal, as different manufacturers take different approaches in device design and development. With this in mind, here are five tips when looking to purchase protective equipment and products to keep staff safe:
1. Make sure that the safety product you are considering is safe and meets NIOSH’s proposed testing protocol for safety. While NIOSH works to finalize the testing protocol for CSTDs, some researchers have used the originally proposed protocol to assess the various devices on the market, due to the protocol’s rigorous standard.
Although a CSTD may comply with the letter of the law with regards to device design, that doesn’t necessarily mean that it fulfills the criteria to the highest standards. Take the time to read through NIOSH and other safety organizations’ testing protocols to determine for yourself whether the CSTD you are considering is of the quality and provides the level of protection that your staff deserves.
2. Ensure products prevent leaks at all potential connection points. One of the main causes of contamination are leaks, so it is worth researching whether a product eliminates leakage or not. On an occassion that the product is found to leak, it is prudent to better understand the root cause and location. Some leaks may not always be obvious, as shown by recent research by Masson, Henry, Lanher, Noirez, and Rondelot. During the study, fluorescein, the solution used, was not found on the gloves of the researchers but was found on the CSTD devices themselves. For this reason, it may be worthwhile to trial a product before purchasing it.
3. Check that the product can be used with all chemotherapy drugs. As well as ensuring that the products keep staff safe, it is also worthwhile to check ensure they are compatible with most, if not all, chemotherapy drugs. In 2015 the Food and Drug Administration (FDA) issued a statement warning healthcare professionals against using Treanda Solution with CSTDs, adapters, and connectors containing polycarbonate or acrylonitrile-butadiene-styrene (ABS). It has been identified that use of these resins cause the plastics to melt when they come in contact with Active Pharmaceutical Ingredient (API) or solvents such as N, N-dimethylacetamide (DMA). When selecting a CSTD, it is essential to review the Package Insert to understand whether all drugs in your formulary can be used with the selected product. If not, there is a potential for waste and risk of exposure to your healthcare staff.
4. Determine if the product is a fully contained system where there is no question of whether a drug is being filtered out. Fully contained systems have several advantages over filter-based systems. Firstly, they are designed to prevent external microbes from entering the system while preventing hazardous vapors and aerosols from escaping. Secondly, fully contained systems have a proposed NIOSH testing protocol, while filter-based systems have no such requirements defined. There is still a lingering question on the efficacy of a filter-based system’s ability to prevent the escape of hazards outside of a drug vial and its capacity to maintain a safe environment with drugs that are developed in the future. Additionally, some commonly used inorganic drugs, such as Cisplatin may not be neutralized by a charcoal filter nor by a paper filter due to the mechanism of action of such filters.
5. Ease of use within an existing workflow. Medical equipment is expensive enough without having to change all of your current systems to accommodate a new product you would like to use. Therefore, before you commit to any products, it is prudent to assess its compatibility with the way your pharmacy currently works. This will also make the transition period, as your staff becomes familiar with the new equipment, easier and smoother for workers and patients.
Ronak Kadakia is with Equashield.