U.S. Centers for Disease Control and Prevention defines a closed system drug-transfer device (CSTD) as a system that “mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system.” CSTDs are designed to provide protection against hazardous exposures to healthcare workers who are compounding and administering hazardous drugs. While CSTDs are not the only means of protection, they play a crucial role in hazardous drug safety measures.
Tell us about your role and experience at Martha’s Vineyard Hospital and how the facility is using CSTDs?
I am a board-certified sterile compounding pharmacist and in my current role at Martha’s Vineyard Hospital (MVH), I serve as the lead sterile compounding operations pharmacist.
Throughout the past several years, two different brands of closed-system transfer devices (CSTDs) have been utilized at MVH pharmacy and the outpatient infusion department. The majority of hazardous compounds prepared at MVH are intravenous chemotherapy drug solutions that are administered by chemo certified nurses at the outpatient infusion department. At MVH, the use of CSTDs is the primary standard for hazardous compounding and administration with exceptions. These exceptions may include drug-device chemical incompatibilities or routes of administration that require an open system.
What is your responsibility to your employees and/or patients in ensuring their safety?
Reducing the risk of exposure to hazardous drugs requires a multi-faceted approach with the overall goal of lowering contamination levels to a reasonably achievable point
and eliminating unnecessary human exposure.
Engineering controls that create and maintain negative pressure within the compounding area, CSTDs, staff educational programs, personal protective equipment, and institutional standard operating procedures are examples of individual strategies that address different aspects of the hazardous compounding process. The combination of all these safety measures helps to guarantee hazardous contamination prevention and control.
I work with pharmacy leadership, engineering control certifiers, pharmacy compounding technicians, pharmacists, nursing staff, environmental monitoring labs, and hospital environmental services to ensure proper functioning of engineering controls, safe compounding practices, and effective decontamination procedures. My other responsibilities are staff education, hazardous drug risk assessment, development of hazardous compounding policies and procedures, and keeping up to date with the latest technologies and regulations.
In light of recent PPE shortages due to the pandemic, I work with pharmacy buyers to ensure an uninterrupted supply of appropriate personal protective equipment and their availability to hazardous compounding staff.
Who should be involved in the process when selecting a CSTD for an organization, and when should an in-house test be done?
I think the discussion surrounding the selection of a CSTD must include representatives from multiple disciplines such as manufacturer, pharmacy, nursing, administration, contracting, and supply chain. Personnel directly involved with hazardous compounding and administration (i.e., the end-users), are an integral part of these discussions and their opinion is enormously valuable when it comes to details that matter the most. For in-house testing, enough time should be allowed between testing and go-live in order to ensure staff training and SOP development.
What features and benefits should be considered when selecting a CSTD for the pharmacy staff?
When selecting a CSTD, the most important feature that should be considered is simply the efficacy. This is the ability of the system to form and maintain closed drug pathways, dry connections between the components and an impenetrable pressure equalization mechanism that contains contaminated air while maintaining the product sterility through it all.
Unfortunately, evaluating clinical efficacy of CSTDs is not always straight forward. A universal and standardized protocol for evaluation of these systems is yet to be established. However, the draft NIOSH test protocol and growing number of research and review articles published on testing and comparison of these systems are available and can be cautiously referenced. It is important to note that while NIOSH acknowledges the existence of research and advertisements that report their CSTD performance based on its draft protocol, it reiterates the fact that the protocol has not been finalized and its many key components are under construction.
Ergonomic design factors to consider include the amount of force required for assembly, the potential for injury due to long-term repetitive motions, the number of pieces required, and the ease of unwrapping the components. The issue of reduced user dexterity due to double gloving should be kept in mind during this evaluation.
Factors that help narrow the choices include: clear proof of locking completion and system activation, the user’s unobstructed view of the drug product, the mechanism in which inadvertent disengagement or dislodgement of the pieces is prevented, chemical compatibility with drugs, physical compatibility with various medical instruments, devices and drug containers, ability of the system to deliver drugs through desired routes of administration, dead space and delivery of small volumes, disposal and its impact on the waste management process, packaging, manufacturer/supplier ongoing support, and of course, overall cost.
What features and benefits should be considered when selecting a CSTD for the nursing staff of an organization?
In addition to the features mentioned above, it is beneficial for nursing staff to consider size and bulkiness of the components when it comes to patient comfort during extended infusions particularly when they carry portable infusion pumps while performing daily activities.
Security of the connections and risk of accidental CSTD dislodgment or disengagement during patient ambulation should also be considered.
Challenges?
The most frequently reported challenges faced by compounding staff are risk of inadvertent unscrewing of the syringe from the CSTD at the time of de-accessing the vial or bag adaptor, difficulty in aligning and connecting the pieces, and arm/shoulder fatigue.
Another issue is the inability to use the MVH designated standard CSTD for filling and priming portable pump cassettes due to the size of the components and reported patient discomfort during infusion. Trending chemo wipe testing data has shown that most of the contamination detected on tested surfaces are related to drugs that are administered via portable infusion pumps. We have tackled this issue by implementing a second line of CSTDs that are smaller in size and create less discomfort for patients. When it comes to cost and storage space limitation, it is preferable to have a “one-size-fits-all” system.
MVH pharmacy is in the process of reviewing an updated version of the currently used CSTDs. The goal is to eliminate the existing challenges while benefiting from updated design and added features.
What do you feel are the advantages of your CSTD system?
The overall experience working with CSTD at MVH has been positive and reassuring. Among many advantages, reliable pressure equalization method, dry connection mechanism, needle safety, useful design updates by the manufacturer, FDA clearance, customer support, and availability of credible research done on system’s hazard containment and product sterility preservation, are the most significant.
BIOGRAPHY
Orchid Motahari, Pharm.D. BCSCP, Martha’s Vineyard Hospital, Sterile Compounding Oversight
As a new foreign graduate pharmacist, I started my career in the U.S. working as a long-term care, home infusion, and later on hospital pharmacist in Las Vegas, Nevada. I moved to Massachusetts a few years later and since 2013, I’ve had the pleasure of working at Martha’s Vineyard Hospital (MVH) as the lead sterile compounding operations pharmacist. Recently, I became board-certified in the sterile compounding field and these days I am mostly involved in the MVH hazardous and non-hazardous cleanroom construction project.
