A Cleaner, Safer Facility: Leveraging CSTDs with Cleaning Protocols to Reduce Hazardous Drug Contamination

Occupational Exposure to Hazardous Drugs: What You Need to Know

Wherever hazardous drugs are compounded and administered, healthcare professionals and patients are at risk of harmful exposure. According to the National Institute for Occupational Safety and Health (NIOSH), "About 8 million U.S. healthcare workers are potentially exposed to hazardous drugs, including pharmacy and nursing personnel, physicians, operating room staff, environmental services workers, workers in research laboratories, veterinary care workers, and shipping and receiving personnel”.¹

Occupational exposure to antineoplastic drugs can result in a broad spectrum of negative health impacts. These negative outcomes can include headaches, rashes, dizziness, sore throat and cough. More significant health effects may extend to impaired fertility, pregnancy loss, congenital disabilities and some types of cancer.²

NIOSH has published guidelines for healthcare professionals and employers on the proper handling of hazardous drugs in the healthcare workplace. This guidance includes guidance on how to reduce hazardous drug risks with set protocols, personal protective equipment (PPE) and the use of closed-system transfer devices (CSTDs). In addition, the United States Pharmacopeia’s USP <800> regulations provide practice and quality standards for handling hazardous drugs to promote healthcare worker safety, patient safety and environmental protection.

The EU has also published guidance for the safe management of hazardous medicinal products at work. These guidelines advise healthcare workers on reducing hazardous drug exposure. While non-binding, the EU recommendations offer practical advice to protect healthcare workers from occupational hazardous drug exposure.

Studies suggest that hazardous drug contamination is common in healthcare facility settings. One study demonstrated hazardous drug residues on various surfaces in the pharmacies and other areas at 6 cancer treatment centers in Canada and the USA. Measurable amounts of cytotoxic agents were found in 75% of the pharmacy samples and 65% of administration area samples.³

Cleaning protocols can reduce contamination levels, but not necessarily enough to reduce drug residue to acceptable levels. Another study in 6 hospitals in British Columbia, Canada demonstrated that 61% of surfaces sampled were contaminated with antineoplastic drug residue. After cleaning, contamination levels were lower, but still statistically significant. Some surfaces even had higher contamination levels after cleaning.⁴

These studies and others suggest that hazardous drug contamination may be pervasive in pharmacy and nursing areas where antineoplastic agents are prepared and handled. They also indicate that, even with guidelines, engineering controls, PPE and safe handling, the risk of healthcare worker exposure remains.

Recognizing the risk of persistent drug residue to healthcare workers and patients, USP <800> and the US Occupational Safety and Health Administration (OSHA) recommend the use of CSTDs where hazardous drugs are compounded and administered.^5,6

As defined by NIOSH, CSTDs like Simplivia’s Chemfort^® are “drug transfer devices that mechanically prohibit transfer of environmental contaminants into the system, as well as escape of hazardous drug or vapor concentrations outside of the system”.⁷ CSTDs are specifically designed to safeguard healthcare professionals who handle hazardous drugs by reducing the risk of occupational exposure. At the same time, CSTDs also protect patients who are receiving treatment by maintaining drug sterility.

The guidelines listed above recommend the use of CSTDs during drug preparation and compounding in addition to the use of primary engineering controls like safety cabinets and cleanrooms. Studies indicate that using CSTDs as a supplemental protective measure can reduce hazardous drug residue in healthcare settings.⁸ CSTDs are particularly recommended for healthcare facilities that operate without engineering controls.

Evidence suggests that using CSTDs as part of regular work practice can reduce or eliminate occupational exposure to hazardous drugs. This protective capacity is demonstrated even when using CSTDs without other controls.^9,10 But in combination with additional protective measures like stringent cleaning protocols (e.g., of drug vials upon receipt), using CSTDs can result in a meaningful reduction of hazardous drug residue.

For example, a study published by University Hospitals Birmingham NHS Foundation Trust showed that connecting a Simplivia Syringe Adaptor Lock (SAL) in an isolator reduced cytotoxic residue on syringe surfaces, on nurses’ gloves and on connect and disconnect during administration compared to standard hub caps.¹¹

Additional research found that using CSTDs in combination with effective cleaning protocols can dramatically reduce the risk of hazardous drug exposure. A study published in Pharmaceutical Technology in Hospital Pharmacy evaluated different locations in pharmacy and nursing areas that used both CSTDs and standardized cleaning. No detectable cytotoxic residue was found in 90 samples.

This shows the benefits of combining drug packaging upon arrival and surfaces potentially contaminated by these packages or previous preparations with closed system drug transfer devices to create a safer working environment.¹²

The studies described above support the consistent use of CSTDs like Simplivia’s Chemfort^® in combination with standardized cleaning procedures to reduce exposure to hazardous drug surface contamination in treatment settings.

The leading Chemfort^® product family is designed to minimize hazardous drug exposure, significantly reducing risks for both healthcare professionals and patients.

The Chemfort^® CSTD has meets acceptance criteria of the unified NIOSH protocol (2016), ensuring compliance with the highest industry safety standards. Chemfort^® also allows leak-free disconnection and has passed stringent microbial ingress tests to maintain drug sterility. Simplivia’s Chemfort^® CSTD is compatible with all known hazardous drugs and has been tested with real hazardous drugs.

In addition, Chemfort^®’s easy-to-use, ergonomic design makes it brilliantly simple for healthcare professionals to handle the device confidently and efficiently.

The economic benefits of Simplivia’s Chemfort^® are also significant. A low number of part numbers reduces overstocking and handling time. Chemfort^® additionally maintains sterility for up to 7 days and allows for up to 10 connection-disconnection cycles, further reducing waste and decreasing expenditure. By optimizing inventory and minimizing waste, healthcare facilities can manage their resources more effectively, ultimately improving operational efficiency and reducing costs.

Simplivia’s leading Chemfort^® closed system drug-transfer devices provide a simple, safe and cost-effective solution to occupational hazardous drug exposure.

For more information and to book a demo, contact us.