A new closed-system drug-transfer device (CSTD), called Halo (Corvida Medical), is able to dramatically reduce contamination from hazardous drugs on surfaces where the drugs are administered, according to results from a 17-center study funded by the National Cancer Institute.
"During administration of antineoplastic drugs, there can be droplet or airborne exposure to these drugs if nurses don't use anything at all to reduce exposure," Kristin Rupp, RN, Desert Regional Medical Center Comprehensive Cancer Center, Palm Springs, California, told Medscape Medical News. "With this new closed-system drug-transfer device, results showed that there were no escapes of either [5-fluorouracil] 5-FU or cyclophosphamide during simulated administration of the drugs, and the difference in contamination levels at baseline compared with after the new CSTD use was highly significant [P < .001]," she added.
Rupp presented the study here at the Oncology Nursing Society (ONS) 2017 Annual Congress.
The study was designed to assess the effectiveness of the new CSTD in reducing surface contamination during the administration of 5-FU and cyclophosphamide where spills and leaks are likely to occur. "Baseline wipe samples from administration locations — two on the floor under the IV pole and one on the arm of the infusion chair — were collected for existing contamination," Rupp and colleagues note in their abstract. Stainless-steel templates were then placed over the sampled surfaces and a fixed amount of the two chemotherapy agents were mixed and infused over the templates using the new CSTD system.
Wipe samples from the templates were then analyzed for the presence of either 5-FU or cyclophosphamide by an independent laboratory. The limit of detection set for each drug was 0.002 ng/cm2. "A total of 204 wipe samples were collected from the 17 centers, 102 at baseline and 102 with the CSTD after simulated administration," researchers note.
At baseline,74% of the wipes had detectable levels of either cyclophosphamide or 5-FU. Levels of drug on these baseline wipes varied from below the limit of detection to 0.36 ng/cm2 for cyclophosphamide and to 3.88 ng/cm2 for 5-FU.
"Following simulated administration using all components of the new CSTD, 2% of wipe samples were at or slightly above the limit of detection, at 0.003 ng/cm2 for 5-FU and 0.002 ng/cm2 for cyclophosphamide," researchers report.
As Rupp explained to Medscape Medical News, prior to 1999, many facilities, including the one where she now works, had no system in place to protect nurses from exposure to hazardous chemotherapy drugs when administered.
"Then in 1999, we converted to the PhaSeal [Becton, Dickinson] system, and with this system, minimal levels of cyclophosphamide and 5-FU were detected in the prestudy wipe areas, so levels were already below normally accepted safe guidelines," she noted. The new Halo CSTD further reduced those residual levels to virtually zero, she said. Furthermore, the new CSTD is reportedly very easy to use.
"I've been an oncology nurse for 27 years and we have been using the other CSTD, but with this one, there are fewer steps involved and it's very easy to handle," Rupp affirmed. "And since nurses need to be protected from antineoplastic hazardous drug exposure, having a device that effectively reduces surface contamination improves the safety in the clinical oncology workplace," she concluded.
The Halo CSTD received an ONB product code classification from the Food and Drug Administration in 2015.
Asked by Medscape Medical News to comment on workplace exposure to hazardous drugs in general, Thomas Connor, PhD, from the National Institute for Occupational Safety and Health (NIOSH) in Cincinnati, Ohio, said that while he is not very familiar with the Halo product in particular as it is relatively new, several groups, including his own, have done research on CSTDs and find that they can reduce surface contamination and worker exposure when used as part of a comprehensive workplace safety plan.
"Workers certainly need to be trained on any new type of equipment," Dr Connor said in an email. "And it is imperative that the manufacturers of these devices work with the healthcare professionals to properly train them and to be available when questions or issues with their use arise," he added.
"But once nurses are properly trained and see the advantages [to these devices], they will likely be more inclined to use CSTDs in drug administration," he said.
Survey From 46 Drug Spills
In a separate study presented at the meeting, senior author Christopher Friese, PhD, RN, University of Michigan School of Nursing in Ann Arbor, and colleagues examined what safety practices nurses at 12 institutions employed when a chemotherapy spill occurred. A total of 393 participants completed a survey on a secure study website when hazardous drug spills occurred.
Out of 46 chemotherapy spills reported to date, nurses involved in the spills were not wearing a gown in 19 (41.6%), and nurses in a similar proportion (41.3%) reported using only one pair of gloves. In 25 spills (54.5%), nurses reported using two pairs of gloves as recommended.
Almost all nurses, at 91.3%, reported washing their hands with soap and water after a spill, as is recommended. However, the remainder used an alcohol-based hand gel.
As Dr Friese told Medscape Medical News in an email, there are now at least 3 decades of research showing that workers, including nurses, do not wear personal protective equipment (PPE) as recommended by NIOSH.
"Suboptimal use of PPE increases the likelihood of hazardous drug exposure and resulting health effects," Dr Friese added.
For example, Dr Friese and colleagues have found that nurses do not wear liquid-proof gowns when handling chemotherapy drugs or that they reuse them in between handling activities. "Given the potential for exposure from spills and incidental contact with contaminated surfaces, we want to reemphasize the need to wear a liquid-impermeable, single-use gown during hazardous drug handling and dispose of the gown immediately after activities have ended," Dr Friese said.
He also noted that laboratory-based studies show that gloves can become contaminated or lose integrity when handling hazardous drugs. Thus, current NIOSH recommendations indicate that wearing two pairs of gloves that have been tested against hazardous drugs should be worn when handling such drugs. Again, as Dr Friese pointed out, the new data show that nurses routinely do not wear two pairs of gloves when handling hazardous drugs, and this increases their risk for exposure.
Another source of concern is handwashing, he added. "For infection-control reasons, nurses have assumed that alcohol-based hand gel is equivalent to handwashing with soap and water," Dr Friese explained. "While true for infection control, this is not true when handling hazardous drugs. So one of our study's key messages is to wash hands with soap and water after handling hazardous drugs. Alcohol-based hand gels may worsen exposure risk," Dr Friese emphasized.
Moreover, the CSTDs used by nurses in the study were not used as recommended in all the spills. In 12 spills, the nurses reported the device failed, although Dr Friese suggested the failures might reflect inadequate training on proper CSTD use.
"We recognize that oncology nurses are busy and their work demands are high, but we want to remind them that they are worth the investment and if we can take care of our oncology nurses and ensure their safety, we will have a healthy and strong oncology nursing workforce to meet the needs of our patients and families," he concluded.
Dr Connor also suggested that, from his perspective, one of the key issues is the nurses' perception of the level of risk. "Some surveys have shown that nurses do not feel that there is a risk from exposure to these drugs or that the risk is low," he said. "They may also be unaware of the published reports on adverse effects of these drugs in healthcare workers or that the drugs may be absorbed through the skin," Dr Connor added.
However, he also notes that surveys have shown that, in some settings, protective equipment may not always be available to workers.
Ultimately, it may just come down to workload and the demands of having to care for so many cancer patients. "We have seen in our work that nurses are often extremely busy," Dr Connor said, "and innovations and activities that require extra time are not always their primary concern."
The Halo CSTD study was funded by the National Cancer Institute. Neither Kristin Rupp nor Dr Friese had any relevant financial relationships, nor did Dr Connor.
Oncology Nursing Society 2017 Annual Congress. May 5, May 4, 2017. Denver, Colorado. Abstract 79, Abstract 416
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