Criticisms of Cochrane Review on closed-system transfer devices remain valid

McDiarmid, Melissa A.; Polovich, Martha; Power, Luci A.; Connor, Thomas H.; Kienle, Patricia C.

doi:10.1093/ajhp/zxz137

Cited by 5 publications

(6 citation statements)

References 5 publications

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“…has since published a follow up article stating that the criticisms of the Cochrane review remain valid. 26 This discussion is outside of the scope of the present study.…”

Section: Introductionmentioning

confidence: 79%

Integrity performance assessment of a Closed System Transfer Device syringe adaptor as a terminal closure for Luer-Lock syringes

Wilkinson¹,

Walker²,

Machníková³

et al. 2021

Preprint

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ObjectivesTo investigate the container closure integrity of a Closed System Transfer Device syringe adaptor lock in combination with disposable Luer-Lock syringes as the terminal closure device. The UK NHS Pharmaceutical Quality Assurance committee requires syringe integrity data for final storage devices of aseptic products such as chemotherapy drugs when prepared in advance and stored prior to use as is standard practice for dose banded drugs. The assessment comprised both physical and microbial integrity testing of the combination closed system/ Luer-Lock syringes containers at syringe sizes: 1mL, 20mL, and 50mL.MethodsIntegrity testing was performed as described in the NHS Pharmaceutical Quality Assurance Committee Yellow Cover Document 2nd edition 2013 with Chemfort™ (Simplivia, IL) syringe adaptor lock devices as replacement for sterile blind hubs. Microbiological integrity was assessed according to Method 1 part 1.4 using Brevundimonas diminuta at 32°C for up to 14-days contact time. Physical integrity was assessed using Method 3 of the yellow cover document which is a dye intrusion method. Dye intrusion was assessed both visually and using a validated ultraviolet-visible spectrophotometer method.ResultsChemfort™ syringe adaptor lock/ Luer-Lock syringe combinations were shown to be: (1) free of microbiological contamination after 14-days contact time, (2) free of dye intrusion at all syringe sizes tested (n=61 in total). The data demonstrates 100% closure integrity of the final container system when Chemfort™ syringe adaptor lock replaces the syringe hub as the terminal closure device.ConclusionsSyringe adaptor lock components complied with the NHS Pharmaceutical Quality Assurance Committee Yellow Cover Document syringe integrity requirements when used as the terminal closure of Luer-Lock disposable syringes from 1mL up to 50mL. Therefore, syringe adaptor lock (Chemfort™) can be used as the terminal closure system for pre-filled syringes of chemotherapeutic drug products prepared in advance in UK NHS Pharmaceutical Technical Services.

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“…has since published a follow up article stating that the criticisms of the Cochrane review remain valid. 26 This discussion is outside of the scope of the present study.…”

Section: Introductionmentioning

confidence: 79%

Integrity performance assessment of a Closed System Transfer Device syringe adaptor as a terminal closure for Luer-Lock syringes

Wilkinson¹,

Walker²,

Machníková³

et al. 2021

Preprint

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“…In the light of the available studies, that meta-analysis concluded that there remains a substantial degree of uncertainty about the financial benefits or whether routine use of CSTD in addition to safe exposure to hazardous drugs has an impact on exposure reduction, short-or long-term health outcomes, or financial benefits. 13 In an article criticizing that Cochrane analysis, 14 it was noted that there are many erroneous evaluations on the basis of this review and its value for the oncology community is questionable. The analysis received serious criticism for many reasons, including the lack of homogeneity in the performance of CSTDs (specifically, what type of device was included in the data synthesis), and the failure to consider whether there are differences in health outcomes, which were beyond the scope of most of the included studies.…”

Section: Closed-system Transfer Devices (Cstds)mentioning

confidence: 99%

“…In an article criticizing that Cochrane analysis, 14 it was noted that there are many erroneous evaluations on the basis of this review and its value for the oncology community is questionable. The analysis received serious criticism for many reasons, including the lack of homogeneity in the performance of CSTDs (specifically, what type of device was included in the data synthesis), and the failure to consider whether there are differences in health outcomes, which were beyond the scope of most of the included studies.…”

Section: Medical Devices Used For Safe Chemotherapy Applicationsmentioning

confidence: 99%

Section: Medical Devices Used For Safe Chemotherapy Applicationsmentioning

confidence: 99%

“…The article presenting the criticisms emphasized that CSTDs have an important place in a comprehensive safe use program and it is critical that laboratory-based studies are conducted to evaluate the efficacy of CSTDs. 14 In a survey study conducted by Canadian oncology healthcare practitioners 15 to explore the use of CSTDs, the impact of various stakeholders on their use, and the challenges the users face in using these medical devices, it was ascertained that although the use of CSTD was common in oncology practice settings there were some variations between institutions. The biggest challenges associated with the use of CSTDs were identified as cost, lack of information about the compatibility of CSTD with a drug or product, and hesitation about the impact of CSTD on drug quality.…”

Section: Closed-system Transfer Devices (Cstds)mentioning

confidence: 99%

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A review of medical devices used for safe chemotherapy applications: Focus on ONCOERA^® IV GROUP products

Tekin

Karadoğan

Kısmet³

2022

J Oncol Pharm Pract

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Objective The healthcare workers and the workers in the manufacturing industry of chemotherapy drugs are exposed to the “hazardous” effects of these drugs during production, transportation, distribution, administration, and disposal. In order to be protected from these harmful effects, personal protective equipment and medical devices providing safe applications are used. The aim of the present article is to review of medical devices used for safe chemotherapy applications in line with the information obtained from the literature. Data sources The international and national reliable sources, were used in the literature review for data analysis by using the keywords including chemotherapy, chemotherapy drugs, antineoplastic drugs, cytotoxic drugs, hazardous drugs, exposure to chemotherapy drugs, side effects of chemotherapy drugs, closed-system drug transfer devices, healthcare staff, needle-free devices, needle-free connectors, surface contamination, and phthalates. Data summary In order to minimize cytotoxic drug exposure, international standards were developed in the mid-1980s stating that all cytotoxic drugs should be prepared preferably in a ventilated biological safety cabinet, nurses dealing with the use of these drugs should use appropriate personal protective equipment, and in case of cytotoxic drug spillage, predefined cleaning and decontamination protocols should be followed. Although the risk of acute and long-term toxic effects in healthcare workers has decreased in recent years with these applications in the preparation and administration of cancer drugs, measurable contamination occurs in the workplace. A large number of medical devices have been developed for minimizing this type of contamination with chemotherapy drugs. In this article, these medical devices have been reviewed in detail under subtitles of closed system transfer devices, needle-free devices, and valve technology. Conclusions Until the results of the evaluations to be made in new studies prove the opposite, the use of these devices with additional protection measures taken, especially during the application of dangerous drugs, is of great importance in terms of patient and employee safety.

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Assessment of efficacy of postinfusion tubing flushing in reducing risk of cytotoxic contamination

Claraz

Riff

Vert

et al. 2020

American Journal of Health-System Pharmacy

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Purpose Infusion of cytotoxic drugs carries the risk of occupational exposure of healthcare workers. Since disconnecting an infusion line is a source of contamination, flushing of tubing after infusion of cytotoxic agents is recommended, but the optimal volume of rinsing solution is unknown. The objective of this study was to assess whether postinfusion line flushing completely eliminates cytotoxics. Methods Infusions were simulated with 3 cytotoxics (gemcitabine, cytarabine, and paclitaxel) diluted in 5% dextrose injection or 0.9% sodium chloride injection in 250-mL infusion bags. Infusion lines were flushed using 5% dextrose injection or 0.9% sodium chloride solution at 2 different flow rates. The remaining concentration of cytotoxics in the infusion line was measured by a validated high-performance liquid chromatography (HPLC) method after passage of every 10 mL of flushing volume until a total of 100 mL had been flushed through. Results All cytotoxics remained detectable even after line flushing with 80 mL of flushing solution (a volume 3-fold greater than the dead space volume within the infusion set). Gemcitabine and cytarabine were still quantifiable via HPLC even after flushing with 100 mL of solution. Efficacy of flushing was influenced by the lipophilicity of drugs but not by either the flushing solvent used or the flushing flow rate. After 2-fold dead space volume flushing, the estimated amount of drug remaining in the infusion set was within 0.19% to 0.56% of the prescribed dose for all 3 cytotoxics evaluated. Conclusion Complete elimination of cytotoxics from an infusion line is an unrealistic objective. Two-fold dead space volume flushing could be considered optimal in terms of administered dose but not from an environmental contamination point of view. Even when flushed, the infusion set should still be considered a source of cytotoxic contamination.

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Criticisms of Cochrane Review on closed-system transfer devices remain valid

Cited by 5 publications

References 5 publications

Integrity performance assessment of a Closed System Transfer Device syringe adaptor as a terminal closure for Luer-Lock syringes

Integrity performance assessment of a Closed System Transfer Device syringe adaptor as a terminal closure for Luer-Lock syringes

A review of medical devices used for safe chemotherapy applications: Focus on ONCOERA^® IV GROUP products

Assessment of efficacy of postinfusion tubing flushing in reducing risk of cytotoxic contamination

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Criticisms of Cochrane Review on closed-system transfer devices remain valid

Cited by 5 publications

References 5 publications

Integrity performance assessment of a Closed System Transfer Device syringe adaptor as a terminal closure for Luer-Lock syringes

Integrity performance assessment of a Closed System Transfer Device syringe adaptor as a terminal closure for Luer-Lock syringes

A review of medical devices used for safe chemotherapy applications: Focus on ONCOERA® IV GROUP products

Assessment of efficacy of postinfusion tubing flushing in reducing risk of cytotoxic contamination

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Product

Resources

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A review of medical devices used for safe chemotherapy applications: Focus on ONCOERA^® IV GROUP products