Gloves Standards and Occupational Exposure to Antineoplastic Drugs in the European Context.

BACKGROUND AND AIMS

Over 12 million healthcare professionals in Europe are exposed to hazardous medicinal products, including antineoplastic drugs. Dermal route is recognized as the primary route of exposure to antineoplastic drugs, emphasizing the critical importance of skin protection provided by gloves, which necessitates a careful and specific selection process. This study aims to compare the current European standard EN 16523-1:2015 + A1:2018 with the ASTM D6978-05(2023) standard used in the United States.

METHODS

Firstly, the three main performance parameters to consider when selecting gloves are described: standardized breakthrough time, standardized permeation rate, and cumulative permeation. Subsequently, the current European and American standards are compared based on the following criteria: part of the glove tested, substances tested, standardized permeation rate, test duration, test temperature, and the information provided on the glove packaging. Additionally, and with a focus on safety, clear examples of how to interpret graphical symbols and indications available on glove packaging are provided to enhance the transferability of the information contained in this study to healthcare settings.

RESULTS

There is a significant disparity between the requirements of the two standards. Indeed, the only European standard applicable in the context of glove permeation by antineoplastic drugs requires a standardized permeation rate 100 times less stringent than the American standard and does not include any hazardous drugs in its list of substances to be tested. By proposing a list of 24 antineoplastic drugs to be tested, a test temperature of 35 ± 2°C (compared with 23 ± 1°C in the European standard), and by specifically targeting the thinnest part of the glove, the American standard is closer to real-world conditions of use compared to its European counterpart.

CONCLUSION

This study underscores the limitations of current European standard, advocating for regulatory updates to better protect healthcare professionals, while emphasizing the complexity of selecting appropriate gloves for antineoplastic and hazardous drug exposure.

CLINICAL TRIAL REGISTRATION

Not concerned.