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Published on 6 October 2008

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Standards for cytotoxic protection: are we asking the right questions? EN374-3 vs ASTM D 6978-05

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When workers don gloves to handle cytotoxics, can they be sure their glove has the best protection? Should workers have to settle for a mediocre safety standard? Do companies that purchase gloves tested to EN374-3 have employees’ best interests at heart? The answer is simple: No

Harry Kirk

Business Development Director
Nitritex Ltd
Newmarket
UK

Countless thousands of operators working in hospital pharmacies expose themselves daily to the dangers surrounding cytotoxics, especially when the gloves they use have not been tested to the latest, most relevant standard.

So who can provide superior-quality gloves that not only remove latex allergy issues but also offer testing results that reflect more stringent in-use scenarios? The answer may be closer than you think.

Nitritex Ltd, a technology-based UK manufacturer of gloves specifically designed for use in the chemotherapeutic market, has introduced its BioClean P-Zero, BioClean Ultimate and BioClean Emerald gloves, all of which have been tested to the ASTM D 6978-05 standard.

The performance of the Nitritex gloves far eclipses that of the glove market leader, supplied by a wellknown, German-based company.

This is despite the fact that the German brand is on average
twice the thickness of the BioClean range of chemotherapy gloves.

In response to the hazardous nature of and dangers involved in handling cytotoxic drugs, the new standard (ASTM D 6978-05)[1] demands that breakthrough of the drug is deemed to have occurred when the permeation rate has reached 0.01 μg/cm2/min compared with EN 374-3,[2] which uses 1.00 μg/cm2/min as its testing level. Therefore, ASTM D 6978-05 is 100 times more stringent than its European counterpart.

The current standard by which the majority of gloves and garments are tested is EN374-3, which determines the resistance of protective gloves to permeation by chemicals and microorganisms. While the EN374-3 offers some value in terms of safety determination, there are a number of key differences
to be noted between the methodologies, as outlined in Table 1.

The protection provided by gloves has become a key issue for operators working with cytotoxic drugs.

While EN374-3 is an acceptable standard for general chemicals protection, to ensure the greatest protection for handlers of cytotoxic drugs it is essential that ASTM D 6978-05 is adopted as the standard test method for chemotherapy gloves.

[[HPE40.69]]

References
1. British Standards Institution. EN 374-3:2003. Protective gloves against chemicals and microorganisms: determination of resistance to permeation by chemicals. London: BSI; 2003.
2. American Society for Testing and Materials. D 6978-05: standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs. West Conshohocken (PA): ASTM; 2005.

[[HPE40.70]]



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