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

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Should workers have to settle for a mediocre safety standard? Do companies which purchase gloves tested to EN374-3 have employees’ interests at heart? The answer is simple: no

Harry Kirk

Sales and Marketing 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 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 well-known, 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 micro-organisms. 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 below.

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 the ASTM D 6978-05 is adopted as the standard test method for chemotherapy gloves. â–

References
1. British Standards Institution. EN 374-3:2003. Protective gloves against chemicals and micro-organisms: 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.

For any additional queries relating to the t­esting methodologies and results discussed above, please contact Nitritex Ltd on +44 (0) 1638663338 or email the company at [email protected]

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