Understanding the Evolution of Chemo Gown Testing Standards

In healthcare and pharmacy, cleanroom apparel such as chemotherapy gowns is crucial in safeguarding healthcare workers from hazardous drug exposure. However, until recently, testing protocols for chemotherapy gowns were not clearly defined, which led to ambiguity about their performance and protection. Manufacturers often had to rely on existing standards not explicitly tailored to gowns, drawing their own conclusions from the results.

The Challenges with Previous Standards

Before 2022, two primary testing protocols were available for evaluating the effectiveness of chemo gowns: ASTM F739 and ASTM D6978.

• ASTM F739, the standard for liquid permeation of protective clothing materials, provided insights into how gowns could be evaluated. However, it did not offer all the necessary parameters for testing chemotherapy gowns, leaving gaps that manufacturers had to address. Manufacturers addressed one gap by choosing the drug concentration for testing, potentially choosing low concentrations, unlike higher concentrations, as outlined in ASTM D6978. 

• ASTM D6978, primarily focused on chemotherapy gloves, became the go-to standard for testing gowns, mainly due to the lack of a gown-specific method. This standard, as required by USP <800> for chemotherapy gloves, tested for breakthrough in the protection barrier, but the parameters were not ideally suited for gowns.
  

Due to a lack of clear direction, some manufacturers followed ASTM D6978 for testing gowns, which only required reporting results without pass/ fail parameters.

The Introduction of ASTM F3267: A New Standard for Gowns

In 2022, ASTM introduced a new standard, F3267, designed for chemotherapy gowns. This standard draws from the existing F739 method and includes some of the same drugs from D6978. However, the new standard specifies where to test on the gown, temperature conditions, breakthrough thresholds, and clear pass/fail criteria. There are pass/fail criteria for two levels of protection: broad, the highest protection level, and selective, the lowest protection level.

Impact of the New Standard on Gown Performance

Gowns that were previously tested using ASTM D6978 (the glove standard) often showed breakthroughs with drugs like Carmustine and Thiotepa, which are challenging to block. However, when the identical gowns were tested using ASTM F3267, they showed no breakthrough for these drugs. This shift is mainly due to the differences in the testing parameters, including the temperature and breakthrough thresholds.

Conclusion

The shift to ASTM F3267 brings much-needed clarity and specificity to the testing of chemotherapy gowns. Offering clear parameters and criteria tailored to gowns fills the gap left by previous standards, reducing confusion and improving the protection of healthcare workers. Contec Healthcare’s CritiGear HD Chemo gowns meet broad-level protection as outlined by ASTM F3267. For more information on the new testing standard and our gowns, don’t hesitate to contact your local Contec Healthcare sales representative.

References:
Cockcroft et al. Hospital Pharmacist. January 2001. 8(8):226-32. Protect yourself during material handling.