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 November 2007
Tech News

Proposed Protective Clothing Standards Deal with Hypodermic Needles and Chemotherapy Drugs

Subcommittees of ASTM International Committee F23 on Personal Protective Clothing and Equipment have recently begun to develop two proposed new standards that would help protect healthcare workers and others from the hazards of needle puncture and contact with chemotherapy drugs. Subcommittee F23.20 on Physical is developing WK15392, Test Method for Protective Clothing Material Resistance to Hypodermic Needle Puncture, while F23.30 on Chemicals is working on WK15563, Specification for Protective Clothing to Be Used against Chemotherapy Drugs.

Needle Puncture Standard to Protect Healthcare Workers
While there are several products designed to offer resistance to medical needle puncture on the market, there is not currently a standard for testing this type of puncture resistance. A proposed new ASTM standard, WK15392, Test Method for Protective Clothing Material Resistance to Hypodermic Needle Puncture, would fill this gap.

Cliff Richardson, director of research and development at Higher Dimension Materials, Inc., and chair of the WK15392 task group, says that the closest test method for needle puncture now available is ASTM standard F 1342, Test Method for Protective Clothing Material Resistance to Puncture, which provides a method for measuring nail-like puncture resistance. “However, the type of puncture probes used in F 1342 are very different from needle puncture because a medical needle has a much smaller diameter and has sharp cutting edges near the tip of the needle,” says Richardson. “Consequently, it is much harder to design a flexible material that can stop a medical needle than it is to design a flexible material that can stop a more nail-like probe such as those described in F 1342.”

The proposed standard will allow consumers of medical needle puncture resistant products to know the level of protection provided by those products that they purchase. While doctors and nurses are the most obvious examples of those who would benefit from this information, others who would benefit include people who dispose of waste materials and police officers who may have to frisk people with needles in their pockets.

Richardson invites participation in the ongoing development of WK15392. “One thing that we need in particular is some type of standardization of medical needle geometry,” says Richardson. “For example, when we say that we are testing with a 25 G needle, we need to specify the precise geometry of that needle. One possible way to do this would be to get engineering drawings of medical needles from one of the major needle manufacturers and use that to specify the standard test probes.” Richardson also notes that input from those in the medical and law enforcement fields regarding the types of needs that are most often involved in accidental “sticks” would be very useful in the development of WK15392.

Technical Information: Cliff Richardson, Higher Dimension Materials, Inc., Oakdale, Mich.
Phone: 651/651-2562

Proposed Specification Will Protect Against Chemotherapy Drugs
The pervasive use of chemotherapy drugs in the treatment of cancer and other serious diseases has created a number of specific hazards in the healthcare community. Because protection has often been provided haphazardly and inconsistently to healthcare workers who mix and administer these drugs, Subcommittee F23.30 has now begun work on a proposed new standard, WK15563, Specification for Protective Clothing to Be Used against Chemotherapy Drugs.

According to Jeffrey Stull, president, International Personnel Protection, Inc., and chair of Committee F23, WK15563 is being patterned after D 6978, Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, which was recently developed by Committee D11 on Rubber. However, Stull notes that, unlike D 6978, WK15563 will be a specification and will detail both barrier and physical qualities of gowns used for healthcare workers handling chemotherapy drugs.

“Two levels of barrier performance are proposed within the draft specification to address the different levels of exposure that might be expected in a healthcare setting — larger volumes in mixing or preparation of the drugs and lower volumes or splatter in administration of the drugs,” says Stull. He notes that this distinction is important because higher barrier requirements may dictate tradeoffs for function and comfort of gowns that might be unacceptable for most healthcare work conditions. Having two levels of barrier protection covered in the proposed standard will allow healthcare facilities to decide on the appropriate level of protection.

Stull notes that WK15563 is in the early stage of development and encourages all interested parties to participate in work on the proposed standard. The subcommittee would be particularly interested in comments from end-user groups or medical facilities relative to their experiences with clothing used to prevent exposure to chemotherapy drugs. //

Technical Information: Jeffrey O. Stull,
International Personnel Protection, Inc., Austin, Texas
Phone: 512/288-8272

ASTM Staff: Stephen Mawn
Phone: 610/832-9726

Upcoming Meeting:
Jan. 29-31, 2008
January Committee Week
Ft. Lauderdale, Fla.