Safety and validation issues in considering a switch from glass to plastic tubes for both collection of blood specimens from donors for testing and for the analytic phase of testing

An East Coast colleague who works for a blood collection organization is interested in updated information on the use of plastic versus glass specimen collection tubes for routine infectious disease screening tests for donors and pretransfusion patient compatibility testing (ABO, Rh, antibody screening, and crossmatching). She is also interested in any updated information on the use of plastic versus glass tubes for the actual analytic phase of testing, since it is common practice to aliquot samples from the collection tube into a secondary tube for use during the analytic phase of testing.

She comments that her organization routinely uses GLASS specimen collection tubes at their manufacturing locations throughout the US, and that at least two of these centers are located within California. She has been informed that California (CAL-OSHA) now requires labs and hospitals to use plastic tubes for collection and testing of blood samples, whenever suitable plastic tubes are available, and that several hospitals in California have been instructed by CAL-OSHA to cease using GLASS tubes for routine specimen collection, if suitable PLASTIC TUBES are available for the testing being ordered. Institutions that fail to switch from GLASS tubes to PLASTIC tubes have been issued monetary penalties. Because of fear over fines, several California hospitals have switched almost entirely to using specimen collection tubes that are plastic, with few exceptions where plastic tubes are not available for the type of testing being done.

She is currently facing a situation where one of the manufacturing locations in California is requesting a variance to collect donor samples into plastic K₂EDTA tubes as opposed to glass K₃EDTA tubes for testing with one of their hematology analyzers. She has found an article in Laboratory Hematology (July 5, 2002) by staff members of the Massachusetts General Hospital and Harvard Medical School that supports use of the K₂EDTA. The article also contains a recommendation by the International Council for Standardization in Hematology that supports K₂EDTA as the anticoagulant of choice. She also found an article in MLO (February 2003) by Richard Fairfax of OSHA that discusses the necessity of switching to plastic wherever possible. She realizes that to make such a change in sample collection tubes would require correlation and validation studies, which are time-consuming.

The question she wishes to pose is "Given that CAL-OSHA is requiring safer collection containers (i.e. plastic) to avoid glass puncture wounds (one of the most common injuries in healthcare), is there any reason (other than the time and effort to validate plastic tubes) not to change from glass to plastic specimen collection tubes for blood bank testing across the board, both within California and in the other states where they have donor centers?"

Editor's NOTE: The following earlier discussions are germane to this new discussion:

• Switching from glass tubes to plastic tubes for blood bank laboratory testing
• Use of plastic tubes for collection of patient samples as well as for testing (ABO/Rh determination, unexpected antibody detection and identification, and crossmatching)

The following comments have been received.

ADDENDA Jan. 31, 2005

1. An American colleague wonders if any blood banks in the United States currently use plain red top plastic tubes for routine red cell grouping, Rh typing, and antibody screening.
   
   
2. Editor's query: For those blood banks that are using plain red top plastic tubes for blood bank testing, when did you learn that plastic red top tubes received FDA clearance for that intended use? The editor is not aware that such clearance has been granted.

ADDENDA Feb. 2, 2005

3. A colleague in Los Angeles has provided information that at least one company has recently obtained FDA clearance ("substantially equivalent" letter) for the use of red top plastic tubes for immunohematology testing including but not limited to ABO grouping, Rh typing, antibody screening, red cell phenotyping and DAT testing, which requires red blood cells or serum.

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Ira A. Shulman, MD
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Elizabeth M. St. Lezin, MD
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