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SafetyAlerts
March 11, 2000

FDA Alternative Products and Procedures Used to Prepare Phlebotomy Sites at Blood Donor Centers

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A recent recall of some single-use, prepackaged, skin preparation products has generated concerns about methods and products that may be used for arm preparation prior to the collection of blood and blood components by establishments whose current procedure includes the use of the recalled prepackaged products.

The following arm preparation procedures have been approved by the FDA and may be used to prepare the phlebotomy site prior to
blood and plasma collection should an alternative procedure be needed. Licensed establishments should document the use of the products/procedures listed below in an annual report.

Method 1

1.Using a sterile swab, scrub area for 30 seconds with 0.7% aqueous scrub solution of iodophor Compound (e.g., PVP- iodine or poloxamer-iodine complex). Excess foam must be removed with a sterile swab, but the arm need not be dry before the next step.

2.Apply iodophor complex solution (e.g., 10% PVP-iodine). Using a sterile swab, begin at the intended site of venipuncture and move gradually outward in concentric circles, to form a total prepped area measuring at least 3 inches in diameter. Let stand for 30 seconds. This solution contains only 1% free iodine and need not be removed before completing venipuncture.

3.If not ready to do venipuncture immediately, cover the area with dry sterile gauze.

4.If the donor bends the arm, or the prepared site is touched with the fingers or with any other non-sterile object, the complete arm prep must be repeated.

NOTE: Bulk solutions may be substituted for the prepackaged, single-use, products. Antiseptic solutions used in donor arm preparation cannot be sterilized, however, antiseptic solutions prepared in bulk may be used for several months if properly handled. Some scrub solutions have additives such as alcohol or an iodophor compound to retard growth of organisms. If the bulk product to be used requires dilution, only small quantities, enough for a few days should be diluted. Bulk bottles of iodine solutions must be tightly capped when not in use to prevent evaporation of the alcohol that could result in a greater iodine concentration. Higher concentrations of iodine may cause skin reactions.

Method 2

1.Using a sterile swab, scrub vigorously with 15% aqueous (not alcoholic) soap or detergent solution for at least 30 seconds to clean away fat, oils, dirt, skin cells, and other debris.

2.Remove soap and froth with 10% acetone in 70% isopropyl alcohol (one part acetone in nine parts isopropyl alcohol) using a new sterile swab and allow to dry.

3.Apply tincture of iodine (2-3 Ѕ % in 70 % ethyl alcohol). Using a sterile swab, begin at intended site of
venipuncture and move gradually outward in concentric circles, to form a total prepped area measuring at least
3 inches in diameter and allow to dry.

4.Using a sterile swab, remove iodine with 10% acetone in 70 % isopropyl alcohol. Allow the solution to dry.

5.If not ready to perform venipuncture immediately, cover site with dry sterile gauze.

6.If the donor bends the arm, or the prepared site is touched with the fingers or with any other non-sterile object, the complete arm prep must be repeated.

NOTE: When using bulk solutions, see note above.

Method 3

1.Apply a minimum of 1 ml of One Step Gel directly to the venipuncture site by squeezing the gel bottle directly
over the intended area.

NOTE: 1 ml of gel is equivalent to an amount of gel resting on the arm of approximately ѕ inch in diameter (or about the size of a penny).

2.Using a sterile applicator and while holding at an approximate 30 degree angle, begin scrubbing in a circular motion over about a 1 inch area directly over the venipuncture site. Continue this for a minimum of 30 seconds.

3.After scrubbing for 30 seconds, use the same applicator to begin at intended site of venipuncture and move gradually outward in concentric circles, to form a total prepped area measuring at least 3 inches in diameter.

4.Using a second sterile applicator and starting from the center of the 3 inch prepped area (venipuncture site)
remove excess gel by moving gradually outward in concentric circles.

5.Allow site to air dry according to manufacturer's instructions.

6.If the donor bends the arm, or the prepared site is touched with the fingers or with any other non-sterile object, the complete arm prep must be repeated.

The establishment's previously approved venipuncture preparation procedure for donors who are allergic to iodine may also be used for donors not allergic to iodine until alternative iodine containing products have been obtained.

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Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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