FDA warning to healthcare professionals: use sterile prep pads!

This post was authored by Brian Nash and posted to The Eye Opener on February 8th, 2011.

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Sterile Prep Pads

On February 1, 2011, the FDA issues a News Release about the use of non-sterile alcohol prep pads in certain clinical situations.

“Non-sterile pads are not intended to prep patients prior to procedures requiring strict sterility measures and should not be used on patients with a depressed immune system, to prep patients for catheter insertion, or to prep patients prior to surgery.”

This reminder/warning was issued in the wake of a recall on January 5th of all lots of alcohol prep pads and swabs manufactured by The Triad Group of Hartland, Wisconsin citing concerns about the product’s potential contamination with Bacillus cereus, a bacterium that can be harmful to humans.

While I guess we all need reminders now and then, do healthcare professionals really use non-sterile pads for pre-procedure prep when sterile technique is called for? Isn’t this basic training?

We have heard over and over again about the problems with infection control in medical facilities. Isn’t this a basic way to improve infection control – using sterile prep pads when doing open or penetrating skin procedures? Oh my!

While we in law deal with the end-result of failures to use “sterile techniques” – including the basic concept of using sterile pads - is this really such a problem in the healthcare industry that the FDA needs to remind providers to use the right kind of pad?

A number of our readers are members of the healthcare profession. Tell us – please, is this really a problem in the industry? Are there not basic protocol, stock control, safety measures in place that deal with this apparent problem? The rest of our readers either have been a patient or have a family member who’s been a patient; have you ever encountered a problem with an infection because your provider used the wrong type of prep pad?

Image from dailymed.nlm.nih.gov

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2 Responses to “FDA warning to healthcare professionals: use sterile prep pads!”

  1. TheresaNo Gravatar says:

    It all boils down to two things…….money and carelessness!!!
    Having taught clinical skills in medicine, there is a difference between aseptic technique and sterile technique. Each is used for different procedures and requires varying skin preparation. An intramuscular injection or basic venipuncture requires a sterile alcohol pad. Intravenous blood cultures or suture repairs require Betadine-type preparation of the skin. Surgical procedures require strict and broad skin preparation with betadine-scrub sponges. I am not sure of any procedure that allows for a non-sterile cotton ball soaked from an open bottle of isopropyl alcohol! Yet, the lab affiliated with my doctor’s office uses this last option for basic phlebotomy procedures!! They might think I am crazy, but I do insist on the use of a sterile alcohol prep pad instead of their “standards”.
    Anything that is individually packaged or sterile is much more expensive than non-sterile, bulk items. And have you looked at the price of Betadine? Next time you go to a pharmacy, go check out how much a 6 or 8 oz bottle of Betadine costs; you will be amazed!
    Reimbursement for medical procedures is very minimal considering what is involved these days, and the “businessmen” of medicine, cut costs where possible. Once upon an eon ago, the same Vacutainer hub was re-used for multiple patients; they just changed the needle. Now, the whole assembly gets tossed into a sharps container. This fills the sharps containers much more rapidly than needles alone. Then, there is proper disposal of the sharps containers. It goes on and on, such that the provision of medical care is quite costly in comparison to days of old, but reimbursement simply has not changed to reflect the times. We have an over-burdened Medicare and Medicaid system that is only going to get worse. Not to enter into another subject, but you can now imagine why there is a worsening crisis with primary care providers! Cost of care, including malpractice insurance, are soaring while reimbursement is dwindling; anyone knows that this is a recipe for disaster.

  2. Brian NashNo Gravatar says:


    Really appreciate the great information from someone who knows from the “medical side.”

    What you’re saying about the cost issue(s) is understandable; however, I wonder what the cost is when people become infected secondary to non-sterile techniques? I bet I can have some pretty good idea if I look though our file cabinets! What do they say about a penny wise and a pound foolish. Again, many thanks for the great information.

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