CONTAMINATED PREPS? Should preps be produced under sterile conditions and stored as such?

Could your preps and disinfectants be contaminated? The answer's yes — and it might be happening more often than you think.

That's right: Infections associated with contaminated antiseptic products may be more common than indicated by manufacturers' reports and the medical literature, according to FDA researchers published in the New England Journal of Medicine. Because preps and disinfectants aren't sterile products, produced under sterile conditions and stored as such, they're open to contamination by microbial organisms during manufacturing or use.

Although it's difficult to know the extent of infections associated with contaminated antiseptics, outbreaks reported in the literature and to the CDC have resulted in adverse outcomes, including localized infections at operative or incision sites, systemic infections and death. Reports have implicated alcohol, iodophors, chlorhexidine gluconate and quaternary ammonium products.

The FDA has now met twice — in 2009 and December 2012 — to consider whether to mandate sterile manufacturing conditions for topical antiseptic products intended for use on non-intact skin. Both times, it decided against stricter rules. But the fact remains: Improper handling can result in contamination of any antiseptic solution. Here's a refresher, to help make sure your antiseptic solutions will be up to the task.

Upon receipt
When antiseptics — including alcohol, iodophors, chlorhexidine gluconate, betadine, bleach and quaternary ammonium products — arrive at your facility, the first thing to do is examine the shipping container and bottles to ensure there's no damage, and that the seals haven't been violated. Look for leakage, particularly around the cap.

HIGH AND DRY Store antiseptic solutions separately, in a cool, dry place, and avoid contact with hands when dispensing.

Storage and dispensing
Store antiseptic solutions in a cool, dry place, carefully following manufacturers' instructions for storage conditions. For safety, store different types of solution separate from one another — for example, keep preps separate from cleaning solutions as a basic precaution to prevent dispensing the wrong product by mistake (however small the chance of that happening).

If possible, buy and use single-use products predominantly. If that's not always realistic, when dispensing, do so only into containers you know are clean and dry. Dispense directly, avoiding contact with hands and, preferably, wear gloves. Another safety note: Label the smaller container immediately, again to guard against potential mix-ups.

If you suspect contamination
When dispensing, visually inspect for particulates, discoloration and leakage, and be alert for an unusual odor. If something appears off, don't use the solution, and don't pour it down the drain. Call the manufacturer or distributor and fill out an FDA MedWatch form (tinyurl.com/b5aafm2) — they'll follow up to determine if the problem is more widespread, or whether it was just that bottle (which would indicate the issue may be in your facility). If it turns out it's OK to dispose of the solution, send it out with your biohazardous waste.

A final caution
Finally, remember that you can't super-sanitize the patient or the OR — so don't mix solutions. But, back to keeping antiseptic solutions from becoming contaminated: Awareness is the key.

"Users should … be aware that microbial contamination can occur when they are opening containers or diluting and storing solutions under nonsterile conditions," write the FDA researchers. "The period during which a container, once opened, can remain safe from extrinsic contamination is unknown. Aware-ness on the part of users may reduce the likelihood that multidose antiseptic products will become contaminated."