A close look at Infections associated with contaminated aniseptic products.
by Kim LaFreniere, PhD., Clinical Affairs, Associate Research Fellow
One might assume that all unit-of-use alcohol and povodine-iodine products are sterile. However, it has become abundantly clear that his is not always the case.
Product sterility – the assurance that your product is not contaminated – is critical to delivering better patient outcomes and ensuring
the safety of a medical team. Clinical infections associated with a variety
of approved products have been reported to the Center for Disease
Control, U.S. Food and Drug Administration, and journals. As a result
of these reports, a number of product recalls have ensued. The reported
outcomes range from localized infections at injection sites to systemic
infections resulting in death.
The reports implicate all commonly used antiseptic categories.
Examples include alcohol, iodophors, chlorhexidinegluconate, and quaternary ammonium products. Some potentially pathogenic organisms, such
as Bacillus cereus, Burkholderiacepacia, Pseudomonas aeruginosa, and
Serratiamarcescens, have been implicated in one or more recent outbreak.
Several recent incidences of product contamination have led to tragic
outcomes: Contamination of antiseptic drug products may occur either
during manufacturing (intrinsic contamination) or during manipulations
by the end user (extrinsic contamination). Although PVP-I manufactur-
ers rely on complex water purification systems that sanitize the water
used in formulating PVP-I solution, bacteria can colonize in water distri-
bution pipes, filters, and pumps.
Infections Associated with Contaminated Antiseptic Products
Product and Mechanism of
Iodophor, including povidone-io-
dine and poloxamer-iodine
Chlorhexidine gluconate alone or
Peritonitis, replacement of dialysis catheter,
pseudoperitonitis, pseudobacteremia, and
infection at dialysis catheter insertion site
Death, bacteremia, removal of indwelling
central venous catheter in patients with
cancer, replacement of dialysis catheter,
pseudobacteremia, wound infection, and
Burkholderia cepacia, Achromo-
bacter xylosoxidans, Ralstonia
Quaternary ammonium com-
pound, including benzalkonium
chloride and benzethonium
Death, bacteremia, septic arthritis requir-
ing prolonged antibiotic therapy and injec-
Burkholderia cepacia and Myco-