April 16, 2007 - Hospitals and surgical centers that are not using certified non-pyrogenic surgical gloves may be exposing their patients to potentially deadly bacterial toxins such as endotoxins and other pyrogens, says Molnlycke Health Care US LLC, manufacturer of the Biogel surgical glove line.
"Implants, sterile medical devices and even pharmaceuticals are required by the FDA to be non-pyrogenic," says Milt Hinsch, technical services director for Biogel surgical gloves. "So, one must ask, why surgical gloves, which can contaminate them during handling, are not? Surgical gloves should be as pristine as the medical products they touch."
Endotoxins (inflammatory substances, or pyrogens, produced by the dead remnants of some Gram-negative bacteria) can be transferred from sterile gloves to instruments, IVs, catheters, sutures, implants, transplantation organs and grafts. To date, Toxic Shock Syndrome (TSS) remains the highest-profile example of a medical complication stemming from endotoxins, but other medical problems associated with these bacterial toxins are diverse and well documented. Endotoxins contribute to medical complications that can lead to severe medical distress and even death in severe situations. They include irritation, rhino-conjunctivitis, pulmonary congestion and asthma, fever, malaise and anaphylactic shock.
"They can have a profound effect on the immune system, producing neurological and endocrinological problems, local inflammation, and systemic reactions such as fevers," Hinsch says. "Research indicates the inflammation and spiked fevers patients often experience after surgery may not always be 'normal' post-operative reactions after all."
While sterilization kills bacteria, the dead cell walls (which in some Gram-negative bacteria release endotoxins) remain on the gloves. Endotoxins tend to be more prevalent on powdered gloves where the starch powder acts as a food source for such bacteria - making these types of surgical gloves more pyrogenic.
To date, only the maker of Biogel gloves have publicized that they conduct pyrogen (endotoxin) testing over their entire surgical glove range. The Biogel production process keeps pyrogen and endotoxin levels to below detection levels the same as those required of general surgical implants and IV tubing. Each and every lot of Biogel gloves is tested to see that it meets non-pyrogenic requirements.
In fact, several styles of low-allergen, powder-free Biogel gloves have been cleared by FDA for a non-pyrogenic claims: Biogel, Biogel Eclipse, Biogel M, Biogel Skinsense Polyisoprene and Biogel Skinsense. The non-pyrogenic claim assures users that Biogel gloves provide the cleanliness level that their surgical patients should demand.
"As more operating rooms switch to powder-free surgical gloves, endotoxin levels will also decrease," Hinsch says. "However, medical facilities should be aware that some powder-free gloves may still have high levels of endotoxins because several processes and components of powder-free manufacturing in uncontrolled environments can similarly introduce bacteria," he explains.