Surgical and patient examination gloves that have cornstarch powder on them or are made of natural rubber latex should be banned because of the serious threat they pose to patients and healthcare workers, said the group Public Citizen in a petition filed late Monday with the Food and Drug Administration (FDA). Further, safer alternatives, such as powder-free, non-latex gloves, are readily available.
For healthcare workers, the major risk posed by the gloves is allergic reactions to latex, some of which can be serious or life-threatening. These allergic reactions can occur when healthcare workers wear latex gloves or when they inhale cornstarch powder bound to latex proteins that has been released from latex gloves worn by others. Breathing in cornstarch powder bound to latex proteins can cause acute asthma attacks and anaphylactic shock in healthcare workers sensitized to latex.
For patients, the danger is also grave. Patients can experience the same types of allergic reactions that occur in healthcare workers. Also, when cornstarch is deposited in tissues during surgery, it can promote infections, delay healing and cause inflammation, among other injuries.
This is the second time Public Citizen has petitioned the agency to ban the use of cornstarch powder in latex gloves. The first time was on Jan. 7, 1998. The next year, the FDA rejected the petition and, instead, proposed regulations to reclassify surgical and patient examination gloves as class II devices requiring special controls, such as warning labels an inadequate response to such a serious health problem.
On Sept. 28, 2008, a group of doctors petitioned the FDA to ban the use of cornstarch powder on all types of surgical and patient examination gloves. Shortly thereafter, on Feb. 24, 2009, the director of scientific affairs and clinical education of a major glove manufacturer requested a similar ban.
"The FDAs prolonged failure to take action eliminating the dangers posed by powdered surgical and patient examination gloves demonstrates a reckless and inexcusable disregard for the health and safety of patients and healthcare workers," says Dr. Michael Carome, deputy director of Public Citizens Health Research Group. "The dangers posed by powdered surgical and patient examination gloves and all latex gloves have been widely recognized throughout the medical profession and the world for many years and are indisputable. Safer, equally effective substitutes are available."
Once again, the FDA is lagging dangerously behind other countries that have moved to limit the use of a harmful product long before the FDA belatedly does so, Carome says. The UK announced a ban of propoxyphene (Darvon/Darvocet) in 2006, more than four years before the FDA banned the dangerous drug. Europe and the UK banned the dangerous diabetes drug rosiglitazone (Avandia) more than seven months ago, whereas the FDA decided not to ban it but merely to restrict its use.
Similarly, the weight-reduction drug sibutramine (Meridia) was banned in Europe in January 2010, but the FDA did not prod manufacturers to remove it from the market until October of that year. In 1998, the German government banned the use of powdered latex gloves.
"Collectively, thousands of lives have been saved and many more injuries spared in these countries because they have placed the health of the public ahead of the concerns of manufacturers of products with no unique benefits, only unique risks," Carome adds.