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cornstarch powder and by latex when used in surgical and patient examination
gloves."
The delay might not be surprising when you consider the FDA has prohibited
only one other medical device in its 110-year existence: prosthetic hair fibers in
1983. Typically, when safety concerns arise, the FDA's first choice is to update
labeling or provide "black box" warnings. But the risks associated with pow-
dered gloves can't be corrected through new or updated labeling, says the
agency.
Moreover, Public Citizen noted in 1998 that labels warning that the gloves
should be washed to remove cornstarch before use were "routinely ignored by
the vast majority of health workers." It cited a 1992 study that showed only 17%
of surgeons and 21% of the surgical nursing staff washed their gloves after don-
ning them.
That's the real problem, says Tom Paolella, a spokesperson for glove manufac-
turer Ansell. "Unfortunately, many wearers of powdered surgical gloves do not fol-
low the proper protocol for use, which is to rinse hands in sterile saline after don-
ning," he says. "Since the 1970s, many national and international standards have
required manufacturers to label sterile glove packages with a specific warning to
remove the powder. Despite these warnings, many users do not comply with this
instruction."
Significant threat?
The cornstarch powder used with gloves is particularly problematic to those who
have latex allergies, according to Public Citizen, because it combines with latex
protein and allergens during manufacturing. The organization says that's led to
"well-documented and frequently reported adverse reactions," including rhinitis,
asthma and anaphylactic shock, "often caused by breathing in the cornstarch pow-
der."
Lori Groven, MSPHN, RN, CIC, infection preventionist at TRIA Orthopaedic
