65
SECTION 3: SWEAT INDUCTION AND COLLECTION
3.4 Risk of Burns
Sweat Testing Poses a Remote Risk of Minor Skin Burns
The pilocarpine iontophoresis sweat test has been an important laboratory tool since the 1950s. It
provides a quantitative test result to confirm or exclude a physician’s diagnosis of cystic fibrosis.
Unfortunately, the test has been accompanied by occasional minor burns.
Minor skin burns have been an unwelcome, adverse side-effect of pilocarpine iontophoresis from
the beginning. Fortunately, such burns are extremely rare with ELITechGroup’s iontophoretic
system. It uses a sophisticated microprocessor current controller and a very low delivery current
of only 1.5 mA. Pilocarpine is contained in unique Pilogel gel reservoirs that are 96% water. These
features substantially reduce, but do not totally eliminate, the possibility of skin burns.
Burn descriptions vary from “tiny black pinholes in the skin” to “crater-like, third-degree burns
two to three millimeters in diameter.” In most of the incidents reported, the patients have
exhibited no sign of pain or discomfort during iontophoresis, and the burn was not discovered
until the electrodes were removed.
Most individuals exhibit sensitivity to pilocarpine that is typically manifested as mild erythema
(redness) of the skin at the electrode locations. In some cases, one or more blister-like welts may
also form. These are often mistaken as burns, but they are simply a reaction of the skin to
pilocarpine. Such “blisters” invariably disappear within 2 to 3 hours, leaving no after-effects.
Based on current data, the reported burn rate is less than 1 in 50,000 procedures. ELITechGroup
prescribes proper test procedures which minimize the risk of burns. It is highly unlikely that a
patient will suffer a burn during the sweat test.
ELITechGroup recommends informing patients (or parents of young patients) of this slight risk and
following all approved procedures. If a burn should occur, follow the appropriate procedures to
determine any treatment needed and notify ELITechGroup immediately. ELITechGroup will gather
information related to the burn and will ask that a qualified professional fill out a short form to
determine whether the burn is reportable to the US FDA or other regulatory authorities.
ELITechGroup will also help determine whether the burn could be related to a malfunction.
To Next Page
Loading...
Need help?
General