Disposal
of Contaminated Devices
Notice to Pharmacy Owners and FDA Inspectors on Checking Medical Devices
for Potential Contamination and Disposing of Contaminated Medical Devices
Many pharmacies flooded or lost power as a result of hurricanes Katrina and
Rita. In order to help pharmacies return to business as soon as possible, the
Food and Drug Administration (FDA) is providing important tips on checking medical
devices for contamination and disposing of contaminated products.
Checking Medical Devices for Contamination
The decision whether or not to dispose of a potentially contaminated medical
device is usually made by the pharmacy owner in consultation with appropriate
federal, state, and local authorities. In determining which medical devices
should be discarded, the owner must assess each product’s current condition
and potential safety risks. For additional information, see FDA advice about
medical devices that have been exposed to unusual levels of heat and humidity.
Electrical or Electronic Equipment
|
Examples:
- Blood pressure measurement devices
- Glucose Meters
- Digital Thermometers
|
- Check packaging for water damage. If the package got wet, the product inside
could be damaged or contaminated. Discard the device if the packaging is wet
or if it shows signs of having been wet (such as water stains or discoloration).
Packaged Devices, Supplies, and Test Kits
|
Examples:
- Bandages and gauzes
- Condoms
- Feminine hygiene products and tampons
- Urinary incontinence pads
- Contact lens supplies and solutions
- Eye drops
- Glucose meters and test strips
- Pregnancy tests
|
- Fertility prediction tests
- Glycated hemoglobin test kits
- Urine dipsticks
- Drugs-of-abuse tests
- pH measurement devices
- Sperm detection devices
- Home Protime meters and strips
- HIV and hepatitis sample collection kits
|
- Check packaging for water damage. If the package got wet, the product inside
could be contaminated. Discard the device if the packaging is wet or if it
shows signs of having been wet (such as water stains or discoloration).
- Check outer packaging for signs of mold. If the outer package has mold
growth on it, the product inside could be contaminated. Discard the device
if the packaging appears to have mold growing on it.
- Check for breaks in package seals. If the package is torn or damaged in
any way that could break its seal, the product inside could be contaminated.
Discard the device if there are breaks in the package seals.
- Determine how long the facility had unusually high room temperatures. Many
test kit reagents are temperature-sensitive and could perform unreliably if
exposed to unusually high storage temperatures for an extended period of time.
Discard packaged test kits if the facility had unusually high room temperatures
for more than 24 hours.
Refrigerated Products
| Examples:
- Laboratory reagents
- Sterilants and disinfectants
|
- Determine whether or not refrigerators were without power. Refrigerated
devices and supplies could perform unreliably if they were exposed to unusually
high storage conditions. Discard refrigerated devices and supplies if the
refrigerator was without power for more than 8 hours.
Disposing of Contaminated Medical Devices
There are not specific guidelines for disposing of contaminated medical devices
from pharmacies. Follow standard procedures for discarding outdated or contaminated
products.
Updated September 27, 2005
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH
