Notice to Pharmacy Owners and FDA Inspectors on Checking Medical Devices for Potential Contamination and Disposing of Contaminated Medical Devices
In order to help pharmacies return to business as soon as possible following flooding or loss of power, the Food and Drug Administration (FDA) is providing the following 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
- 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
- Bandages and gauzes
- 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.
- 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.