USP 800 Standard

We’ve got you covered.

USP 800 becomes official December 1, 2019 of this year. To reach compliance, you need to ensure you are using the correct PPE to minimize exposure to hazardous drugs. V12 Health offers a free USP 800 PPE assessment, to help you take the guesswork out of compliance and provide recommendations designed to help you save money, better protect staff, and improve utilization.

All our new products meet USP 800 standards. For more information visit USP.org

 

What does it mean for PPE

Gowns

  • Gowns must be selected based on the hazardous drugs (HD) handled
  • Gowns must close in the back, be long sleeved, and have closed cuffs that are elastic or knit
  • Gowns must not have seams or closures that could allow HDs to pass through
  • Gowns must be changed every 2–3 hours, immediately after a spill or splash, or per the manufacturer’s information for
    permeation of the gown
  • Gowns worn in HD handling areas must not be worn to other areas

Chemotherapy gowns are tested against the following chemotherapy drugs per ASTM F739-12:

  • Dacarbazine
  • Carmustine (BiCNU)
  • Cyclophosphamide (Cytoxan)
  • Doxorubicin Hydrochloride
  • 5-Fluorouracil
  • Cisplatin
  • Etoposide (Toposar)
  • Paclitaxel (Taxol)
  • Thio-Tepa
  • Mitomycin C
  • Vincristine Sulfate

Gloves

  • Gloves must be powder-free and chemo-tested to ASTM D6978
  • Hands must be washed with soap and water after removing gloves
  • When used for sterile compounding, the outer chemotherapy glove must be sterile
  • Chemotherapy gloves must be changed every 30 minutes unless otherwise recommended (see chemo panel on back of glove boxes for breakthrough times)
  • Gloves must be inspected for physical defects before use

Bouffant Caps and Shoe Covers

  • Head and hair covers (including beard and moustache), shoe covers and sleeve covers provide protection from contact with HD residue
  • When compounding HDs, a second pair of shoe covers must be donned before entering the C-SEC and doffed when exiting the C-SEC
  • Shoe covers worn in HD handling areas must not be worn to other areas
  • Disposable sleeve covers protect areas of the arm that may come in contact with HD

Masks

  • Surgical masks do not provide respiratory protection from drug exposure
  • A fit-tested NIOSH-certified N95 respirator protects against airborne particles for most activities
  • N95 respirators offer no protection against gases and vapors and minimal protection against splashes

Googles and Face Shields

  • Eye and face protection must be worn when there’s a risk for spills or splashes of HD materials when working outside of a C-PEC
  • A full-face piece respirator provides eye and face protection
  • Face shields alone do not provide full eye and face protection—goggles must be used when eye protection is needed