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USP 800: Section 15 – Deactivating, Decontaminating, Cleaning & Disinfecting

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In our last blog post, we looked closely at Section 6 of USP General Chapter 800 to explore the elements of a medical surveillance program as defined within the standards. (It is important to note that November 1, 2023, is the date when the hazardous drug compounding and safe handling standards (USP 800) become enforceable.) The surveillance program is required to monitor the safety of healthcare employees working with hazardous drugs. To ensure a safe workplace, it is necessary to regularly assess the potential risk of employee exposure to hazardous drugs. For that, we recommend our ChemoGLO Wipe Kit – the easiest, fastest, and most reliable way to get quantitative data on potential hazardous drug exposures at baseline and for ongoing risk assessments.

Today, I’d like review Section 15 of USP General Chapter 800 and how ChemoGlo’s Hazardous Drug Clean (HDClean) Wipes are the ideal solution for deactivating, decontaminating, and cleaning hazardous drugs from surfaces. But first, a reminder about who these safety standards are meant to protect. USP 800 hazardous drug compounding and safe handling standards have been developed to protect the health of clinical pharmacists and pharmacy technicians along with other healthcare workers including nurses, physicians, surgeons, physician assistants, respiratory therapists, home health aides, nurses’ aides, healthcare facility housekeeping, janitorial services, and environmental services.

Section 15 of USP General Chapter 800 specifies standards for deactivating, decontaminating, cleaning, and disinfecting all areas where HDs are handled and all reusable equipment and devices. Here are a few key takeaways from Section 15 (we recommend reading and becoming familiar with the full USP 800 document):

• The entity must establish written procedures for decontamination, deactivation, and cleaning, and for sterile compounding areas disinfection. Written procedures for cleaning must include procedures, agents used, dilutions (if used), frequency, and documentation requirements.
• All personnel who perform deactivation, decontamination, cleaning, and disinfection activities in HD handling areas must be trained in appropriate procedures to protect themselves and the environment from contamination.
• All personnel performing these activities must wear appropriate PPE resistant to the cleaning agents used, including two pairs of chemotherapy gloves and impermeable disposable gowns. Additionally, eye protection and face shields must be used if splashing is likely. If warranted by the activity, respiratory protection must be used.
• The deactivating, decontaminating, cleaning, and disinfecting agents selected must be appropriate for the type of HD contaminant(s), location, and surface materials. The products used must be compatible with the surface material.
• Agents used for deactivation, decontamination, and cleaning should be applied through the use of wipes wetted with appropriate solution and not delivered by a spray bottle to avoid spreading HD residue.
• Deactivation renders a compound inert or inactive. Residue from deactivation must be removed by decontaminating the surface.
• Decontamination occurs by inactivating, neutralizing, or physically removing HD residue from non-disposable surfaces and transferring it to absorbent, disposable materials (e.g., wipes, pads, or towels) appropriate to the area being cleaned.
• Because of the growing number of assays available for HDs, additional surface wipe sampling is now possible and should be done to document the effectiveness of any agent used for decontamination of HD residue from work surfaces.

ChemoGLO’s Hazardous Drug Clean (HDClean) wipes are sterile, pre-moistened towelettes that are laboratory tested and proven to deactivate, decontaminate, and clean hazardous drugs from surfaces. Our HDClean Wipes can help you achieve and maintain compliance with USP 800. HDClean was developed to address daily removal of hazardous drug surface contamination in preparation and administration areas such as clean rooms, biological safety cabinets (BSC), laminar flow hoods, counters, infusion chairs, and IV poles and pumps. It's an easy two step wiping procedure using towelettes that effectively decontaminates surfaces by removing hazardous drug surface contamination. HDClean has been laboratory tested to remove surface contamination of a wide variety of hazardous drugs, including chemotherapy drugs, hormone agents, controlled substances, and drugs of abuse.

The HDClean towelette wiping system is the only laboratory tested cleaning system proven to decontaminate surfaces by removing hazardous drug surface contamination. The simple wiping procedure and disposable towelettes offer the convenience of a quick, thorough clean at any time of the day. Some of the advantages of the HDClean wiping system include:
• USP 800 Compliant
• Proven effective in laboratory tests
• Effective on a wide variety of hazardous drugs
• No overpowering odor
• Non-corrosive
• Gamma irradiated for sterility
• Simple towelette wiping procedure
• No residue left on surfaces after use
• Larger towelettes offer expanded cleaning area up to 8 square feet

To order ChemoGLO products or arrange to speak with one of our experts, please email our sales group at orders@chemoglo.com or call 1-877-215-2705 ext. 2