USP <800>
Handling and Safety Standards of Hazardous Drug Compounding
Overview
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Describes the handling of compounded hazardous drugs (known as HDs) and the standards implemented to promote and protect the environmental safety of patients and personnel. The “Handling of HDs includes, but is not limited to, the receipt, storage, compounding, dispensing, administration, and disposal of sterile and non-sterile products and preparations.”
All entities that handle HDs are to implement the outlined standards in their occupational safety plans. In addition, every 12 months, an entity must regularly monitor its list of HDs handled in tandem with the items under the current NIOSH list. It is critical to understand the definitions and best practices in order to meet protection standards in the HD Compounding process effectively.
“*See NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings”
Deactivating, Decontaminating, Cleaning and Disinfecting
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“All spaces in which HDs are handled along with the equipment and devices must be deactivated, decontaminated and cleaned. In addition, sterile compounding areas and devices must be subsequently disinfected.”
All personnel who participate in the Deactivating, Decontaminating, Cleaning and Disinfecting process must be equipped with the proper training and procedures to protect themselves and the environment from contamination.
“Agents used in the deactivation, decontamination, and cleaning stages should exclusively apply the correct solution on wetted wipes.” It is advised to not proceed with any application in the form of spray bottles, to prevent the spread of any residual HD.
Clean Air Essentials provide the industry standard PPE, impermeable disposable gowns, eye protection and face shields that will protect your entity's personnel (if properly used) from the cleaning agents used and contamination.
Cleaning Step | Purpose | Example Products |
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Deactivation |
“Compound is rendered inactive” |
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Decontamination
|
“Removal of HD excess" |
OR |
Cleaning |
“Removal of both organic and inorganic matter” |
|
Disinfection |
“Destroying of Micro-organisms” |
Deactivation
"The process renders a compound inert/inactive."
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- Following deactivation, proceed to remove all residual matter by decontaminating the surface.
- It is advised that appropriate care should be taken with material selection for deactivation due to the potentially harmful effects such as corrosion to stainless steel surfaces caused by sodium hypochlorite.
- For effective prevention, sodium hypochlorite must be treated with sodium thiosulfate and a pairing agent such as sterile alcohol, sterile water, germicidal detergent, or sporicidal agent.
- Deactivation can be completed using the following products:
Clean Air Essentials Guideline: While certain practices may have a "specific" deactivation method. The Clean Air Essentials team is here to provide you with the best deactivating product solutions (EPA-registered oxidizing agents) to achieve complete surface decontamination. Our representatives will guide you through a customized selection process based on your environmental requirements, so you are confident the methods used are safe and effective.
Decontamination
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“The inactivation or physical removal of any remaining HD from non-disposable surfaces to disposable materials (See recommended Clean Air Solutions) in preparation for sterile cleaning.”
Clean Air Essentials Guideline: “Pre-disinfection, surfaces must be cleaned and sterile with the appropriate cleaning solutions.” This includes sterilization of compounding areas.
Cleaning and Disinfecting
"Disinfection is the process of destroying microorganisms."
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- Removal of contaminants from objects, equipment and surfaces in order to fully clean and sterilize the area.
- “Note: Agents used on compounding equipment should not introduce microbial contamination.”
Clean Air Essentials Guideline: “Pre-disinfection, surfaces must be cleaned and sterile with the appropriate cleaning solutions.” This includes sterilization of compounding areas.