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8 Questions Answered About PPE & USP <800> Requirements

Posted by Laura Paxton on Mar 22, 2021 9:20:42 AM
Laura Paxton
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A key way to protect healthcare workers is effective PPE, right? Seems simple enough except that USP <800> has outlined specific PPE requirements that vary depending on the NIOSH category of HD, how they are being handled, and in what part of the facility. 

Because the USP <800> requirements are lengthy and PPE is vital for healthcare worker safety, we receive a lot of questions from clients wanting to ensure they are fully protecting their employees. Here we answer 8 of those questions about PPE, HDs, and USP <800>:

#1. Q: Do we need to gown up when entering a non-sterile compounding room where chemotherapy drugs are stored? 

A: Yes, according to USP <800> all employees must gown up when entering the containment secondary engineering control (C-SEC), if that’s where the HDs are stored. 

#2. Q: Do surgical masks provide enough protection when there is a risk of respiratory exposure to HDs? 

A: No, they do not provide enough protection from HD exposure. A surgical N95 or P-100 respirator provides respiratory protection and a barrier to splashes, droplets and sprays around the nose and mouth ensuring a higher level of protection. Not only is respiratory protection needed when preparing HDs but also when cleaning up spills. 

OSHA also states that respirators must be fit tested annually and sooner if there’s a visible physical change in the employee’s appearance such as facial scarring, dental changes, cosmetic surgery, or obvious changes in body weight. 

#3. Q: Do we need to wear two layers of chemotherapy gloves when handling HDs?

A: Yes, two sets of gloves are required unless administering intact capsules and tablets. Also, chemotherapy gloves must meet ASTM D6978 standards, be powder-free, and must be inspected before and during use.

#4. Q: Does PPE need to be removed and disposed of before leaving the C-PEC? 

A: Yes, all PPE worn should be removed in the C-SEC and disposed of before leaving the C-PEC. All worn PE should be considered contaminated with trace quantities of HDs. 

#5. Q: Are eye and face protection PPE required when administering HDs? If so, what PPE is required by USP <800>?

A: Eye and face protection are required when there is a risk for spills or splashes for instance if administering liquid HDs through a feeding tube, or if an injection could splash. Also, it is required when administering irrigation or inhalation of powder or solution. When working with HDs outside of a C-PEC eye and face protection is required also. It is not required when administering an intact caplet or capsule. 

Eye and face protection such as a full face respirator, goggles, and face shield in combination with goggles are PPE options as outlined by USP <800>. 

#6. Q: How often do gloves and gowns need to be changed? 

A: If no permeation, gowns need to be changed every 2-3 hours, and gloves should be changed every 30 minutes. Of course, if there is a tear or spill or other damage or exposure, gowns and gloves need to be changed immediately. 

#7 . Q: Do healthcare workers always need to wear two shoe covers? 

A: USP <800> requires healthcare workers to wear two layers of shoe covers in the biological safety cabinet (BSC) or the compounding aseptic containment isolator (CACI) because HD contamination is most likely to happen there. You can remove the outer shoe cover prior to entering the anteroom or containment segregated compounding area (C-SCA). 

Shoe covers are not required when administering HDs, but are an extra step to consider in your Assessment of Risk. 

#8. Q: Do personnel who are receiving HDs need to wear PPE?

A: USP <800> requires that anyone handling HDs wear chemotherapy gloves. If personnel wear work gloves, the chemotherapy gloves must be worn underneath the work gloves. 

This list just scratches the surface of the questions about PPE requirements we receive. Many healthcare providers also have questions regarding PPE use and disposal for their specific facilities and operations, and we’re happy to answer your questions too. 

If providing hazardous drug handling information and disposal instructions, including PPE, at the point of care is a challenge for you, contact us for a demo of our Rhazdrugs solution. 

Topics: Rhazdrugs, Policy, USP <800>, Formweb

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