Nufactor Updated Mask Recommendation
By Nufactor - August 14, 2023

Right before the federal government ended the COVID-19 Public Health Emergency on May 11, 2023, the Centers for Disease Control and Prevention (CDC) updated their recommendations for healthcare personnel on May 8. The updates, applicable to all U.S. settings where healthcare is delivered, were made to reflect the high levels of vaccine-and infection-induced immunity and the availability of effective treatments and prevention tools. The guidance provides a framework to implement select infection prevention and control practices based on individual circumstances (e.g., levels of respiratory virus transmission in the community).

Moderate and severe immunocompromising conditions and treatments include many seen in patients who receive immune globulin and monoclonal antibody therapies provided by Nufactor^®. The degree of immunocompromise for the patient is determined by the treating provider, and preventive actions should be tailored to each patient and situation. Conditions and treatments include, but are not limited to the following.

1. Active treatment for solid tumor and hematologic malignancies.
2. Receipt of solid-organ transplant and taking immunosuppressive therapy.
3. Receipt of chimeric antigen receptor (CAR)-T-cell therapy or hematopoietic cell transplant (HCT) (within 2 years of transplantation or taking immunosuppressive therapy).
4. Moderate or severe primary immunodeficiency (e.g., CVID, Selective Antibody Deficiency, Subclass Deficiency, SCID).
5. Advanced HIV infection (people with HIV and CD4 cell counts less than 200/mm3, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV) or untreated HIV infection.
6. Active treatment with high-dose corticosteroids (i.e., 20 mg or more of prednisone or equivalent per day when administered for 2 or more weeks), alkylating agents, antimetabolites (e.g., methotrexate, immunosuppressive drugs used for transplants/other reason (e.g., azathioprine/Imuran®, cyclosporine, mycophenolate/CellCept^®, tacrolimus), cancer chemotherapeutic agents classified as severely immunosuppressive, tumor necrosis factor (TNF) blockers (e.g., infliximab/Inflectra^®/Remicade^®/Renflexis^®, Enbrel^®, Humira^®, Cimzia^®, and Simponi^®), and other biologic agents that are immunosuppressive or immunomodulatory.

Based on CDC recommendations, COVID-19 hospitalization rates, and risk to patients and nurses, Nufactor is adjusting its masking protocol, requiring the use of N-95 masks only in the presence of confirmed or suspected COVID-19 infection, or upon request. Otherwise, surgical masks should be donned. Nufactor is advising patients and will phase in the change starting with infusions after August 21. Nufactor will have patients maintain a supply of N-95 masks in case of a last minute need for them.

The following is Nufactor's protocol and reminders to help prevent infection during nursing visits:

Nursing Visit Standards

1. The day before a visit, the nurse screens the patient for COVID-19.
2. The day before a visit, the nurse screens household members for COVID-19.
3. The day of visit, the nurse self-screens for COVID-19.
4. The day of the visit, before entering the home, the nurse asks if there have been changes since screening the day before.
5. When possible, only the patient and nurse should be in the area/room.
6. When possible, during the visit, maintain distance of 6 feet (e.g., after starting an infusion, monitoring vital signs, etc.) but always stay in visual contact with the patient.
7. The nurse and patient should wear a mask while the nurse is in the home. If household members are present, they also should wear a mask.
8. Standard PPE
• Nurse: surgical mask, gloves (Nufactor provides).
• Patient: surgical mask (Nufactor provides).
• If present, household members should wear CDC-recommended masks, which do NOT include bandanas, gaiters or buffs. (Nufactor does not provide).
9. PPE if COVID-19 (+) or suspect patient/household member:
• Nurse: N-95, eye protection/face shield, gloves, gown (Nufactor provides).
• Patient: N-95 (Nufactor provides).
• If present, household members should wear CDC-recommended masks, which do NOT include bandanas, gaiters or buffs. (Nufactor does not provide).
• Establish the patient in a separate bedroom with a separate bathroom away from others if possible.
10. Patient requests for the nurse to don an N-95 mask under any circumstance will be honored.
11. Nurse requests for an N-95 for themselves mask under any circumstance will be honored.

References/Resources:
• Infection Control: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) | CDC dated 05/08/23
• Symptoms of COVID-19 | CDC dated 10/26/22
• What to Do If You Were Exposed to COVID-19 | CDC dated 08/24/22
• Isolation and Precautions for People with COVID-19 | CDC dated 05/11/23
• Ending Isolation and Precautions for People with COVID-19: Interim Guidance (cdc.gov) 08/31/22
• COVID-19 Testing: What You Need to Know | CDC dated 05/11/23
• Clinical Guidance for COVID-19 Vaccination | CDC dated 06/14/23