CDC Sends Back Proposals to HICPAC on Pathogen Spread in Health Care for Revision

Picture of CDC on a computer screen.

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On January 23, 2023, the CDC announced it is sending back its 2023 proposals regarding the spread of dangerous pathogens in health care to the Healthcare Infection Control Practices Advisory Committee (HICPAC) for revision.¹ Infection Control Today^® (ICT^®) has published 2 articles^2,3 sounding the alarm regarding the potential harm these recommendations could potentially cause and the need to revise the 2023 proposed guidelines.
 
The guidelines describe the categories of touch and air transmission and eliminate the dichotomy of large versus small droplet transmission in favor of spread from a continuum of particle sizes. However, similar to ICT’s previous commentaries,^2,3 the CDC has significant questions regarding the draft infection control recommendations given this newly proposed paradigm.

Composition of HICPAC: Last July 2023, a commentary published by ICT stressed that HICPAC needed to incorporate outside expertise from varying disciplines to help formulate recommendations.² Experts included aerosol scientists, ventilation experts, industrial hygienists, and respirator protection experts. The CDC announced that the process will now utilize a wider range of expertise in their decision-making process.

The CDC announcement stated: “In addition, CDC is working to expand the scope of technical backgrounds of participants on the HICPAC Isolation Guideline Workgroup and eventually among the committee members through established processes in accordance with the Federal Advisory Committee Act (FACA) regulations and guidance.”¹
 
In ICT’s November 2023 article on the HICPAC update,³ the authors were also concerned with “the allowance for the use of surgical masks when treating patients with airborne infections” and “the lack of provisions for air quality standards.”³

N95 Respirators: The CDC is questioning HICPAC if there should be a category (as presently proposed) for the use of surgical masks with pathogens spread through the air and “Should N95 respirators be recommended for all pathogens that spread by the air” ¹
 
The CDC also reminded HICPAC¹ “to make sure that a draft set of recommendations cannot be misread to suggest equivalency between facemasks and NIOSH Approved respirators, which is not scientifically correct nor the intent of the draft language. Although masks can provide some level of filtration, the level of filtration is not comparable to NIOSH approved respirators.”¹

Source Control: Most importantly, the authors of the July ICT commentary authors wrote that the HICPAC recommendations had a lack of provisions for source control.² Source control is critical to preventing the spread of respiratory pathogens. For example, the recent study by Banholzzer and colleagues observed a 69% decrease in SARS-CoV-2 aerosols with mask mandates.³

The CDC also asked HICPAC the following questions: “Should there be a recommendation for use of source control in health care settings that is broader than current draft recommendations? Should source control be recommended at all times in health care facilities?”¹

The latter question is crucial for immunocompromised individuals (and compliance with the Americans with Disabilities Act of 1990) who frequent health care settings and have expressed fear for their safety.³ The CDC reminded HICPAC that “Morbidity and mortality are affected by factors such as…prevalence of personal risk factors that increase the risk of infection.”

Ventilation: The CDC stated: “Although the document does not address engineering controls such as ventilation controls in detail, their importance is acknowledged, and a separate, subsequent guideline will address the issue. The importance of anticipating transmission through the air and using respiratory protection when caring for those with new and emerging pathogens represents another lesson learned from the COVID-19 pandemic.”¹

When to Use Precautions: Regarding when to use precautions, the CDC was clear that absolute proof need not be sought before implementation of precautions, and being proactive, not reactive, is required.

The CDC stated: “The importance of anticipating transmission through air and using respiratory protection when caring for those with new and emerging pathogens represents another lesson learned from the COVID-19 pandemic.” And that “[n]ew and emerging pathogens in which the major mode of transmission has yet to be determined but do not exhibit the ability to transmit over long distances can be assumed to be transmitted via inhalation until shown otherwise.”¹
 
Concerns were raised that interventions focus on preventing severe disease and may not cover significant disabling sequelae. The CDC stated: “There is also concern that adverse outcomes associated with substantial morbidity, such as long COVID, would not be considered in determining whether to apply routine or special air precautions because they might not be considered as representing severe disease.”¹

Effects on Pandemic Preparedness: As presented in a November 30, 2023, written comment to the National Defense Science Board of the Administration for Strategic Preparedness & Response (ASPR),⁴ there is no doubt that we are not effectively preparing for the next pandemic. The discouragement of the use of N95 masks, along with not requiring proper ventilation, does the exact opposite by collapsing our supply chain and inhibiting the construction of negative-pressure rooms.

The CDC has also not modified their 2023 proposals on Enhanced Barrier Precautions for nursing homes, but needless to say, allowing nursing home residents who are colonized with carbapenem-resistant Enterobacteriaceae, methicillin-resistant Staphylococcus aureus, or Candida auris to participate in normal activities will not be effective source control. A better option would be screening decolonization and, when this fails, cohorting with residents with compatible microbiomes.⁵

Conclusion: The narrative that the use of N-95 masks, negative pressure rooms, and effective source control is too burdensome needs to be weighed against the Federal estimate of the cost of $9.6 million per life lost.⁶ But even more concerning is the newly posted preprint from Beijing China which describes a cell-cultured mutated SARS-CoV-2 related virus which has a 100% fatality rate in human ACE2-transgenic mice.⁷ Disease “X” may have been found, and we must be fully prepared for the next pandemic.

References

1. Jernigan D, Howard J. A CDC Update on the Draft 2024 Guideline to Prevent Transmission of Pathogens in Healthcare Settings. Centers for Disease Control and Prevention. Accessed January 23, 2024. https://blogs.cdc.gov/safehealthcare/draft-2024-guideline-to-prevent-transmission-of-pathogens-in-healthcare-settings/ 
   
2. Kavanagh K, Thomason J, Cormier L. One Step Forward, 2 Back: CDC's Proposals for Infection Control in Health Care Facilities. Infection Control Today. July 24, 2023. Accessed January 23, 2024. https://www.infectioncontroltoday.com/view/one-step-forward-2-back-cdc-s-proposals-infection-control-health-care-facilities
   
3. Banholzer N, Zürcher K, Jent P, et al. SARS-CoV-2 transmission with and without mask wearing or air cleaners in schools in Switzerland: A modeling study of epidemiological, environmental, and molecular data. PLoS Med. 2023 May 18;20(5):e1004226. doi: 10.1371/journal.pmed.1004226. PMID: 37200241; PMCID: PMC10194935. Accessed January 23, 2024. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10194935/
   
4. Kavanagh KT. Public Comment. National Defense Science Board. ASPR. Nov. 30, 2023. Accessed January 23, 2024. https://www.healthwatchusa.org/HWUSA-Initiatives/PDF-Downloads/20231130-ASPR-Masking-Requirements.pdf
   
5. Kavanagh KT. Public Comment on Enhanced Barrier Precautions.CDC HICPAC Meeting June 9, 2023, YouTube Video: https://lnkd.in/gy8FX6Ex Accessed January 23, 2024.
   
6. Guidelines for Regulatory Impact Analysis.DHHS, ASPE. 2016. Accessed January 23, 2024. https://aspe.hhs.gov/sites/default/files/migrated_legacy_files/171981/HHS_RIAGuidance.pdf
   
7. Wei L, Liu S, Lu S, et al. Lethal Infection of Human ACE2-Transgenic Mice Caused by SARS-CoV-2-related Pangolin Coronavirus GX_P2V(short_3UTR), bioRxiv. Jan. 4, 2024. Accessed January 23, 2024. https://www.biorxiv.org/content/10.1101/2024.01.03.574008v1.full#ref-6