Health Care Workers' Comfort Ratings for Elastomeric Half Mask Respirators Versus N95® Filtering Facepiece Respirators During the COVID-19 Pandemic.

BACKGROUND: Reusable elastomeric half-mask respirators (EHMR) are an alternative to address shortages of disposable respirators. While respirator discomfort has been noted as a barrier to adherence to wearing an N95 filtering facepiece respirator (FFR) among health care personnel (HCP), few have examined EHMR comfort while providing patient care, which was the purpose of this study. METHOD: Among a cohort of 183 HCP, we prospectively examined how HCP rated EHMR tolerability using the Respirator Comfort, Wearing Experience, and Function Instrument (R-COMFI) questionnaire at Study Week 2 and Week 10. At the completion of the study (Week-12), HCP compared EHMR comfort with their prior N95 FFR use. Overall R-COMFI scores and three subscales (comfort, wear experience, and function) were examined as well as individual item scores. FINDINGS: The HCP reported an improved overall R-COMFI score (lower score more favorable, 30.0 vs. 28.7/47, respectively) from Week 2 to Week 10. Many individual item scores improved or remained low over this period, except difficulty communicating with patients and coworkers. The overall R-COMFI scores for the EHMR were more favorable than for the N95 FFR (33.7 vs. 37.4, respectively), with a large proportion of workers indicating their perception that EHMR fit better, provided better protection, and they preferred to wear it in pandemic conditions compared with the N95 FFR. CONCLUSION/APPLICATION TO PRACTICE: Findings suggest that the EHMR is a feasible respiratory protection device with respect to tolerance. EHMRs can be considered as a possible alternative to the N95 FFR in the health care setting. Future work is needed in the EHMR design to improve communication.

Practical Considerations for Navigating Withdrawal from the Federal Select Agent Program.

Introduction: Clear guidance is provided by the Federal Select Agent Program (FSAP) to assist registered entities in nearly all facets of compliance with the Federal select agent regulations (7 CFR Part 331; 9 CFR Part 121; 42 CFR Part 73). If a registered entity chooses to discontinue its registration, detailed instructions for registration withdrawal are deeply embedded within a document entitled "eFSAP Form 1 Amendment Instructions," which is found on the FSAP website within the electronic Federal Select Agent Program (eFSAP) Resource Center. Methods: Using the information found within the eFSAP Form 1 Amendment Instructions, as well as extensive written and verbal guidance provided by the lead assigned entity point of contact at the FSAP, we completed the FSAP withdrawal process during a 12-month period between 2022 and 2023. Discussion: This commentary shares our recent professional experiences navigating the FSAP withdrawal process at the University of Texas Health Science Center at Houston (UTHealth Houston). Successes, challenges, and lessons learned are shared so that others planning or considering withdrawing may benefit from our experience. Conclusion: The resources provided for withdrawal within the eFSAP Form 1 Amendment Instructions are relatively basic, and additional details are not currently found in other FSAP guidance documents. Therefore, direct communication and support from the FSAP to the entity Responsible Officials are imperative to ensure a safe, secure, and compliant withdrawal.

Provider experiences with daily use of elastomeric half-mask respirators in health care.

BACKGROUND: During public health emergencies, demand for N95 filtering facepiece respirators (N95 FFRs) can outpace supply. Elastomeric half-mask respirators (EHMRs) are a potential alternative that are reusable and provide the same or higher levels of protection. This study sought to examine the practical aspects of EHMR use among health care personnel (HCP). METHODS: Between September and December 2021, 183 HCPs at 2 tertiary referral centers participated in this 3-month EHMR deployment, wearing the EHMR whenever respiratory protection was required according to hospital protocols (ie, when an N95 FFR would typically be worn) and responding to surveys about their experience. RESULTS: Participants wore EHMRs typically 1 to 3 hours per shift, reported disinfecting the respirator after 85% of the removals, and reported high confidence in using the EHMR following the study. EHMRs caused minimal interference with patient care tasks, though they did inhibit communication. DISCUSSION: HCP who had not previously worn an EHMR were able to wear it as an alternative to an N95 FFR without much-reported interference with their job tasks and with high disinfection compliance. CONCLUSIONS: This study highlights the feasibility of the deployment of EHMRs during a public health emergency when an alternative respirator option is necessary.

A Means of Codifying Safety Cross-Training Knowledge Expectations for Biosafety Professionals.

Introduction: The health and safety issues encountered by biosafety professionals in the daily conduct of their work is rarely limited solely to potentially infectious pathogens. A basic understanding of the other types of hazards inherent to laboratories is necessary. As such, management of the health and safety program at an academic health institution sought to ensure crosscutting competency for its technical staff, including staff members within the biosafety program. Methods: Using a focus group approach, a team of safety professionals from a variety of specialties developed a list of 50 basic health and safety items that any safety specialist should know, inclusive of basic but important information about biosafety that was considered imperative for staff members to understand. This list was used as the basis for a formal cross-training effort. Results: Staff responded positively to the approach and the associated cross-training, and overall compliance with an array of health and safety expectations was experienced across the institution. Subsequently, the list of questions has been shared broadly with other organizations for their own consideration and use. Discussion/Conclusion: The codification of the basic knowledge expectations for technical staff within a health and safety program at an academic health institution, which includes the biosafety program technical staff, was warmly received and helped establish what information was expected to be known and what issues warranted input from other specialty areas. The cross-training expectations served to expand the health and safety services provided despite resource limitations and organizational growth.

Sustainability Considerations for Consumables Used in Microbiological and Biomedical Laboratories.

Introduction: The 6th edition of the Biosafety in Microbiological and Biomedical Laboratories includes Appendix L on sustainability that describes a series of considerations for biocontainment facilities. But many biosafety practitioners may not be familiar with sustainability options that are available, feasible, and safe for laboratory settings as training in this realm is not common. Methods: With a particular focus on consumable products used in containment laboratory operations, a comparative assessment was made regarding sustainability activities employed in the healthcare setting, where significant advances have been achieved. Results: Table 1 has been created that describes various consumables that result in waste as part of normal laboratory operations, and the biosafety and infection prevention considerations have been highlighted along with options regarding waste elimination or minimization that have been successfully employed. Conclusion: Even if a containment laboratory has already been designed, constructed, and is in operation, sustainability opportunities exist for the reduction of environmental impacts without compromising safety.

Assessing the Established Competency Categories of the Biosafety, Infection Prevention, and Public Health Professions: A Guide for Addressing Needed Professional Development Training for the Current and Next Pandemic.

A recent series of widespread infectious disease outbreaks has highlighted commonalities and differences between three key professions that operate on the front lines of response in support of research and/or direct healthcare providers: biosafety, infection prevention, and public health. This assessment, which builds upon previous study by the authors, examines the stated professional competency categories for these three areas, highlighting similarities and differences. This assessment is important as these professions are being drawn together in an operational environment driven by the current pandemic and inevitably future disease outbreaks. Cross-training opportunities for the various professions are proposed.

Pivoting the Biosafety Program in Response to COVID-19: Recommendations of Key Services and Tasks to Consider for the Next Pandemic.

Introduction: With the onset of the COVID-19 pandemic, a rapid adjustment of work tasks was necessary for many biosafety programs (and other safety programs) to address drastic shifts in workload demands amid pandemic-related shutdowns and subsequent needs for supporting COVID-19-related safe work protocols, diagnostic testing, research, vaccine development, and so forth. From a program management standpoint, evaluating and understanding these tasks were critically important to ensure that appropriate support and resources were in place, especially during such unprecedented times of rapid change and significant impact to normal life and routine. Methods: Described here are examples of how the biosafety program at The University of Texas Health Science Center at Houston (UTHealth Houston) addressed these challenges. Results: As part of this required pivot, key services and tasks emerged into three distinct categories: (1) those that were temporarily diminished, (2) those that had to continue despite COVID-19 and the associated shutdowns for safety or compliance purposes, and (3) those that dramatically increased in volume, frequency, and novelty. Conclusion: Although the adjustments described were made in situ as the pandemic evolved, the cataloging of these tasks throughout the experience can serve as a template for biosafety programs to plan and prepare for the next pandemic, which will inevitably occur.

N95 respirator reuse, decontamination methods, and microbial burden: A randomized controlled trial.

PURPOSE: To evaluate the effectiveness and ease of N95 respirator decontamination methods in a clinic setting and to identify the extent of microbial colonization on respirators associated with reuse. METHODS: In a prospective fashion, N95 respirators (n = 15) were randomized to a decontamination process (time, dry heat, or ultraviolet C light [UVC]) in outpatient clinics. Each respirator was re-used up to 5 separate clinic sessions. Swabs on each respirator for SARS-CoV-2, bacteria, and fungi were obtained before clinic, after clinic and post-treatment. Mask integrity was checked after each treatment (n = 68). Statistical analyses were performed to determine factors for positive samples. RESULTS: All three decontamination processes reduced bacteria counts similarly. On multivariate mixed model analysis, there were an additional 8.1 colonies of bacteria (95% CI 5.7 to 10.5; p < 0.01) on the inside compared to the outside surface of the respirators. Treatment resulted in a decrease of bacterial load by 8.6 colonies (95% CI -11.6 to -5.5; p < 0.01). Although no decontamination treatment affected the respirator filtration efficiency, heat treatments were associated with the breakdown of thermoplastic elastomer straps. Contamination with fungal and SARS-CoV-2 viral particles were minimal to non-existent. CONCLUSIONS: Time, heat and UVC all reduced bacterial load on reused N95 respirators. Fungal contamination was minimal. Heat could permanently damage some elastic straps making the respirators nonfunctional. Given its effectiveness against microbes, lack of damage to re-treated respirators and logistical ease, UVC represents an optimal decontamination method for individual N95 respirators when reuse is necessary.

A Cyclotron Decommissioning Radiological Assessment Exercise Performed by Student Mentees Underrepresented in the Radiation Safety Profession.

Cyclotrons used in nuclear medicine imaging accelerate protons, deuterons, and helium ions to bombard a target, which produces nuclear reactions that generate positron-emitting radionuclides. Secondary neutrons are nonuniformly emitted in these reactions and induce heterogeneous activation of the cyclotron components and concrete vault enclosure. This poses radioactive waste management complications when decommissioning a cyclotron facility, since the objective is to ensure that exposures are within regulatory limits and as low as reasonably achievable (ALARA). The McGovern Medical School in The University of Texas Health Science Center in Houston housed a Scanditronix MC40 cyclotron that produced short-lived radioisotopes for Positron Emission Tomography (PET) imaging from 1984 to 2001 until Tropical Storm Allison rendered it inoperable. The purpose of this study was to provide underrepresented Science, Technology, Engineering and Mathematics (STEM) students an ALARA experience with a practical problem encountered in the radiation safety profession. Gamma dose rate measurements were performed with both a Mirion InSpector 1000 spectrometer and Fluke 451P survey meter in the vault at locations identified as hotspots based on preliminary scoping surveys with the Ludlum model 44-9 detector. However, gamma spectra were measured with the spectrometer exclusively at hotspots along the west wall. Results indicated the maximum gamma dose rate of 129 ± 31 nSv h was about 2 times background near the central beam transport line of the now inoperable cyclotron. Furthermore, gamma emission peaks were identified in the spectra from trace amounts of Co and Eu in the vault's concrete walls.

Characterization of Work Settings in Which Biosafety Professionals Conduct Operations: Results from the First Survey of the Biosafety Analytics Initiative Survey Series.

Introduction: With the endorsement and support of the ABSA International Council and the Prevention, Preparedness and Response (P2R) Academy of The University of Texas Health Science Center at Houston (UTHealth) School of Public Health, a survey to characterize the work settings in which biosafety professionals operate was conducted. The survey was the first of a planned series of 10 solicitations in support of an overarching "Biosafety Analytics Initiative," the goal of which is to identify commonalities, trends, possible benchmarking opportunities, and professional training needs. Methods: The survey was developed, tested, and then distributed electronically for a 3-week period between May 29 and June 19, 2019. Results: A total of 228 ABSA International members completed responses (15.6% of total membership). The results of the survey indicate that 59.7% of the total membership respondents conduct operations in the public or private academic setting, but when separated by domestic vs international respondents, 38% of the international respondents operate in government (nonacademic) settings. The bulk of biosafety activities were reported as providing support to BSL-1 and BSL-2 laboratories, with more than 90% of respondents indicating that they support work with risk group 1 and 2 organisms. Approximately 60% of the biosafety programs responding reported being organizationally aligned within institutional Environmental Health & Safety programs. Conclusion: The results of this survey serve as a foundation for current and future ABSA International priorities regarding professional development, recruitment, and training opportunities.

U.S. Medical Examiner/Coroner capability to handle highly infectious decedents.

In the United States of America, Medical Examiners and Coroners (ME/Cs) investigate approximately 20% of all deaths. Unexpected deaths, such as those occurring due to a deceased person under investigation for a highly infectious disease, are likely to fall under ME/C jurisdiction, thereby placing the ME/C and other morgue personnel at increased risk of contracting an occupationally acquired infection. This survey of U.S. ME/Cs' capabilities to address highly infectious decedents aimed to determine opportunities for improvement at ME/C facilities serving a state or metropolitan area. Data for this study was gathered via an electronic survey. Of the 177 electronic surveys that were distributed, the overall response rate was N = 108 (61%), with 99 of those 108 respondents completing all the questions within the survey. At least one ME/C responded from 47 of 50 states, and the District of Columbia. Select results were: less than half of respondents (44%) stated that their office had been involved in handling a suspected or confirmed highly infectious remains case and responses indicated medical examiners. Additionally, ME/C altered their personal protective equipment based on suspected versus confirmed highly infectious remains rather than taking an all-hazards approach. Standard operating procedures or guidelines should be updated to take an all-hazards approach, best-practices on handling highly infectious remains could be integrated into a standardized education, and evidence-based information on appropriate personal protective equipment selection could be incorporated into a widely disseminated learning module for addressing suspected or confirmed highly infectious remains, as those areas were revealed to be currently lacking.

Assessing the Biological Safety Profession's Evaluation and Control of Risks Associated with the Field Collection of Potentially Infectious Specimens.

Because the origins of the biological safety profession are rooted in the control and prevention of laboratory-associated infections, the vocation focuses primarily on the safe handling of specimens within the laboratory. But in many cases, the specimens and samples handled in the lab are originally collected in the field where a broader set of possible exposure considerations may be present, each with varying degrees of controllability. The failure to adequately control the risks associated with collecting biological specimens in the field may result in illness or injury, and could have a direct impact on laboratory safety, if infectious specimens were packaged or transported inappropriately, for example. This study developed a web-based survey distributed to practicing biological safety professionals to determine the prevalence of and extent to which biological safety programs consider and evaluate field collection activities. In cases where such issues were considered, the data collected characterize the types of controls and methods of oversight at the institutional level that are employed. Sixty-one percent (61%) of the survey respondents indicated that research involving the field collection of biological specimens is conducted at their institutions. A majority (79%) of these field collection activities occur at academic institutions. Twenty-seven percent (27%) of respondents indicated that their safety committees do not consider issues related to biological specimens collected in the field, and only 25% with an oversight committee charged to review field collection protocols have generated a field research-specific risk assessment form to facilitate the assembly of pertinent information for a project risk assessment review. The results also indicated that most biosafety professionals (73% overall; 71% from institutions conducting field collection activities) have not been formally trained on the topic, but many (64% overall; 87% from institutions conducting field collection activities) indicated that training on field research safety issues would be helpful, and even more (71% overall; 93% from institutions conducting field collection activities) would consider participation in such a training course. Results obtained from this study can be used to develop a field research safety toolkit and associated training curricula specifically targeted to biological safety professionals.