A Crisis-Responsive Framework for Medical Device Development during the COVID-19 Pandemic. Preprints.org. 09.24.2020. We present a crisis-responsive design framework designed to assist with product development under pandemic conditions. The framework utilizes extensive stakeholder engagement, comprehensive and dynamic needs assessment, local manufacturing, and product testing for the accelerated development of healthcare products. We contrast this framework with traditional medical device manufacturing and discuss relevant regulatory policies. Finally, we make recommendations aimed at improving future resilience to healthcare emergencies.
Considerations for the Selection and Use of Disinfectants Against SARS-CoV-2 in a Healthcare Setting. Open Forum Infectious Diseases. 08.31.2020. We outlined a process of fully characterizing over 350 products on the EPA List N, including pH, method of delivery, indication for equipment sterilization, and purchase availability. We then developed a streamlined set of guidelines to help rapidly evaluate and select suitable disinfectants from List N, including practicality, efficacy, safety, and cost/availability. This resource guides the evaluation of ideal disinfectants amidst practical considerations posed by the COVID-19 pandemic.
Assessing the quality of nontraditional N95 filtering face-piece respirators available during the COVID-19 pandemic. medRxiv. 07.27.2020. We conducted a survey of mask in the inventory of major academic medical centers in Boston, MA to determine provenance and manufacturer. We then tested filtration performance of masks from this inventory (more information at cleanmask.org). Many of the masks did not provide levels of filtration acceptable for use in healthcare settings. Based on these results, and in consultation with occupational health officers, we make six recommendations for end users to assist in acquiring legitimate products.
3D Printed frames to enable reuse and improve the fit of N95 and KN95 respirators. medRxiv. 07.26.2020 We developed a 3D-printed frame for N95 and KN95 masks, using readily available materials and 3D printing, which can replace defective or broken bands and improve mask fit.
Regulatory and safety considerations in deploying a locally fabricated, reusable, face shield in a hospital responding to the COVID-19 pandemic. Med. 06.21.2020 We describe our face shield design and testing process and provide an overview of regulatory considerations associated with its fabrication and testing. All designs, materials used, testing protocols, and survey results are reported in full to facilitate the execution of similar face shield efforts in other clinical settings.
Personal Protective Equipment for COVID-19: Distributed Fabrication and Additive Manufacturing. American Journal of Public Health. 06.18.2020. A discussion of community level response to PPE shortages during the COVID-19 pandemic, and the role of regulatory sciences in preparing for future crisis.
A pilot study of the impact of facial skin protectants on qualitative fit testing of N95 masks. Journal of the American Academy of Dermatology. 06.17.2020. Facial skin protectants can interfere with N95 fit. Healthcare workers electing to use skin protectants should confirm appropriate fit prior to use in clinical settings.
Assessment of the Qualitative Fit Test and Quantitative Single-Pass Filtration Efficiency of Disposable N95 Masks Following Gamma Irradiation. JAMA Network Open. 05.26.2020 A sterilizing dose of gamma radiation severely reduces the filtration efficiency of disposable N95 masks. Furthermore, a qualitative fit test did not reflect this degradation, indicating that fit tests alone should not be used to assess mask integrity.
Analysis of SteraMist ionized hydrogen peroxide technology in the sterilization of N95 respirators and other PPE. medRxiv. 05.08.2020 We describe the succesful sterilization of N95 Filtering face piece respirators (N95 masks) using ionized hydrogen peroxide delivered by SteraMist technology in an environmental chamber (a small room). Masks sterilized in this way retain function and fit to NIOSH standards as evaluated by a commercial pre-certification laboratory. Other PPE including PAPR hoods was also successfully sterilized.
Covid-19 — The Law and Limits of Quarantine. The New England Journal of Medicine. 03.18.2020 Quarantines and travel bans are a common response to new infectious diseases but are of limited utility for highly transmissible diseases, and can be counterproductive. With a virus such as SARS-CoV-2, they cannot provide a sufficient response; newer, more creative legal tools that emphasize support rather than restriction are required.
PanFab is committed to making its designs and findings publicly available to ensure that medical professionals, hospitals, and other individuals can benefit from the work. The most important forum for engineers, scientists and clinicians to describe their activities to the international community is via peer-reviewed publication. When you publish, you attempt to be as objective as possible, you subject your ideas to public scrutiny and you declare any conflicts of interest. Research papers are durable products that are also the basis of changes in Federal policy. It is the intention of the PanFab group to document as many of its findings as possible in a peer-reviewed format.