COVID-19: Our response to the N95 shortage

Making Your Own Resusable Elastomeric Respirator

FAQs: Masks and Filters

FAQs: Adapters and Face Shields

WARNING: These components have not been FDA approved for use. You are solely responsible for

obtaining FDA approval or determining whether an Emergency Use Authorization (EUA) for use by a

healthcare provider (HCP) as personal protective equipment exists.

Links to 3D Printed Parts discussed in above video:

25mm Ring Adapter

26mm Ring Adapter

27mm Ring Adapter

T Adapter

Elbow Adapter



For printing, material, and cleaning information for these parts, please refer to the FAQs section.

We have conducted a small pilot study with fit testing, and will utilize this device to protect our front line health care workers should the need arise. However, this device is NOT APPROVED FOR USE at Boston Children’s Hospital at this time.

If you have questions regarding this video, please contact one of our team members via email (see below). Please DO NOT call the hospital as the clinical team here will be unable to answer any questions regarding the methods described in this video.

Heung Bae Kim, Co-Director, Surgical Innovation Fellowship, Heung.kim@childrens.harvard.edu

Farokh Demehri, Co-Director, Surgical Innovation Fellowship, Farokh.demehri@childrens.harvard.edu

Robert Crum, Surgical Innovation Fellow, Robert.crum@childrens.harvard.edu

Brianna Slatnick, Surgical Innovation Fellow, Brianna.slatnick@childrens.harvard.edu

Kyle Wu, Surgical Innovation Fellow, Kyle.wu@childrens.harvard.edu

Lumeng Yu, Research Fellow, Lumeng.yu@childrens.harvard.edu

LEGAL DISCLAIMER: The device created as part of this publication should NOT be used as a replacement for conventional and approved Personal Protective Equipment (“PPE”). The device has not been industry tested nor has it been NIOSH approved. The publication of this article shall not constitute or be deemed to constitute any representation by the authors, their affiliates, and Boston Children’s Hospital and is intended for educational purposes only. The decision to use this devise is solely your own.

We emphasize that this device has not been assessed for its comparative efficacy to prevent nosocomial infection in health care workers compared with the standard-of-care, the N-95 mask. We conducted only a limited proof-of-concept fit testing in a non-clinical environment to assess the device for its effect on work-of-breathing, CO2 retention by transcutaneous measurement, and continuous pulse oximetry. We found no increase in work-of breathing, CO2 retention, or hypoxemia in the test.

THE AUTHORS, THEIR AFFILIATES, AND BOSTON CHILDREN’S HOSPITAL DISCLAIM ANY WARRANTY, EXPRESS OR IMPLIED, INCLUDING THOSE OF QUALITY, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR INFRINGEMENT, AND WILL NOT BE LIABLE FOR ANY LOSSES OR DAMAGES IN CONNECTION WITH THE USE OF THE DEVICE DESCRIBED HEREIN.

USE AT YOUR OWN RISK.

Frequently asked questions (FAQs) What is the purpose of this device and what is it being used for?

This device is to be used in cases when certified respirators are no longer available in an attempt to protect the user from pathogens during the COVID19 pandemic. What are these filters typically used for?

These filters are typically attached either directly to an endotracheal tube or in-line with ventilator circuits to filter bacterial and viral contaminated air from contaminating the ventilator and surrounding environment. Is there directionality to the filters?

The filter used is capable of bi-directional flow. The plastic casing in which the filter is embedded does have a smaller and larger side such that only the smaller will fit into your plastic mask. Is this equivalent to an N95 respirator? Due to time constraints and testing availability we are not able to make any comparisons to the N95 respirator but hope to provide additional information as we further test the device. What straps can be used?

We have demonstrated using elastic straps that were sourced from nebulizer masks; however, any elastic or rubber strap that can create a good seal can be substituted. What is the duration the filter can be used?

At this time, we have not been able to determine the duration of use before replacement is required. What other masks can we use an alternative?

Masks that create a reliable seal to the user's face are required for the device to function. We recommend fit testing prior to use if possible and this is especially true for a different type of mask. Do not use a mask with a one way valve. How to wear eye protection?

This is an evolving issue. For those who wear glasses, many are able to wear them comfortably with the respirator in place. If you are uncomfortable wearing your glasses, try readjusting the mask down lower on your face and then repeating a “user fit test” to ensure an adequate seal. You can also try a smaller face mask size. This mask has not yet been tested with a face shield or goggles. At this time it should be used with existing goggles or face shields that accommodate the mask. What straps can be used?

Please refer to our video entitled “FAQs: Adapters and Face Shields” for methods of using various elastics. What if I don’t have a hook ring?

We have created a 3D printable ring adapter that allows standard anesthesia masks to be used with a variety of elastic straps. Please refer to our video entitled “FAQs: Adapters and Face Shields” for a demonstration on how to use the ring adapter. What size ring adapter should I print?

The outer diameter of the front cylinder on most standard anesthesia mask is typically 25, 26, or 27mm. Please measure the outer diameter of your mask before printing the appropriate size ring adapter. What material should I print the ring adapter with and how can I clean the adapter?

Since this component is not in direct contact with the human body, most rigid non-porous 3D-printed material that can be effectively cleaned and disinfected can be considered for use. It is up to you to select the material that best fits your application; however, some examples of materials include photopolymers, thermally sintered thermoplastics, or vapor-polished (extruded) ABS. Since extruded PLA plastic cannot be effectively vapor-polished, and due to its intrinsic porosity, this material is not recommended for biomedical applications. To clean, remove from mask assembly daily, and clean with warm soapy water. Rinse with cold water and thoroughly air-dry before storing. What material should I print the T adapter or elbow adapter with and how can I clean the adapters?

You should use a material that is approved for human use as air is breathed through this component. Typically, only biocompatible stereolithography materials (which meet out-gassing safety standards) can be used. Examples of some materials include FormLabs Surgical Guide resin or Carbon UMA, RPU, EPU, CE, EPX, and SIL resins. To clean, remove from mask assembly daily and wipe down all external and internal surfaces daily with isopropyl alcohol and thoroughly air-dry before storage.

Team Peter Betit, MBA, RRT-NPS

Director, Respiratory Care/ECMO

Department of Respiratory Care/ECMO

Boston Children’s Hospital, Boston, MA Mark Brown, BSRT, RRT-NPS

ECMO Specialist

Department of Respiratory Care/ECMO

Boston Children’s Hospital, Boston, MA Robert W. Crum, MD

Surgical Innovation Research Fellow

Boston Children’s Hospital

General Surgery Resident

New York Presbytertian Hospital - Columbia, New York, NY Farokh Demehri, MD

Co-Director Surgical Innovation Fellowship

Assistant Professor of Surgery, Harvard Medical School

Attending, Department of Surgery

Boston Children’s Hospital, Boston, MA Steven Fishman, MD

Chief, Department of Surgery

Stuart and Jane Weitzman Family Chair in Surgery

Co-Director, Vascular Anomalies Center

Boston Children’s Hospital, Boston, MA Heung Bae Kim, MD

Co-Director Surgical Innovation Fellowship

Professor of Surgery, Harvard Medical School

Weitzman Family Chair in Surgical Innovation

Vice-Chair of Surgery for Clinical Operations Pediatric Transplant Center

Boston Children’s Hospital Chad Pires, CHMM

Manager Environmental Health and Safety

Boston Children’s Hospital, Boston, MA John R. Priest, BSRT, RRT-NPS

ECMO Specialist

Department of Respiratory Care/ECMO

Boston Children’s Hospital, Boston, MA Brianna L. Slatnick, MD

Surgical Innovation Research Fellow

Boston Children’s Hospital

General Surgery Resident

Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ Steven J. Staffa, MS

Biostatistician III

Department of Anesthesiology, Critical Care and Pain Medicine

Boston Children’s Hospital, Boston, MA Christopher Weldon, MD, PhD

Associate Professor of Surgery, Harvard Medical School

Director, Pediatric Surgery Critical Care Fellowship

Boston Children’s Hospital, Boston, MA Kyle C. Wu, MD

Surgical Innovation Research Fellow

Boston Children’s Hospital

Neurosurgery Resident

Brigham and Women’s and Boston Children’s Hospitals, Boston, MA Alexander Y. Yang, BS

Medical Student

Harvard Medical School, Boston, MA Lumeng J. Yu, MD

Research Fellow, Vascular Biology Program and Department of Surgery

Boston Children’s Hospital

General Surgery Resident

Beth Israel Deaconess Medical Center, Boston, MA

More about the fellowship

Program description

The Surgical Innovation Fellowship (SIF) is a two-year program at Boston Children’s Hospital that exposes surgical residents to all aspects of healthcare innovation. The Department of Surgery in collaboration with the Innovation and Digital Health Accelerator and the Simulator Program (SIMPeds) have developed an innovation journey that is supported by a network of advisors that provide fellows with the knowledge and mentorship they need to take an idea from the drawing board to the bedside. During the two year program, the fellow will experience the entire device and software innovation pathway including hands on experience in market analysis, design, prototype engineering, product management, customer discovery, sales, patent and regulatory filing, etc. In addition to the surgical innovation projects, the fellow will gain experience in clinical and scientific research and will remain clinically active within the Department of Surgery, taking in house call and participating in didactic activities related to Pediatric Surgery and Transplantation.

Mission

To create future surgical innovators within an interdisciplinary environment that combines clinical experiences with a unique hospital based innovation platform.

Vision

To be the premier destination for surgeons who wish to become “bridgetenders” between healthcare challenges and the delivery of innovative solutions back to the bedside.

Curriculum

The curriculum is designed with 3 major pillars

Projects Core Curriculum in Innovation Academic: Clinical research and publications

Projects

The Surgical Innovation Fellow will begin the first year by joining multiple projects already in process and becoming oriented to the language and methodologies utilized through teamwork. They will slowly transition into identifying their own projects and ideas, learning the process of needs analysis, feasibility, risks, and ultimately transitioning to a clear, actionable project of their own. By the end of their first-year, they will have moved towards execution on their primary project. At the end of their fellowship, fellows should have a product ready for commercialization or licensing

Core Curriculum

The curriculum is dynamic with general themes at specific time points matching the evolution of identifying a need, devising a plan, developing solution and bringing the solution to market. Core concepts identified can be reordered depending on need an interest. Ultimately, the fellow will have general exposure to all topics with deep dives in specific areas of interest to the deemed innovation study. There are a specific set of topics that are tied to ongoing projects and or advisors.

Academic

The Surgical Innovation Fellow will be expected to continue with clinical care, clinical research, publication of case reports, review articles, primary research, etc, as well as publications associated with the innovation process. Goals will be set for both academic output as well as areas of interest.

Experiences