SafeBVM – Reducing patient harm from manual ventilation.

SafeBVM - reduce harm

MVIP

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phone home Sotair

phone home MVIP

The Problem

The manual resuscitator, also known as the bag valve mask (BVM), is the standard means of providing emergency ventilatory support.
Poor manual ventilation technique is a well-documented problem that occurs irrespective of a provider’s qualifications, training, experience, and confidence.
There are minimal safeguards for manual ventilation with a BVM. This results in high provider variability in breath delivery and can lead to serious complications.⁸

Pressure Delivered During Manual Ventilation

High Provider Variability

Solution

MVIP

98%

Of responders delivered at least one breath that was inadequate or excessive per 90-second period.⁸

MVIP

SafeBVM’s Manual Ventilation Improvement Program (MVIP) focuses on 4 pillars: assessment, education, skills competency, and safety/quality improvement.
This turn-key training program addresses every aspect of manual ventilation and ensures that the provider’s skills are sharp year-round.
MVIP includes the implementation of SafeBVM’s award-winning and recently FDA-cleared medical device, the Adult Sotair Device, in the field to reinforce what providers learned and minimize patient harm.

Sotair

71%

Of the time, air enters the stomach when ventilating the lungs with a manual resuscitator.⁹

Sotair

Air enters the stomach (gastric insufflation) at peak pressures crossing 20-22 cmH₂O.^1,2,3
Sotair limits the flow of air at 55 L/min. For an adult with normal lung compliance and resistance, this corresponds to a maximum pressure of approximately 20 cmH2O.
Adult Sotair™ Device received 510 (k) clearance from the US FDA for minimizing gastric insufflation.
Because Sotair functions based on flow and not pressure, it can safely ventilation patients with a collapsed lung causing lower compliance or obstructed airway with a high resistance.

Improve Your Manual Ventilation Today

Our Supporters

Awarded 2 grants by the NIH, one Phase II SBIR/STTR grant, and one grant in collaboration with UMASS Memorial Medical Center

Awarded Phae I SBIR contract by the AFWERX/AF Ventures initiative of the US Air Force

Awarded Phase I & II SBIR/STTR grants by the National Science Foundation

Sotair (1st & 2nd gen) was selected as a winner in 2019 and 2022 for the EMSWORLD Innovation Awards

Sotair was published as a potential solution to reduce barotrauma, overventilation, and underventilation in periods of extended manual ventilation

Selected in 2020's International Top 20 (out of 1800)

Out of 130 companies, SafeBVM was 1 of 2 companies that were awarded grants

Won Gold Prize in the 2019 European Design Awards

Awarded a small business grant for the development and commercialization of SafeBVM's technology

Selected for the 2021 program focused on companies looking to improve care, reduce costs and create new efficient approaches to problems within the medical industry

Selected into the highly competitive NASDAQ Milestone Makers Program

Won 1st place at the University of Minnesota's 2019 Design of Medical Device Conference

Selected out of 100 companies for 2020 MC Boston Cohort

Testimonials

safeBVM’s device does limit pressure delivered and can be utilized with monitoring devices if needed. This inexpensive accessory to manual ventilation is a must at reducing harmful pressure during emergency care in and out of the hospital. Once approved, this device will be a tool that Respiratory Therapists (RTs) around the world will utilize to provide a safe means for resuscitation. I look forward to a successful collaboration that can assist in making manual ventilation safer in the future

Joe Holley,
MD FACEP FAEMSMedical Director of the State of Tennessee EMS,
Associate Professor in Emergency Medicine at University of Tennessee Health Science Center