Surgical Protective Barrier Enclosures With Integrated Gloves
Receives FDA Emergency Use Authorization
LAKE CHARLES, LA (May 14, 2021) – six months ago, when Jeremy Gormly, CRNA, walked out of the OR he told Mark Moore, “That’s the first time since coronavirus I’ve walked out of a surgery and didn’t feel dirty.” Moore nodded enthusiastically. Gormley had just used Moore’s newly designed ISCOUBE™, an added layer of protection to PPE’s, for a surgical procedure.
Moore, a 36-year CRNA, designed the negative pressure barrier device out of necessity to protect everyone in the OR including himself from airborne pathogens. This month, Moore’s firm, Prep Tech, is the first company in the U.S. to receive an Emergency Use Authorization (EUA) from the FDA for two unique protective barrier enclosures.
Working in tandem with the U.S. Army since mid-2020 through both a Licensing and Cooperative Research and Development Agreement (CRADA), Prep Tech has taken a leap forward in their mission for protecting the surgical front line. Similar in scope to ISOCUBE™, the Army’s version referred to as CAMIC (COVID-19 Airway Management Isolation Chamber), was developed for the same reasons. By sharing technology through the agreements, the Army tested and affirmed Prep Tech’s designs as being easy to use and viable for healthcare workers concerned with airborne contamination exposure.
According to Dr. Erich Wolf, MD, PhD, Neurosurgeon, Co-founder and Chief Medical Officer of Prep Tech. “The CAMIC license and CRADA between the Army and our firm allowed Prep Tech and Army inventors to co-develop the best possible devices to help protect health care workers and patients.”
ISOCUBE™ SS is a multi-use stainless-steel base and rail system. ISOCUBE™ ONE is a single-use base and rail system. Both devices have a single-use, clear, negative pressure plastic sheet chamber and attach to a standard hospital or surgical bed, or stretchers, and extend around the patient’s head, neck, and shoulders. Access holes with four (4) integrated gloves, are built into the isolette chamber to allow for isolated patient access. The negative pressure environment is generated via wall-mounted hospital vacuum lines or 1-2 negative pressure pumps equipped with in-line HEPA filter(s).
Unlike the very few other commercially available barrier enclosures, both patent pending ISOCUBE™ models include integrated gloves, a removable drape, and an integrated tubing portal for use with standard surgical airway hoses. Each ISOCUBE™ unit takes up a very small footprint in hospital surgical suite storage and is economical enough to be purchased in multiples to be on-hand when a Covid or suspected Covid patient comes into the hospital.
“We envision ISOCUBE™ becoming a standard in hospitals globally as the world continues to face the spread of infectious diseases,” said Dr. Erich Wolf. “Prep tech has created two tools, available now, that surpass anything similar on the market”.
Visit www.preptechmed.com/isocube to learn more, order, and protect healthcare workers from continued pathogen exposure.
ABOUT PREP TECH
Prep Tech, LLC and its subsidiary Prep Tech Supplies, LLC are Louisiana-based medical device companies founded by Certified Registered Nurse Anesthetist Mark Moore, CEO, and Co-Founder/Medical Officer Dr. Erich Wolf, MD, PHD, a biomedical engineer and neurosurgeon. Prep Tech’s mission is to develop innovative procedures and tools to improve the way healthcare professionals work inside and outside operating rooms including their patented skin prep device, ULTRAPREP™, that increases OR efficiencies by 15-30% in certain extremity surgeries. Their headquarters is located in Lake Charles, Louisiana with operations in Lafayette, Louisiana and distributors nationwide. For more information visit preptechmed.com or contact Pete Prados, COO via firstname.lastname@example.org.
ABOUT ISOCUBE™ FDA EUA
Healthcare facilities using ISOCUBE™ must make available the accompanying Patient Fact Sheet and Healthcare Provider Fact Sheet to patients and Healthcare Professionals, provided at pretechmed.com and on the FDA website. ISOCUBE™ has neither been cleared or approved by FDA, but has been authorized for emergency use by FDA under an EUA for use by HCP as an extra layer of barrier protection in addition to PPE to prevent HCP exposure to pathogenic biological airborne particulates by providing temporary isolation of hospitalized patients with suspected or confirmed diagnosis of COVID-19, at the time of definitive airway management, or when performing any airway-related medical procedures, or during certain transport of such patients during the COVID-19 pandemic. The emergency use of the ISOCUBE™ has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.