Battelle Archives - Medical Design Sourcing

Battelle, Spark Biomedical partner on opioid use disorder detection, treatment

Battelle announced today that it entered into a collaborative agreement with Spark Biomedical to jointly run a pilot clinical study.

Through the joint study, the two companies aim to advance the remote detection and treatment of opioid use disorder (OUD) using wearable biosensors.

According to a news release, the study’s primary objective is to collect physiological data from the biosensors for patients experiencing opioid withdrawal symptoms, cravings and addiction-related physiological stressors using the Battelle NeuroHub system. Once data is acquired, the team will develop an artificial intelligence (AI) algorithm to detect withdrawal using objective physiological biomarkers.

Once the study is completed, Spark and Battelle intend to use the resulting AI algorithm to develop a new, more objective physiological assessment tool for opioid withdrawal measurement, as well as to develop AI and machine learning algorithms for understanding mental heal…

FDA revokes Battelle mask decontamination EUA

The FDA has revoked its authorization for Battelle Memorial Institute to decontaminate used N95 respirators for healthcare workers.

In a letter dated April 30, 2021, the agency said it revoked the EUA at Battelle’s request. The Columbus, Ohio-based research organization asked to withdraw the EUA for its Critical Care Decontamination System (CCDS) in an April 2 letter. Battelle said it is no longer operating or marketing the vaporized hydrogen peroxide systems, according to the revocation letter.

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FDA says to limit mask decontamination to 4 cycles

(Image courtesy of Brian McGowan on Unsplash)

Soon after healthcare workers began warning of personal protective equipment (PPE) shortages, companies and other organizations started claiming their decontamination systems could reprocess used filtering facepiece respirators (FFRs) such as N95s up to 20 times.

The FDA began issuing emergency use authorizations (EUAs) for FFR decontamination systems with a range of allowable cycles and major media organizations and nurses began to question the claims about the number of times an FFR could be safely decontaminated and reused. Companies, universities and other organizations gained EUAs for sterilizing masks up to 10 times (Sterilucent and Steris), and Stryker (up to two times), with a total of 13 organizations now holding 15 such EUAs.

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FDA restricts re-use of certain respirators for COVID-19

Certain respirators made in China and respirators with exhalation valves should not be decontaminated for re-use by healthcare workers, the FDA announced today.

The agency revised these respirators’ emergency use authorizations (EUAs) to reflect the changes. The particular respirators from China “may vary in their design and performance,” the FDA said, basing its decision on test results from the National Institute for Occupational Safety and Health (NIOSH).

The agency also revised the EUAs for certain decontamination systems so they are are no longer authorized to decontaminate non-NIOSH-approved respirators manufactured in China. These systems now may only decontaminate NIOSH-approved, non-cellulose respirators that do not have an exhalation valve as well as certain imported, non-NIOSH-approved respirators with exhalation valves.

Manufacturers with revised EUAs include Stryker, Duke, Advanced Sterilization Products, Sterilucent, Steri…

Battelle under fire for decontamination system performance

Contaminated shipment of personal protective equipment delivered for Battelle CCDS decontamination system (Image from Battelle)

Major media outlets are questioning the ability of the Battelle Critical Care Decontamination System (CCDS) to safely reprocess used N95 respirators up to 20 times, as the company has claimed.

The FDA granted the nonprofit tech development company an emergency use authorization in March for its vaporized hydrogen peroxide system to decontaminate N95 respirators used by healthcare providers during the COVID-19 pandemic.

Nurses and nurses’ organizations have complained that respirators reprocessed by Battelle’s system began to fail after far fewer than the 20 cycles the company claims is safe, according to reports by NBC and the Boston Globe.

In April, National Institutes of Health scientists said N95 respirators can be decontaminated effectively and maintain…