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  • Feature Story

Beyond BAC: Breathalyzer Technologies for Detecting Infections

Breathalyzer device manufacturers and developers take aim at coronavirus detection.

Female breathing into a tube

November 3, 2020

Breathalyzer devices and technologies may soon be redeployed for additional public health applications, particularly to detect the presence of coronavirus. Commonly used to measure blood alcohol content (BAC), fast-acting, breath-based tests can yield quantitative results in a matter of seconds to facilitate the selection of candidates for undergoing follow-up in-vitro diagnostic (IVD) testing via blood or serum samples, or other methods such as nasal swabs. Utilizing breathalyzer screening not only helps lower the cost of diagnostic care but also helps make it more accessible for facilities and environments where the spread of contagious infection is high.

Regulatory compliance and standards conformity

In order to be used as diagnostic screening devices, breathalyzers will need to conform to local government regulations pertaining to healthcare equipment. Manufacturers will also need to ensure conformity of their devices to a variety of associated safety, performance, and risk management standards, including (but not limited to):

Innovative manufacturers working on breathalyzer technologies for the detection of coronavirus and other infections should also consider pre-certification engagement risk analysis with a third party, such as UL. Procedures to evaluate electromechanical safety of breathalyzers for BAC applications have already been established and can support similar evaluations for breathalyzers for COVID-19 and other disease detections.

Cybersecurity and other considerations

Manufacturers must also consider potential cybersecurity risks and vulnerabilities associated with breathalyzer technologies. Many breathalyzer designs involve connectivity to a network to compile and analyze statistical results and/or for patient display. Therefore, the small devices may also pose potential personal health information cybersecurity risks that should also be carefully considered before products are submitted for market access. In such instances, conformity to the UL 2900 Series of Standards and the UL Cybersecurity Assurance Program (UL CAP) can help mitigate these risks.

In terms of non-clinical, biomedical considerations, breathalyzer mouthpieces should also undergo evaluation for possible skin irritation through rigorous biocompatibility and materials testing. Safe reuse of these devices may also be facilitated via sterilization and durability evaluation. Finally, breathalyzer packaging and transportation processes should undergo pressure testing to ensure products can be distributed properly to designated users.

Once human factors procedures have been completed to assess intuitive product design and clear instructions for use, UL engineers can then verify applicable usability standard conformity.