FDA modifies imaging guidance for duration of COVID-19 crisis
The Food and Drug Administration has issued temporary guidance to expand the availability of medical imaging systems and related hardware/software until the current public health crisis abates.
The guidance, which permits temporary modification of standard protocols, is additionally aimed at mitigating circumstances that could lead to avoidable COVID-19 exposure for patients, providers and others working with or around imaging equipment and related systems.
The 19-page guidance document describes circumstances in which FDA currently believes a deviation from standard protocol would and would not create undue risk.
Examples of circumstances in which FDA currently believes a modification would not create undue risk include:
- Expansion of indications for use beyond the cleared/approved indications (e.g., extremity-only use expanded to other body parts) to acquire images in situations where no alternatives exist at a facility; and
- Design modifications to improve the ability to clean, disinfect and/or sterilize the product.
Examples of circumstances in which FDA currently believes a modification would create undue risk include:
- Modifications that reduce the ability to clean, disinfect, and/or sterilize portions of the device that come into direct contact with the patient; and
- Modifications that introduce new types of reconstruction algorithms.
Click here for FDA’s brief overview of the guidance document and here for a PDF of the full document.
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.