FDA clarifies ‘remanufacturing’ in final guidance

FDA clarifies ‘remanufacturing’ in final guidance

The Food and Drug Administration released final guidance clarifying the definition of “remanufacturing” for reusable medical devices needing maintenance or repair, advising that manufacturers include instructions necessary for proper servicing and provide examples of activities that constitute remanufacturing. The guidance is in response to public comments, including from the American Hospital Association and American Society for Health Care Engineering, highlighting the need for clarity, considering the different regulatory implications between “servicing” and “remanufacturing” of a medical device.

ASHRAE publishes errata for Standard 170

An errata sheet for American National Standards Institute/ASHRAE/American Society for Health Care Engineering Standard 170-2021, Ventilation of Health Care Facilities, includes additions, changes and deletions. Design parameter terms and requirements of ventilation systems in inpatient spaces, such as radiology rooms and behavioral and mental health facilities, have been updated in Table 7-1, Design Parameters — Inpatient Spaces. Updates have also been made for references in Table 8-1, Design Parameters — Specialized Outpatient Spaces, such as removing a reference to a different guideline. Additionally, the errata sheet includes revisions for temperature ranges in Table 9-1, Design Parameters for Residential, Health, Care, and Support-Specific Spaces.

Cohort warns against operational technology cyber risks

A cohort, including the Cybersecurity and Infrastructure Security Agency, Federal Bureau of Investigation and the National Security Agency, provided information to help organizations protect operational technology (OT) from cyberattacks. The group encourages organizations to take immediate action, including changing all default passwords of OT devices and using strong, unique passwords; limiting exposure of OT systems to the internet; and implementing multifactor authentication for all access to the OT network. The group warns of pro-Russia hacktivists targeting and compromising small-scale OT systems in North America and Europe. 

The Joint Commission launches new accreditation

The Joint Commission is launching its Telehealth Accreditation Program for eligible hospitals, ambulatory and behavioral health care organizations, effective July 1. The accreditation program provides updated, streamlined standards to provide organizations offering telehealth services with the structures and processes necessary to help deliver safe, high-quality care using a telehealth platform. The Telehealth Accreditation Program’s requirements contain many of the standards similar to other Joint Commission accreditation programs, such as requirements for information management, leadership and medication management. Requirements specific to the new accreditation program include streamlined emergency management requirements; new standards for telehealth provider education and patient education; and a new chapter focused on telehealth equipment, devices and connectivity.