According to a Report and Order, the new rules will allow the deployment of unlicensed field disturbance sensors (a kind of radar device) to operate in the 60 GHz band. Field disturbance sensors are increasingly being used in a variety of important applications, including sensors that alert users to children that have been left in dangerously hot motor vehicles, and mobility and health devices that can detect hand gestures and respiratory functions.
The 60 GHz band has traditionally been available for unlicensed operation of indoor/outdoor communication devices based on the WiGig standard, as well as wireless local area networking devices. Prior to the issuance of its Report and Order, the FCC has issued waivers of its rules in selected cases. Allowing the use of the expanded band range is expected to foster the deployment of additional devices that leverage the benefits of field disturbance sensors and speed the introduction of new and advanced radar-based devices to market.
The PPE Regulation, which took effect in April 2018, replaced the EU’s original PPE Directive (89/686/EEC). The Regulation is aligned with the EU’s new Legislative Framework policy and includes slight modifications to the scope and risk categorization of products.
Under the Regulation, personal protective equipment is defined as “equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person’s health and safety hazards.” Specifically excluded from the scope of the Regulation is equipment designed specifically for use by armed forces or law enforcement personnel, equipment to be used for self-defense (except for that intended for sporting activities), and equipment intended for the protection or rescue of individuals on vessels or aircraft.
The extensive list of CEN and Cenelec standards was published in the Official Journal of the European Union and replaces all previously published standards lists for the Regulation.
According to a Citation and Order issued by the U.S. Federal Communications Commission (FCC), officers of the FCC’s Enforcement Bureau launched an investigation in June 2022 into claims by T-Mobile that harmful interference to its cellular services in the York, PA area was emanating from surveillance security cameras installed at a single-family home in York, PA occupied by Luis Martinez.
The Bureau’s investigation confirmed T-Mobile’s findings, and Enforcement Bureau officers instructed Martinez to either remove the cameras or readjust the camera’s settings so that the device operated within the 2.4 GHz band. Although Martinez reportedly disconnected the cameras, he eventually switched them back, reinitiating the interference.
Authorized by the FDA for sale in October 2022, OTC hearing aids are expected to help address a condition experienced by nearly 30 million adults in the U.S. who live with a mild to moderate degree of hearing loss. OTC hearing aids can be purchased in stores and online and no longer require a prescription or a visit to a licensed healthcare professional, provided that the purchaser is 18 years of age or older.
The FDA’s updated information page on OTC hearing aids provides detailed information on labeling requirements for hearing aid packaging, as well as detailed guidance on the factors that consumers should consider when purchasing them. It also provides a list of additional resources about OTC hearing aids available elsewhere on the FDA’s website.
Posted to the FDA’s website, the brief video, titled “Tips for Heath Care Facilities: Cybersecurity Incident Preparedness and Response,” provides an overview of how facilities can create an emergency preparedness plan for cybersecurity incidents. The video also provides suggestions for helping to ensure patient safety during a prolonged cybersecurity event.
The new video is one of a series of three released to date on the issue of cybersecurity risks impacting medical devices. The previously released videos include “Cybersecurity Awareness for Connected Medical Devices” and “Tips for Clinicians: Keeping Your Patients’ Connected Medical Devices Safe.”