AHA expresses concern on FCC's Channel 37 decision
The Federal Communications Commission (FCC) yesterday approved rules to permit unlicensed devices to operate on the same channel as the Wireless Medical Telemetry Service (WMTS) used by hospitals for patient monitoring devices. Also know as TV White Space devices, the unlicensed devices include garage door openers, cordless phones and Bluetooth technologies.
The American Hospital Association (AHA) shared concerns that the new rule could interfere with wireless monitoring, preventing doctors and nurses from receiving vital patient information. There are more than 360,000 WMTS patient monitors in hospitals today.
At the Aug. 6 hearing, the FCC insisted that unlicensed devices would not interfere with a hospital's WMTS, which operates on Channel 37. "Wireless medical telemetry devices and radio astronomy services will continue to have interference protection on Channel 37," FCC Chairman Tom Wheeler said at the hearing.
The AHA, three senators and 16 members of Congress asked the FCC to delay the action by three months, giving medical technology stakeholders and the unlicensed community more time to work out a technical sharing agreement.
Although the request was denied, the FCC did approve a mechanism to increase the buffer zone between a hospital's WMTS and unlicensed devices. However, hospitals that request the buffer will be required to demonstrate that larger protection zones are necessary.
"We remain highly concerned that if the rules adopted today are left unchanged, patient safety could be compromised," says AHA Executive Vice President Rick Pollack. "We will continue to work with Congress, the FCC and device developers to seek a remedy that puts patients first."
Also this week:
FDA recommends additional steps in duodenoscope reprocessing
The Food and Drug Administration (FDA) provided a detailed list of supplemental duodenoscope reprocessing measures that recommends hospitals and health care facilities use in addition to meticulously following manufacturer reprocessing instructions. The FDA says taking one or more of these additional steps could help further reduce the risk of infection and increase the safety of these medical devices.
FDA alerts users to cybersecurity vulnerabilities of infusion system
The Food and Drug Administration (FDA) is alerting users of the Hospira Symbiq Infusion System to cybersecurity vulnerabilities with the infusion pump. Hospira and an independent researcher confirmed that Hospira's Symbiq Infusion System could be accessed remotely through a hospital's network. The FDA strongly encourages health care facilities using the system to transition to alternative products.
OSHA updates guide on training requirements for OSHA Standards
The Occupational Safety and Health Administration's (OSHA) training-related requirements have been excerpted and collected in an updated booklet. The training requirements contained in the booklet are organized into five categories of OSHA standards: general industry, maritime, construction, agriculture, and federal employee programs.
OSHA proposal clarifies recordkeeping rules for work injuries and illnesses
The Occupational Safety and Health Administration issued a notice of proposed rulemaking that clarifies an employer's continuing obligation to make and maintain an accurate record of each recordable injury and illness throughout the five-year period during which the employer is required to keep the records. The rule was published in the July 29 issue of the Federal Register. Members of the public can submit written comments on the proposed rule at http://www.regulations.gov by Sept. 28.
Joint Commission updates Physical Environment Portal
The Joint Commission added a module on standard EC.02.05.01 for utility systems to its Physical Environment Portal. The Physical Environment Portal, which aims to reduce findings of noncompliance within health facilities, is a partner project with the American Society for Healthcare Engineering.
FDA alert on implantable left ventricular assist devices
The Food and Drug Administration (FDA) is alerting health care providers, patients and caregivers about serious adverse events associated with left ventricular assist devices. These adverse events include an increased rate of pump thrombosis (blood clots inside the pump) with Thoratec's HeartMate II and a high rate of stroke with the HeartWare HVAD since approval of the devices. The FDA is also aware of bleeding complications associated with both devices.
CDC awards nearly $110 million to track infectious diseases
The Centers for Disease Control and Prevention increased its funding to track and respond to infectious diseases to $110 million, a $13 million increase from the previous fiscal year.
Also, a new CDC mathematical modeling projects there will be increases in drug-resistant infections and Clostridium difficile if no immediate, nationwide improvements in infection control and antibiotic prescribing are taken. The CDC calls for a communitywide coordinated approach to curb the threat.
