Options abound for hospitals looking to capitalize on these new data transfer technologies, but so do potential pitfalls. For any hospital considering adopting these new solutions, here are some of the key questions and considerations that should be top of mind. The post New Technology is Revolutionizing Clinical Trial Data Management — Here’s How Research Hospitals Can Seize the Moment appeared first on MedCity News .
Rural healthcare has always run on ingenuity, resilience, and community trust. What has too often been missing is the infrastructure strong enough to match that and sustain it at scale. That is what makes this moment different. The post Building the Backbone of Rural Health: Meeting the Reality on the Ground appeared first on MedCity News .
The chair of the NHS’s groundbreaking new online hospital trust has been named as business leader and former supermarket chief executive John Browett. NHS Online, which will provide virtual specialist care for patients through the NHS App and video consultations, has now been formally established as the Online NHS Trust. John is a former chief […]
EMA’s Emergency Task Force (ETF) is engaging with the African Medicines Agency (AMA) and its national regulatory authorities (NRAs), leveraging expertise from the WHO-AFRO…
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units. — AVEVA Drug Delivery Systems, Inc. · Class III · Ongoing · 59,808 pouches (4,272 Individual Folding Carton (IFC))
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station). — GE Medical Systems Information Technologies Inc · Class II · Ongoing
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. — Medline Industries, LP · Class I · Ongoing
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. — Medline Industries, LP · Class I · Ongoing
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to … — Abiomed, Inc. · Class I · Ongoing
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station). — GE Medical Systems Information Technologies Inc · Class II · Ongoing
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. — Medline Industries, LP · Class I · Ongoing
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. — Medline Industries, LP · Class I · Ongoing
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. — Medline Industries, LP · Class I · Ongoing
Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled these syringes because the outer carton and blister pack are labeled as a 1 mL Luer Lock Tuberculin Syringe (Product Code 1180100777), but the syringes inside are U-100 insulin syringes. — Medline Industries, LP · Class II · Ongoing
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. — Medline Industries, LP · Class I · Ongoing
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system. — Bolton Medical Inc. · Class I · Ongoing
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. — Medline Industries, LP · Class I · Ongoing
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. — Medtronic Neuromodulation · Class II · Ongoing
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to lo… — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · Ongoing
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station). — GE Medical Systems Information Technologies Inc · Class II · Ongoing
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to lo… — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Class II · Ongoing