From the April 2021 issue of HealthCare Business News magazine
FDA lifts injunction on Philips defibrillators
Last April the FDA gave Philips the green light for its Emergency Care and Resuscitation business to resume development and distribution of defibrillators in the U.S., following a two-and-a-half-year injunction.
The injunction was issued through a consent decree in November 2017 after the FDA accused the company of violating current good manufacturing requirements mandated by the Federal Food, Drug and Cosmetic Act (FD&C Act) and of being noncompliant with quality system regulations in its manufacturing of AEDs and Q-CPR Meters.
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"The injunction lift is an important milestone for Philips, as we have enhanced the regulatory compliance processes in our ECR business and throughout the company," said Frans van Houten, CEO of Royal Philips, in a statement. "Providing our customers with safe and reliable products and solutions remains our highest priority, and I am proud that our AEDs save lives daily, with their very high reliability record."
The injunction required the Dutch healthcare giant to stop manufacturing defibrillators at two U.S. facilities until the FDA could inspect and certify that the sites complied with Quality System Regulations.
Philips subsequently restructured its quality control function and appointed new leadership, retrained personnel and introduced culture change initiatives to become compliant with the necessary regulations.
Robotic PCI exposes patients to 20% less radiation, says new study
Applying robotic percutaneous coronary intervention exposes patients to 20% less exposure compared to manual PCI, according to a study in May by Corindus, a Siemens Healthineers company. The investigators found that using a robotic PCI solution like Corindus’ CorPath GRX System cuts the amount of exposure for patients without increasing fluoroscopy time or contrast utilization.
“CorPath GRX is designed to remove the physician from the radiation field during the procedure,” Corindus CEO Mark Toland told HCB News. “They control the robot while watching a high-definition monitor from behind a protective shield or inside a control room adjacent to the lab. This reduces physician radiation exposure by over 95%.”
Fluoroscopy systems expose interventional cardiology patients to more radiation than any other medical specialty, putting them at increased risk for cancer, cataracts, and other radiation-related illnesses. The authors note that raising the table, and hence, the patient, away from the radiation source is associated with minimized dose exposure. Robotics can perform this maneuver without limiting the operator’s ability to work, as the devices are being held and driven inside the robot.