The U.S. FDA's emergency authorization of medical devices—meant for temporary use when the COVID-19 pandemic began 18 months ago—is still in effect. That’s a major issue for healthcare safety insider, Marcus Schabacker, MD, PhD, president and CEO of ECRI, who sees the potential dangers posed to patient safety.
Flawed. That’s how Marcus Schabacker, CEO of ECRI, describes the device approval process for granting emergency use authorizations during the COVID-19 pandemic. And now, he says it’s time the U.S. FDA and the industry re-examine the quick process that could compromise patient safety.
Lake Forest, Ill.-based RoundTable Healthcare Partners announces that it has established Healthcare Components Group through the acquisitions of independent service organizations American Optics and Replacement Parts Industries, or RPI.
The EndoSound Vision System is an add-on device that consists of a compact ultrasound beam-former, reusable transducer, and disposable mounting kit that fastens onto any flexible upper gastrointestinal video endoscope to convert it into an endoscopic ultrasound system.
A number of cyberattacks have garnered headlines lately—namely the Colonial Pipeline ransomware attack in May and the December 2020 SolarWinds data breach—but experts say that policymakers are overlooking a very vulnerable industry: healthcare.