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Probo Medical Acquires IMAX Medical

Probo Medical, a leading global provider of medical imaging equipment, parts, repair and service, has announced the acquisition of IMAX Medical (“IMAX”). Terms of the transactions were not disclosed.

MR Conditional Electrode Line Receives FDA Clearance

Rhythmlink International, LLC has announced FDA clearance of a new product line. Sticky Pad Surface Electrodes, a line of peel and stick-on electrodes for Intraoperative Neurophysiological Monitoring (IONM) and Electroencephalography (EEG) are now FDA Cleared MR Conditional for 1.5 and 3 Tesla MRI environments.

SpinTech Acquires MR Innovations

Detroit-based MRI technology company SpinTech, Inc. has acquired medical-imaging research and technology developer Magnetic Resonance Innovations, Inc. (MR Innovations).

KA Imaging to Present Poster at ECR 2021

KA Imaging, a company that develops innovative X-ray imaging solutions, announced that a poster reporting on results from a study examining the feasibility of lateral chest dual-energy subtraction radiography using a stacked single-exposure multi-layer x-ray detector will be presented by Sebastian Maurino, a medical physicist at KA Imaging, at this year’s European Congress of Radiology (ECR).

ECRI Lists Top Health Technology Hazards

Hundreds of medical products have been authorized for temporary use in the past year to meet the unprecedented need for life-saving equipment and supplies during the COVID-19 pandemic. Today, ECRI cautions that meticulous management of these Emergency Use Authorization (EUA) products is crucial to protecting patients, health care workers and hospital operations.

ECRI, an independent nonprofit organization, listed the complexity of managing devices that have been authorized through the EUA process at the top of its 2021 Top 10 Health Technology Hazards report.

“Emergency Use Authorization is a lower standard than is used to assess safety and effectiveness through FDA’s normal clearance process, and it requires more work on the part of the hospital,” says Marcus Schabacker, MD, PhD, president and chief executive officer of ECRI.

Through its EUA process, FDA can green-light previously unapproved products – or new indications for previously cleared products – as acceptable for use during an emergency. Hospitals need to watch for safety and performance issues, monitor the device’s authorization status daily and know what to do with the device when the EUA ends, according to ECRI experts.

“Failing to do so could create safety risks for patients and liability risks for the hospital,” adds Schabacker, because once the EUA designation ends, the legal protections that support the use of EUA devices on new patients vanish.

EUAs can be ended at any time. For example, in August 2020, FDA revoked the EUA for a class of protective barrier enclosures after they were found to increase health care workers’ exposure to airborne particles, rather than limiting exposure.

“We’re concerned that hospitals might not have adequate processes in place to deal with this complex challenge,” says Schabacker. “Our new guidance can act as a roadmap for hospitals and health systems broadly. Additionally, through our alerts tracking reports, we are providing actionable advice. If more support is needed, ECRI is here to help.”

Now in its 14th year, ECRI’s Top 10 Health Technology Hazards identifies health technology concerns that warrant attention by health care leaders. ECRI’s team of biomedical engineers, clinicians and health care management experts follows a rigorous review process to select topics for the annual list, drawing insight from incident investigations, reporting databases and independent medical device testing.

“The coronavirus pandemic accelerated the adoption of some technologies and introduced risks we haven’t addressed before,” says Schabacker. “ECRI remains committed to building awareness about technology hazards to keep patients safe, especially for those technologies that have undergone shortened safety and effectiveness processes.”

ECRI’s full list of health technology hazards for 2021 includes:

  • EUA device management | Complexity of managing medical devices with COVID-19 Emergency Use Authorization
  • Drug name auto-display | Fatal medication errors can result when drug entry fields populate after only a few letters
  • Telehealth adoption | Rapid adoption of telehealth technologies can leave patients and data at risk
  • Imported N95-style masks | May fail to protect health care workers from infectious respiratory diseases
  • Consumer-grade devices | Relying on consumer-grade products can lead to inappropriate health care decisions
  • UV disinfection | Hasty deployment of UV disinfection devices can reduce effectiveness and increase exposure risks
  • Software vulnerabilities | Vulnerabilities in third-party software components present cybersecurity challenges
  • AI in diagnostic imaging | Artificial intelligence applications for diagnostic imaging may misrepresent certain patient populations
  • Remote operation risks | Remote operation of medical devices designed for bedside use introduces insidious risks
  • 3D printing quality | Insufficient quality assurance of 3D-printed, patient-specific medical devices may harm patients

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