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Activ Surgical Announces FDA Clearance for ActivSight Intraoperative Imaging Module

Activ Surgical announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s ActivSight Intraoperative Imaging Module for enhanced surgical visualization.

Metrex Surface Disinfectant Portfolio Secures EPA Approval

The U.S. Environmental Protection Agency (EPA) has approved all eight surface disinfectant products made by an infection prevention leader, Metrex, as effective against SARS-CoV-2, the novel coronavirus that causes COVID-19.

Olympus Supports Safety Actions Regarding Surgical Smoke

Olympus has announced its support of The Joint Commission’s recommended safety actions for managing the hazards of exposure to surgical smoke for health care staff in operating rooms.

Exofin Fusion Redesign Receives FDA Approval

Chemence Medical, a leader in medical cyanoacrylate devices and products, announced the U.S. Federal Drug Administration’s (FDA) 510(k) approval of the company’s redesigned exofin fusion skin closure system.

AORN Joins AHA, AdvaMed in Issuing ‘Re-entry Guidance’ for Medical Device Reps

The Association of periOperative Registered Nurses (AORN), the American Hospital Association (AHA), and AdvaMed today released “Re-entry Guidance for Health Care Facilities and Medical Device Representatives.” As health care professionals and organizations consider when and how to safely resume elective surgeries paused during the COVID-19 pandemic, this guidance adds principles and considerations to support the vital collaboration between health care personnel and medical device representatives.

The guidance for re-entry builds on the April 17 joint statement by AHA, AORN, the American College of Surgeons, and the American Society of Anesthesiologists – entitled “Roadmap for Resuming Elective Surgery” – with expanded, clinically based recommendations supporting the safe return of medical device representatives into health care facilities, consistent with the AdvaMed Code of Ethics.

The guidance seeks to align access standards and processes across health care facilities, with principles and considerations rooted in health authority guidance, including from the CDC, FDA, and state and local authorities.

AORN’s CEO/Executive Director, Linda Groah, MSN, RN, CNOR, NEA-BC, FAAN said, “Nurses and medical device representatives are partners in providing safe patient care and, due to COVID-19, their communications have been interrupted. We believe this guidance will reactivate these important relationships in a manner that is safe for the patients as well as the healthcare workers and device representatives.”

“Many patients have waited and postponed elective and non-emergent care, understanding what our priorities had to be, but hospitals and health systems realize non-COVID health issues also need to be addressed in a timely fashion. It is important to recognize that so-called elective care or scheduled care often involves providing treatments and procedures that are critical to caring for those with chronic illnesses such as cancer and heart disease, and delays in care can result in worsening conditions for these vulnerable patients,” said Michelle Hood, executive vice president and chief operating officer of AHA.

“Too many patients are going without the care that is absolutely vital to their health. Lives are being lost or irreparably ruined as countless Americans forego the care they can no longer afford to put on pause. It’s time for essential scheduled procedures and surgeries to resume, and this guidance we’re releasing shows how that can be done safely and responsibly,” said president and CEO of AdvaMed Scott Whitaker.

The recommended framework calls for hospitals to be the primary provider of personal protective equipment (PPE) to control for potential contamination, so that PPE is prioritized to providers where it is most needed. The guidance accounts for crisis capacity situations by allowing for company reps to be the back-up providers of their own PPE for emergency procedures. The guidance also recommends against COVID-19 diagnostic testing of asymptomatic reps, so that diagnostic testing resources can be prioritized for patients, symptomatic health care workers, and those with known or suspected exposures, consistent with CDC and other clinical guidelines.

For more information on the AdvaMed Code of Ethics, including Section XIII, which defines and clarifies the appropriate role of medical technology company reps in the clinical setting, please click here.

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