COVID-19 to impact general surgery procedures in U.S. in 2020, says GlobalData

Most of the hernia procedures to be performed in the U.S. will be delayed due to the COVID-19 crisis, with the exception of a minority of symptomatic cases, but will start to resume towards the end of the second quarter (Q2) of 2020, according to data and analytics...

3NT Medical Announces FDA Clearance for Colibri Endoscopy System

3NT Medical, a privately held corporation dedicated to developing single-use specialized endoscopes for the diagnosis and treatment of ear, nose and throat (ENT) disorders, has announced the FDA 510(k) clearance for the Colibri Micro ENT Scope, the world's first...

ASCA Supports ASC Response to the COVID-19 Pandemic

By Bill Prentice As I write this message, COVID-19 cases in the U.S. are continuing to rise and health care providers, federal and state officials and private citizens across the country are beginning to come to grips with the magnitude of the response needed to...

Challenging Assumptions, Evaluating Routines Can Aid Quality

By Nicholas Schmitz, PMP, LSSBB Across our personal and professional lives, we all fall into many routines; it’s part of how we’re able to perform so many different tasks every day. Have you ever arrived at work (or home), only to realize you don’t even really...

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.



Submit a Comment

Your email address will not be published. Required fields are marked *