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Staying Positive During the Pandemic

The good news for patients in need of outpatient surgery is that, across the country, health care providers and policymakers have recognized that elective surgery is not the same thing as optional surgery and are allowing ASCs to remain open to provide this care.

Handling of Explanted Medical Devices Addressed in AORN’s Revised Guideline for Specimen Management

SP professionals must manage explants safely and properly any time a request is made to sterilize an explanted device, such a screw, hip, plate and so on, for return to the patient.

Disinfection Methods – Straightforward or Complicated?

With all the different cleaning, disinfecting and sterilizing processes that go on inside of hospitals, I find disinfection to be the most complex and complicated among them.

Steam Sterilization Standard ST79 Receives Community-Driven Update

After three years, a widely used standard in health care and industry has undergone an important update.

FDA Appears Focused on Ethylene Oxide

Before they can be marketed as “sterile,” many medical devices are sterilized by the device manufacturer or contract sterilizer using ethylene oxide before they are delivered to healthcare facilities.

A new FDA Voices entry titled “Preventing Medical Device Shortages by Ensuring Safe and Effective Sterilization in Manufacturing” is now available.

The entry is co-written by Suzanne B. Schwartz, M.D., M.B.A., Deputy Director of the Office of Strategic Partnerships and Technology Innovation and Acting Office Director, Center for Devices and Radiological Health (CDRH), and CAPT Elizabeth F. Claverie-Williams, M.S., Microbiologist and Branch Chief, Infection Control Devices Branch, CDRH.

The FDA is particularly aware of issues relating to sterilization during manufacturing – and the potential device shortages that can occur if there are problems during this process. So, the FDA is working to help ensure this process is carried out in a safe and effective manner.

One topic of interest discussed in the piece is ethylene oxide. This is a hot topic of discussion in health care circles. On Monday, the U.S. Food and Drug Administration (FDA) announced two Innovation Challenges to encourage the development of new approaches to device sterilization. The challenge submission period ends October 15. Find out more about the challenges here.

As the FDA Voices entry states “The issue of ethylene oxide emissions and potential medical device shortages is a serious one. As the FDA works with industry and stakeholders, the hope is that challenging them to present effective, efficient, and innovative solutions will help the agency prevent medical device shortages due to sterilization issues in the future.”

The FDA Voices entry is available online at fda.gov.

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