FDA, Cardinal Health Assess Scope of Potential Contamination Risk

Dr. Jeffrey E. Shuren MD, JD, Director - CDRH Offices: Office of the Center Director, released the following statement on Thursday (January 16, 2020): “On Jan. 11 and again on Jan. 15, 2020, medical device manufacturer Cardinal Health alerted its customers to...

U.S Health System Uses Medtronic Stealth Autoguide Cranial Robotic Guidance Platform

Phoenix Children’s Hospital is the first-ever health system in the U.S. to receive and deploy the newly FDA-cleared Medtronic Stealth Autoguide platform.

Cook Medical TriForce Peripheral Crossing Set Now Available

Cook Medical’s TriForce® Peripheral Crossing Set is now commercially available. As of January 2020, these products are available to physicians in the United States to support procedures to treat patients with vascular obstructions.

PENTAX Medical Launches IMAGINA Endoscopy System in U.S.

IMAGINA offers practitioners a modern user interface and unique endoscope design to provide excellent visualization, improve the operator experience and positively influence long-term patient care costs.

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



Submit a Comment

Your email address will not be published.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