5/12/15

Medical Devices and the Risk of Infection During Procedures

By on 9:49 AM

The recent attention regarding contamination of duodenoscopes with a deadly superbug known as Carbapenem-resistant Enterobacteriaceae (CRE) has the infection control industry wondering whether stellar practices that we promote, teach and oversee are enough to prevent this ongoing threat to patients undergoing procedures such as endoscopic retrograde cholangiopancreatography (ERCP) with medical devices that are risky due to their complex design.

One has to wonder whether it would be in the best interests of all involved parties to require redesign of these devices in order to lessen the risk of transmission of infection.

The U.S. Food and Drug Administration (FDA) has been working with the manufacturers of several devices, including duodenoscopes, to improve their cleaning procedures. However, the issue with duodenoscopes is that despite following strict manufacturer’s instructions, which several facilities have done, these devices are very difficult to clean due to their intricate design and that is a huge area of concern.

FDA is convening an advisory panel next week to discuss recent CRE outbreaks, and the hope is that they will be able to recommend further steps for all involved with ERCP to protect patients from undesirable consequences.

While infection prevention practices have made great progress in recent years, we still have a long way to go in the interest of patient safety. This is a multi-disciplinary need, and one that must involve regulatory agencies as well as manufacturers and healthcare personnel.

Phenelle Segal, RN, CIC, FAPIC

Phenelle Segal, RN, CIC, FAPIC, is the founder and president of Infection Control Consulting Services LLC (ICCS). Phenelle has more than 30 years' experience providing customized comprehensive infection control and prevention services to healthcare facilities nationwide. Her services focus on assisting hospitals, ambulatory surgery centers, dental office and oral surgery practices, doctor's offices, nursing homes and other organizations with implementing and maintaining an infection control program that: complies with The Joint Commission, AAAHC, Centers for Medicaid and Medicare Services (CMS) and other regulatory agencies; respond to situations of noncompliance; and improve the processes for reducing risk.