FDA Alert on Ultrasound Transducers
by Barbara Kram, Editor | June 19, 2006
FDA has issued an Alert
regarding the sterilization of
biopsy transducers
like the ones shown here
regarding the sterilization of
biopsy transducers
like the ones shown here
June 19, 2006
Daniel Schultz, MD, director of the Center for Devices and Radiological Health, FDA, has issued the following important announcement:
Dear Colleagues:
This is to alert you to the importance of properly cleaning and sterilizing reusable ultrasound biopsy transducer assemblies (i.e., transducer device and associated accessories), and to provide recommendations for doing so. If these devices are not correctly reprocessed between patients, residual material from a previous patient may contaminate the biopsy needle and needle guide when the system is reused for biopsies. This could lead to patient infections.
On April 3, 2006, the Department of Veterans Affairs (VA), Veterans Health Administration issued a Patient Safety Alert related to a particular company's ultrasound transducer assemblies. During patient safety rounds, the lumen of a needle guide of an ultrasound transducer assembly was found to be soiled. The alert provided recommendations on reprocessing that brand of transrectal ultrasound transducer, which is widely used throughout the VA. FDA is issuing this notification as a supplement to the VA alert because we believe inadequate reprocessing procedures may be a problem for all invasive ultrasound transducer assemblies.
Background
Health care professionals use ultrasound transducer assemblies to view body structures and obtain biopsy samples under ultrasonic guidance. To facilitate biopsy, these devices may have a needle guide attached that directs the insertion of a biopsy needle. The procedure often involves placing the transducer in a body cavity where contact with blood, other body fluids, or feces is likely. During this procedure, the transducer assembly should be covered with a sterile barrier sheath (e.g., a condom). It is important to follow the manufacturer's labeling with regard to the use of sterile covers for each particular device in order to reduce the risk of patient infection.
Insertion of the biopsy needle is often repeated through the guide. Since a biopsy needle contacts the needle guide before it penetrates sterile tissue for biopsy, the needle and needle guide should be reprocessed as critical devices. * The biopsy needle and its containing guide must always be sterilized. This should apply even if a sterile barrier sheath is used on the transducer assemblies during a biopsy procedure, as the sheath is compromised by the penetration of the needle.
[* Critical devices require sterilization between patients unless they cannot withstand the rigors of sterilization. In these cases only, high level disinfection can suffice for the parts that cannot be sterilized. Definitions for critical device, semi-critical device, high-level disinfection, and sterilization available at: ANSI/AAMI ST58:2005, Chemical Sterilization and High-Level Disinfection in Health Care Facilities. http://www.aami.org].
Daniel Schultz, MD, director of the Center for Devices and Radiological Health, FDA, has issued the following important announcement:
Dear Colleagues:
This is to alert you to the importance of properly cleaning and sterilizing reusable ultrasound biopsy transducer assemblies (i.e., transducer device and associated accessories), and to provide recommendations for doing so. If these devices are not correctly reprocessed between patients, residual material from a previous patient may contaminate the biopsy needle and needle guide when the system is reused for biopsies. This could lead to patient infections.
On April 3, 2006, the Department of Veterans Affairs (VA), Veterans Health Administration issued a Patient Safety Alert related to a particular company's ultrasound transducer assemblies. During patient safety rounds, the lumen of a needle guide of an ultrasound transducer assembly was found to be soiled. The alert provided recommendations on reprocessing that brand of transrectal ultrasound transducer, which is widely used throughout the VA. FDA is issuing this notification as a supplement to the VA alert because we believe inadequate reprocessing procedures may be a problem for all invasive ultrasound transducer assemblies.
Background
Health care professionals use ultrasound transducer assemblies to view body structures and obtain biopsy samples under ultrasonic guidance. To facilitate biopsy, these devices may have a needle guide attached that directs the insertion of a biopsy needle. The procedure often involves placing the transducer in a body cavity where contact with blood, other body fluids, or feces is likely. During this procedure, the transducer assembly should be covered with a sterile barrier sheath (e.g., a condom). It is important to follow the manufacturer's labeling with regard to the use of sterile covers for each particular device in order to reduce the risk of patient infection.
Insertion of the biopsy needle is often repeated through the guide. Since a biopsy needle contacts the needle guide before it penetrates sterile tissue for biopsy, the needle and needle guide should be reprocessed as critical devices. * The biopsy needle and its containing guide must always be sterilized. This should apply even if a sterile barrier sheath is used on the transducer assemblies during a biopsy procedure, as the sheath is compromised by the penetration of the needle.
[* Critical devices require sterilization between patients unless they cannot withstand the rigors of sterilization. In these cases only, high level disinfection can suffice for the parts that cannot be sterilized. Definitions for critical device, semi-critical device, high-level disinfection, and sterilization available at: ANSI/AAMI ST58:2005, Chemical Sterilization and High-Level Disinfection in Health Care Facilities. http://www.aami.org].
