News
ICViewExpert PerspectivesMedical World NewsVideosWebinars
Conference
Infection Control TodaySupplements And Featured Publications
CME/CEJob BoardPartnersSponsoredWhitepapers
Print SubscriptioneNewsletter
Educator of the Year Nomination FormEducator of the Year Official RulesEducator of the Year
Advanced Technology
Bug of the Month
COVID-19
Environmental Services
HAIs
Hand Hygiene
Long-Term Care
Operating Room
Personal Protective EquipmentPersonal Protective Equipment
Prevention
Sterile Processing
Surface Disinfection
Vascular Access
Spotlight -
  • Expert Perspectives on Personal Protection Guidelines and Standardization Practices
  • Bug of the Month
Advanced Technology
Bug of the Month
COVID-19
Environmental Services
HAIs
Hand Hygiene
Long-Term Care
Operating Room
Personal Protective EquipmentPersonal Protective Equipment
Prevention
Sterile Processing
Surface Disinfection
Vascular Access
    • News
    • Conference
Advertisement

Custom Ultrasonics Signs Consent Decree to Stop Manufacturing Washer/Disinfector Until Problems are Corrected

Feb 7, 2007
Article

The Food and Drug Administration (FDA) announces that Custom Ultrasonics, Inc., (CUI) has signed a consent decree of permanent injunction in which it has agreed to stop manufacturing and distributing its System 83 Plus Washer/Disinfector and the System Plus 83 Mini-flex Washer/Disinfector until it brings the methods and controls used to manufacture the devices into compliance with FDA's Current Good Manufacturing Practice requirements of its Quality System (QS) regulation. In addition, the company has agreed to develop and implement adequate written medical device reporting procedures. The consent decree was signed by Judge Timothy J. Savage and entered on Jan. 25, 2007 in the U.S. District Court for the Eastern District of Pennsylvania.

The FDS says that the company's actions posed a potential public health hazard because endoscopes that are not properly cleaned and disinfected can be a source of transmission of pathogens between patients, causing life-threatening infections. The FDA is not aware of any adverse events. An endoscope, which is a tube inserted into the body, enables doctors to visualize internal organs. Endoscopes are used in many areas of the body, including the digestive tract, the respiratory tract and the urinary tract.

The FDA advises healthcare providers using these products to discontinue using them if another option is available and to contact the firm for more information. Other options include using an alternative device or following appropriate protocols to manually wash and disinfect the device. If no alternative is available, then healthcare providers should carefully weigh the risks and benefits of using these products.

Source: FDA

Related Videos
Medical investigators going over data. (AdobeStock 589197902 by Wasan)
CDC logo is seen on a laptop. (Adobe Stock 428450603 by monticellllo)
Association for the Health Care Environment (Logo used with permission)
Ambassador Deborah Birx, , speaks with Infection Control Today about masks in schools and the newest variant.
mRNA technology  (Adobe Stock 485886181 by kaptn)
Ambassador Deborah Birx, MD
Woman lying in hospital bed (Adobe Stock, unknown)
Photo of a model operating room. (Photo courtesy of Indigo-Clean and Kenall Manufacturing)
GIANTmicrobes at the 2023 APIC Annual Conference and Exhibition.  (Photo by the author)
Related Content

Weekly Rounds: Data-Driven Action Against COVID-19, Emerging Pathogens, HIV Vaccine Trials Begin, and More

September 22nd 2023

NIH Announces HIV Vaccine Clinical Trial Begins

September 20th 2023

Organized Disinformation Fanning the COVID-19 Flames of Vaccine Hesitancy  

September 18th 2023

Hot Topics in IPC: COVID-19 Updated Booster, Legionella Infections, and Hospital Leadership

September 18th 2023

Protecting HCWs: Plague Doctor's Masks to the Personal Protective Equipment of Tomorrow

September 15th 2023

AHE Exchange Conference & Solution Center 2023 Review

September 14th 2023

Weekly Rounds: Data-Driven Action Against COVID-19, Emerging Pathogens, HIV Vaccine Trials Begin, and More

September 22nd 2023

NIH Announces HIV Vaccine Clinical Trial Begins

September 20th 2023

Organized Disinformation Fanning the COVID-19 Flames of Vaccine Hesitancy  

September 18th 2023

Hot Topics in IPC: COVID-19 Updated Booster, Legionella Infections, and Hospital Leadership

September 18th 2023

Protecting HCWs: Plague Doctor's Masks to the Personal Protective Equipment of Tomorrow

September 15th 2023

AHE Exchange Conference & Solution Center 2023 Review

September 14th 2023

Weekly Rounds: Data-Driven Action Against COVID-19, Emerging Pathogens, HIV Vaccine Trials Begin, and More

September 22nd 2023

NIH Announces HIV Vaccine Clinical Trial Begins

September 20th 2023

Organized Disinformation Fanning the COVID-19 Flames of Vaccine Hesitancy  

September 18th 2023

Hot Topics in IPC: COVID-19 Updated Booster, Legionella Infections, and Hospital Leadership

September 18th 2023

Protecting HCWs: Plague Doctor's Masks to the Personal Protective Equipment of Tomorrow

September 15th 2023

AHE Exchange Conference & Solution Center 2023 Review

September 14th 2023
Related Content
Advertisement

weekly rounds with infection control today

Weekly Rounds: Data-Driven Action Against COVID-19, Emerging Pathogens, HIV Vaccine Trials Begin, and More

September 22nd 2023
Article

Take 5 minutes to catch up on Infection Control Today®’s highlights for the week ending September 24, 2023.


NIH Announces HIV Vaccine Clinical Trial Begins

NIH Announces HIV Vaccine Clinical Trial Begins

September 20th 2023
Article

A new preventative vaccine has been developed incorporating technology funded by the NIH since 2004. The trials will be conducted in the United States and South Africa.


Vial of COVID-19 vaccine, bottle for injection with syringe.  (Adobe Stock 331786954 by myskin)

Organized Disinformation Fanning the COVID-19 Flames of Vaccine Hesitancy  

September 18th 2023
Article

Randomized controlled trials show masks are effective. With COVID-19, even one mistake in protective gear usage could lead to infection and obscure results.


In this Hot Topics in IPC, Saskia v. Popescu, PhD, MPH, MA, CIC, FAPIC, discusses COVID-19 vaccines and boosters, Legionella infections from transplants, and hospital leadership.

Hot Topics in IPC: COVID-19 Updated Booster, Legionella Infections, and Hospital Leadership

September 18th 2023
Article

In this Hot Topics in IPC, Saskia v. Popescu, PhD, MPH, MA, CIC, FAPIC, discusses COVID-19 vaccines and boosters, Legionella infections from transplants, and hospital leadership.


Plague doctor, a physician who treated bubonic plague.  (Adobe Stock FILE #: 559266031 by Worldillustrator)

Protecting HCWs: Plague Doctor's Masks to the Personal Protective Equipment of Tomorrow

September 15th 2023
Article

Plague doctors' historical attire was an early form of PPE. While modern PPE has improved, the quest for better, more comfortable protection continues as we aim for a future where health care workers can provide care confidently.


AHE: Association for the Health Care Environment  (Photo used with permission by AHE)

AHE Exchange Conference & Solution Center 2023 Review

September 14th 2023
Article

Health care environmental professionals met in Dallas, Texas, from July 31 to August 2, 2023, at the AHE Exchange Conference & Solution Center. Infection Control Today® asked Rock Jensen, AHE advisory board chair and administrative director of support services for Yuma Regional Medical Center in Arizona, about AHE’s areas of emphasis for leadership in environmental services (EVS).

Advertise
About Us
Editorial Board
Contact Us
Job Board
Terms and Conditions
Privacy
Do Not Sell My Personal Information
Contact Info

2 Clarke Drive
Cranbury, NJ 08512

609-716-7777

© 2023 MJH Life Sciences

All rights reserved.
Home
About Us
News