Custom Ultrasonics passes FDA validation of automated endoscope reprocessors

Published: 10-Apr-2018
Cleaning

The US Food and Drug Administration has determined that the System 83 Plus AERs may now be used to reprocess only the Olympus TJF-Q180V duodenoscope and the Pentax ED-3490TK duodenoscope


The US Food and Drug Administration, FDA, has notified health care facilities that Custom Ultrasonics has completed validation testing of the System Plus AERs with specific duodenoscopes and FDA has determined that the validation data demonstrate the System 83 Plus can effectively achieve high-level disinfection of the Olympus TJF-180V duodenoscope and the Pentax ED-3490TK duodenoscope.

As a result, the System 83 Plus AERs may now be used to reprocess only the Olympus TJF-Q180V duodenoscope and the Pentax ED-3490TK duodenoscope. The System 83 Plus is not validated for the reprocessing of Fujifilm duodenoscopes or duodenoscopes with open elevator wire channels.

The news follows on from a Consent Decree between Custom Ultrasonics and the FDA, due to, among other things, repeated violations of the Quality System Regulation. The issue dates back to September 2012, when the FDA ordered Custom Ultrasonics to cease manufacturing and distributing, and to recall the System 83 Plus Washer/Disinfector.

In April 2015, FDA inspected Custom Ultrasonics to evaluate compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA’s Quality System regulations, and the Consent Decree.

The recall order took place in November 2015 to all Custom Ultrasonics’ AERs from health care facilities due to the firm’s violations of the FD&C Act, applicable regulations, and the Consent Decree.

As a follow-up, Custom Ultrasonics was inspected in April 2017. This inspection verified the corrections implemented by Custom Ultrasonics, and found the firm in compliance. The FDA allowed the company to resume manufacturing, marketing, and distribution of the System 83.

The FDA said it will continue to work with Custom Ultrasonics as the firm takes steps to fully comply with requirements of the FD&C Act.

  • Companies:
  • US Food and Drug Administration (FDA)
See more

You may also like

Regulatory

Warning Letters: Lessons from an FDA Captain

Read more
Redica Systems’ Jerry Chapman talks to FDA's Ileana Barreto-Pettit

Trending Articles

  1. You need to be a subscriber to read this article.
    Click here to find out more.
    What is ISO 8 cleanroom classification? Each cleanroom class is denoted by a maximum concentration of particles per cubic meter or cubic foot of air. ISO 8 is the second lowest cleanroom classification
  2. You need to be a subscriber to read this article.
    Click here to find out more.
    Battling biofilms in cleanrooms Michelle Locke from Teknomek discusses how it is possible to combat the persistent threat of biofilms with the right cleanroom furniture, equipment, and cleaning protocols
  3. The details of dust extraction in controlled environments To choose the right machine, the nature of the dust and the statutory regulations for its handling and removal, as well as classification of the machine and filter technology, must be considered. Daniel Took from archer reminds us, the lower the Threshold Limit Value (TLV) for dust, the higher the health risk
  4. Sterile transfer expert ABC Transfer chooses exclusive distributor in Italy Amira has been chosen by ABC to be the exclusive distributor of ABC Transfer Rapid Transfer Port products in Italy
  5. New accreditation launched detailing how to apply ISO 14644 to data centres Capitoline has added a new accreditation to its training course on how to apply ISO 14644 air sampling and monitoring practices to the data centre environment

Upcoming event

EMPQ Essentials and Real-World Strategies for Successful Cleanroom Qualifications

16 January 2025 | Virtual See all

You may also like

Regulatory

Warning Letters: Lessons from an FDA Captain

Redica Systems’ Jerry Chapman talks to FDA's Ileana Barreto-Pettit
Regulatory

FDA gives out 483 form to Torrent Pharma citing "inadaquate cleaning procedure"

The pharma giant from India has been give the form citing three main issues
Cleaning

Study finds $1 per reaction LAMP assay works for BCC testing

The novel assay has been assessed for detecting the bacteria responsible for many pharmaceutical product recalls, Burkholderia cepacia complex
Cleaning

Understanding cleanroom behaviours in compounding pharmacies

Protecting patients from poor-quality compounded drugs is a fundamental part of the US Food and Drug Administration’s (FDA) drug compounding programme and the pharmacies must adhere to strict cleanliness standards. FDA Microbiologist, Djamila Harouaka, explains
Regulatory

FDA recommends Eskbiochem recall hand sanitiser with 81% methanol

The FDA has advised consumers to not use hand sanitiser manufactured by Eskbiochem in Mexico due to the potential for methanol poisoning
Regulatory

FDA proposes to recall Cantrell Drug products

The US Food and Drug Association has reported deficiencies in quality and sterility of compounded drug products at the Cantrell Drug Company facilities
Cleaning

FDA alert for alcohol pads and antiseptic towelettes made by Foshan Flying Medical Products

The US FDA is concerned over a lack of sterility assurance and other quality issues with specific products made by the Chinese company from Foshan City, Guangdong Provence
Subscribe now