1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Regulation

Sen. Murray Prods Duodenoscope-Makers On Continued Contamination Issues

 
• By Sue Darcey

Sen. Patty Murray sent a letter this week to the three sole US duodenoscope-makers – Olympus, Fujifilm and Pentax – asking the firms to bring the contamination rates on their scopes down to between 0% and 1%. Murray's letter pointed to recent “troubling findings” from the FDA on rates of contamination from high-concern organisms.

an Olympus TJF-Q180V duodenoscope
An Olympus duodenoscope, the Evis Exera II, TJF-Q180V, which was redesigned to make cleaning and reprocessing easier for users • Source: Olympus Corp.

The ranking member of the US Senate Health, Education, Labor and Pensions (HELP) Committee on 9 May demanded answers from three duodenoscope-makers on whether closed-channel duodenoscopes remain safe, given recent findings of high contamination rates by the Food and Drug Administration.

“While important steps have been taken to reduce outbreaks, it is unacceptable that one in 20 patients who undergo a...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Regulation

Increasing Safety Concerns Spur Scrutiny of Device Plastics Use

 
• By Elizabeth Orr

With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.

UK Healthtech Center Of Excellence Given Key MHRA Digital Regulation Role

 
• By Ashley Yeo

Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.

Where Do Questions Surrounding The EU’s AI Act Leave The Medtech Industry?

 
• By Amanda Maxwell

The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.

Medtech Giants Brace for Tariffs Impact: Responses Range From Financial To Philosophical

 
• By Marion Webb, Shubham Singh, and Nancy Pham

Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.

More from Policy & Regulation

MDUFA VI Launches With Public Meeting, Call For Comments

 
• By Elizabeth Orr

Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.

Permanent FDA Top Lawyer Expected After HHS Counsel Confirmation

 
• By Sue Sutter

Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.

FDA Drops Package Labeling Guidance For Hernia Mesh Manufacturers

 
• By Brian Bossetta

The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.