More about tubes misconnections

A week ago I blogged about Luer locks misconnections, and today there was an article in the New York Times about this issue. The author of this article blames the FDA for allowing these situations to continue to exists. International efforts are hindered by politics and probably a lack of focus and/or funding. Oh well...

Al Franken gets involved in the 510(k) process

Al Franken, the senator from MN, is talking with industry and FDA about the proposed changes to the 510(k) process, see The Hill/Healthwatch blog.


The FDA's 510(k) process, used to clear medical devices for sale in the US, is no longer suited to the sheer volume of new ideas and new technologies developed to help the medical community to diagnose and treat diseases. In one word, the process is broken. However, fixing it is extremely difficult: on one hand it should not become so cumbersome that innovative small and startup companies cannot afford to develop new products; on the other hand the process needs to be robust enough to protect the public's health. I am glad that politicians weigh in and hopefully provide viewpoints that may balance the discussions. But I also think that nobody will "get it right" because there is no one right answer that covers all situations adequately.

Luer lock misconnections

Luer locks connect medical tubes such as IV tubes and enteral feeding tubes. Sometimes incompatible tubing sets get inadvertently connected, resulting in patient injury or death.

I thought these problems were solved a long time ago, but the FDA does not seem to think so! The FDA has sent a letter to stakeholders to warn them and to ask industry to make these Luer locks incompatible for systems that should not be interconnected.

Colonoscopy made easy

If you've ever had a colonoscopy, you'll know that these procedures are inconvenient and sometimes painful. So you'll be happy to know that the FDA has cleared a virtual colonoscope based on CT techniques, made by iCAD in NH. This technology uses CT to find polyps 6mm in size or larger.

Topsy-turvy: Irish investment in the US.

An Northern-Irish company invests in the US by opening a plant in West Virginia - see this article in the BBC News. Yes, I know Northern Ireland is not the same as the Republic of Ireland, but still one wonders about the timing!

Venture funding up 52% - is there relief in sight for startup companies?

Venture capital investments in the life sciences industry increased by 52% during the second quarter of 2010 compared with the year-prior quarter, with $2.1 billion going toward 234 deals related to biotech and medical devices, according to the MoneyTree report by the National Venture Capital Association and PricewaterhouseCoopers. See this article.

Higher standards for device approval?

Group Calls for Higher Standards for Device Clearances, Approvals
The FDA is being pressured from within to adopt device approval standards similar to those used for drugs. Claiming that weaknesses in the agency’s device approval and clearance process have allowed potentially ineffective devices on the market, a recently published article co-authored by Peter Lurie, a senior adviser in the FDA’s Office of Compliance, asks Congress to raise the approval standards for devices to more closely match those required for drugs. Lurie wrote the article as deputy director of Public Citizen’s Health Research Group before FDA Commissioner Margaret Hamburg hired him last year.
Devices & Diagnostics Letter