Just Say No: FDA permits marketing of the first hand-held device to aid in the detection of bleeding in the skull

I read that headline and said, “Wow!, finally I won’t need to CT all those patients’ heads!”

FDA permits marketing of the first hand-held device to aid in the detection of bleeding in the skull

Helps to determine if immediate CT scan is needed

The U.S. Food and Drug Administration today allowed marketing of the first hand-held device intended to aid in the detection of life-threatening bleeding in the skull called intracranial hematomas, using near-infrared spectroscopy.

via Press Announcements > FDA permits marketing of the first hand-held device to aid in the detection of bleeding in the skull.

But then, wait, said I, is it any good? Apparently Not:

The FDA granted the de novo petition for the Infrascanner Model 1000 based on a review of data comparing results from 383 CT scans of adult subjects with Infrascanner scan results. The Infrascanner was able to detect nearly 75 percent of the hematomas detected by CT scan. When CT scans detected no hematoma, the Infrascanner detected no hematoma 82 percent of the time. The Infrascanner Model 1000, however, is not a substitute for a CT scan.

Anyone considering purchasing one of these based on those numbers? If so, I’ll sell you a random number generator for 1/2 of what they’re asking.

Stated another way, this device will miss more than 25% of intracranial hematomas that are present, and will tell you it’s there when it’s not 18% of the time.

Not ready for prime time. I feel bad for the detailers who are sent out to see this thing, and worse for the patients it’s used on.

 

Brought to my attention by @EMNews on twitter. (In case you missed it, I’m getting a lot of my bloggable stuff from Twitter. I don’t blog most of what I comment on. Imagine what you’re missing! Get to twitter, and follow me @gruntdoc).

HHS Audits the 1% … and the Rest: First HIPAA Privacy and Security Audits Begin – Davis Wright Tremaine

As the original twitterer ( @NickGenes ) said, “…because there wasn’t enough bureaucracy & expense in healthcare yet”.

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has begun the process of notifying covered entities that they are among the unlucky few who have been selected for the first Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy and security audits under the Health Information Technology for Economic and Clinical Health (HITECH) Act. …

While the first twenty covered entities have been selected, approximately another 130 remain in this audit round. HHS has indicated that it hopes to continue with proactive audits in the future and expects to become more aggressive in its enforcement of complaints.

via HHS Audits the 1% … and the Rest: First HIPAA Privacy and Security Audits Begin – Davis Wright Tremaine.

Yes, this is HITECH, the Son of HIPAA, but it all started with HIPAA.

Is it worth pointing out that HIPAA exempted itself from the unfunded mandate and paperwork reduction rules when it was enacted? I pointed out then that their assertion that it wouldn’t cause an increase in paperwork, nor was it an unfunded mandate was really unlikely.

How many Millions of dollars and man-hours are we pouring down these regulatory holes?

 

Amazon.com: Customer Reviews: Wenger 16999 Giant Swiss Army Knife

Comments on products can be pretty silly, but sometimes they get the Muse going.

For instance, this dainty little Swiss Army Knife:

Wenger 16999 Giant Swiss Army Knife

Has spawned an hours’ reading and chuckling with the top most being:

Found this…stuck into a stone while on vacation. I’m impressed with it, generally. Unfortunately, it turns out that removing it made me the new king of Switzerland, which is a lot of responsibility.

via Amazon.com: Customer Reviews: Wenger 16999 Giant Swiss Army Knife.

 

Worth the effort to read the comments. Some pretty darn creative people out there…

via Dave in Texas, on Ace.mu.nu