How 'bout that new law suit ladies

It is unclear from the press release, was Masimo directly involved in the data collection/processing in this evaluation? Or did Allegheny Health manage that piece on their own?

"Allegheny Health Network to Begin Non-Invasive Hemoglobin Monitoring: Masimo Strategic Partnership Pursues Newest Methods for Improved Patient Care"
Alan Russell, Ph.D., Chief Innovation Officer for Allegheny Health Network
Robert Keenan, MD, Chief Quality Officer, for Allegheny Health Network’s Allegheny General and West Penn Hospitals
11/10/2014
http://www.prweb.com/releases/2014/11/prweb12314055.htm

 

Is there really any question, or whose protocols used?

 

Assessment of Masimo's Radical-7 continuous SpHb measurements on trauma patients by Moore, et al. doesn't look any better...

"Evaluation of noninvasive hemoglobin measurements in trauma patients"
Laura J Moore, et al
published online 10/23/13;
American Journal of Surgery
http://www.americanjournalofsurgery.com/article/S0002-9610(13)00486-8/fulltext

Conclusions:
1. “Comparison of 861 paired values from 418 patients showed a variance of 3.89 to -3.84 g/dL, showing a nonsignificant correlation between Masimo hemoglobin [Radical-7 continuous SpHb] and laboratory hemoglobin values.

2. “The Masimo Radical 7 [SpHb] system evaluated in this study…is not ready to be used as an initial noninvasive evaluation tool in the acute treatment of severely injured trauma patients.”

3. There was a poor correlation between Masimo hemoglobin and laboratory hemoglobin and large numbers of missing data.

4. On the basis of the poor correlation, the Masimo Radical 7 device cannot currently be used to guide transfusion therapy.”

 

This article in the OCR cracks me up... Joe Kiani & Senator Barbara Boxer leading the march on whistleblower protection and disclosure of fatal pt errors!

Sen. Boxer visits O.C. to discuss medical errors
Senator says there are not enough protections for whistleblowers to give “unvarnished, firsthand accounts” of what happens inside hospitals.
From The Orange County Register
Published: Nov. 7, 2014

Masimo CEO Joe Kiani wants Congress to pass a law that would bar Medicare from reimbursing for procedures that accidentally led to a patient’s death, and said he believes hospitals should be mandated to provide quarterly updates on its number of fatal errors.
“I’m not a bigger fan of bigger government, believe me,” he said. “But in some areas, transparency and simple incentives, it could make a difference.”
Still, he added, “We’re not counting on the government.”
http://www.choc.org/news/sen-boxer-visits-o-c-discuss-medical-errors/

 

How patient safety driven of Joe Kiani to push for mandatory disclosure of fatal errors committed quarterly...not by medical device manufacturers such as himself, but by hospitals! That way the accountability for preventable patient deaths might fall more squarely on hospitals, and less on vendors. How convenient, coming from a vendor who's been working with the Senate HELP Committee to increase vendor protection from malpractice litigation in exchange for vendors' commitment to report adverse events to patient safety organizations.

I wish Joker had followed up his humble suggestion with a few pointers on how to properly conduct an investigation of adverse events, i.e. fatal patient error(s) Having received a warning letter in August for failing to do so, joker learned the hard way that such mandatory investigations are subject to enforcement and stiff penalties by the FDA. I thought Joker might be willing to share pearls of wisdom on the subject, and maybe an update. Guess not.

 

What if an ensuing "adverse event" investigation determines the accidental patient fatality was caused by a faulty medical device, and not the procedure? It wouldn't seem fair to expect the hospital to follow a reporting protocol that holds them any more accountable (or the vendor any less accountable) for the pt death than deserved.

 

Don't ask more questions or doubt authority like that again. If you must doubt, doubt logic it is the enemy. Be obedient and gullible, but with an air of confidence. Just stay in formation and keep moving in this general direction. Smile, whatever you do...don't stray from the roadmap. You will be alright. Stay down, be quiet. Look happy.
Good luck.

 

I wouldn't rely on Masimo to provide updates on their federal troubles.

 

Entitled and out of touch is the jackass who dismisses our government
as something he "can't count on."
As though the vulnerable predicament he's in wasn't hard-earned.
One thing he can definitely count on? Karma.

 

In this sample of 861 subjects, the Radical-7 continuous SpHb measurements had variance of 3.89 to -3.84 g/dL is a swing of >7.7 g/dL.
In the name of uselessness, what's the sense of having an Hb measurement tool w/ variance of nearly 8 grams? I don't see a screening or diagnostic function there at all, or any function except maybe a fuel function. for my campfire function.

 

What a joke. A variance of 7.7 g/dl covers the spectrum of Hb's normal range (~10-17).
Is there utility for an Hb measurement whose variance spans the entire range of clinical diagnoses? Man oh man, joker wasn't kidding when he said there's a lot of inertia working against sphb sales efforts. How do the reps stay motivated? I'd rather scoop whaleshit at Seaworld. At least there theshit is real, and I can believe in it.

 

Why should device manufacturers be any less exposed to public/proper authorities or held any less accountable than hospitals for accidental pt deaths caused by their product or service? If hospitals are expected to disclose their preventable fatal errors/practices, I don't see why device manufacturers shouldn't be expected to do same w/ their product/services.
http://www.choc.org/news/sen-boxer-visits-o-c-discuss-medical-errors/

 

With no new FDA approvals since May, Masimo is forced to try out new markets. Surprisingly their low-cal chocolate buns aren't too bad.

Masimo chocolate bun
Nutrition facts: 181 calories
http://www.myfitnesspal.com/food/calories/masimo-choc-bun-50673809

 

A new trend in healthcare?

Regional One Medical Center, Memphis, TN--
Regional One Medical officials say patient safety is their number one priority but a report Wednesday says they're failing at it."
http://m.newsdaily24h.com/2014/30/10/regional-medical-center-gets-an-f-in-patient-safety-n1427459.html

 

No trend. Just a couple loose cannons
getting called out

 

Shame on fools who hijack admirable titles like "Patient safety advocate"
and get busted not actually giving a shiot.

Is pleasing to see the media jump all over these imposters
as they've done recently to Regional One Medical Center and Masimo Corp.

"Regional Medical Center gets an F in patient safety"
http://m.newsdaily24h.com/2014/30/10/regional-medical-center-gets-an-f-in-patient-safety-n1427459.html

"Medical Company May Be Falling Short Of Its Patient Safety Ideals
http://www.npr.org/blogs/health/2014/10/06/353524314/masimo-medical-company-may-be-falling-short-of-its-patient-safety-ideals

"FDA TO DEVICE MAKER: COMPLAINTS NOT PROPERLY INVESTIGATED"
http://www.patient-safety-blog.com/fda-to-device-maker-complaints-not-properly-investigated/

 

The "Patient safety advocate" title is for those who earn it.
The media is making it easier to spot imposters.

"Regional Medical Center gets an F in patient safety"
http://m.newsdaily24h.com/2014/30/10/regional-medical-center-gets-an-f-in-patient-safety-n1427459.html

"Medical Company May Be Falling Short Of Its Patient Safety Ideals
http://www.npr.org/blogs/health/2014/10/06/353524314/masimo-medical-company-may-be-falling-short-of-its-patient-safety-ideals

"FDA TO DEVICE MAKER: COMPLAINTS NOT PROPERLY INVESTIGATED"
http://www.patient-safety-blog.com/fda-to-device-maker-complaints-not-properly-investigated/

 

Reality check: Based on Moore; et al. findings, here's an example of how much variance may exist between a Masimo Raical 7 continuous Sphb monitor and a lab analyzer...
A continuous SpHb measurement of 10.0 g/dL means the subject's actual Hb could be as low as 6.16 g/dL (dangerously anemic) or as high as 13.89 g/dL (healthy as an ox).

With this reality-check in mind, can someone please enlighten us on how SpHb instruments could be deemed useful by surgeons who perform surgeries on bloody people.
http://www.americanjournalofsurgery.com/article/S0002-9610(13)00486-8/fulltext

 

Caution: I bought 10 of these Masimo "chocolate buns."
Of which, 6 were strawberry and three vanilla. None were actually buns, but croissants and sponge cakes. And they all sucked except the strawberry sponge cake.

 

Those will be corrected before full market release.
Probably