Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Tuesday, December 28, 2010

Do you worry about Dirty Electricity when you go car shopping? EMF Health Effect Research

I'm in the market for a new automobile. I don't think my current GM model has much life left in it after only 160,000 miles, bad transmission sensor, think the full pump is about to expire. I really wanted to get a hybrid, with the Toyota Prius being at the top of the list. In doing my due diligence research I changed my mind because the Prius seems to suffer from the problem of 'Dirty Electrcity'.

http://en.wikipedia.org/wiki/Toyota_Prius:

"The Prius has been known to emit excessively high electromagnetic fields. ICNIRP guidelines stipulate that the maximum long term exposure should not exceed 1mG but the Prius measures higher than 24mG in some locations, such as the rear right seat. ICNIRP guidelines are not law in many (if any) countries. The World Health Organization in conjunction with the ICNIRP conducted a study and found levels above 3mG contribute to a child's risk of developing leukemia. At 12mG, the electromagnetic radiation is so strong it's able to block the body's ability to inhibit cancers (in this case breast cancer) using melatonin. The Toyota Prius exceeds 12mG (up to 24mG) in some areas of the cabin. However Toyota claims that the Prius emits similar fields to conventional gasoline vehicles. The high voltage power cable from the traction battery and the forward electric drive motor/generator passes directly under the drivers seat."

In my blog on EMP I covered the work of the late Dr. Robert Becker, which I think it is important enough to repeat here:

I can not stress enough that anyone interested in the medical research field and/or the effects of our ever increasing exposure to EMF's, must read The Body Electric: Electromagnetism and the Foundation of Life by the late Robert Becker and Gary Selden. All research in the field starts here. One key point worth mentioning is that Becker's research showed that low power signals of the same frequency had biological effects that higher power levels of the same signals did not have.


 

Some will assume that because that work was done decades ago that the issues have been solved by now, alas not, which leads us to the relatively new book Dirty Electricity: Electrification and the Diseases of Civilization by Samuel Milham MD MPH. Dr. Milham covers the research since the time of Dr. Becker.

Less you think that health problems are limited to power lines and hybrid batteries, we must wonder what our modern wireless society is doing to our health and that of future generations as we design our fancy new Embedded Systems. There have been a few voices crying warnings in the wilderness such as my friend Dr. Nick Begich, who in 1999 wrote Cell Phone Convenience or 21st Century Plague? along with my friend the late James Roderick, that was originally published in 1999 in Explore! magazine, followed by the book Earth Rising II: The Betrayal of Science, Society and the Soul in 2002.

Here in 2010 we find Should You Be Snuggling With Your Cellphone? by Randall Stross. [The text is also available from the Risk Digest, should you find the previous link behind a pay-wall.]

Microwave News is a good place to stay up to date on what is happening in the health versus wireless technology arena. For example this obscure report released on the 21st of December 2010 in Epidemiology.

We should not fall into the cynical trap thinking that all EMF exposures are bad. In the early part of the twenty century before the American Medical Association and Big Pharma corrupted health care, there was a thriving Electromedicine Community. As far back as the time of Tesla we can find items like his Violet Ray. A glass tube filled with Argon that gives off a purplish glow when it is plugged in. Mine is extremely noisy and the smell of Ozone waif's through the air, so I don't use it much. The Inert Gas FAQ may interest you as well as the out of print book Einstein Doesn't Work Here Anymore by Maurice B. Cooke, should you be interested in such things.

Perhaps the best document work of lost Electromedicine knowledge is the work of Royal Raymond Rife as documented in Barry Lynes book The Cancer Cure That Worked: 50 Years of Suppression.


 



"It ain't so much the things we don't know that get us into trouble. It's the things we know that just ain't so." -- Artemus Ward and/or Josh Billings.

Sunday, August 15, 2010

Parts Shortage, the dreaded "A" word: Allocation

There is an old story of when HP was little more than a garage, that Motorola bought one of their signal generators.  When the new generator arrived at Motorola, it did not work.  Being the best of geeks, the Motorola people took the unit apart, rather than getting on the phone as would happen most places today.  What the Motorola engineers found in some transistor sockets was a sheet of paper that read: "We shipped, you didn't".


DigiTimes is reporting that Passive component manufacturing equipment makers [are] extend[ing] delivery lead times, due to a shortage of parts.  One could presume the passive components the machines are indented to produce, are the parts that can not be gotten.  Que artist M. C. Escher classic Drawing Hands...


On the other hand we might also presume that the passive component manufactures can't get parts, because of the industry wide fab capacity shortage.  Not enough places in the world to build the ICs that we depend on for our products.


That some of the major fabricators set on large known earthquake faults doesn't give me the warm fuzzies either for a long term outlook.  Many of my designs are typically for industrial infrastructure, where life cycles are measured in decades, not the eighteen month cycle of Cell Phones.  I want parts that are going to around for a while, and a company that I can depend on them to deliver.


Some of the companies I work with are small, one, was until recently, only two people, others less than 50.  Many in heavily regulated industries.  To change anything in a product requires submitting paperwork to the Government, at costs into the thousands of dollars.  When a MegaCorp decides that your usage of only tens-of-thousands of their parts per year, is to little to be bothered with, is not something I can adequately put into words here on a family oriented blog.  How do I get MegaCorp to paying for these Paper Pusher type changes that part shortages bring about?


What brings my rant to light here today, is that on Friday a purchasing agent told me that the large component distributor Arrow Electronics Inc., reported that Atmel gave all of Arrow's allocation (Millions?) of DataFlash memories to a "special large customer".  Arrow's people are livid, and you probably are now too, if you were waiting for such parts.


I'll speculate that this has to do with Atmel Enters into Definitive Agreement with INSIDE Contactless for Sale of SMS Business and Atmel Completes Sale of Wafer Manufacturing Operation in Rousset, France to LFoundry GmbH.  'You buy our memory card business, and we'll see that you get the memories that you require'; at everyone else's expense.


Going forward before I design in a part I'm going to find out if the company has their own fabs.  Doesn't mean that some Bean Counter won't sell it in the future, but you can only do what you can do...


Have you been impacted by the current allocation crises, yet?

Sunday, May 16, 2010

Maxim Infusion Pump Design Application Note

To continue what seems to be turning in to a series on Infusion Pumps, Maxim has just released (May/10th/2010) Application Note 4675 Important considerations for insulin pump and portable medical designs by John Mossman.

"Abstract: This tutorial discusses critical considerations requiring attention when designing an insulin pump, including FDA regulation, form-factor requirements, and power-budget constraints. It also provides summary coverage of self-testing, flow sensing, alarms, and electrostatic-discharge variables."

The App. Note gives a good high-level description of what kind of hardware needs to go into an Infusion Pump design. Weak in the area of firmware.

Past blogs about Infusion Pumps:

What has been your experience with Maxim's delivery performance? I've worked in two companies where designing in Maxim parts is outright banned, because of them not delivering parts on schedule, consistently. To bad, as on paper Maxim makes some parts that would really be useful in designs.

Sunday, May 2, 2010

FDA says commercial software kills, but Open Source won't?

In the last couple of weeks the Food and Drug Administration (FDA) has decided to take on the external Infusion Pump industry. Saying that these devices have harmed to many people, because of bad interface designs, and bad software.

  • "Software Defects. Many of the problems that have been reported are related to software malfunctions. For example, some pumps fail to activate pre-programmed alarms when problems occur, while others activate an alarm in the absence of a problem. Other software errors can lead to over- or under-infusion. In one case, a software problem called a “key bounce” caused an infusion pump to occasionally register one keystroke (e.g., a single zero, “0”) as multiple keystrokes (e.g., a double zero, “00”)."
  • "User Interface Issues. There have also been numerous reports of confusing or unclear on-screen user instructions, which may lead to improper programming of medication doses or infusion rates. For example, the design of the infusion pump screen may not make clear which units of measurement (e.g., pounds versus kilograms) should be used to enter patient data, leading to inappropriate dosing."

An infusion pump is a medical device that delivers fluids, such as nutrients and medications, into a patient’s body in controlled amounts. Infusion pumps are in widespread use in clinical settings such as hospitals, and in the home.

The FDA is going to be holding a public meeting May 25 and 26, 2010, from 8 a.m. to 5 p.m. Persons interested in attending the meeting must register by 5 p.m. on May 18, 2010.

"The Food and Drug Administration (FDA) is announcing a public meeting regarding external infusion pumps. The purpose of the meeting is to inform the public about current problems associated with external infusion pump use, to help the agency identify quality assurance strategies to mitigate these problems, and to solicit comments and input regarding how to bring more effective external infusion pumps to market."fu

The public meeting will be held at the Hilton Silver Spring hotel, 8727 Colesville Rd., Silver Spring, MD 20910.

To correct these Infusion Pump problems the FDA has started their Infusion Pumps Improvement Initiative.

The FDA has partnered with the University of Pennsylvania to create the Generic Infusion Pump (GIP) project. This project is to develop a set of generic infusion pump (safety) models and reference specifications that can be used as a reference standard to verify safety properties in different classes of infusion pumps. They supply an example State Machine among other things.

While I think that the FDA University Partnership is a good thing, I have blogged in the past about the split between industry practice and academic research, where I ask How do we get safe software from Academia that deals with real world economics of real hardware?. I've sat on Government committees in the past where I was the only person who actually had to ship a product. Without input from people doing the work on the ground directives from-on-high usually result in impossible to meet requirements, that allows one to ship a prodcut. Lets hope that this Open Source initiative saves lives.

The FDA offering its in-house expertise to help prevent malfunctions in infusion pump software. "FDA’s software experts are proficient in static analysis of software code, which can help to identify programming errors. In its letter to infusion pump manufacturers, FDA is offering manufacturers the option of submitting the software code used in their infusion pumps for analysis by agency experts prior to premarket review of new or modified devices, in order to facilitate the early detection and correction of any design defects."

The FDA is launching a new infusion pump website, which features basic information about infusion pumps and commonly seen problems. The site also describes actions that patients and professionals who interact with infusion pumps – including hospital staff and administrators, as well as home users – could take to help prevent safety problems. FDA encourages all users to report infusion pump problems, in order to help the agency develop a better understanding of the risk-benefit profile of these devices and take appropriate actions to enhance patient safety.

Something else the FDA has started to take on is Home Use Medical Devices. Homes can present design challenges that we as designers do not think of because we see them so often they do not enter our conscious mind, such as Cat Fur. For example cat fur in a patient's kidney dialysis tubing entered the patient's body and caused peritonitis, a potentially life-threatening infection of the membrane that lines the organs inside the abdomen. [Was the cat fur left over from the static tests?]

A more generic problem in the medical arena is Alarm Fatigue. Having just spent a lot of time in the hospital with my late father, I know how annoying, and how often the various medical alarms are turned off or ignored. Philips warning letter illustrates the point: Switching the alarm source from Heart Rate to Pulse without considering that ECG and arrhythmia alarming is not available in this mode about bad interface and Alarm Fatigue.

Over at Safety Leaders you can find a lot more information on medical mistakes such as the documentary, Chasing Zero: Winning the War on Healthcare Harm.