Proventix RFID-Hand Washing System in Use at Princeton Baptist Medical Center – Alabama

This is yet another hand washing technology solution using RFID from a company called Proventix.  When the staff member enters the room they need to wash their hand and upon exiting the room the machine anticipates another washing before leaving the patient room.  Last year I wrote about another system called Hygreen that does the same thing and you can read more about their system at the links below.  The hospital using the Proventix system is located in Alabama. 

Real Time Monitoring of When you Washed your Hands – Don’t Touch that Patient Until You Have Washed Your Hands

One Smart Hospital In Virginia Invests in Hand Washing Technology – It’s in the Tag

The article talks about how they have set the software preferences as an incentive and not a “watch dog” during the pilot phase to see how this works as the entire idea is not to punish but rather to use in a positive fashion.  Now when you continue down further reading here there are plans in the making to put his software and system on steroids, by making better use of the screen such as displaying patient vitals and perhaps recent lab results, visible while washing hands!

What is real interesting too is the customization of the messages viewed, catch the one with the latest sports news too in the images below, that one should be real popular, obviously maybe seen after any other vital messages have been shown.  nGage is the name of the software that does the reporting work for the data. 

From the website:

“nGage includes an electronic monitoring record in the background that works as a health maintenance system. It can look at and respond with two types of information: predictive and preventative. Predictive information is time-based, giving details related to the specific disease state of the patient. Preventative information is event-based. Because the nGage system is integrated with the healthcare facility’s information system, vital signs that are entered into the facility’s system are recognized and communicated to the screen at the hand hygiene station. CDC guidelines say that a healthcare worker will engage in a hand hygiene event before patient contact. At that compliance event, information critical to the patient’s care can override any other communication. It can include data such as the patient’s vital signs and how those signs are different from their norm.”

The video below shows how it works and also at the end there’s some added J and J recall information that just happened to be on the same newscast it appears.

Thus far 42 patient beds are connected as well as the nurses stations for a total of 80 RFID stations.  Each staff member wears their own name tag that contains an RFID chip for identification.  These appear to be all hard wired with Ethernet but who knows if wireless could be next.  BD

June 10, 2010—Princeton Baptist Medical Center, in Birmingham, Al., reports that it has seen a 36 percent reduction in patient visit time resulting from a health-care acquired infection (HCAI) since it began employing an RFID-based hand-washing compliance system in February 2010. That equates to 125 fewer bed days since February in which patients were hospitalized for infections gained while receiving treatment at the facility. The system, known as nGage, was provided by Proventix, with Synapse Technologies providing and installing customized readers and tags that operate at 2.4 GHz and utilize the IEEE 802.15.4 (ZigBee) specification.

This was almost a no-brainer," says Paula Davenport, Princeton Baptist Medical Center's director of surgical services. "As we all know, hand washing is one of the primary ways to prevent the spread of infections." Since the system was installed, she notes, "We definitely have seen an improvement in infection rates."

During the past few years, other hand-hygiene systems using RFID have been developed and commercially introduced (see RFID Debuts as Hand-Washing Compliance Officer and Patient-Safety Center Tests RFID-enabled Hand Sanitizers). Some issue alerts by pager or phone, and some produce an audible announcement to notify a health-care worker who has failed to wash his or her hands. Princeton Baptist wanted a system, however, that would be easy and enjoyable to use, rather than something that would have a punitive effect on its staff (such as embarrassing them with audible alerts). Although the Proventix system can send alerts to pagers or phones, Davenport says, the hospital wanted only to encourage workers to wash their hands, not issue an alert when they failed to do so.

Although the medical center is initially displaying only generic information regarding the value of hand washing and its impact on diseases such as the flu, in the future, Proventix software will cause the screen to display personalized information for the dispenser user, as well as providing health-care information about the patient who may be in the room in which that dispenser is located. (For example: "Alert: Patient is a fall risk.") If a user is a physician with an interest in updates specific to certain medical regulations, for instance, that is what he or she will see on the display. What's more, CNN headlines or sports results could be provided as well, if so requested.

Upon approaching the hand-washing station, he or she must press the dispenser lever to use the sanitizer or soap and water. At the same time, the software links the ID number of the individual standing in front of the station with the dispenser's activation. The software then displays messages specific to that user (currently, all Princeton Baptist employees receive the same message, describing the importance of hand washing on reducing infections, and providing statistics to reinforce that message), and also stores a record of the event, indicating when and where the employee has washed his or her hands.

RFID-based Hand-Hygiene System Prevents Health-care Acquired Infections - RFID Journal

Technorati Tags: Handwashing, technology, Princeton Baptist Medical Center, Proventix, Synapse, RFID, healthcare, nGage, hospital acquired infections

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FDA Seizes Chinese Honey – Contains Antibiotic Chloramphenicol Used to Fight Bacterial Infections

The antibiotic, chloramphenicol is used by veterinarians and is sometimes given to bees to protect them from disease.  China has moved into being the number one country for producing honey, giving our US manufacturers some very stiff competition. 

If you go back a few years there was the case of the “honey laundering” where honey from China was first sent to Australia and then exported to the US basically at the time to avoid trade barriers.  With transparency we certainly are finding out what is in the food that comes from China and we can all remember back to the melamine incident with mile and dried milk products.  The FDA has banned chloramphenicol for use in any food products and even big companies like Sue Bee are importing honey from China and they have their own internal testing for the drug and are still finding it in their samples in their lab.  When Sue Bee returns the product there’s no word on how it may or may not get back into the pipeline by potentially being sold to someone else. 

Argentina, Vietnam and Canada are also big exported of honey to the US as bee colonies in the US continue to dwindle.  BD

Honey imported from China has been seized by the FDA in Philadelphia. The honey contained a potentially fatal ingredient that is not approved for use in food products by US regulators. The ingredient chloramphenicol is actually an antibiotic that fights certain bacteria. However, it can cause aplastic anemia, leukemia and a number of other serious conditions. The powerful antibiotic is only used in cases where a person has not responded to any other treatment methods.

Agents seized 64 drums of the tainted honey valued at 32 thousand dollars. The honey was imported by the California based company Sweet Works. The California company got the honey from the Chinese honey manufacturer Cheng Du Wai Yuan Bee Products and then sent it on to the Delaware Avenue Distribution Center in Philadelphia. The honey was only stored in the warehouse after Alfred Wolff of Chicago purchased the bulk supply. The FDA and US Marshals are investigating the matter further.

Chinese Honey Seized by FDA » Tech Jackal

Technorati Tags: FDA, China, food recalls, healthcare, antibiotics, chloramphenicol, honey

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Texas Blue Cross Sues Pfizer Over Off Label Drug Marketing and Kickbacks to Physicians – 3 Drugs Named

Bextra, Geodon, and Lyrica are the three drugs in question with off label use.  This sounds pretty aggressive as Blue Cross wants quite a few “cash” rewards, to the point of 3 months worth of Pfizer’s advertising budget.  Pfizer has already settled 40 similar cases and one with the US Government.  Pfizer has since gone back to the FDA to try to win approval to market Lyrica for anxiety and was turned down, so this remains off label.

FDA Says No to Pfizer’s Pain Medication Lyrica for Generalized Anxiety Disorder

Last year there was the record $2 billion dollar settlement with the Department of Justice on similar allegations, so this sounds kind of like a “me too” suit in view of other cases that have been resolved with the only difference here is that an insurance company is looking for restitution which may be a bit more difficult.  BD 

A Texas health insurance company is suing Pfizer Inc. saying the drug maker deceptively marketed three of its top-selling drugs, illegally encouraging doctors to prescribe them for non-approved uses and paying kickbacks to doctors.

Health Care Service Corp., which runs Blue Cross Blue Shield of Texas and covers 12.4 million people in four states, filed the lawsuit against Pfizer on June 4.  Pfizer has settled other similar lawsuits and agreed in September to pay $2.3 billion in civil and criminal penalties over its promotion of Bextra, Lyrica, Geodon and other drugs.

The lawsuit names Pfizer, its Pharmacia & Upjohn unit and four individuals: Rick Burch, who led Pfizer's arthritis and pain drug business; Jake Friedman, who led the business responsible for promoting drugs including Lyrica and Geodon; Mark Brown, who was involved in marketing anti-infection and HIV and AIDS drugs; and Matthew Lustig, a district sales manager in South Florida.

Texas Blue Cross plan sues Pfizer over marketing | Pharmaceutical Processing

Technorati Tags: Blue Cross, Legal Suit, Pfizer, off label marketing, kickbacks, healthcare reform, health insurance, Pharmacia, Upjohn, drugs, prescriptions

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FDA Ruling with Genetic Testing Puts A Big Hold on the “Genetic Benefit Management Cash Cow” For Retail Stores Marketing to Consumers

This heated debate has been kicking around for a while now and until retail pharmacies actually pushed the button with making test available for purchase of the “box” at the stores things were somewhat moving along ok for those who wanted to have their DNA sequenced.  Today, things get very confused when we as consumers try to differentiate the difference between knowledge and marketing, in other words do we need/want this, or is it just one more attempt to make a buck.  I have been following this along and the strategic alliances that were forming here were a bit disturbing with some of what we were seeing out there, so perhaps the FDA stepping in here was not a bad thing.  You can read a couple paragraphs from a recent prior post below and catch the drift.  

Pharmacy Benefit Managers Striking Alliances with Genomic Test Companies – A New Left Hook in Shaping Portions of Healthcare Reform With Genetic Benefit Managers?

“Insurance companies now are taking a look at the cost side and are exploring some of these areas with the pharmacy benefit managers.  The insurance companies can only go so far with the GINA laws and their new partners for information appear to be in the area of the PBM; however, how all this works is continuing to develop.  The pharmacy benefit managers more than likely will be playing a larger role with the physicians with information about prescribing drugs for patients, again based on genomics and possibly recommending that certain patients be given certain tests.  It gets a bit complicated here as the payers are still in their own rite, trying to figure out which tests they should allow, and again this is based on cost.  Getting a prescription for some simple allergy relief one day might become a very complicated issue with having a multitude of data to look at before that prescription is written.

Next up, privacy with sharing patient information with payers and how this will get utilized too, as a payer will need to know, or want to know that a DNA test shows before potentially allowing some medications and treatments to be covered, especially when it comes to areas like oncology for example where the cost is high.  CVS has affiliated itself and through the Minute Clinics has an arm to provide DNA testing within the stores/clinics.  You may have a provider wanting to prescribe a certain medication and a negative given for coverage based on a DNA test on file, just some new potential conflicts that could be on the horizon as interpretations are queried.” 

I wrote about the FDA decision below.

FDA States Genetic Tests Are Considered a Medical Device And Thus Need FDA Approval

There are also some hospitals and universities that are working to offer genomic education to physicians which is a good thing. 

FDA Listing of In Vitro Diagnostics - Letters Sent to 5 Companies

Navigenics has taken the approach to include the physician in this area and that is a good thing so if patients have had some sequencing done, they have an idea as to what is going on. 

Beth Israel Deaconess Medical Center and Navigenics Partner to Make Personalized Genomics Training Available for Physicians

If you take a look at the companies receiving letters from the FDA, it also included Knome, founded in part by George Church, which is where gene sequencing all began at Harvard.  I’m sure the company along with 23AndMe will answer the FDA inquiries and we will hear the outcome.  These companies have not made any retail affiliations and are not on the “retail cash cow” to make profits from consumers in this fashion, again that is what blew the doors off the barn here with marketing and actual consumer/patient/doctor information sources being exploited.  I still feel that an individual with proper guidance should be able to have their genes sequenced, but the flurry created for profits with retail operations and control over medications by pharmacy benefit management lead this to get out of hand.

This is no way is related to having a specific genomic test done for one or two medications for a selection of a drug to be used for treatment.  That part of the clinical side is already inter woven into treatment plans and is done in coordination with a physician requesting a test.  The danger of the retail involvement here comes around to some privacy issues as Pharmacy Benefit Management data bases DO NOT fall under HIPAA, thus who knows what information would be bought and sold about you with reference to “wellness groups” and especially those owned by health insurance companies.  Read that again if you missed it, wellness companies owned by health insurance companies to drive profits to the bottom line, and if you happen to get healthier in the profit making process then they can sell this as a real success to investors and others.  

Granted there’s a lot of good to wellness programs if they are implemented properly and work as a “true”partner to the consumer with information, but trying to figure out which is which sometimes is a problem with the vast marketing and intelligence added to what is seen on the web today.  I know as a consumer I want a “real”partner and not a marketed fabrication to just drop money to the bottom line profits, I feel that is a better selection process.  Basically this ruling from the FDA results bottom line from health insurance companies wanting some bottom line profits and control instead of working from a pure motivation angle.  It is what it is and if you read between the lines, and there are many posts on this blog that address different areas, you will see how they are inter twining themselves into so many other areas outside of providing care, some good and some not so good, but pay attention to these alliances as you will need to really learn how to read between the “marketing” lines today. 

On the web I read where Pathway Genomics is backing out of the consumer marketing side of sequencing who was the partner for Walgreens and one of the recipients of the FDA letters.

Walgreens Stores To Offer Genetic Testing From Pathway Genomics Over the Counter

Pharmacy benefit managers like Medco will be looking at their future plans of action too since they purchased a partner who does genomic sequencing earlier this year called DNA Direct and I was not able to locate who their “sequencing machine” partner is at present.   

Medco Also Entering Into the Field of “Genetic Benefit Management” With Making New Tests Available

With the retail profit cash cow going into actions, this certainly appears to have caught the attention of the FDA and it will be interesting to see how it goes from there.  In a good way, the FDA did clamp down on the “marketing for profit areas here” and hopefully their action will help keep genomics clearly in focus with clinical outcomes and studies without furthering the interest in the over all retail cash cow and genetic benefit management factors being marketed loosely, without a full addressing of privacy issues at hand.  BD 

The U.S. Food and Drug Administration has decided that the personalized DNA tests sold by companies like 23andMe are medical devices subject to government regulation, and the federal agency says the tests must be vetted by regulators if they are to remain on the market.

That’s what Navigenics intends to do, according to this post on the company’s blog:

We believe our services comply with all existing federal and state regulations, and look forward to continuing our dialogue with the FDA to ensure transparency and the optimal use of genetic information as it applies to personalized medicine.

23andMe took a similar position, arguing that people have a right to know their genetic information and that the FDA should not stand in their way.

Personalized DNA testing kits should be regulated as medical devices, the FDA says | Booster Shots | Los Angeles Times

Technorati Tags: genomics, personalized medicine, DNA, healthcare, sequencing, Biotech, pharmacogenomics, FDA, medical devices, Navigenics, 23AndMe, Knome, Illumina, George Church

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Cardiologist Charged With Performing Unnecessary Stent Procedures – Whistle Blower Reported Exaggerated Blockage Percentages

In addition to the surgical procedures, authorities are questioning if and how medical record information was either entered inaccurately or changed to indicate a higher percentage of blockage with the patients who underwent surgery.  When a comparison was run against other doctors performing the same surgical procedures, they found the doctor was averaging twice the number of procedures.  

The information provided by the whistle blower in this case, a reported hospital employee is going to be a key part of the entire investigation as well.  A board reviewed the cases and found that the actual numbers with the x-rays showed less than 50% blockage with a board examination.  The doctor is also looking at some malpractice suits and the the case has also gained the attention of the Senate.  Now the state is reviewing other physicians with questionable stent rates and the FBI is investigating another doctor in the DC area showing a high rate of stent procedures.

Clinical guidelines state that a 70% or better blockage is the number used to determine if a patient should require a stent, so this is where the investigation primarily lies to determine how many were actually at  70% or above.  The doctor himself somewhat agreed that some of the cases were lower than 70% when he originally dictated his notes.  The doctor stated there was also other clinical symptoms that were assessed with each patient too, but the review board stated they didn’t find anything in the charts to substantiate.  This will be an interesting case to follow as review boards can be a bit slanted as some of the physicians on the boards may have something reported in their cases too that they may not want revealed or any attention brought about, and the article states that normally random cases are reviewed, but I would guess in this case, random would not be the choice here, or at least I would hope not. 

One thing for sure that all of us can learn just from this article is to read up on the internet if you are a patient in this situation and ask questions, what is your reported blockage rate, at least ask that question and ask if there are other things going on with your body that may have an impact here too.  This case borders on fraud accusations with generating money for these procedures and I can tell you having experienced a case with my own senior mother, there are some of these folks out there that recommend and do procedures that are not needed. 

One other potential area here to think about too are the manufacturers who make the stent, this is a huge marketing war here and just to throw in another potential area, was there any influence from the companies that could have been involved here too? 

Will the “Stent Wars” Ever End – We Want to Be Able to Afford them Boston Scientific Files Cross Appeal

There’s a lot of money spent in legal wars over stent patents here and again, it’s not completely out of the question to ponder if there could have been some outside influence here too, but again maybe not but something to give some thought to for a potential side line.  BD 

The regulatory board responsible for licensing doctors in Maryland has filed administrative charges against a Towson cardiologist accused of performing hundreds of unnecessary procedures, beginning a process that could strip him of the authority to practice medicine in the state.

In a 19-page document made public Friday morning, the Maryland Board of Physicians accuses Dr. Mark G. Midei of "gross overutilization of health care services" and "willfully making a false report or record in the practice of medicine," among other violations of state law.

Midei, who ran the cardiac catheterization lab at St. Joseph Medical Center until last year, is alleged to have put stents in the arteries of patients who did not need them. He is also accused of falsifying medical records to make it appear that the patients were candidates for the expensive — and sometimes dangerous — procedure.

If the board's charges are upheld, Midei could be fined and lose his medical license. Board members have scheduled a conference Aug. 4 to discuss the case with Midei at their Baltimore offices.

"He expressed a little bit of surprise" when told by a St. Joseph review committee that he had an "established pattern of overestimating," the document states.

In a statement e-mailed to The Sun on Friday morning, St. Joseph said it has cooperated in the Board of Physicians' investigation, but declined to comment further.

The board's investigation included detailed reviews of five of Midei's cases. In each, Midei wrote in the patient's records that they suffered from an 80 percent blockage of a coronary artery, which needed to be propped open with a stent. But a subsequent review of X-ray images showed less than 50 percent blockage

The first hint of trouble came in November 2008, when the board received an anonymous complaint from someone claiming to be a St. Joseph employee and accusing Midei of "medical fraud," the charging document says. The person gave the board a list of 36 stent procedures that were supposedly unnecessary, performed between July and November of that year. The accuser reiterated the allegations in late April 2009, in a letter that purported to list 41 other unwarranted stent procedures.

Cardiologist charged under medical practice act - baltimoresun.com

Technorati Tags: cardiology, stents, doctors, Maryland, healthcare, fraud, procedures, patients, peer reviews, hospitals

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Handheld MRI Scanners Could Be On the Way Soon With Breakthrough in Magnetic Technology

Having a small hand held unit is one way to reduce exposure, and the technology is not quite ready to be put on the shelf yet, but it is in the works to develop a hand held device.  The article states additional tweaking is required to match the power of a full MRI type magnet, but they believe it can be tweaked to double the current power. 

When you stop and think about how expensive MRIs are, this could make a serious difference and not for use for all scanning, but for localized searches for blood clots and cancer proteins it could be done right in the office of the future.  BD 

Nuclear magnetic resonance spectroscopy is a handy scientific tool to have around (for instance, it's the fundamental tech behind magnetic resonance imaging, or MRI). It's ability to identify and study things like protein structures and chemical compositions make it fantastically flexible, but there is a huge drawback: The size and expense of the superconducting magnets necessary for precision NMR make it an immobile and expensive process. But researchers in Germany have created a portable magnet that could shrink NMR devices from room-size to palm-size.

The breakthrough won't replace the large MRI machines necessary for a good medical scan, but it could be the basis for handheld devices that analyze archaeological artifacts on-site or identify blood clots or cancer proteins right in the physician's office, or even in remote areas far from conventional lab resources.

Such high-res, portable NMR can only reach a magnetic field strength of 0.7 tesla (large medical imaging magnets produce ten times that) but that's just the beginning. Researchers think they can tweak the current design to wrench 1.5 tesla from a portable NMR device, and by using magnets of different materials they might even reach two tesla. Not bad for something that fits in the palm of your hand.

Breakthrough In Magnet Technology Could Lead to Handheld MRI Scanners | Popular Science

Technorati Tags: MRI, magnetic fields, magnet, imaging, medical devices, science, NMR

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Is a Non Technical FDA Recall System Like Another BP Oil Spill Waiting to Happen One Day

I don’t mean that the FDA has anything to do with oil, but by comparison if you look at how long, since 2004 since the FDA made the commitment to create a recall program that is easy and accessible for consumers, well we have waited about 6 years.  In that time though we have had some really neat technologies enter the picture and we are about at the point where we need to start working on this.  Recalls will grow in number simply due to the higher level of intelligence we have today in identifying software issues, malfunctioning devices, side effects and so on.  

When you stop and think about the software end of things with devices (especially those that require software) think about your operating system updates you get with Windows, Apple, Linux and so on.  Even the big guys are constantly updating and improving their software and those are entire operating systems, so this part of the issue with devices is not going to go away any time soon, but we need to learn to live with it and adapt and be able to react quickly with a system that gets to hospitals, consumers, doctors immediately.  

The ECRI institute has a website with Medical device safety reports where you can search and find a multitude of device problems and where you can report them and there’s a lot there. 

For nearly 30 years, ECRI Institute has gathered and investigated reports of incidents involving medical devices from healthcare providers, patients, and manufacturers from around the world. As a result, thousands of devices have been recalled or modified by their manufacturers. We encourage healthcare providers, patients, and manufacturers to report medical device related incidents and deficiencies to us so we can determine whether a report reflects a random failure or one that is likely to recur and cause harm. Reports can also be submitted to us by letter, telephone, or fax. ECRI Institute acknowledges receipt of the report and informs the reporting party of our finding and opinions in cases for which we can provide guidance; otherwise, we log the report in our system and monitor the situation for developing trends of similar problems. As soon as members of ECRI Institute's staff--clinical engineers and other technical specialists who have expertise in biomedical, electronic, chemical, radiologic, and computer technologies--determine that specific device hazards and problems may exist, ECRI Institute informs the manufacturers and encourages them to respond constructively and correct the problem. The name of the reporting institution and of the person making the report is never revealed without permission.

Recently in the news we have had Johnson and Johnson as being in the public eye with their recalls and today I read where the government says they are not cooperating and they say they are and have submitted documents, so are they 2 speaking the same language?  You know the folks doing the asking may not be able to understand what is being sent and the people sending the information may not be understanding what the Senate wants either, this can go on forever if we ignore it. 

Just like anything else we can’t rely on manual systems to feed a huge crowd so we need to do some serious thinking as when you look now at how drugs and device recalls are handled, you either have to watch the news or read the FDA newsletters, press releases, etc., in other words still a manual process and people miss stuff and so does the FDA for that matter.  Below is a good example of one that was missed but through bloggers and other news outlets people were finally aware, as it was not in the normal web page of the FDA. 

The Unknown FDA Recall of Bayer's Yaz Contraceptive Pills (And Some Prempro Too)

Now what is going to happen when we get hit with several recalls at once, more than a couple companies, and some being consumer products sold over the counter, again this is going to keep coming at us and with each one hopefully the companies get better at correcting, whether it is software, ingredients in drugs, or whatever the case is for the recall.  Safety is going to suffer with this antiquated system we have, like I said the BP oil spill of the FDA could very well be lurking.  Is the process going to resemble something like the BP coffee spill?  This has a bit of demented humor but makes a point with the video below. 

I have made posts about people being implanted with a device that was recalled and for what ever reason, it was not pulled and used in surgery, the device malfunctioned and patients die.  To me this is totally preventable as we have technology to solve this and there are more incidents like this that occur than you think.  This process of using your phone as a scanner is almost easier than using your phone to make a call. 

Do Microsoft Tags Belong in Healthcare? (Microsoft.gov publication of this post)

Do Microsoft Tags Belong in Healthcare

“We are lucky to have Barbara Duck of The Medical Quack write a guest blog post.
Barbara has quite the blog on the medical industry. She was kind to write an amazing post, concerning Tag & Health. Enjoy!”

Do Microsoft Tags Belong in Healthcare?  I Have Some Ideas on This Subject

If you read the Medical Quack you may have seen some of my recent posts on how I think this technology would prove to be an asset to healthcare.  Healthcare, like every other industry today is inundated with information and rapid communication is key.  We have more mobility today with telehealth and other wireless  capabilities emerging into an area that is growing by leaps and bounds, almost faster than we can keep up.  We read about safety notifications and their timeliness and availability all the time, and thus my thoughts grew into the area of another avenue of using cell phones to help keep up.

The opportunity to turn a cell phone into a “scanner” with real time information is huge.  As mentioned above, this can be a daunting task at times and we have people at all different stages with using technology today and in my opinion, using a cell phone makes sense, when all one has to do is open a program on the phone and simply “shoot and aim” and relative information would be available instantly.  Back in October of 2009 I kept reading about all the recalls of devices and created my first opinion/idea post here.  It just made sense to me. 

Tracking Medical Device Recalls – Sounds Like A Good Place for a Microsoft Tag Data Base at the FDA

Some hospitals have used RFID to work with getting recalled devices off of the hospital shelves and this is great, but what about those who have not, and furthermore, what about the consumers and/or patients.  For instance I could be looking for new safety information about an over the counter drug that has been on the news, while someone else who has an implanted heart device may be looking for something else, but one thing in common is that we both need access quickly.

Scan that knee, hip, defibrillator before you use it, takes a few seconds and will help hospital registries function and less mistakes.  Hospitals work hard to do a good job at this, but I continue to read stories to where patients have been implanted with a device that had been recalled and it was missed.  One story in particular involved a man who was implanted with a heart device that had been recalled and he died when it malfunctioned.  To me, this could have been a preventable incident and a life could have been saved if a simple scan would have put up the red flags to not use the device.

Microsoft Tags on CBS Early Show – Wake Up FDA, Pharma and Medical Device Companies –Scan Those Drugs, Medical Devices and Synchronize with an FDA Tag Data Base – Recalls, Theft Tracking and More….

Microsoft Tags in Healthcare – Comments and Demonstration at “Microsoft Connected Conference” with Surface

Everybody that reads here, knows I am a fan of Tags and I have an entire series of how they can be used in healthcare, they work with RFIDs too.  Watch the video and see how they are used for entertainment.  I guess that must come first, you think?   This is all free too.  Had some great comments on Twitter too.

This comment talks about how great they work on an IPhone and sees as an enhancement at the hospital.

This IT person says, yes, combine with RFID at the hospital as they already work with bar coding.

One other item to note these can be an avenue to get information in to your PHR with your phone with HealthVault too, so that becomes easier if consumers already use the program for other functions, again so darn easy to use, a no brainer.   Something this simple to use will stand to enhance consumers with the use of Health IT too so we get more “participants” all the way around. 

The former chairman of the FDA last week called for increased corporate accountability and with Tags the FDA would also have an easier time themselves monitoring compliance with a synchronized data base. 

We are not that far away from the day to where the current system will be totally unmanageable and not be able to keep up with the demand, times are changing and the FDA needs to change too if we are ever going to see more accountability from companies as they FDA can only be in so many places at one time and the longer the technology is delayed the lower the level of trust from the American public especially when we can begin work on the technology that is available today.

One other little point worth mentioning, have you ever strained to read the very small print on products with safety information?  I’m getting older like the rest of us in the US and by using a cell phone to scan information, guess what, it turns your phone into one big magnifying glass too, I like that a lot.   As well as recall information, safety updates could be included too. 

Back in 2008 I wrote about a solution involving technology for the food side of this issue with assuring we have quality products without drugs and contamination.

FDA to detain food shipments from China – Why not add some technology to the inspection processes?

I don’t think in view of the current events, there was a lot of choice here for the FDA, and we do need to know that the quality of both our food and pharmaceutical products is good.  With today’s speed of data transmissions, a server farm could be set up to monitor this type of activity and before an over seas factory began to export to the US, this would be a prerequisite to be established.  Each lot before packaged would send the chemical content back to the central gathering agency and report in, with both the US agency and the local factory itself having the information at hand. 

Right now consumers want information and it is great that we are building data bases to provide community information, but are we being like the oil business and putting all the technology into the building stage and not having any back up/clean up plans?  It certainly seems in methodology that this is going right in the same direction and little or no thoughts are going into preparedness. 

One day we will have recalls coming at us right and left as we will need technology to sort them out and give us instant access.  I just noticed a new FDA announcement this morning with counterfeit products with surgical mesh!  Tags can readily help identify the fakes from the real products too.  BD

http://www.youtube.com/watch?v=2AAa0gd7ClM

Technorati Tags: Recalls, FDA, drugs, medical devices, software, technology, healthcare reform, healthcare, safety

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FDA States Genetic Tests Are Considered a Medical Device And Thus Need FDA Approval

The companies who market and provide the interpretations of course are not the processing end of having your genes sequenced.  They are sent out to a company that has the “machine” that does the processing.  The results of the sequencing are returned to the company for the interpretation process so this involves more than just the company doing the interpretation.  Last week 23AndMe was in the news over a mix up with interpretations being given to the wrong individuals.

23AndMe Mixes Up Test Results – Incorrect Processing With Approximately 96 Consumer Samples

The mix up as what has been posted occurred at the location where the sequencing process was done.  I spent many years in logistics and mix ups with shipping are a common occurrence, but with technology in the last few years it is becoming less of a problem.  Logistics companies invest heavily with technology for tracking, etc.  From what I read it appears that someone at the processing end mislabeled the results with the wrong name, and thus it rolls downhill from there, so the logistics portion appears to be ok, it’s just that the orders and names were mixed up and yes it is still a human that does labeling here.  I did an interview with Helicos, one of the companies that makes the “sequencing machine” and you can find out more about the machine process at the link below.

Helicos BioSciences and Personalized Medicine - Featured Interview with Dr. Patrice Milos

In addition, back in December 2008 I had a post that covers some of the areas of interpretation. 

Interpreting the Genome - understanding all the data

So in essence, that “box” you get to submit your DNA for testing is now considered an extension of the sequencing machine to be called a medical device.  I know it sounds a bit strange that the “box” is now a medical device, but it is the combined process that lead the FDA to categorize testing companies as marketing a “medical device”. 

With sending letters to the 5 companies the FDA is asking each to submit their tests for FDA review.  DNA testing is becoming very entangled in many areas of our lives today as police agencies are using it to identify and help solve crimes too, which is a different interpretation without a full genetics background, or least as we know to date, and who knows if areas like that will expand too and how much information they really gather and analyze too. 

FDA Listing of In Vitro Diagnostics - Letters Sent to 5 Companies

I somewhat look for that area of testing to enter into this arena in time as analysis information seems to be a huge addiction and once people have a taste of this, they want more.  Many cities and municipalities are starting DNA banks too so that part of the process will be interesting to watch as well to see when the healthcare/crime solving paths of DNA processing begin to cross at some point and privacy issues come in to play there.  

Basically with consumer marketing with getting some general sequencing provided the FDA is concerned about further mix ups as that is what seemed to ignite this situation along with retail drug stores wanting to sell the “box” on the shelf.  This error factor that occurred also shows the importance of using bar coding and RFID to ensure samples are not mixed up when identifying the owner at the “machine” level too.  Not too long ago, Provenge the prostate cancer vaccine was in the news of being approved by the FDA and part of their process in providing “safety” was to ensure a tracking system so errors did not occur as such.  Now of course here we are talking a very expensive procedure with blood samples and a cancer drug, but the process of tracking and ensuring the property identify are the same.

Microsoft Tags – Microsoft MSDN Posts Ideas from the Medical Quack About Use in Healthcare!

I have several posts on this blog about Tags, 3D bar coding and when keeping track of lab samples we need this today as labs are busy places and doing a lot of testing and the FDA in fact should look into this for a process of recalls too, which today is cumbersome and relies on people reading their website for official notices.  Once your test is submitted, you the consumer get your Tag to trace as well as the company providing the DNA research services for you.  We do this with parcels, so why not DNA testing.  It would actually give credibility to the company doing the DNA testing and keep their contracted processors on their toes too just knowing you the consumer is checking for status all along the way of handling your order.

In the meantime the FDA wants the companies to submit their processes for approval since they are now considered a device.  This is not unusual as recent efforts at the FDA considered Cheerios a drug, again coming back to their marketing campaigns and what they advertised so we may see some additional classifications like this in the future too.  BD

WASHINGTON - The Food and Drug Administration is issuing regulatory letters to five genetic test makers, the first sign that the government is cracking down on companies that claim to use DNA samples to predict inheritable diseases.

The letters posted online deal with specific tests marketed by: 23andMe Inc., deCODE Genetics, Illumina, Navigenics and Knome Inc.

FDA cracks down on genetic tests from 5 firms - More health news- msnbc.com

Technorati Tags: genomics, personalized medicine, DNA, healthcare, sequencing, Biotech, pharmacogenomics, FDA, Tags, 3D barcoding, medical devices

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“The Vanishing Oath” Documentary – One MD Talks About the Process of Being Sued - The Diminishing Doctor-Patient Relationship

Here’s some additional clips from “The Vanishing Oath”.   Here’s my first post from last week in case you missed it and there’s an additional film clip talking to a doctor who is just out of residency for a few years and the stress levels, as well as working part time at Blockbuster so she herself can have health insurance.  

The first clip talks about the legal aspects of what happens on the other side when the patient sues.  First off a short discussion with the “on television” advertising attorney, then we flip over to listen to the doctor who was sued.  His case was filed 3 years after the event, then 3 years of depositions.  A diagnosis was missed and this is one of 3 doctors in the case and there were 3 other specialists involved.  Court case went 3 weeks when the office was closed down and no income or patients during that time.  What is interesting is to hear the mal practice attorney himself admit that the whole legal system with malpractice is greatly exaggerated. 

There’s also a short clip about a pediatrician speaks a little bit about how the current system about the intangible costs like lost sleep and causes him to question himself at times with the current broken system. 

Dr. Wes a blogging cardiologist actually set up a screening for the movie and below is his video recount and comments, a couple from consumers and one from a doctor who attended.  Everyone admits to the same tone, the consumers have no clue what goes on behind the scenes.   Dr. Wes recommends the video to anyone thinking about going into the medical profession so your eyes are wide open going in as things are very different today compared to days of years past.  BD

“We all know the focus is to save money, but at what cost, the relationships that we enjoy as people, especially important when we need healing and depend on our doctors to help us.  Granted we have a lot more information online today and should take advantage as patients to be better informed, but what may patients may not see or realize is the push on the other side that affects the doctors in all of this.   

 

 

The Vanishing Oath from CrashCart Productions

You can also buy the film on Amazon for $21.99 or use your PayPal account to purchase. 

The Medical Quack: “The Vanishing Oath” – Documentary About the Diminishing Doctor-Patient Relationships When the Environment Does Not Allow Doctors To Care

Technorati Tags: physicians, patients, healthcare, healthcare reform, documentary, medical, medical billing, health insurance, non participants, government, technology, health IT, primary care, Vanishing Oath

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Microsoft Releases Health Plan Sales Solution for Microsoft Dynamics CRM – Software for the Payers To Prepare for Health Exchange Intelligence

Microsoft now has software for the other side of the business, the payers.  I have posted a few times about Microsoft CRM Dynamics and even one post that Cerner had made about integrated with Dynamics a while back. 

CRM - Microsoft Dynamics Healthcare Presentation

Marketing analysis is going to become more detailed from the insurers.  Anyone using Dynamics has the option to host at their own location or in the cloud as the Azure platform expands.  I tried a few years ago to get more hospitals to listen up with CRM software but a few years ago not too many were interested and I used to say that an EHR is a highly sophisticated CRM program of sorts with a few other goodies thrown in.  Long and short of all of this, insurers are getting new “machine gun” technology” algorithms, so we need to do the same to keep up somewhere along the line so we no longer have to battle with “swords and daggers” as we know how those odds work.  We just still need some hybrids as leaders and examples if that ever becomes possible in government and finally kill off the dying paradigm of “its for those guys over there”.  BD

Press Release:

Platform enables health plans to better recruit and retain customers while preparing for future state health information exchange requirements.

LAS VEGAS — June 10, 2010 — Microsoft Corp. today announced at America’s Health Insurance Plans (AHIP) Institute 2010 the Health Plan Sales Solution for Microsoft Dynamics CRM, a strategic sales and service-enabled customer relationship management (CRM) platform that will allow health plans to quickly and easily move their marketing and sales processes online to better manage and monitor sales, member service and retention. As a result, health plans will be able to better compete in the individual and small-group market, reduce multiple points of failure in their current sales, service and retention processes, and interoperate with state health insurance exchanges.

The Congressional Budget Office estimates that health reform will expand coverage to 32 million by 2019 and 24 million will be enrolled through exchanges by 2019, not counting employer coverage, meaning health plans need to quickly take advantage of this short window of growth or risk losing share and revenue to competitors. According to a recent Gartner report, “Health insurers that do not have effective online sales and service functionality for the individual market must immediately establish such capabilities to compete in the current market and meet future requirements of exchanges.”*

“In light of changing regulations, health plans must now focus on winning share and loyalty through adaptive and efficient sales processes and exceptional customer experience while preparing to integrate sales and service processes with each health insurance exchange in 2014,” said Dennis Schmuland, director, U.S. Health Plans Industry Solutions, Microsoft. “Through a comprehensive CRM strategy that is pre-integrated with various touch points in the sales process, our Health Plan Sales Solution for Microsoft Dynamics CRM enables insurers to easily and quickly capture critical sales data, reduce the cost of sales, service, and retention, and interoperate with state health insurance exchanges by 2014.”

The Health Plan Sales Solution for Microsoft Dynamics CRM is an interoperable framework that allows for more seamless integration with existing systems and applications. Partners can pre-integrate their solution to offer health plans a seamless workflow across different applications, and a number of Microsoft’s trusted partners, including Ingenix, CosmoCom Inc., VUE Software and Colibrium Partners LLC, are already supporting this framework.

The platform enables insurers to more easily design and deploy a complete CRM strategy that spans acquisition, retention, health and care management, and service, and it tightly integrates social media sites into the sales, service and retention processes. With the platform, payers also will be able to reduce custom legacy integration costs and maximize their existing investment in both Microsoft and non-Microsoft technologies. In addition, the Microsoft Dynamics CRM solution can be deployed wholly on-premise, in Microsoft’s cloud computing platform, or as a hybrid solution that provides the flexibility, improved security and cost management that health plans want.

“Health insurance is an increasingly complex and challenging environment to work within because of the ever-shifting regulatory, patient and business landscape, which directly impacts our underwriting efforts,” said Jeff Berry, vice president, Underwriting, Blue Cross and Blue Shield of Kansas City. “By deploying the Tuo product suite integrated with Microsoft Dynamics CRM, we will be able to quickly expand and change underwriting methodologies as the market shifts without costly development efforts. This will help us achieve significant efficiencies, which directly benefit our customers.”

About Microsoft in Health

Microsoft is committed to improving health around the world through software innovation. Over the past 13 years, Microsoft has steadily increased its investments in health, with a focus on addressing the challenges of health providers, health and social services organizations, payers, consumers, and life sciences companies worldwide. Microsoft closely collaborates with a broad ecosystem of partners and develops its own powerful health solutions, such as Amalga and HealthVault. Together, Microsoft and its industry partners are working to advance a vision of unifying health information and making it more readily available, ensuring the best quality of life and affordable care for everyone.

About Microsoft

Founded in 1975, Microsoft (Nasdaq “MSFT”) is the worldwide leader in software, services and solutions that help people and businesses realize their full potential.

* Health Insurance Exchanges Play a Key Role in Health Insurance Reform, April 20, 2010, Joanne Galimi and Robert H. Booz

Technorati Tags: Microsoft Dynamics, CRM, health insurance, healthcare, software, Dynamics, customer relations management, algorithms, business intelligence

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Hospital Tagging Babies for Tracking - “Tagging Tots”

This will help stop people from kidnapping babies for sure.  It appears to be some type of RFID device and is attached at the belly button.

It almost reminds me a bit of the tags we see in the stores to prevent shoplifting and requires a special tool to remove it.  It doesn’t hurt or harm the baby in any way and actually the newscaster with the story in the video said she experienced this at another hospital and was highly in favor.

We are already hearing about hospitals using RFID and other systems in the ER Rooms too.  Last year in Hoag Hospital a Hi-Tech solution was installed in their ER department.  BD 

Hoag Hospital Installs Hi-Tech Emergency Room Patient Tracking System – Orange County

 

Nebraska - A hospital comes up with a creative way to make sure newborn babies cannot be kidnapped from the nursery. Tagging a tot is how a Nebraska hospital is bringing peace of mind to new parents.

They are using a special chip to keep track of newborns ultimately preventing possible abductions. It works like a GPS but is slightly different using radio frequencies instead of satellite.

Nebraska Hospital Uses New Baby Tracking Device

Technorati Tags: RFID, hospital, babies, safety, kidnapping, nursery, nurses, healthcare, Heatlh IT

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ScrubsGallery.com – June Reader Discount

Again, I thank ScrubsGallery.com for advertising with the Medical Quack. 

This month they are offering a discount on General Nursing Scrubs with the special code below.  BD 

For a limited time, you can get a 10%  with nursing uniforms by using the code “savescrubs_l2” on your order!

Next time you need to order scrubs or other healthcare apparel, please check out their website and compare. 

Thanks again to ScrubsGallery.Com for supporting the Medical Quack!!

Technorati Tags: MedicalQuack, ScrubsGallery.com, Advertising, lab coats, scrubs, healthcare, apparel, sponsored ads

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Rapping About Stem Cells (Video) All You Want to Know!

Maybe we should get the folks over at Extormity to rap about EHRS (grin).  The folks over at InVivo Blog came up with this one.  Watch for the outtakes at the end of the filming.  BD

The IN VIVO Blog: And Now, It's Time for a Rap About Stem Cells

Technorati Tags: Stem cells, rapping, education, InVivo, blogs, healthcare, technology

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Long Beach Memorial Medical Center in Talks to Acquire Community Hospital of Long Beach – The Best Thing That Can Happen Here

Ok I’m a little outspoken, but have some personal experience here that goes back a few years.  This hospital was run by executives that literally “ran for the hills” when I was present as a consultant doing some work for them, not everyone of course or I would have had no work there as there were some calling for my services.  They need Health IT in the worst way and it goes to years of neglect and fear from the number of “non participant” managers they had. 

They are moving ahead now but I had to work with an IS manager that should have never been in the position he was.  He was promoted to that job as the higher up executives shared no interest in Health IT, thus had no clue what type of individual and what skills they needed to fill the job.  I literally went around the system and found computers on the network with no virus protection!  In addition to that I found employees who had Active Directory access (Outlook Exchange) that were not added to Group Policy…hello…was there anyone home!  Employees were using peer to peer video and music sharing programs and nobody even knew why they should not be on a hospital network!  We have all read the many posts on this blog and all over the internet about confidential information being shared. 

I did some consulting on a software nutrition program to be used with grants for the outreach programs with Cal State Long Beach students and the IS manager didn’t even know how to install an instance of SQL server and had to help on that and I didn’t know their network configurations but could help him figure it out! Thank goodness I took my tablet to all the meetings I had with this individual as he remembered nothing.  See there are real advantages to not using paper even for handwritten notes and I could query and find my notes in a heartbeat. 

In addition, they had no remote support so I showed and instructed the IS manager on how to set up an internal VNC (which is free) network of software support so they could give users support without having to physically leave the IS department.  Since this time they have had a couple other IS managers in place who were notches ahead of this one individual. 

Please acquire this hospital and help them out or at least contract for some IT service from the areas of expertise that Memorial has!  They have a lot of great people working there and it was not their problem at all, just management that was scared to death to talk any type of Health IT.  I tried 3-4 years ago to get some interest in CRM and like talking to a blank wall.  I have never seen upper management with such a big “fear” factor in my entire life of consulting. 

Long Beach Memorial Hospital on the other hand is the exact opposite and very much up to date, and I have never done any consulting there, but have a couple of interviews with how they progressed with technology and this is why I say they need to acquire that small hospital and help them out so more people don’t lose jobs. 

If you look in the upper right hand corner of this blog at the QIK videos, look at video number 2 to hear their Chief of Cardiology, Dr. Mike at the hospital who is a great guy and doctor.  He spoke a little bit after one of my presentations about some of the “free” technology help they could avail themselves of, since they weren’t getting any advice otherwise and I offered to do a presentation to help out.   A while back I encourage the hospital and with the help of Dr. Mike they entered the hospital into the Siemens “Win an MRI” contest too.  Dr. Mike, by the way saw the notice on this blog and got involved. 

Many of the physicians at Long Beach Community are also on staff at Long Beach Memorial as well so from here it looks like it could be a good match. 

What happened there at Long Beach Community Hospital in those years should never be allowed to occur with lack of technology, it was sad and needless, and again the big fear of technology and tech denial were the big things driving it all, again so very sad!  I was frustrated as I could not seem to perk that “level of curiosity” here as hard as I tried. 

Ok enough of a rant here, so let’s look at how far Long Beach Memorial is moving along, they are doing wonders by comparison.  A while back I had the chance to interview Dr. James Leo on their conversion to electronic medical records.  It’s a great interview with Dr. Leo going into some really good detail with their innovations through the change over too.

Long Beach Memorial Center’s Conversion to Electronic Medical Records – Interview with Dr. James Leo

The Children’s Hospital at Long Beach Memorial recently opened a brand new facility and I had a chance to take a tour with the CFO not too long ago and what they did with building the new hospital in using both “green” technology as well as Health IT was phenomenal.  After the tour I attended the opening ceremony.  

Miller Children’s Hospital Long Beach – Brand New Pavilion Carries Focus on Patients and “Green”

This could end up being a real plus for both hospitals!  BD 

Long Beach (Calif.) Memorial Medical Center is in excusive talks to acquire Community Hospital of Long Beach following a period during which the 452-bed medical center would operate the 81-bed hospital, they said in a joint announcement. 

Community Hospital of Long Beach reported a loss of $1.1 million on revenue of $313.3 million in the fiscal year ended Sept. 30, 2009, according to the online American Hospital Directory. Long Beach Memorial, meanwhile, tallied a profit of $53.7 million on revenue of $1.8 billion for the period ended June 30, 2009, according to the directory.

Calif. hospitals explore possible acquisition - Modern Healthcare

Technorati Tags: Long Beach Community Hospital, Long Beach Memorial Hospital, healthcare, Health IT, tech denial, acquisitions and mergers, software, IS, IT

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