Electronic Data Transmission from Medical Devices

As a former med student who has become an engineer I might take a stab at this.

The biggest hurdle is integrating the data. All of these devices speak in their own language. It is like trying to archive all of the speeches in every different country and language into one place. You need a massive amount of translating somewhere along the way to create a database that is coherent.

To a limited degree that is happening, but it very difficult to get all of the many players to agree on what that common language should be and the transmission protocols that carry them.

Struggles like these are common. Even now the music and video industries are jockeying to develop new standards for the DVD and CD formats. The good news is that there is a lot of profit to be made once they settle on that format. In the medical industries the profit that would drive those changes is probably not as robust as in the commercial DVD business.

If a manufacture of say an X-Ray machine decides that they want to implement some standard, if one becomes reality, they have to determine what the extra engineering costs are to implement that, what the manufacturing costs are, and what the market payback will be. If doing that does not improve their current market share, then it is not going to happen. So, from a business point of view there may not be a compelling case to do it. However, the first hurdle is determining a standard.

One way around the standard problem is for a third party to make a universal translator (like Star Trek). We call them Happy Boxes in the aviation business. Again, there must be a compelling profitable reason to drive that and you need the financial muscle to make it happen. For any one company to do that would be a monumental task gathering all the different protocols, writing the software, and designing hardware to translate the signals and their protocols into some universal format that can be integrated into a single usable database.

Either way, it is a great idea and it will eventually happen, but I think it is a long uphill path to get there.

What kind of practice do you have? Do you have a specialty?

Ted, you say you moved to the U.S. There's something here that may not be true wherever you come from: especially in the medical business, you can't walk across the street without being sued. No matter how well something works, if it ever fails - and what doesn't? - the manufacturer is liable. So the profit potential must be HEEEUGE to overcome this barrier. (I've written before about how many great ideas Medtronic passes up.)

Another problem is the pressure that the nurses are under to provide care to the patients that are more severely ill than in days gone by. They are expected to be able to not only log-in all the pertinent data/information, dispense the medications (electronically recording the data) and deal with the patient, families and medical staff (doctors, specialists, etc.). Many times (particularly in older hospitals) there is not enough space in the room for equipment required to perform the data collection, med dispensing, assesment, etc. As you also mention with all the different systems trying to communicate there are often different systems required, thus your nurse is not only a patient care specialist, but an IT technician as well. Please correct me if I am wrong, but even some of the best and biggest hospitals (Stanford for one) are still using paper, because all the records are in one folder and all you have to know is how to read. Which does bring up one thing that the computers have definitely made easier, reading the prescription and doctors chicken scribbling.

Hello I appreciate your input and I agree to all you are saying. I see it everyday in practice at my work. Yet, I am looking for something very simple compared with what you rightly describe as gigantic tasks by manufacturers to adopt to a standard language, (if such things would happen would set these the standards?), or the start trek approach of the company willing to do that. What I have in mind is storing the ultimate results in a database. For example a blood gas analyzer determines the O2 or PCO2 partial pressures and pH in blood. Usually the results are expressed in numbers delivered to physicians in pieces of papers or their electronic records. Can a device direct these test results to a database and store them? The same for the medical devices that have as ultimate results images (X-rays). I believe that there are only few languages used to produce images. Can they worked in order to fit to a database? I apologize for my poor technical language and I hope you understand what I mean. If something is unclear let me know please. Thanks

Add to the above, issues regarding privacy. You can't even find out about yourself these days without already knowing most of the answers, unless happen to be a criminal that is...

One more "also this:"

The technology is also in a constant state of flux. If you look up any of even the most widely adopted standards, you'll find that they have a history of being changed periodically as new developments come available.

I think it would take a dominant player in the medical device manufacturing arena, with the desire to make all their devices subjugated to a uniform communications standard in order to promote a new derivative product, before this could happen.

Before reading other posts, I would have said: "Isn't this already in place? Isn't the data either in image form (Xrays, CAT scans, etc.) or alphanumeric form? When I take my daughter to the orthopedic office, her Xrays are available electronically, as images, whether or not they were taken on site." Is the problem in file formats (e.g., TIFF vs JPEG) or is there a need for one machine to communicate with another in something closer to machine code? (So one can reprocess data from the other?). This may all be clear to the medical types, but perhaps a couple of examples or analogies would help non-medical types come up with suggestions.

Ted, My background is EE and CIS. More info needed to the overall system, but here's the summary. 1)File formats(lossless (probable) or lossy)including compatibility with web based GUI unless custom GUI is used. 2)Database formats (see XML) this is the text based language used to adapt multiple formats to other multiple formats (the many to many database issue)where all XML formats can be hosted by one "happy box", as mentioned by prior post. 3)Periodic Capacity and need for daily bandwidth requirements. 4)System architecture of overall system interfaces is key. 5)See open software PGP,mySQL, apache server, etc for free software to generate entire system, but be aware of GNU licensing issues. 6)Physical interface : probably want to use fast USB2.0 or IEEE1394b interface and high speed hard drive for collection. 7)Use server software to deliver across internet in Real Time or in block data over night time. 8)Don't be hiding information in images (steganography), the DHS folks will be at your doorstep. 9)Bottom-line after all is said and done--can you make a profit. Your cost must be less than 20% of price for typical market products, but with medical and the posted issue this could be much greater

This is something. Although I do not understand anything on it. It is a start for me however kind of building stones. The costs: whatever the costs might be in general they are one time costs (except for maintenance, new features, etc) and the market is huge (borderless). With a careful market analysis, we can determine who the buyer of the service will be. I do not think that physicians are the buyers. Contrary to the common wisdom and the pressure that monmouth software companies put on them to buy their products, they do not need such systems. The medical profession is still based services revolving around one patient rendered at least by one provider at a time (sometimes many provider at a time). It is not like other industries where the computer device has helped mass production. Quite the opposite that people tend to undermine. The other crap that of computerized order entry or the stupid thing of error management is quite a waste that has led to multimillion computer systems that everybody hates. Doctors do not need reminders for doses of not even 10 drugs that they use in daily practice. Authorities should ban remote computerized order entry or that practically is the management of patients remotely. This is outrageous that a physicain make orders for the treatment of the child of a parent that brough him to ER for a lifethreatening condition. My point: doctors will never need a computer system to manage the patients. Then who will? Most of all the payers, the government/s, the policy makers, the academia, the industry sector research and develpment branches. Each of them will need certain data to continue in thier business. Look google, my space, and other websites how they have turned on repositories of data that so much in demand. Sorry for this long outburst. Although I appreciate very much commenting in this site I would like that you contact me directly at ttodhe@aol.com thanks

You will also need to check with the FDA on this...Since you are dealing with patient information they may consider this a medical device. You will also need to make sure that the information can not ne comprimised or accessed by unauthorized persons. I believe that this is a HIPAA (not sure of accronym is correct) requirement. You stated: "The medical profession is still based services revolving around one patient rendered at least by one provider at a time (sometimes many provider at a time)." What happens if you have a patient with the name of John Smith and another patient with the name of John Smith? I agree that services are based around one patient but how do you differentiate John Smith from John Smith? In order to do this you assign a unique identifier to patients, now you have started to increase the layering of information (increase your information overhead [another piece of data that needs to be stored and tracked]). With what you say "The other crap that of computerized order entry or the stupid thing of error management is quite a waste that has led to multimillion computer systems that everybody hates." The error management is requied to make sure that the correct patient information is displayed and does not create a faulty diagnosis (Faulty diagnosis means... law suit for the physician and law suit for the equipmetn/software manufacturer!) Typically systems of the type you are contemplating will not be a couple of hundred dollars but will be more in the area of 100's of thousands of dollars and not in the realm of the family practice office.

The type of systems you are talking about are generally called clinical systems. They are more or less fully available right now but the cost of implementation is high so getting the hospitals to sign on is a lengthy process although the hospitals realize that this is where the future lies. The 2 key players in this game are Siemens Health Services and GE. There are a number of other very minor players.

I am afraid that I have to disagree with this. It is true that, as I said in my previous message, there are many companies that dominate the market like Siemens, GE (although I do not know of any clinical system that has been adopted; I know that they have participated and perhaps won the bid for computerizing the national health service in UK), CITRIX, and other. Their products are simply not usable by doctors. My previous employer, a big hospital in NYC, was using one these systems. I believe that they have dropped it now. Such systems are cumbersome, time consuming for the physicians and other staff, too many flags and warnings most of which are being constantly ingored, too many and uneccessary clicks/steps to reach to a point, and prone to flaws and mistakes. Increasingly, various authors are writing in medical litearture about drawbacks of such system. The worst these big companies do is that they exercise presure and force on providers and force them to buy thier products surprisingly with a great success so far (I was told it is politics, something hard to believe for me as a newcomer in this country). The funny thing is that while hospitals have these systems in use, the executive staff say such systems are state of the art. The next day they have switched to the other but not before they have wasted hundred of millions and much more worth in productivity. During these last days I have been searching in three web sites about about innovations that have been issued a patent in this field. There is a lot of interesting stuff. The most amazing was one patent documetn describing an innovation that claims about a device that is implanted WITHIN the body (Internal Aggregate Data Device or something like that) of the person that collects information from medical devices OUTSIDE the body (external devices such as ECG, etc.) stores them and then periodically uploads them into a computer OUTSIDE the body (wirelessly, fortunately. At least they were not claiming to do that through wires coming out of body. Out of body, which part?) and then these data can be used by the doctors as need arises. This is sick fantasy. It is like espionage James Bond movies. The things is that such claims embody valuable information about monitoring and storage of data, processing and the display, and over all data transmission between various systems. I am amazingly surprised why they do not get it right as it should be. Sorry folks I am not going to elaborate further because that simple things that I have in mind is worth something. This site is great. You all have a nice labor day weekend.

Any clinical system you may have been involved with in NYC hospitals is of a prior generation and was unwieldly for that reason. Newer systems are better and that is why hospiatals are migrating their systems in that direction. The benefits are huge. Is it the answer to all the issues? No, as I said it is however headed in the right direction. The reason hospitals invest millions is becasuse there are substantial revenue savings involved with the newer systems that make them cost effective. The overall benefits do trickle down to the patients through improved services. Advances in the ways of doing things have to be payed for as you go. For example if you had a computer with Windows 3.x and you say I am not going to buy another computer and waste my money on an interim system, I'll just wait till I can buy the final developed product. Well, lo and behold you will be operating in the dark with outdated and unsupported product because the world has moved on and left you behind. Your computer with a Windows 3.x OS cost $3,000 and now open the papers and you can buy a Windows XP system for $500. You'd be stupid not to buy a new system and take advantage of the increased benefits of newer technology. Did you waste money by buying the $3,000 system 10 years ago. No, because the benefits were there then also. Politics are an issue but generally in this case they seek to maintain the status quo, not to stick one's neck out and not to seek new ways of doing things. The formula for success is very complex.

Medical Technology - Higher Reliability Arena

I strongly believe that medical technology need to cover risk factors and must come through high reliability evaluation process. This must be true for hardware as well software that goes in diagnostics of sickness and handling of medical emergencies. Whatever is used, including software much be highly trustable.

While failure may take place, heavy compensation for death or disability need to be paid. Any negligence caused by use of inferior medicine or non-standard equipment to be punished. Person must know the risk ahead of implementation of treatment and must agree to take risk but that is no excuse of negligence at all.

Not for medical use tag is very essential on equipments that are not covered by risk factor and are not subjected to rigorous reliability tests.

What if some instrument gives wrong result and does not warn about possible error and one takes medical treatment and suffers as a result of wrong information. I have a blood pressure equipment bought in UK which gives very wrong results and it does not warn if battery was low or the result to be trusted or not. I think this company can be put to serious trial of negligence.

Imagine a pacemaker devices implanted in the body gives shock or fails to work or leaks heavy metal in the body and poisons the body or is triggered by electric spark or mobile phone RF. After all such devices are for over 10 years reliable working and one can't put a person on operation table the next day.

Medical instruments needs to be proved worthy and must undergo tough tests of reliability and need to be covered of all risks and payment to the person likely to suffer from its use. No hotchpotch technology should ever be allowed for medical use.

In one cancer hospital I found that they were giving radiation exposure without monitoring if the machine was actually delivering the dose or not. They even didn't know if the radiation was ever stopped or not. All they were doing to push the button and look for timer. If person did not receive dose then the person will be dead due to no radiation dose and if machine was giving extra dose or source was always on then both operators and patients were to suffer serious radiation burns. They had equipments for radiation warning that had never worked, as they never replaced the battery. Most of the monitoring equipments were kelp in the closed selves, as they feared theft. In one factory I even found a man holding open radiation source in his hand, which was radiating lots of harmful beta radiations. Some technicians and nurses were found spending a lot of time in Radiation therapy room taking tea breaks and rest. I also found small children playing in radiation areas and mothers were never told that pregnant women are restricted in such zone.

There is lots of negligence, lots of problems in medical area and this area need to be improved such that people can get best chance to have good life again.

Shyam
Radiological Health Physicist, India