In computers, medical software is a significant branch of software engineering. Many medical devices that monitor or control patients are predominantly controlled by software. Medical devices are frequently regulated and must comply with local and regional laws. In the European Union, these includes the Medical Devices Directive. In the United States, the Food and Drug Administration has increased its involvement in reviewing the development of medical device software starting in the mid-1980s, where coding errors in a radiation therapy device (Therac-25) resulted in the overdose of patients.[1] FDA is now focused on regulatory oversight on medical device software development process and system-level testing.[2] In the recent years,1995-2005 IEC 62304 has become the benchmark standard for the development of medical software.
Contents |
Medical Software could be classified simply into the following groups, depending on its use. This is called utilitarian classification by Harry Gouvas 1988, but sometimes there are overlaps:
Examples: A program that monitors and shows the heart rate, blood pressure and blood oxygen, a monitor, is the built-in diagnostic software, Category IIa. A free medical program called eg "Infection" that accepts symptoms and makes diagnosis of infection, belongs to the Ib. A program for example the "Scan" which is loaded on a CT scanner and processed by the X-ray signal, to reproduce the picture, belongs to a class IIa. A program eg the "Press" built in "chip" a digital sphygmomanometer, belongs to a class IIa. A program example in "Coral" of a company that manufactures total hip and Freedoms (PC designer) belongs to the class IVb, while the program eg the "Coral-CAD" embedded in machines for cutting and construction of intentional belongs to IVa. The software that controls the machine Laser Surgeons in patients with myopia automatically belongs to the class IIIa. As noted above there may be overlaps. This is particularly true in the category (I). A medical education program, might well have as its object to diagnose or treat disease.[3]
Computer Aided Diagnosis is a procedure in which an appropriate medical Medical Software can diagnose illness, using patient data processed by the computer. These data were once only symptoms, laboratory findings, and radiographic findings, but were inputed as text only, not allowing image processing (eg software for bone tumors "TUMOR", 1991). Currently registered and processed at the Medical Software, and photos. For example, there is a Dermatology Software that processes a picture and give skin lesion diagnosis by comparison to a database (Skin Lesions, Expert System). The definition given by the English Wikipedia entry on Computer Aided Diagnosis, no literature, is obviously inadequate and wrong. He writes: "Computer aided Diagnosis are procedures in medicine that assist doctors in the interpretation of medical images". This article will not deal with the integrated diagnostic medical software industry, it is almost nonexistent communications and publications on this because of the confidentiality of manufacturing firms. We will deal with free Diagnostic Medical Software. As is known by the announcement in 1945 of the Computer ENIAC and the subsequent large-type systems IBM 360, o journalistic world had a new invention as "the machine in the future will answer all questions." It is characteristic of the two-page article in the newspaper "Acropolis" in 1967 entitled "Electronic Brain: A machine will answer all questions". Medicine that has been recognized as an apple and leave the eye, is the Differential Diagnosis of the process that is followed by their doctors to make diagnosis. No other profession or machine can do this work because it requires a complex algorithm thought that even in the hands of excellent doctors in the world, have error rates above 20%. Diagnosis is a complex process, and physicians should be trained 6 years to acquire the basic knowledge of (Medical School), and others 6-7 years to specialize in one subject (medical specialty). The gift of a doctor to memorize a lot of knowledge but rather to properly process this knowledge with sharp critical thinking is a valuable and scarce resource that is not presently be analyzed. There are rare cases of patients with unclear clinical picture, be hospitalized for a month, have done a test volume, and nobody knowing what they are. This course was previously ad nauseam. Marshal Papagos for example in Greece, died months after hospitalization, and no one knows the cause of death, and marched on the bench tops European dozens of Medicine and Surgery. Today the phenomenon tends to decrease dramatically due to the high-tech, but still there. Early in the decades 1960-1980 Independent medical research and medical groups in the U.S. received the message from the invention of computers and watching in front, thought to use these machines (main frames) for differential diagnosis in difficult cases, designing the appropriate software. Of course the reaction was intense. Raised objections to the application of Computer in Diagnosis (Computer Aid Diagnosis) with the main argument as "If the computer makes a mistake, the failure of software, who will bear the criminal responsibility of medical error?". Of course, this is wrong, because the final diagnosis signing will bring the doctor, and the role of the PC will be helpful. Even today, the medical community sees with eyes half free medical diagnosis software, but accepts de facto when incorporated in a machine, because you can not do otherwise. Who ever complained, because CT or MRI or Ultrasound not catch any diseases? Before marketed the first Personal Computer IBM-PC (year 1983-1984), the U.S. already created the first experimental Medical Software Specifically target use. Perhaps the first Medical Software warming is the "BRAIN" of the neurologist D. Filkenstein (year 1976) for the differential diagnosis of complex neurological diseases. "MYCIN" software was followed by E. Shortliffe University Stanford USA, for the differential diagnosis of microbial infections. But what caused a lot of noise and optimism was the "INTERNIST / CADUCEUS" researchers Pople and Myers, University of Pittsburg, USA, which could process 4,000 symptoms and diagnostic parameters from 500 diseases of Internal Medicine (Internal Medicine). Since then , nobody knows what happened to these software, and if converted into a format suitable for running on PC.
As mentioned above, today the internationally applied Medical Software has settled in the following areas:
Education and medical practice over days, new prospects are enormous as are the following possibilities:
It is certain that the technology at the Medical Software and Medical Devices running fast. The average doctor, let alone the average citizen, unable to keep pace. But the years that medical knowledge and access to high quality medical services, was the prerogative of few, gone for good. Whether this development will bring improvement of health of the population of the earth, that is another question that requires much thought for a response.
The first form of medical software for PC that were traded worldwide were operating programs for Clinic and Hospital Management, and of course they ran into a MS-DOS operating platform. Even today this is happening. Such programs are prevalent in the days during practice. So do register patients, record history and management of financial data. Just be improved and run on Windows. But especially in Greece was the inverse paradox. Even before release programs and historical patient records of patients, Harry Gouvas, Orthopaedic Surgeon and Nick Polyzos, programmer,software engineer, designed in two years 1985-1987 and after working 6 months in 1987 showed public primordial for the current data plan on Artificial Intelligence software "OSTOUN", designed in language Turbo Pascal. This software, running on MS-DOS, announced its type and was issued in printed and electronic form. Facilitated a new doctor, to see instantly what can be hidden behind a range of musculoskeletal pain, and was the first Medical Software in Greece, and also in Europe [4]. In 1990 the two above Harry Gouvas and Nick Polyzos designed and presented the Medical Software "EXAM" an automatic guidance software for the Clinical Orthopaedic Examination of patients that "do not escape anything"[5]. In 1992 after working 12 months, Harry Gouvas and Chris Karatzoglou, created a spectacular season for Medical Software in Greek and English Version, with the name "TUMOR". It was implemented on Artificial Intelligence in programming tool Clipper and D-BASE III PLUS and belonged to the group "Systems of Knowledge Base". In this software, the user at a time of 60 seconds, records clinical data from a patient with known bone tumor, and after the radiological signs of bone tumor by radiography. The program processes the data, compares with the database and is statistical diagnosis, in 10 seconds. Eg. Bone cyst (98%), Osteoeides Osteoma (68%), etc. Since the tests were the success rate of software TUMOR was 99%. Due to lack of funding, this Software is not converted for use in a Windows [6] Later in 1994 the two above, created the Medical Software "ORTHO" for recording patient orthopedic clinic and retrospective statistical analysis.