The intelligent infusion pump precisely controls the dose to be administered. The automatic defibrillator pulls the heart attacker back from the edge of death. The pacemaker and artificial heart ensure that blood is delivered to the body at normal frequency to maintain life...
Medical instruments have created miracles, but the more advanced they are, the more sophisticated they are, the more they rely on computer software. And once the program goes wrong, it may take life.
As a result, scientists began to develop an "open source" model of medical instrument design platform that both enhances safety and encourages innovation.
Fatal error
The United States is the world's largest market for healthcare products, and more than half of the medical devices sold in this market rely on computer software and often multiple software. A pacemaker software may consist of more than 80,000 lines of source code, a smart infusion pump requires 170,000 lines of source code, and an MRI scanner requires more than 7 million lines of source code.
According to the US Food and Drug Administration (FDA), between 2005 and 2009, there were nearly 20,000 cases of serious injuries caused by electronic infusion pumps, and more than 700 deaths, of which software errors were the most common cause. For example, the operator only presses the button once, and a certain code in the program is wrong, resulting in multiple repeated instructions, which will cause overdosing.
Source code medical instrument
Congenital deficiency
In addition to human control factors, some medical instrument software is "congenitally insufficient." Before the instrument was put on the market, manufacturers were often less secure when testing software, not as cautious as other high-risk manufacturing industries such as avionics, and lacked the sensitivity to follow up on software engineering.
Insop Lee, a professor of computer science at the University of Pennsylvania, said: "Many manufacturers don't understand or want to use new tools developed in computer science."
What is even more disturbing is that these medical instrument software are insecure, and often have to wait until life is known. The source code of most medical instrument software is closed, and the patent rights are in the hands of manufacturers. This can prevent commercial competitors from “plagiarizing†and “cottageâ€, but it also hinders software security technicians from discovering flaws and loopholes.
In theory, the FDA has the right to request to view the source code of each instrument software approved by it, but it has not become a practice, but to allow manufacturers to verify the security of their own software, the fairness of this "self-examination" and The effectiveness can be imagined. Two years ago, in order to reduce the accident rate of infusion pumps, the FDA proposed free software testing for infusion pump manufacturers, but so far no manufacturer has accepted the "goodwill" of the FDA.
New concept
Since manufacturers are unwilling to cooperate, scientists have decided to start from scratch and build a medical instrument industry based on a new concept. The foundation of this philosophy is open source technology.
In an open source system, the software author or copyright owner opens up the source code of the program for others to use, view, or modify, providing sufficient space to discover bugs and continuously improve the software. Open source technology advocates believe that this will make software products more secure.
The "Universal Infusion Pump" project jointly developed by the FDA and the University of Pennsylvania is an attempt based on an open source model. The researchers first collected all the problems that may occur in the infusion pump, designed the existing and new infusion pumps on the market into mathematical models, conducted risk tests one by one, and wrote the program code according to the model with the best performance against risk. Manufacturers can also modify the program as needed to add features to differentiate their products from their competitors.
The University of Wisconsin-Madison's two medical physiologists, Rock McKay and Sulendra Pragapatati, hope to design a radiotherapy with high-resolution CT (X-ray tomography) and PET ( The positron emission tomography) is a combination of diagnostic functions.
Prajapati said that the cost of manufacturing such a machine is only a quarter of the price of a similar scanner on the market. The cost of purchasing and maintaining PET-CT diagnostic equipment on the market today is high, and instruments in open source mode are more sustainable. "If you can build a machine by yourself, you can repair it if you are broken."
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