Open source, a “natural” solution for medical devices

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Medical devices are an integral part of the range of resources available to the medical profession to best perform its mission. Their design should leave little room for improvisation or chance, because at the end of the chain, it is often a patient who can suffer the consequences. Open source provides an answer to this problem by allowing a sharing and an audit by a maximum of specialists of “security flaws”.

Health is a particularly regulated and monitored area. In terms of medical equipment , the constraints are just as strong. Hence the idea of ​​using the same methods that have proven themselves in the field of open source software for their design.

A parallel that can be made to illustrate the topic concerns software whose main function is to ensure the confidentiality of certain exchanges through encryption mechanisms. These often open source software have their code exposed publicly. One could then think that it is easy to circumvent them, but it is not so. On the contrary. The opening of the code allows a constant review and a detection of the defects which can then be corrected quickly.

The opening of the code also makes it possible to disseminate the tool as widely as possible, thus reinforcing the possibility of increasing the number of people who will audit the code and propose improvements and corrections. This is about creating a community of interest around software.

The same mechanism can apply to hardware. This is known as open-hardware or open hardware . The specifications, that is, the production plans are made public.

Still many “closed” solutions

In the medical field, the use of patents and manufacturing secrets is still the rule as it is considered the only way to maximize the gains from research and development work. If from a financial point of view this is probably true, it is not always in the interest of the patient sometimes victim of the failure of medical equipment.

A study from the University of Patras, Greece, shows that one in three medical devices sold in the United States was recalled between 1999 and 2005. The FDA discovered that drug infusion pumps were linked to 20,000 serious injuries and more than 700 deaths between 2005 and 2009.

For the moment, work on open source medical devices remains in the field of experimentation. Here are some examples of open source projects:

  • The generic infusion pump project;
  • The Open Source Medical Device Initiative at the University of Wisconsin – Madison is working on a high resolution medical body scanner combined with a radiotherapy machine;
  • The Raven Surgical Robot is an open source system (see photo at the top) that was designed at the University of Washington, Seattle. Personally it makes me a little afraid.
  • The Plug-and-Play Medical Device Interoperability Program is a $ 10-million initiative (funded by the US National Institutes of Health with FDA support) to implement standards. open;
  • The medical equipment coordination structure, currently under development at Kansas State University, aims to create an open source hardware platform that includes interchangeable buttons and displays, as well as software that connects them to sensors. and other devices