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Risk of Medical Device Injury: Closed Code May Sour Medical Devices

The reliability of a medical device such as a pacemaker, medicine pump or defibrillator is a life or death issue. When a medical device fails, most people think about the deficiency in the appliance or hardware and overlook the brains of the device. But it turns out that the software used in medical devices is just as important to the reliable functionality of the device and the health of the person the device assists.

The failure of medical device software is a serious issue. Between 1999 and 2005, one-third of all medical devices sold in the U.S. that rely on software were recalled for problems with that software.

The vulnerability of software-based medical devices stems from two concerns: software bugs and hacking. For example, problems with code can cause the accidental misadministration of medicine. According to The Economist, software errors in drug pumps were involved in 20,000 serious injuries and 700 deaths between 2005 and 2009.

And medical devices that are networked can be open to hacking. Research has shown how an implantable defibrillator is susceptible to being reprogrammed to withhold treatment or to deliver unnecessary shocks.

Does Closed Software Code Result in Defective Medical Devices?

Experts say the root of both problems lies in the medical device industry's use of closed and proprietary software, which inhibits the industry's ability to use the latest software engineering advances and contributes to a safety culture that is lacking.

Closed and proprietary code prevents individuals outside of the medical device company from being able to access and improve upon the code. The system makes it more difficult for security researchers who do not work for medical device companies to review code for safety flaws and to make beneficial changes that would likely eliminate injuries caused by medical devices.

Under the industry's regulatory structure, no other party regularly reviews the code of medical devices because the Food and Drug Administration (FDA) mostly leaves the review of medical device software up to the medical device companies. Academic researchers are frustrated with the system and are working on developing an open source platform for medical devices that would allow anyone to review and improve the software.

Under an open source system, medical device software would be subject to greater scrutiny, which would make the products safer for patients. The open source model would also lower cost. Current medical devices are expensive to purchase and maintain. An open source platform would allow for a greater proliferation of knowledge so that the information required to fix a certain medical device would not be limited to the particular company that produces it. Despite the benefits of an open source model, there is a major drawback. The current regulatory system inhibits the introduction of open source devices into the marketplace.

While FDA regulations do not require the analysis of medical device software for problems, the creation of such software does have to be well-documented. In the world of open source software creation, it can be difficult to systematically document every progression of the software's development when collaborators may not be a part of one entity with a formal documentation process.

To take advantage of the benefits of an open source system, the FDA is slowly warming to the idea and is developing standards for the interconnectivity of devices between different manufacturers. The open source-versus-closed source issue is just one element in the FDA's effort to improve the medical device approval process. Congress is reviewing a bill that would improve the FDA's regulatory power regarding the approval of new medical devices. The proposed law would prohibit the marketing of a new device based on existing technology previously determined to be problematic.

Contact Trolman, Glaser, & Lichtman, PC

Trolman, Glaser & Lichtman, P.C.
747 Third Avenue, 23rd Floor | New York, NY 10017
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Contact trolman, glaser & lichtman, PC

747 Third Avenue, 23rd Floor | New York, NY 10017|Phone: 212-750-1200|Toll-Free: 1-888-484-5529|Fax: 212-980-4011|Email