A recent report said medical device software is under-regulated and recommended the Food and Drug Administration develop procedures to ensure the safety and efficacy of products before they go to market, according to an LA Times report.
According to the report, more than half of medical devices use software — an increase from one in four reported between 1983 and 1997. Software problems are now the third-leading cause for recalls of medical devices.
A patient death in 2007 was one of more than 700 linked to faulty software in infusion pumps, in addition to being one of more than 10,000 complaints received annually about the devices between 2005 and 2009. Following the incident, the FDA recalled approximately 200,000 pumps from one manufacturer and tightened regulations of the products.
Despite this effort, the FDA has still been criticized for failing to adopt standard practices for developing and screening software products before they go to market. Many software-based devices, including insulin pumps, infusion pumps and defibrillators, are cleared by the FDA through the 510(k) process, which can accelerate approval by involving little or no clinical testing.
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According to the report, more than half of medical devices use software — an increase from one in four reported between 1983 and 1997. Software problems are now the third-leading cause for recalls of medical devices.
A patient death in 2007 was one of more than 700 linked to faulty software in infusion pumps, in addition to being one of more than 10,000 complaints received annually about the devices between 2005 and 2009. Following the incident, the FDA recalled approximately 200,000 pumps from one manufacturer and tightened regulations of the products.
Despite this effort, the FDA has still been criticized for failing to adopt standard practices for developing and screening software products before they go to market. Many software-based devices, including insulin pumps, infusion pumps and defibrillators, are cleared by the FDA through the 510(k) process, which can accelerate approval by involving little or no clinical testing.
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New Trimodality System in Trials Could Improve Imaging
New Approach Shows 40% Savings for Perioperative Pediatrics
Amerinet, Cardinal Health Sign Agreements for Medical, Surgical and Pharmaceutical Supplies