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Industry Unveils Radiation Therapy Patient Protection Effort At FDA Meeting

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers of linear accelerators and other devices for radiation oncology treatments are endorsing an industry "Radiation Therapy Readiness Check Initiative" to help prevent treatment errors

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‘Paradoxical’ FDA Recalls Report Credits Industry Collaboration For Improved Quality, But Uncovers Troubling Data About Older Devices

Medical devices on the market for more than five years are recalled more often than younger ones, according to a recent FDA 10-year retrospective report on corrections and removals. “There is an intuitive appeal to the argument that devices that come to the market in an early point in their lifespan – say, the first year – are more likely to be subject to recalls, but that is simply not true,” CDRH Office of Compliance Director Steven Silverman says. Other notable report findings: troubles with components and software are the leading causes for most recalls; problems with AEDs, ventilators and infusion pumps have triggered an increase in high-risk class I recalls; and domestic manufacturers recall products at a much greater volume than those outside the United States.

Firms Tout Tech To Address Wrong-Patient, Wrong-Site Radiotherapy Errors

Radiation therapy accessory products can offer new hope for reducing medical errors that stem from treating the wrong patient or the wrong body site, device makers told FDA at a recent meeting

Firms Tout Tech To Address Wrong-Patient, Wrong-Site Radiotherapy Errors

Radiation therapy accessory products can offer new hope for reducing medical errors that stem from treating the wrong patient or the wrong body site, device makers told FDA at a recent meeting

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