Intended for healthcare professionals

Letters Food and Drug Administration

FDA is gold standard of review

BMJ 2010; 341 doi: https://doi.org/10.1136/bmj.c7004 (Published 07 December 2010) Cite this as: BMJ 2010;341:c7004
  1. Mark B Leahey, president and CEO1
  1. 1Medical Device Manufacturers Association, Washington, DC, 20005, USA
  1. bbenner{at}medicaldevices.org

Brownlee and Lenzer had clearly made up their minds about the Food and Drug Administration (FDA) and medical device community before writing their article.1 It is unfortunate that they didn’t acknowledge the cutting edge advances and improvements to patient care medical devices provide every day.

Today, with such medical advances, the average American can expect to live to 78, a 65% increase over the past 100 years. The medical device industry is perhaps one of the greatest unsung contributors to increased life expectancy. Research has shown that since 1980 death rates have declined 16% and Americans spend 56% fewer days in hospital, partly because of medical devices.

Brownlee and Lenzer seem quick to focus on select instances of unfortunate results, while failing to acknowledge the overwhelming success rate and positive experiences of millions of Americans each year. A recent study of FDA approved medical devices from the past five years showed that less than 1% were recalled.2 Most recalls were attributed to manufacturing and design problems in a postmarketing setting.

Perhaps worse, they rely on “expert” commentary by two people with a long history of unfair and unfounded criticism towards regulators and medical device manufacturers.

Both the FDA and medical device industry share common goals to ensure patient safety and promote innovation so that patients can lead healthier more productive lives. Perhaps the next time these authors decide to look at one of America’s most innovative and patient driven industries they will acknowledge this part of the story.2

Notes

Cite this as: BMJ 2010;341:c7004

Footnotes

  • Competing interests: None declared.

References

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