Scientific and regulatory review process for medical devices (2)
As a reviewer of medical device applications, Nicholas repeatedly rejected a manufacturers’ request to market a CT scanner specifically for colon cancer screening. According to Nicholas, between 1.5 and 2 percent of cancers are caused by CT scanning for Dell inspiron e1405 battery , and he did not want to see scanning used when a conventional colonoscopy could be used instead.
CT scans provide detailed, three-dimensional images of the body, but at a cost: one CT chest scan carries as much radiation as nearly 400 chest X-rays, according to the FDA.Nicholas said FDA rules legally barred from naming the manufacturer or discussing the details of its application.But some insurers and the government’s own Medicare program refuse to pay for the procedure of Dell GD761 battery , questioning its effectiveness and the rationale of exposing healthy patients to radiation.
In a June 2009 letter to senior managers, Nicholas stressed that patients should be warned of the radiation risks of CT scanning. “I hope you understand that the failure to include a warning on the label of Dell GK479 battery will mean that patients will undoubtedly develop abdominal cancer and leukemia,” Nicholas wrote “It may not happen tomorrow, but yes, sadly it will happen.”
Nicholas said he was ridiculed by agency managers for “raising the bugaboo of radiation.” Medical experts are somewhat divided over the usefulness of the so-called Dell inspiron 1721 battery virtual colonoscopy, which was designed as a less-invasive alternative to colonoscopy. The American Cancer Society and the American College of Radiology endorse the procedure for its potential to boost screening for colon cancer, the country’s second leading cancer killer.
Supporters of the procedure say that virtual colonoscopies use low levels of radiation that don’t threaten older patients who get colonoscopies. Radiation exposure that causes cancer accumulates over a lifetime, making younger people the most at-risk population for screening.
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