Terrorist use of an RDD — often called “dirty nuke” or “dirty bomb” — is considered far more likely than use of a nuclear explosive device.
An RDD combines a conventional explosive device — such as a bomb — with radioactive material. Other radiation-emitting products, such as TVs and microwave ovens, are not used medically, and therefore, are regulated by the FDA under a different law.Medical devices are classified and regulated according to their complexity and degree of risk to the public. Such RDDs appeal to terrorists because they require limited technical knowledge to build and deploy compared to a nuclear device. For example, devices that are life-supporting, life-sustaining, or implanted, such as pacemakers, must receive FDA approval before they can be marketed.But medical devices haven't always come under such scrutiny. In fact, it wasn't until the late 1970s that the FDA actually gained authority to pre- approve medical devices under the 1976 Medical Device Amendments. While medical devices were not put into the act, no one could have imagined the ways in which medical device technology would grow, change and, like food and drugs, need to be regulated during the coming years.A Flood of Fraudulent ContraptionsThe earliest recorded fraudulent medical device marketed in the United States was Dr. The area affected could be placed off-limits to the public for several months during cleanup efforts.Before an Radiological Dispersion Device (RDD) EventThere is no way of knowing how much warning time there will be before an attack by terrorists using a Radiological Dispersion Device (RDD), so being prepared in advance and knowing what to do and when is important. Within 10 years of Perkins' death in 1799, the device was exposed as a fraud.Despite such occasional deceptive enterprises, President Theodore Roosevelt saw no need to ask for legislation concerning medical devices 200 years later, when the Pure Food and Drugs Act was enacted. Devices used by the doctors of his day, such as stethoscopes and scalpels, were comparatively simple, and any hazards or defects were readily apparent. Such devices stood at the edge of medicine--helpful but not essential--and therefore posed little real or perceived threat.But by 1917, fraudulent medical devices, such as nose straighteners, height-stretching machines, and heated rubber applicators advertised as a cure for prostate gland disorders, began flooding the market. It was clear to the FDA that the law should be expanded to include agency authority over medical devices. Before World War I, the FDA was taking action against quack drugs and devices claiming to be radioactive--some of them highly dangerous.


They can be any protected space, provided that the walls and roof are thick and dense enough to absorb the radiation given off by fallout particles.During an Radiological Dispersion Device (RDD) EventWhile the explosive blast will be immediately obvious, the presence of radiation will not be known until trained personnel with specialized equipment are on the scene. One such device was known as a radium belt, which carried a disc alleged to contain the element.
It would be safer to assume radiological contamination has occurred - particularly in an urban setting or near other likely terrorist targets - and take the proper precautions. According to proponents, someone wearing the belt would never have appendicitis or gallbladder disease, or perhaps, any other ailment.Most of the FDA enforcement activity at the time was concerned with getting fraudulent devices like these off the market. Post Office--both charged with overseeing devices and enforcing criminal penalties for mail fraud under the Postal Fraud Statutes--the FDA could take no action on its own.The Need for Medical Device RegulationWhat was clearly needed, according to many, was national regulation of the medical device industry. Besides being subjected to enforcement actions against products that had already tragically demonstrated their danger to people, medical devices were officially defined as drugs.
If you manage to avoid breathing radioactive dust, your proximity to the radioactive particles may still result in some radiation exposure.If the explosion or radiological release occurs inside, get out immediately and seek safe shelter. Drown's Radio Therapeutic Instrument.Proponents of this device claimed it could cure ailments ranging from a simple fungus growth to a potentially fatal kidney malfunction. Drown's machine, in truth, was incapable of diagnosing or curing.Such devices were successfully removed from the market. Extensive congressional hearings were held on proposals to revise the FD&C Act in a number of different ways, including a requirement that medical devices be regulated comparably to, but separately from, new drugs. The issue of medical devices was then set aside so that health officials could focus on the tragedy.Congress considered a comparable device law when it passed the 1962 drug amendments.
The companion bill, however, to require pre-market approval of new medical devices under the same type of system applied to new drugs was deleted from that final legislation.The Medical Device Amendments of 1976During the 1960s and into the 1970s, the FDA's attention turned to the wide range of life-saving medical devices. The committee recommended that any new legislation be specifically targeted to the device industry, because devices presented entirely different issues from drugs.


And in 1975, hearings took place on problems that had been reported with the Dalkon Shield intrauterine device, which caused thousands of reported injuries. Those two incidents helped underscore the need for the Medical Device Amendments, enacted in 1976.President Gerald R.
The agency's first device performance standard was developed for impact-resistant lenses in eyeglasses and sunglasses.The final provisions of the 1976 amendments closely resemble the Cooper Committee recommendations. In addition to the medical device inventory and classification requirements, Class III device manufacturers were required to notify the FDA prior to marketing. New devices that were substantially equivalent to pre-1976 devices could be marketed immediately, subject to any existing or future requirements for that type of device.Good Manufacturing Practice (GMP) regulations also were authorized at that time. Link, former director of the FDA's then Bureau of Medical Devices, at a 20th anniversary of the medical device law.
Thus, the final law greatly strengthened the FDA's authority to regulate medical devices, but retained the fundamental concept of the Cooper Committee report that regulation should be carefully tailored to the type of device involved.More Medical Device MilestonesThe Safe Medical Devices Act (SMDA) was passed in 1990, and represents the first reform of medical device law since the 1976 amendments. This law modified the amendments to give the public greater protection against dangerous medical devices.Specifically, the SMDA requires nursing homes, hospitals, and other health care facilities that use medical devices to report to the FDA incidents suggesting that a medical device probably caused or contributed to a patient's death, serious illness, or serious injury.
Manufacturers are now required to conduct post-market surveillance on permanently implanted devices whose failure might cause serious harm or death, and to establish methods for tracing and locating patients who depend on such devices.
The MDUFSA amends the user-fee system created by the original Medical Device User Fee and Modernization Act of 2002, which allows the FDA to charge a fee for medical device product reviews. The agency uses these funds to hire staff and develop better systems to support effective and timely product reviews, to enact needed regulatory reforms, and to ensure that reprocessed devices are as safe and effective as the original devices.



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