A medical device would also have to be safe for its operators.

Yes. I suspect, if anything develops, we're going to hear about illnesses among the TSA workers standing beside these things.

I just found this review:

http://myhelicaltryst.blogspot.com/2010/11/tsa-x-ray-backsca...

# "The X-ray dose from these devices has often been compared in the media to the cosmic ray exposure inherent to airplane travel or that of a chest X-ray. However, this comparison is very misleading: both the air travel cosmic ray exposure and chest X-rays have much higher X-ray energies and the health consequences are appropriately understood in terms of the whole body volume dose. In contrast, these new airport scanners are largely depositing their energy into the skin and immediately adjacent tissue, and since this is such a small fraction of body weight/vol, possibly by one to two orders of magnitude, the real dose to the skin is now high."

# "In addition, it appears that real independent safety data do not exist."

"Essentially, this means that the X-ray source used in the Rapiscan system is the same as those used for mammograms and some dental X-rays, and uses BOTH 'soft' and 'hard' X-rays. Its very disturbing that the TSA has been misleading on this point. Here is the real catch: the softer the X-ray, the more its absorbed by the body, and the higher the biologically relevant dose! This means, that this radiation is potentially worse than an a higher energy medical chest X-ray.

With that being said, because the scanners have both a radiation source AND a detector in the front AND back of the person in the scanner, it is actually possible for the hardware to conduct a classic, through-the-body X-ray. The TSA claims that the machines are not currently being used in that way; however, based on the limited engineering schematics released in the safety documents, they could be certainly be easily reconfigured to do so by altering the aluminum-plate (or equivalent) filter or by changing the software. So the hardware has the capability to output quite high doses of radiation, however a biological dose is a function of the time of exposure as well as the proximity to the source and the power of the power of the source. Unfortunately, it is difficult to determine which zones in the scanner are 'hottest' because that information is masked in the document. An excerpt of the safety evaluation from Johns Hopkins is shown below to give you sense of how much other information is being withheld. Ultimately my point is this: even though the dose may actually be low, these machines are capable of much higher radiation output through device failure or both unauthorized or authorized reconfiguration of either hardware or software."

" Which brings me to how the scanner works. Essentially, it appears that an X-ray beam is rastered across the body, which highlights the importance of one of the specific concerns raised by the UCSF scientists... what happens if the machine fails, or gets stuck, during a raster. How much radiation would a person's eye, hand, testicle, stomach, etc be exposed to during such a failure. What is the failure rate of these machines? What is the failure rate in an operational environment? Who services the machine? What is the decay rate of the filter? What is the decay rate of the shielding material? What is the variability in the power of the X-ray source during the manufacturing process? This last question may seem trivial; however, the Johns Hopkins Applied Physics Laboratory noted significant differences in their test models, which were supposed to be precisely up to spec. Its also interesting to note that the Johns Hopkins Applied Physics Laboratory criticized other reports from NIST (the National Institute of Standards and Technology) and a group called Medical and Health Physics Consulting for testing the machine while one of the two X-ray sources was disabled (citations at the bottom of the page).

These questions have not been answered to any satisfaction and the UCSF scientists, all esteemed in their fields and members of the National Academy of Sciences have been dismissed based on a couple of reports seemingly hastily put together by mid-level government lab technicians. The documents that I have reviewed thus far either have NO AUTHOR CREDITS or are NOT authored by anyone with either a Ph.D. or a M.D., raising serious concerns of the extent of the expertise of the individuals and organizations evaluating these machines. Yet, the FDA and TSA continue to dismiss some of the most talented scientists in the country..."

"Furthermore, when making this comparison, the TSA and FDA are calculating that the dose is absorbed throughout the body. According the simulations performed by NIST, the relative absorption of the radiation is ~20-35-fold higher in the skin, breast, testes and thymus than the brain, or 7-12-fold higher than bone marrow. So a total body dose is misleading, because there is differential absorption in some tissues. Of particular concern is radiation exposure to the testes, which could result in infertility or birth defects, and breasts for women who might carry a BRCA1 or BRCA2 mutation. Even more alarming is that because the radiation energy is the same for all adults, children or infants, the relative absorbed dose is twice as high for small children and infants because they have a smaller body mass (both total and tissue specific) to distribute the dose. Alarmingly, the radiation dose to an infant's testes and skeleton is 60-fold higher than the absorbed dose to an adult brain!

There also appears to be unit conversion error in the Appendix of the report, which was recently cited by the FDA in response to the UCSF scientist's letter of concern, which might mean that the relative skin dose is 1000-fold higher than the report indicates (pg Appendix B, pg ii, units of microSv are used in an example calculation, when it appears that units of milliSv should have been used). I attempted to contact the author, Frank Cerra, to query whether this was a computational mistake or an unexplained conversion; however, none of his web-published email addresses are valid and there was no answer by phone. I cannot rule out that a conversion factor was used that was not described in the methods, and would welcome confirmation or rebuttal of this observation."

"Finally, I would like to comment on the safety of the TSA officers (TSO) who will be operating these machines, and will be constant 'bystanders' with respect to the radiation exposure. The range of exposure estimates is a function of where an officer stands during their duty, what percentage of that duty is spent in the same location and how often the machine is running. A TSO could be exposed to as much as 86-1408 mrem per year (assuming 8 hours per day, 40 hours a week, 50 weeks per year and between 30-100% duty and 25-100% occupancy, as defined by the Johns Hopkins report), which is between 86%-141% of the safe exposure of 100 mrem. At the high end, if for example a TSO is standing at the entrance of the scanner when it is running at maximum capacity, then that officer could hit their radiation exposure limit in as few as 20 working days (assuming an 8 hour shift). While we may not be very happy with our TSOs at the moment as the face of these policies, we need to keep in mind that they really should be wearing radiation badges in order to know their specific exposure (especially for those officers who may also have to receive radiation exposure for medical reasons)."

Safety reports that should be considered invalid due to the fact that one of the two X-ray sources was disabled during testing:

1. Medical and Health Physics Consulting, Radiation Report on Rapiscan Systems Secure 1000 (March 21, 2006).

2. Medical and Health Physics Consulting, Radiation Report on Rapiscan Systems Secure 1000 (June 5, 2008).

3. Medical and Health Physics Consulting, Supplement to Report dated June 5, 2008 (October 28, 2008).

4. National Institute of Standards and Technology Assessment of Radiation Safety and Compliance with ANSI N43.17-2002 Rapiscan Dual Secure 1000 Personnel Scanner (July 9, 2008).