I think it is good the Food and Drug Administration is going to require some “controls” to be built in. However, I hope they don't generate another burdensome amount of paperwork.
Equipment, procedures need monitoring
If they would just require the imaging and nuclear medicine people to comply with ISO 9001:2008, especially clauses 7.5 and 7.6, they may accomplish what they are looking for as related to this issue.
If any device that is used to meet “customer” requirements that can be calibrated is checked for being in calibration within the time frame the unit is designed for and they have the records this was done, then they would be sure the equipment is functioning correctly. Then if the procedures associated with the exposures are followed and there are records of this, the exposure to patients and employees should be minimized.
It all boils down to doing the right thing right at the right time every time.
The management should have internal audits done—as ways to improve their operations—and these should focus on assuring the procedures and equipment are operating correctly.
With all this in place—which pays off in many ways—the FDA would only need to check the records periodically to verify this was all working correctly.
Mickey ChristensenPresidentTQM SystemsBaton Rouge, La.
I’d like to raise the question about radiation exposure on airport body and luggage searches. Will the FDA look into that?
Dharma V. RodriguezSan Antonio
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