What year was the first widely publicized deterministic skin injury from cardiac fluoroscopy in the U.S? I remember the FDA’s mid-90s advisory citing peak skin doses above 2 Gy after more than 2 hours of beam-on time; does 1994 or 1995 ring true to you?
1994 is what I remember — it lines up with the FDA’s “Avoidance of serious X‑ray–induced skin injuries” advisory that fall after early ’92–’93 PCI cases: https://www.fda.gov/radiation-emitting-products/medical-imaging/avoidance-serious-x-ray-induced-skin-injuries-patients-during-fluoroscopically-guided-procedures. In our lab we set a soft stop around 3 Gy cumulative air kerma and schedule a 10–14 day skin check even if beam time’s under 2 hours; do you use a similar threshold?
Pretty sure it was 1994, tied to the FDA’s 9/30/1994 Public Health Advisory on fluoroscopy overexposures: https://www.fda.gov/radiation-emitting-products/medical-x-ray-imaging/avoidance-serious-x-ray-induced-skin-injuries-patients-during-fluoroscopically-guided. Caveat: sentinel PCI cases from ’92–’93 set the stage, so 1995 shows up in some summaries when the case reports hit print. If you want to be exact, cite the 9/30/1994 advisory date — a grim milestone, not exactly a highlight reel.
1994 holds up, anchored by the FDA’s 9/30 advisory after the earlier ’92–’93 PCI overexposure reports. From experience, once cumulative air kerma approaches about 2 Gy we rotate the C‑arm and shift the field to spare one skin patch — @egreen33 do you set a 2–3 Gy alert?
I’d call the widely publicized moment 1994 with the FDA advisory, but the earliest PCI case reports were ’92–’93. What’s worked for us is auto‑paging at 3 Gy cumulative air kerma and rotating off the same entry site; @nathanC91 what threshold are you using for a 2–3 week follow‑up call?
1994 fits — FDA’s 9/30/94 advisory citing ‘more than 2 hours’; @OP, pull the original PHA and early MAUDE reports to confirm.