Quality improvement guidelines for recording patient radiation dose in the medical record for fluoroscopically guided procedures

Journal of Vascular and Interventional Radiology

Volumn 23, Issue 1, 2012, Pages 11-18

  Miller, Donald L ^a,b   Balter, Stephen ^c   Dixon, Robert G ^e   Nikolic, Boris ^f   Bartal, Gabriel ^h   Cardella, John F ^g   Dauer, Lawrence T ^d   Stecker, Michael S ⁱ  

^a CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

^b Uniformed Services University of the Health Sciences and the Walter Reed National Military Medical Center   (United States)

^c Och Spine at New York Presbyterian Hospitals   (United States)

^d MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^e UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^f ALBERT EINSTEIN MEDICAL CENTER   (United States)

^g GEISINGER HEALTH SYSTEM   (United States)

^h MEIR MEDICAL CENTER   (Israel)

ⁱ BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANGIOCARDIOGRAPHY; CATHETER ABLATION; COMPUTER ASSISTED TOMOGRAPHY; DOSIMETRY; FLUOROSCOPY; HUMAN; MEDICAL RECORD; NOTE; OUTCOME ASSESSMENT; PATIENT MONITORING; PATIENT SAFETY; PRACTICE GUIDELINE; PRIORITY JOURNAL; RADIATION ABSORPTION; RADIATION DOSE; RADIATION DOSE DISTRIBUTION; RADIATION INJURY; RADIATION SAFETY; STOCHASTIC MODEL; TOTAL QUALITY MANAGEMENT; TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT; UNCERTAINTY;

EID: 84855398632     PISSN: 10510443     EISSN: 15357732     Source Type: Journal    
DOI: 10.1016/j.jvir.2011.09.004     Document Type: Article

References (72)

1. Miller DL, Balter S, Wagner LK, et al. Quality improvement guidelines for recording patient radiation dose in the medical record. J Vasc Interv Radiol 2004; 15:423-429. (Pubitemid 38590865)
2. Miller DL, Balter S, Wagner LK, et al. Quality improvement guidelines for recording patient radiation dose in the medical record. J Vasc Interv Radiol 2009; 20(suppl):S200-S207.
3. Fink A, Kosecoff J, Chassin M, Brook RH. Consensus methods: Characteristics and guidelines for use. Am J Public Health 1984; 74:979-983. (Pubitemid 14059576)
4. Leape LL, Hilborne LH, Park RE, et al. The appropriateness of use of coronary artery bypass graft surgery in New York State. JAMA 1993;269:753-760. (Pubitemid 23039081)
5. Food and Drug Administration. Public Health Advisory: avoidance of serious x-ray-induced skin injuries to patients during fluoroscopically-guided procedures. Rockville, MD: Center for Devices and Radiological Health, 1994. Available at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ PublicHealthNotifications/ucm063084.htm. Accessed April 28, 2011.
6. Food and Drug Administration. Recording information in the patient's medical record that identifies the potential for serious x-ray-induced skin injuries. Rockville, MD: Center for Devices and Radiological Health, 1995. Available at http://www.fda.gov/Radiation-EmittingProducts/ RadiationEmittingProductsandProcedures/MedicalImaging/MedicalX-Rays/ ucm117030.htm. Accessed April 28, 2011.
7. Shope TB, Balter S. Regulations and recommendations relevant to interventional radiology. Syllabus: a categorical course in physics - physical and technical aspects of angiography and interventional radiology. Oak Brook, IL: Radiological Society of North America, 1995;195-205.
8. International Commission on Radiological Protection. Avoidance of radiation injuries from medical interventional procedures. ICRP Publication 85. Ann ICRP 2000; 30:7-67.
9. National Council on Radiation Protection and Measurements. Radiation dose management for fluoroscopically guided interventional medical procedures. Report No. 168. Bethesda, MD: NCRP, 2011.
10. Conference of Radiation Control Program Directors. Technical White Paper: Monitoring and tracking of fluoroscopic dose. CRCPD Publication E-10-7. Frankfort, KY: Conference of Radiation Control Program Directors, 2010. Available at http://www.crcpd.org/Pubs/white-papers.aspx. Accessed April 28, 2011.
11. Killewich LA, Singleton TA. Governmental regulations and radiation exposure. J Vasc Surg 2011; 53(1 suppl):44S-46S.
12. International Commission on Radiological Protection. Radiation protection in medicine. ICRP Publication 105. Ann ICRP 2007; 37:1-63.
13. American College of Radiology. ACR-SIR Practice Guideline for the Reporting and Archiving of Interventional Radiology Procedures. Reston, VA: American College of Radiology, 2009. Available at http://www.acr.org/ SecondaryMainMenuCategories/quality-safety/guidelines/iv.aspx. Accessed April 28, 2011.
14. International Atomic Energy Agency. International basic safety standards for protection against ionizing radiation and the safety of radiation sources. Safety Series No. 115. Vienna: IAEA, 1996. Available at http://www-pub.iaea.org/ MTCD/publications/PDF/Pub996-EN.pdf. Accessed April 28, 2011.
15. Koenig TR, Mettler FA, Wagner LK. Skin injuries from fluoroscopically guided procedures: part 2, review of 73 cases and recommendations for minimizing dose delivered to the patient. AJR Am J Roentgenol 2001; 177:13-20. (Pubitemid 32578044)
16. Balter S, Hopewell JW, Miller DL, Wagner LK, Zelefsky MJ. Fluoroscopically guided interventional procedures: a review of radiation effects on patients' skin and hair. Radiology 2010; 254:326-341.
17. Huda W, Peters KR. Radiation-induced temporary epilation after a neuroradiologically guided embolization procedure. Radiology 1994; 193:642-644. (Pubitemid 24366928)
18. Lichtenstein DA, Klapholz L, Vardy DA, et al. Chronic radiodermatitis following cardiac catheterization. Arch Dermatol 1996; 132:663-667. (Pubitemid 26174107)
19. Shope TB. Radiation-induced skin injuries from fluoroscopy. Radiographics. 1996; 16:1195-1199. (Pubitemid 126448478)
20. Vehmas T. Hawthorne effect: shortening of fluoroscopy times during radiation measurement studies. Br J Radiol 1997; 70:1053-1055. (Pubitemid 27464207)
21. Padovani R, Bernardi G, Quai E, et al. Retrospective evaluation of occurrence of skin injuries in interventional cardiac procedures. Radiat Prot Dosimetry 2005; 117:247-250.
22. Suzuki S, Furui S, Isshiki T, et al. Patients' skin dose during percutaneous coronary intervention for chronic total occlusion. Cathet Cardiovasc Interv 2008; 71:160-164. (Pubitemid 351293757)
23. Glaiberman C. How to create a quality assurance program for radiation safety in interventional radiology. Tech Vasc Interv Radiol 2010; 13:194-199.
24. Balter S, Rosenstein M, Miller DL, Schueler B, Spelic D. Patient radiation dose audits for fluoroscopically guided interventional procedures. Med Phys 2011; 38:1611-1618.
25. Stevens NT, Steiner SH, Smith IR, MacKay RJ. Monitoring radiation use in cardiac fluoroscopy imaging procedures. Med Phys 2011; 38:317-326.
26. International Commission on Radiological Protection. The 2007 Recommendations of the International Commission on Radiological Protection. ICRP publication 103. Ann ICRP 2007; 37:1-332.
27. Mahesh M. Fluoroscopy: patient radiation exposure issues. Radiographics 2001; 21:1033-1045.
28. International Electrotechnical Commission. Report 60601 medical electrical equipment-part 2-43: particular requirements for the safety of x-ray equipment for interventional procedures. Geneva: IEC, 2000.
29. International Electrotechnical Commission. Report 60601 medical electrical equipment-part 2-43: particular requirements for the safety of x-ray equipment for interventional procedures, 2nd ed. Geneva: IEC, 2010.
30. International Commission on Radiation Units and Measurements. Patient dosimetry for x rays used in medical imaging. Report 74. J ICRU 2005; 5:1-113.
31. Hall EJ. Radiation biology for pediatric radiologists. Pediatr Radiol 2009; 39(suppl 1):S57-S64.
32. Miller DL, Balter S, Schueler BA, Wagner LK, Strauss KJ, Vano E. Clinical radiation management for fluoroscopically guided interventional procedures. Radiology 2010; 257:321-332.
33. Balter S. Interventional fluoroscopy: physics, technology, safety. New York: Wiley-Liss, 2001.
34. Servomaa A, Karppinen J. The dose-area product and assessment of the occupational dose in interventional radiology. Radiat Prot Dosimetry 2001; 96:235-236. (Pubitemid 32899001)
35. Vano E, Ubeda C, Leyton F, Miranda P, Gonzalez L. Staff radiation doses in interventional cardiology: correlation with patient exposure. Pediatr Cardiol 2009; 30:409-413.
36. Wagner LK, Eifel PJ, Geise RA. Potential biological effects following high x-ray dose interventional procedures. J Vasc Interv Radiol 1994; 5:71-84.
37. Waite JC, Fitzgerald M. An assessment of methods for monitoring entrance surface dose in fluoroscopically guided interventional procedures. Radiat Prot Dosimetry 2001; 94:89-92. (Pubitemid 32433138)
38. Castellano IA, McNeill JG, Thorp NC, Dance DR, Raphael MJ. Assessment of organ radiation doses and associated risk for digital bifemoral arteriography. Br J Radiol 1995; 68:502-507.
39. Vehmas T. Radiation exposure during standard and complex interventional procedures. Br J Radiol 1997; 70:296-298. (Pubitemid 27129879)
40. Ruiz-Cruces R, Pérez-Martínez M, Flores A, Cristófol J, Martínez-Morillo M, Díez-de-los-Ríos A. Patient dose in radiologically guided interventional vascular procedures: conventional versus digital systems. Radiology 1997; 205:385-393. (Pubitemid 27467315)
41. McParland BJ. A study of patient radiation doses in interventional radiological procedures. Br J Radiol 1998; 71:175-185. (Pubitemid 28075832)
42. Vano E, Gonzalez L, Ten JI, Fernandez JM, Guibelalde E, Macaya C. Skin dose and dose-area product values for interventional cardiology procedures. Br J Radiol 2001; 74:48-55. (Pubitemid 32162022)
43. van de Putte S, Verhaegen F, Taeymans Y, Thierens H. Correlation of patient skin doses in cardiac interventional radiology with dose-area product. Br J Radiol 2000; 73:504-513. (Pubitemid 30311492)
44. Miller DL, Balter S, Cole PE, et al. Radiation doses in interventional radiology procedures: the RAD-IR study part II. Skin dose. J Vasc Interv Radiol 2003; 14:977-990. (Pubitemid 36959515)
45. Balter S, Detorie NA, Mahesh M. Federal regulations (effective June 2006) require dose monitors on all new fluoroscopes: how will this help clinicians keep track of patient dose? J Am Coll Radiol 2007; 4:130-132.
46. Wagner LK. You do not know what you are doing unless you know what you are doing. Radiology 2002; 225:327-328. (Pubitemid 35239229)
47. Geise RA, O'Dea TJ. Radiation dose in interventional fluoroscopic procedures. Appl Radiat Isot 1999; 50:173-184. (Pubitemid 29048999)
48. Hwang E, Gaxiola E, Vlietstra RE, Brenner A, Ebersole D, Browne K. Real-time measurement of skin radiation during cardiac catheterization. Cathet Cardiovasc Diagn 1998; 43:367-370. (Pubitemid 28153194)
49. Wagner LK, Pollock JJ. Real-time portal monitoring to estimate dose to skin of patients from high dose fluoroscopy. Br J Radiol 1999; 72:846-855. (Pubitemid 29423593)
50. Balter S, Shope TB Jr, Fletcher DW, Kuan HM, Chan RC. Techniques to estimate radiation dose to skin during fluoroscopically guided procedures. In: Balter S, Chan RC, Shope TB Jr, editors. Intravascular brachytherapy fluoroscopically guided interventions. Madison, WI: Medical Physics Publishing, 2002;731-764.
51. Geise RA, Ansel HJ. Radiotherapy verification film for estimating cumulative entrance skin exposure for fluoroscopic examinations. Health Phys 1990; 59:295-298. (Pubitemid 20315448)
52. Vañó E, Guibelalde E, Fernández JM, González L, Ten JI. Patient dosimetry in interventional radiology using slow films. Br J Radiol 1997; 70:195-200. (Pubitemid 27091023)
53. Giordano C, D'Ercole L, Gobbi R, Bocchiola M, Passerini F. Coronary angiography and percutaneous transluminal coronary angioplasty procedures: evaluation of patients' maximum skin dose using Gafchromic films and a comparison of local levels with reference levels proposed in the literature. Phys Med 2010; 26:224-232.
54. Nicholson R, Tuffee F, Uthappa MC. Skin sparing in interventional radiology: the effect of copper filtration. Br J Radiol 2000; 73:36-42. (Pubitemid 30105405)
55. den Boer A, de Feijter PJ, Serruys PW, Roelandt JRTC. Real-time quantification and display of skin radiation during coronary angiography and intervention. Circulation 2001; 104:1779-1784. (Pubitemid 32963342)
56. Miller DL, Balter S, Noonan PT, Georgia JD. Minimizing radiation-induced skin injury in interventional radiology procedures. Radiology 2002; 225:329-336. (Pubitemid 35239230)
57. Fajardo LC, Geise RA, Ritenour ER. A survey of films for use as dosimeters in interventional radiology. Health Phys 1995; 68:595-599.
58. American College of Radiology. ACR Technical Standard for Management of the Use of Radiation in Fluoroscopic Procedures. In: Practice Guidelines and Technical Standards 2008. Reston, VA: ACR, 2008;1143-1149. Available at http://www.acr.org/SecondaryMainMenuCategories/quality-safety/guidelines/ med-phys/management-fluoro-procedures.aspx. Accessed April 28, 2011.
59. Digital Imaging and Communications in Medicine (DICOM). Supplement 94: diagnostic x-ray radiation dose reporting (dose SR). Rosslyn, VA: National Electrical Manufacturers Association, 2005. Available at http://www.dclunie.com/ dicom-status/status.html#SupplementsByNumber. Accessed April 28, 2011.
60. International Electrotechnical Commission. Publicly available specification-medical electrical equipment-radiation dose documentation-part 1: equipment for radiography and radioscopy, PAS 61910-1 ed 1.0. Geneva: IEC, 2007.
61. Balter S, Blendinger H. DICOM dose: capture and reporting. In: Dössel O, Schlegel WC, editors. World Congress on Medical Physics and Biomedical Engineering, September 7-12, 2009, Munich, Germany. Radiation protection and dosimetry. Biological effects of radiation. Berlin Heidelberg: Springer, 2009;70-73.
62. Bolch W, Lee C, Wayson M, Johnson P. Hybrid computational phantoms for medical dose reconstruction. Radiat Environ Biophys 2009; 49:155-168.
63. Khodadadegan Y, Zhang M, Pavlicek W, et al. Automatic monitoring of localized skin dose with fluoroscopic and interventional procedures. J Digit Imaging 2011; 24:626-639.
64. Fletcher DW, Miller DL, Balter S, Taylor MA. Comparison of four techniques to estimate radiation dose to skin during angiographic and interventional radiology procedures. J Vasc Interv Radiol 2002; 13:391-397. (Pubitemid 34298818)
65. Performance standards for ionizing radiation emitting products. 21 Code of Federal Regulations 1020.32. Available at http://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1020.32. Accessed April 28, 2011.
66. Kwon D, Little MP, Miller DL. Reference air kerma and kerma-area product as estimators of peak skin dose for fluoroscopically guided interventions. Med Phys 2011; 38:4422-4229.
67. Neil S, Padgham C, Martin CJ. A study of the relationship between peak skin dose and cumulative air kerma in interventional neuroradiology and cardiology. J Radiol Prot 2010; 30:659-672.
68. O'Dea TJ, Geise RA, Ritenour ER. The potential for radiation-induced skin damage in interventional neuroradiological procedures: a review of 522 cases using automated dosimetry. Med Phys 1999; 26:2027-2033. (Pubitemid 29442288)
69. Miller DL, Balter S, Cole PE, et al. Radiation doses in interventional radiology procedures: the RAD-IR study part I. Overall measures of dose. J Vasc Interv Radiol 2003; 14:711-727. (Pubitemid 36718105)
70. Storm ES, Miller DL, Hoover LJ, Georgia JD, Bivens T. Radiation doses from venous access procedures. Radiology 2006; 238:1044-1050. (Pubitemid 43289937)
71. Stecker MS, Balter S, Towbin RB, et al. Guidelines for patient radiation dose management. J Vasc Interv Radiol 2009; 20(suppl):S263-S273.
72. Food and Drug Administration. Initiative to reduce unnecessary radiation exposure from medical imaging. White Oak, MD: Food and Drug Administration, 2010. Available at http://www.fda.gov/Radiation-EmittingProducts/ RadiationSafety/RadiationDoseReduction/ucm199904.htm. Accessed April 28, 2011.