Download FDA White Paper - Smith & Nephew

Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging 

)HEUXDU\         

&HQWHUIRU'HYLFHVDQG5DGLRORJLFDO+HDOWK 86)RRGDQG'UXJ$GPLQLVWUDWLRQ

Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

Table of Contents  Executive Summary....................................................................................................................2

Background .................................................................................................................................2   7\SHVRI0HGLFDO,PDJLQJ3URFHGXUHV    &RQFHUQVDERXW5DGLDWLRQ([SRVXUH    8QQHFHVVDU\5DGLDWLRQ([SRVXUH  Factors Contributing to Unnecessary Radiation Exposure ....................................................6   ,VVXHV5HODWHGWR'HYLFH8VH    ,VVXHV5HODWHGWR&OLQLFDO'HFLVLRQ0DNLQJ  Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging .....................8   3URPRWH6DIH8VHRI0HGLFDO,PDJLQJ'HYLFHV    6XSSRUW,QIRUPHG&OLQLFDO'HFLVLRQ0DNLQJ    ,QFUHDVH3DWLHQW$ZDUHQHVV  Conclusion ................................................................................................................................11





Executive Summary /LNHDOOPHGLFDOSURFHGXUHVFRPSXWHGWRPRJUDSK\&7 IOXRURVFRS\DQGQXFOHDUPHGLFLQH LPDJLQJH[DPVSUHVHQWERWKEHQHILWVDQGULVNV7KHVHW\SHVRILPDJLQJSURFHGXUHVKDYHOHGWR LPSURYHPHQWVLQWKHGLDJQRVLVDQGWUHDWPHQWRIQXPHURXVPHGLFDOFRQGLWLRQV$WWKHVDPH WLPHWKHVHW\SHVRIH[DPVH[SRVHSDWLHQWVWRLRQL]LQJUDGLDWLRQKHUHLQDIWHU³UDGLDWLRQ´ ZKLFK PD\HOHYDWHDSHUVRQ¶VOLIHWLPHULVNRIGHYHORSLQJFDQFHU$EDODQFHGSXEOLFKHDOWKDSSURDFK VHHNVWRVXSSRUWWKHEHQHILWVRIWKHVHPHGLFDOLPDJLQJH[DPVZKLOHPLQLPL]LQJWKHULVNV 0DQDJLQJWKHULVNVRIFRPSXWHGWRPRJUDSK\&7 IOXRURVFRS\DQGQXFOHDUPHGLFLQHLPDJLQJ SURFHGXUHVGHSHQGVRQWZRSULQFLSOHVRIUDGLDWLRQSURWHFWLRQDSSURSULDWHjustificationIRU RUGHULQJDQGSHUIRUPLQJHDFKSURFHGXUHDQGFDUHIXOoptimizationRIWKHUDGLDWLRQGRVHXVHG GXULQJHDFKSURFHGXUH7KHVHW\SHVRILPDJLQJH[DPVVKRXOGEHFRQGXFWHGRQO\ZKHQ PHGLFDOO\MXVWLILHG:KHQVXFKH[DPVDUHFRQGXFWHGSDWLHQWVVKRXOGEHH[SRVHGWRDQRSWLPDO UDGLDWLRQGRVH±QRPRUHRUOHVVWKDQZKDWLVQHFHVVDU\WRSURGXFHDKLJKTXDOLW\LPDJH,Q RWKHUZRUGVHDFKSDWLHQWVKRXOGJHWWKHULJKWLPDJLQJH[DPDWWKHULJKWWLPHZLWKWKHULJKW UDGLDWLRQGRVH )'$FDQDGYDQFHWKLVJRDOE\XVLQJRXUUHJXODWRU\DXWKRULW\MXGLFLRXVO\ZKLOHDOVRFROODERUDWLQJ ZLWKWKHKHDOWKFDUHSURIHVVLRQDOFRPPXQLW\ 7KLVGRFXPHQWDQQRXQFHVWKHODXQFKRIDFRRSHUDWLYHInitiative to Reduce Unnecessary Radiation Exposure from Medical Imaging7KURXJKWKLVLQLWLDWLYH)'$DQGRXUSDUWQHUVZLOO WDNHVWHSVWR  3URPRWHVDIHXVHRIPHGLFDOLPDJLQJGHYLFHV  6XSSRUWLQIRUPHGFOLQLFDOGHFLVLRQPDNLQJDQG  ,QFUHDVHSDWLHQWDZDUHQHVV %\FRRUGLQDWLQJWKHVHHIIRUWVZHFDQRSWLPL]HSDWLHQWH[SRVXUHWRUDGLDWLRQIURPFHUWDLQW\SHV RIPHGLFDOLPDJLQJH[DPVDQGWKHUHE\UHGXFHUHODWHGULVNVZKLOHPD[LPL]LQJWKHEHQHILWVRI WKHVHVWXGLHV

Background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



 6HHIRUH[DPSOHWKHSHUVSHFWLYHRI2EXFKRZVNL1$HWDO³7HQ&ULWHULDIRU(IIHFWLYH6FUHHQLQJ7KHLU $SSOLFDWLRQWR0XOWLVOLFH&76FUHHQLQJIRU3XOPRQDU\DQG&RORUHFWDO&DQFHUV´American Journal of Roentgenology -XQH9ROSS





1. Types of Medical Imaging Procedures 7KHUHDUHPDQ\W\SHV²RUPRGDOLWLHV²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¶VERG\WRSURGXFHRQHWRDKDQGIXORIWZRGLPHQVLRQDOSLFWXUHV²FDOOHGUDGLRJUDSKV² RIDSDUWLFXODUDUHDRIWKHERG\:KLOHSURMHFWLRQUDGLRJUDSK\LQFOXGLQJPDPPRJUDSK\PDNHV XSURXJKO\RIWKHLPDJLQJSURFHGXUHVXVLQJUDGLDWLRQWKDWDUHFRQGXFWHGDQQXDOO\LQWKH 86LWFRQWULEXWHVRQO\RIWKHWRWDO\HDUO\H[SRVXUHWRUDGLDWLRQIURPPHGLFDOLPDJLQJ  'XULQJD&7VFDQDOVRFDOOHGD&$7VFDQ DURWDWLQJVRXUFHSDVVHV[UD\VWKURXJKDSDWLHQW¶V ERG\WRSURGXFHVHYHUDOFURVVVHFWLRQDOLPDJHVRIDSDUWLFXODUDUHD7KHVHWZRGLPHQVLRQDO LPDJHVFDQDOVREHGLJLWDOO\FRPELQHGWRSURGXFHDVLQJOHWKUHHGLPHQVLRQDOLPDJH,QD IOXRURVFRSLFSURFHGXUHDGHYLFHSDVVHV[UD\VWKURXJKDSDWLHQW¶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

7KHDYHUDJHHIIHFWLYHGRVHIURPEDFNJURXQGUDGLDWLRQLVDERXWP6YSHU\HDU0HWWOHU-U)$HWDO ³(IIHFWLYH'RVHVLQ5DGLRORJ\DQG'LDJQRVWLF1XFOHDU0HGLFLQH$&DWDORJ´ Radiology-XO\9RO1R SS   1DWLRQDO&RXQFLORQ5DGLDWLRQ3URWHFWLRQDQG0HDVXUHPHQWVNCRP Report No. 160: Ionizing Radiation Exposure of the Population of the United States0DUFKSS  +HUHWKHDYHUDJHDGXOWHIIHFWLYHGRVHVIURP&7H[DPLQDWLRQVRIWKHKHDGP6Y DQGDEGRPHQP6Y DUH FRPSDUHGWRWKHDYHUDJHDGXOWHIIHFWLYHGRVHIURPDSRVWHURDQWHULRUFKHVW[UD\P6Y 0HWWOHU-U)$HWDO -XO\   1DWLRQDO&RXQFLORQ5DGLDWLRQ3URWHFWLRQDQG0HDVXUHPHQWVNCRP Report No. 1600DUFKSS





Table 1. Radiation Doses from Various Types of Medical Imaging Procedures

Type of Procedure

Average Adult Effective Dose P6Y

Estimated Dose Equivalent 1RRI&KHVW;UD\V

'HQWDO;UD\

D



&KHVW;UD\





0DPPRJUDSK\





&7

E



1XFOHDU0HGLFLQH

F



,QWHUYHQWLRQDO )OXRURVFRS\

G





2. Concerns about Radiation Exposure $FFRUGLQJWRD0DUFKUHSRUWE\WKH1DWLRQDO&RXQFLORQ5DGLDWLRQ3URWHFWLRQDQG 0HDVXUHPHQWV1&53 WKH86SRSXODWLRQ¶VWRWDOH[SRVXUHWRLRQL]LQJUDGLDWLRQKDVQHDUO\ GRXEOHGRYHUWKHSDVWWZRGHFDGHV  7KLVULVHLVODUJHO\DWWULEXWDEOHWRLQFUHDVHGH[SRVXUHIURP &7QXFOHDUPHGLFLQHDQGLQWHUYHQWLRQDOIOXRURVFRS\  1&53HVWLPDWHVWKDWPLOOLRQ&7 VFDQVPLOOLRQQXFOHDUPHGLFLQHSURFHGXUHVDQGPLOOLRQLQWHUYHQWLRQDOIOXRURVFRS\ SURFHGXUHVZHUHSHUIRUPHGLQWKH86LQDQGWKHDXWKRUVSUHGLFWWKDWWKHVHILJXUHVZLOO FRQWLQXHWRJURZ   

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¶VWKH86SRSXODWLRQ¶VSHUFDSLWDH[SRVXUHWRLRQL]LQJUDGLDWLRQIURPDOOVRXUFHVZDV P6Y%\WKDWILJXUHKDGULVHQWRP6Y1DWLRQDO&RXQFLORQ5DGLDWLRQ3URWHFWLRQDQG0HDVXUHPHQWV NCRP Report No. 1600DUFKSS   ,QWKHHDUO\¶VPHGLFDOLPDJLQJDFFRXQWHGIRURIWKH86SRSXODWLRQ¶VSHUFDSLWDH[SRVXUHWRLRQL]LQJ UDGLDWLRQIURPDOOVRXUFHVP6YRIP6Y ,QPHGLFDOLPDJLQJDFFRXQWHGIRURIWKHSHUFDSLWD H[SRVXUHP6YRIP6Y ZLWK&7QXFOHDUPHGLFLQHDQGLQWHUYHQWLRQDOIOXRURVFRS\DFFRXQWLQJIRU DQGUHVSHFWLYHO\1DWLRQDO&RXQFLORQ5DGLDWLRQ3URWHFWLRQDQG0HDVXUHPHQWVNCRP Report No. 1600DUFK SS   1DWLRQDO&RXQFLORQ5DGLDWLRQ3URWHFWLRQDQG0HDVXUHPHQWVNCRP Report No. 1600DUFKSS





&RQFHUQVKDYHEHHQUDLVHGDERXWWKHULVNVDVVRFLDWHGZLWKSDWLHQWV¶H[SRVXUHWRUDGLDWLRQIURP PHGLFDOLPDJLQJ%HFDXVHLRQL]LQJUDGLDWLRQFDQFDXVHGDPDJHWR'1$H[SRVXUHFDQ LQFUHDVHDSHUVRQ¶VOLIHWLPHULVNRIGHYHORSLQJFDQFHU$OWKRXJKWKHULVNWRDQLQGLYLGXDOIURPD VLQJOHH[DPPD\QRWLWVHOIEHODUJHPLOOLRQVRIH[DPVDUHSHUIRUPHGHDFK\HDUPDNLQJ UDGLDWLRQH[SRVXUHIURPPHGLFDOLPDJLQJDQLPSRUWDQWSXEOLFKHDOWKLVVXH  %HUULQJWRQGH *RQ]i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nnecessary Radiation Exposure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¶VVLJQVDQGV\PSWRPVRU ZKHQDQDOWHUQDWLYHPLJKWEHSUHIHUDEOHJLYHQDSDWLHQW¶VOLIHWLPHKLVWRU\RIUDGLDWLRQH[SRVXUH 7KHUHLVEURDGDJUHHPHQWWKDWVWHSVVKRXOGEHWDNHQWRUHGXFHXQQHFHVVDU\H[SRVXUHWR UDGLDWLRQ 

 %UHQQHU'-DQG+DOO(-³&RPSXWHG7RPRJUDSK\$Q,QFUHDVLQJ6RXUFHRI5DGLDWLRQ([SRVXUH´New England Journal of Medicine1RYHPEHU9RO1RSS  %HUULQJWRQGH*RQ]iOH]$HWDO³3URMHFWHG&DQFHU5LVNVIURP&RPSXWHG7RPRJUDSKLF6FDQV3HUIRUPHGLQ WKH8QLWHG6WDWHVLQ´Archives of Internal Medicine'HFHPEHU9RO1RSS  6PLWK%LQGPDQ5HWDO³5DGLDWLRQ'RVH$VVRFLDWHG:LWK&RPPRQ&RPSXWHG7RPRJUDSK\([DPLQDWLRQV DQGWKH$VVRFLDWHG/LIHWLPH$WWULEXWDEOH5LVNRI&DQFHU´Archives of Internal Medicine'HFHPEHU9RO 1RSS  )'$1HZV5HOHDVH³)'$0DNHV,QWHULP5HFRPPHQGDWLRQVWR$GGUHVV&RQFHUQRI([FHVV5DGLDWLRQ ([SRVXUHGXULQJ&73HUIXVLRQ,PDJLQJ´'HFHPEHU$YDLODEOHRQOLQHDW KWWSZZZIGDJRY1HZV(YHQWV1HZVURRP3UHVV$QQRXQFHPHQWVXFPKWP





Factors Contributing to Unnecessary Radiation Exposure 6HYHUDOIDFWRUVPD\FRQWULEXWHWRXQQHFHVVDU\H[SRVXUHWRUDGLDWLRQLQPHGLFDOLPDJLQJH[DPV 1. Issues Related to Device Use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³GLDJQRVWLFUHIHUHQFHOHYHOV´RU³GRVH UHIHUHQFHYDOXHV´DQGWKH\JHQHUDOO\FRUUHVSRQGWRWKHWKRUWKSHUFHQWLOHSRLQWVRIWKH GLVWULEXWLRQVRIPHDVXUHGGRVHYDOXHVIRUSDUWLFXODULPDJLQJSURFHGXUHV  'LDJQRVWLFUHIHUHQFH OHYHOVDUHEHQFKPDUNVWRZKLFKDIDFLOLW\¶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

6PLWK%LQGPDQHWDO'HFHPEHU 'LDJQRVWLFUHIHUHQFHOHYHOVZHUHLQWURGXFHGLQWKH8.153%5&5³3DWLHQW'RVH5HGXFWLRQLQ'LDJQRVWLF 5DGLRORJ\´Doc. NRPB9RO1RSS DQGZHUHLQFOXGHGLQWKHUHFRPPHQGDWLRQVRIWKH,QWHUQDWLRQDO &RPPLVVLRQRQ5DGLRORJLFDO3URWHFWLRQRadiological Protection and Safety in Medicine,&533XEOLFDWLRQ, Annals of the ICRP9RO1R )ROORZLQJWKH(XURSHDQ&RXQFLO'LUHFWLYH(XUDWRPOfficial Journal of the European Communities-XO\1R/SS GLDJQRVWLFUHIHUHQFHOHYHOVKDYHEHHQEURDGO\DGRSWHG LQ(XURSH6HHIRUH[DPSOHWKHIROORZLQJUHIHUHQFHVDQGFLWDWLRQVWKHUHLQ5RGD$5/RSHV0&DQG)DXVWR$0 ³'LDJQRVWLF5HIHUHQFH/HYHOVLQ&RPSXWHU7RPRJUDSK\DW,32&)*(3(´:RUOG&RQJUHVVRQ0HGLFDO3K\VLFVDQG %LRPHGLFDO(QJLQHHULQJ6HSWHPEHU0XQLFK*HUPDQ\IFMBE Proceedings9RO,,,2ODI'|VVHODQG :ROIJDQJ&6FKOHJHO(GV 6SULQJHUSS7UHLHU5HWDO³'LDJQRVWLF5HIHUHQFH/HYHOVLQ&RPSXWHG 7RPRJUDSK\LQ6ZLW]HUODQG´ibidSS  'LDJQRVWLFUHIHUHQFHOHYHOVUHFRPPHQGHGE\$&5DUHDYDLODEOHRQOLQHDW KWWSZZZDFURUJ6HFRQGDU\0DLQ0HQX&DWHJRULHVTXDOLW\BVDIHW\JXLGHOLQHVPHGBSK\VUHIHUHQFHBOHYHOVDVS[ 5HIHUHQFHYDOXHVUHFRPPHQGHGE\$$30DUHSXEOLVKHGLQ*UD\-(HWDO³5HIHUHQFH9DOXHVIRU'LDJQRVWLF 5DGLRORJ\$SSOLFDWLRQDQG,PSDFW´Radiology0D\9RO1RSS,QIRUPDWLRQDERXW1&53¶V 





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ssues Related to Clinical Decision Making &RQFHUQVKDYHDOVREHHQUDLVHGWKDWSK\VLFLDQVPD\ODFNLPSRUWDQWLQIRUPDWLRQWKDWFRXOG LQIRUPWKHLUGHFLVLRQVLQRUGHULQJPHGLFDOLPDJLQJH[DPVWKDWXVHUDGLDWLRQ 2UGHULQJSK\VLFLDQVPD\QRWKDYHDFFHVVWRSDWLHQWV¶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³DSSURSULDWHQHVVFULWHULD´RU³DSSURSULDWHXVHFULWHULD´DVVRFLDWHG

 HIIRUWVWRGHYHORSGLDJQRVWLFUHIHUHQFHOHYHOVLVDYDLODEOHRQOLQHDWKWWSZZZQFUSRQOLQHRUJ&XUUHQWB3URJ6&B KWPO  6HHIRUH[DPSOH0LOOHU'/HWDO³5DGLDWLRQ'RVHVLQ,QWHUYHQWLRQDO5DGLRORJ\3URFHGXUHV7KH5$',5 6WXG\3DUW,,6NLQ'RVH´Journal of Vascular Interventional Radiology$XJXVW9RO1RSSDQG 0DU[09³7KH5DGLDWLRQ'RVHLQ,QWHUYHQWLRQDO5DGLRORJ\6WXG\.QRZOHGJH%ULQJV5HVSRQVLELOLW\´ibidSS   0RUHLQIRUPDWLRQDERXWWKH,PDJH*HQWO\DQG6WHS/LJKWO\FDPSDLJQVLVDYDLODEOHRQOLQHDW KWWSZZZSHGUDGRUJDVVRFLDWLRQVLJ





ZLWKDQXPEHURIPHGLFDOFRQGLWLRQV  +RZHYHUFULWHULDIRUDSSURSULDWHRUGHULQJRIPHGLFDO LPDJLQJH[DPVKDYHQRW\HWEHHQEURDGO\DGRSWHGE\WKHSUDFWLFLQJPHGLFDOFRPPXQLW\

Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging )'$LVODXQFKLQJDFROODERUDWLYHInitiative to Reduce Unnecessary Radiation Exposure from Medical ImagingZLWKDIRFXVRQWKHW\SHVRILPDJLQJSURFHGXUHVWKDWDUHDVVRFLDWHGZLWKWKH KLJKHVWUDGLDWLRQGRVHV&7IOXRURVFRS\DQGQXFOHDUPHGLFLQH 7KURXJKWKLVLQLWLDWLYH)'$ZLOOWDNHVWHSV²GLUHFWO\DQGLQFROODERUDWLRQZLWKRWKHUV²WR PLWLJDWHWKHIDFWRUVFRQWULEXWLQJWRXQQHFHVVDU\UDGLDWLRQH[SRVXUHIURPWKHVHWKUHHPHGLFDO LPDJLQJPRGDOLWLHV7KHJRDORIWKHVHHIIRUWVLVWRVXSSRUWWKHEHQHILWVDVVRFLDWHGZLWKPHGLFDO LPDJLQJZKLOHPLQLPL]LQJWKHULVNV%HFDXVHVRPHRIWKHFRQWULEXWLQJIDFWRUVGHVFULEHGDERYH IDOORXWVLGHRI)'$¶VSXUYLHZZHDUHDOVRUHFRPPHQGLQJFRPSOHPHQWDU\DFWLRQVIRURWKHU JURXSVWRWDNHZKLFKZLOOVXSSRUWDQGEHVXSSRUWHGE\RXUZRUN)'$ZLOOFROODERUDWHZLWKRXU SDUWQHUVDQGRWKHUVWRPRQLWRUDQGDVVHVVWKHLPSDFWRIWKHVHHIIRUWV 1. Promote Safe Use of Medical Imaging Devices )'$RYHUVLJKWRIPHGLFDOGHYLFHVH[WHQGVWKURXJKRXWWKHWRWDOSURGXFWOLIHF\FOHIURP GHYHORSPHQWWKURXJKXVH)'$ZLOOWDNHWKHIROORZLQJDFWLRQVWRVXSSRUWWKHVDIHXVHRIPHGLFDO LPDJLQJHTXLSPHQW 1.1.

Establish requirements for manufacturers of CT and fluoroscopic devices to incorporate additional safeguards into equipment design, labeling, and user training.

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

Partner with the Centers for Medicare and Medicaid Services (CMS) to incorporate key quality assurance practices into accreditation and participation criteria for imaging facilities and hospitals.

8QGHUWKH0HGLFDUH,PSURYHPHQWVIRU3DWLHQWVDQG3URYLGHUV$FW0,33$   &06RYHUVHHV DFFUHGLWDWLRQRIVWDQGDORQHPHGLFDOLPDJLQJIDFLOLWLHV  $GGLWLRQDOO\&06KDVHVWDEOLVKHG 

 $&5¶V$SSURSULDWHQHVV&ULWHULDŠDUHDYDLODEOHRQOLQHDW KWWSZZZDFURUJ6HFRQGDU\0DLQ0HQX&DWHJRULHVTXDOLW\BVDIHW\DSSBFULWHULDDVS[$&&¶V$SSURSULDWH8VH&ULWHULD $8& DUHDYDLODEOHRQOLQHDWKWWSZZZDFFRUJTXDOLW\DQGVFLHQFHFOLQLFDODXFKWP  0HGLFDUH,PSURYHPHQWVIRU3DWLHQWVDQG3URYLGHUV$FWRI3/-XO\6WDW  &)5





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

Recommend that the healthcare professional community, in collaboration with FDA, continue efforts to develop diagnostic reference levels for CT, fluoroscopy, and nuclear medicine procedures locally and also through a national radiation dose registry.

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

&)5 $VLQJOHQDWLRQDOGRVHUHJLVWU\FRXOGEHHVWDEOLVKHGIRUPXOWLSOHW\SHVRILPDJLQJSURFHGXUHVRUVHSDUDWH UHJLVWULHVFRXOGEHHVWDEOLVKHGIRUGLIIHUHQWW\SHVRISURFHGXUHV$OWKRXJKWKHWHUP³UHJLVWU\´LVXVHGKHUHLQWKH VLQJXODU)'$VXSSRUWVHLWKHUDSSURDFK  $&5LVZRUNLQJWRHVWDEOLVKD'RVH,QGH[5HJLVWU\IRUYDULRXVLPDJLQJPRGDOLWLHVWRDOORZIRUFRPSDULVRQV DFURVVSDUWLFLSDWLQJIDFLOLWLHV$&5UHFHQWO\FRQGXFWHGDGRVHLQGH[UHJLVWU\SLORWSURMHFWIRU&7H[DPV0RUH LQIRUPDWLRQLVDYDLODEOHRQOLQHDWKWWSZZZDFURUJ6HFRQGDU\0DLQ0HQX&DWHJRULHVTXDOLW\BVDIHW\15'5DVS[  5DII*/&KLQQDL\DQ.06KDUH'$HWDO³5DGLDWLRQ'RVH)URP&DUGLDF&RPSXWHG7RPRJUDSK\%HIRUHDQG $IWHU,PSOHPHQWDWLRQRI5DGLDWLRQ'RVH5HGXFWLRQ7HFKQLTXHV´Journal of the American Medical Association-XQH 9RO1RSS 





2. Support Informed Clinical Decision Making )'$GRHVQRWRYHUVHHWKHSUDFWLFHRIPHGLFLQHKRZHYHUWKHUHDUHGLUHFWDQGLQGLUHFWDFWLRQV )'$FDQWDNHWRSURYLGHKHDOWKFDUHSURIHVVLRQDOVZLWKWRROVWKDWZRXOGLQIRUPWKHLUGHFLVLRQV ZLWKUHVSHFWWRPHGLFDOLPDJLQJ 2.1.

Establish requirements for manufacturers of CT and fluoroscopic devices to record radiation dose information for use in patient medical records or a radiation dose registry.

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¶VSDSHURUHOHFWURQLF PHGLFDOUHFRUG)'$PD\DOVRUHTXLUHWKDWGHYLFHVEHFDSDEOHRIDXWRPDWLFDOO\UHFRUGLQJ UDGLDWLRQGRVHLQIRUPDWLRQLQDVWDQGDUGL]HG'LJLWDO,PDJLQJDQG&RPPXQLFDWLRQVLQ0HGLFLQH ',&20 VWUXFWXUHGUHSRUWDQGWUDQVPLWWLQJWKLVLQIRUPDWLRQWRDSDWLHQW¶VHOHFWURQLFPHGLFDO UHFRUGRUDGRVHUHJLVWU\6XFKVWHSVZLOOSURYLGHRUGHULQJSK\VLFLDQVZLWKPRUHFRPSUHKHQVLYH LQIRUPDWLRQDERXWDSDWLHQW¶VLPDJLQJDQGUDGLDWLRQGRVHKLVWRU\WRVXSSRUWWKHLUGHFLVLRQVDERXW WKHPRVWDSSURSULDWHFOLQLFDOFRXUVHRIDFWLRQIRUHDFKSDWLHQW 2.2.

Recommend that the healthcare professional community continue to develop and adopt criteria for appropriate use of CT, fluoroscopy, and nuclear medicine procedures, or other procedures that use these techniques.

%XLOGLQJRQWKHHIIRUWVRIYDULRXVSURIHVVLRQDORUJDQL]DWLRQVLQFOXGLQJ$&5DQG$&&)'$ UHFRPPHQGVWKDWWKHKHDOWKFDUHSURIHVVLRQDOFRPPXQLW\FRQWLQXHWRGHYHORSDQGDGRSW DSSURSULDWHXVHFULWHULDIRU&7IOXRURVFRS\DQGQXFOHDUPHGLFLQHSURFHGXUHV(OHFWURQLF GHFLVLRQVXSSRUWWRROVIRURUGHULQJLPDJLQJSURFHGXUHVFRXOGLQFRUSRUDWHWKHVHFULWHULDWR LPSURYHTXDOLW\DQGFRQVLVWHQF\LQFOLQLFDOGHFLVLRQPDNLQJ 3. Increase Patient Awareness $VWKHHIIRUWVGHVFULEHGDERYHSURFHHG)'$UHFRJQL]HVWKHLPSRUWDQFHRIHPSRZHULQJ SDWLHQWVZLWKLQIRUPDWLRQDQGWRROVWRKHOSWKHPDQGWKHLUSK\VLFLDQVPDQDJHWKHLUH[SRVXUHWR UDGLDWLRQIURPPHGLFDOLPDJLQJLQWKHVKRUWWHUPHYHQEHIRUHORQJHUWHUPFKDQJHVWDNHHIIHFW 3.1.

Provide patients with tools to track their personal medical imaging history.

)'$LVFROODERUDWLQJZLWKWKH$&5DQG561$MRLQWWDVNIRUFHFXUUHQWO\FRRUGLQDWLQJ,PDJH :LVHO\WRGHYHORSDQGGLVVHPLQDWHDSDWLHQWPHGLFDOLPDJLQJUHFRUGFDUG  )'$ZLOOPDNHWKLV FDUGDYDLODEOHRQRXUZHEVLWH:KLOHXOWLPDWHO\WKHEHVWZD\RIWUDFNLQJDSDWLHQW¶VKLVWRU\RI UDGLDWLRQH[SRVXUHZLOOEHWRLQFRUSRUDWHLWLQWRWKDWSDWLHQW¶VSDSHURUHOHFWURQLFPHGLFDOUHFRUG DSHUVRQDOUHFRUGFDUGZLOOJLYHSDWLHQWVDQGWKHLUFDUHJLYHUVDPHDQVLQWKHVKRUWWHUPRI 

 7KHQHZPHGLFDOLPDJLQJUHFRUGFDUGZLOOEHDQXSGDWHGDQGHQKDQFHGYHUVLRQRI)'$¶VSUHH[LVWLQJ[UD\ UHFRUGFDUGZKLFKLVFXUUHQWO\DYDLODEOHRQOLQHDWKWWSZZZIGDJRYGRZQORDGV5DGLDWLRQ (PLWWLQJ3URGXFWV5HVRXUFHVIRU