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What the federal X-ray regulations mean to the dentist
T h e F e d e ra l P e rfo r m a n c e S ta n d a rd f o r D ia g n o s tic X -ra y E q u ip m e n t, w h ic h b e c a m e e ffe c tiv e A u g 1, 197 4 , is p r im a r ily d ir e c te d to w a r d m a n u fa c tu r e r s , w h o m u s t p r o d u c e X -ra y e q u ip m e n t th a t p e r fo r m s in a p r e s c r ib e d w a y . It is a n e q u ip m e n t p e r fo r m a n c e s ta n d a r d a n d d o e s n o t re g u la te d ia g n o s t ic X -ra y u se s. T h e d e n tis t, h o w e v e r, h a s r e s p o n s ib ilit ie s in th r e e a re a s — m a in te n a n c e , a s s e m b ly , a n d v a ria n c e fr o m th e s ta n d a r d .
What the federal X-ray regulations mean to the dentist
Orlen N. Johnson, DDS, MS G regory J. Barone, PhD, Rockville, Md
T h e F ed era l P erform an ce Standard for D ia g n o s tic X -ray E q u ip m en t, w h ich b eca m e e ffe c tiv e A u g 1, 1974, w a s issu e d by th e F o o d and D ru g A d m in istration u nder authority o f the R adiation C ontrol for H ea lth and S a fe ty A c t o f 1968 (P u b lic L aw 90-602). T h e a ct requ ires the S ecretary o f H ea lth , E d u ca tio n , and W elfare to con d uct, a radiation con trol program that in clu d es th e d ev elo p m en t and ad m in istration o f eq u ipm en t perform ance standards to red u ce hum an ex p o su re to electro n ic p rod uct radiation. T h is resp o n sib ility has b een d ele g a te d to th e F D A ’s B ureau o f R ad iological H ealth . A lth ou gh th e standard is in tend ed prim arily to p rotect p atien ts from u n n ec essa r y ex p o su re to X rad iation , it a lso o ffers d irect ad van tages to d en tists. In e s s e n c e , th e standard requ ires that X -ray eq u ip m en t b e cap ab le o f p rovid in g m ore reliable d iagn ostic inform ation w ith an in creased level o f radiation p ro tectio n . T h e p ro v isio n s o f the standard are q uite varied. T h e y in clu d e requ irem en ts for lim iting the X -ray field s iz e , for uniform ity and reprodu cibility o f X -ray ex p o su r e , for in d ication and accu ra cy o f 810 ■ JADA, Vol. 95, O ctober 1977
m ach in e fa cto rs su ch as tube k ilo v o lta g e (k V p ), tub e current (m a), and ex p o su re tim e, and fo r b eam q uality. A ls o , the standard sp e c ifie s that m anu factu rers m ust p rovid e ad eq uate inform a tion to both th e p u rch aser-u ser o f th e eq u ip m en t and th e in staller. T w o gen era l p oin ts sh ould be m ade about the standard. F irst, it is an eq u ipm en t p erform an ce standard; it ca n n o t require eq u ipm en t d esign fe a tu res. S e c o n d , the standard d o e s not regulate d ia g n o stic X -r a y eq u ipm en t u sers. It n eith er re quires d en tists to p ractice rad iology in certain w a y s n or p roh ibits them from using X -ray eq u ip m ent for a d esired p urpose. T h erefo re, m o st prac ticing d en tists n eed not be k n o w led g ea b le ab ou t the d eta ils o f th e standard. T h e s e are o f co n cern o n ly to d en tists w h o install or repair their o w n X -ray eq u ip m en t. T h e standard a p p lies to X -ra y eq u ip m en t m an ufactured after A u g 1, 1974. It d o es not require that d en tal X -ra y m ach in es in u se b efo re that d ate be m o d ified , upgraded, or d isca rd ed . A n old X -ra y m ach in e n eed not b e replaced if it is fu n c tioning properly.
T h e standard requires m anufacturers to certify b y m ean s o f a label that their X -ray eq u ipm en t, m anufactured after A u g 1, 1974, co m p lie s w ith the standard. T h e individual co m p o n e n ts o f d en tal X -ray sy stem s that m ust b e certified include the co n trol, the tube h ou sin g a sse m b ly and highv o lta g e gen erator, and the beam lim iting d ev ic e. A sse m b ler s m ust certify that th e X -ray m achine has b een assem b led in acco rd a n ce w ith th e m anu factu rer’s in stru ctions. A fter A u g 1, 1979, on ly certified X -ray eq u ip m en t m ay be in stalled , w h eth er it is n ew or u sed .
The d e n tis t’s respon sibilitie s T h e standard is prim arily d irected at m anufactur e r s, w h o m ust p rod uce X -ray eq u ip m en t that p er form s in a p rescribed w a y . H o w e v e r , eq u ipm en t o w n ers h ave resp on sib ilities in three areas: m ain ten a n c e, a sse m b ly , and varian ce from the stan dard. ■ M a i n t e n a n c e : A cco rd in g to th e standard, eq u ipm en t m anufacturers are required to furnish p urch asers w ith a sch ed u le o f m ain ten an ce step s n e ce ssa r y to k eep the sy stem in co m p lia n ce, as w ell as w ith in stru ctions regarding p rocedu res and p recaution s to b e fo llo w ed b eca u se o f unique featu res o f the eq u ipm en t. It is th e d en tist’s re sp o n sib ility, h o w e v er , to h ave h is X -ray eq u ip m ent m aintained accord in g to the sc h ed u le fur n ished b y the m anufacturer, to en su re com p lian ce w ith the standard for the life o f th e eq uipm ent. F ailu re to fo llo w the m anu factu rer’s m ainten an ce in stru ctions cou ld reliev e th e m anufacturer o f re sp o n sib ility for con tin u ed co m p lia n ce. M an u fac turers m ust repair, rep lace, or refund the c o s t o f certified com p o n en ts that fail, through n o fault o f the u ser, to com p ly w ith the stan d ard .1 I f eq u ip m ent m ainten an ce is perform ed u nder a serv ic e co n tract, the con tract sh ould in clu d e a p rovision to k eep the unit in co m p lian ce w ith the standard by strict ad h eren ce to th e m ain ten an ce s c h e d u le .1 ■ A s s e m b l y : T h e in terco n n ectio n o f major co m p o n en ts to form a d iagn ostic X -ray sy stem and the adjustm ent and testin g o f th e sy stem are th e final step s in the X -ray eq u ip m en t m anufactur ing p ro ce ss. T h e standard r e co g n iz es this fa ct by d efining the installer or assem b ler o f certified co m p o n en ts as a “ m an u factu rer.”
A cco rd in g to the standard, the m anufacturer m ust m eet requ irem en ts o f th e standard w h eth er he in stalls an en tire sy stem (a co m p lete X -ray m ach ine) or adds or rep la ces a sin gle certified co m p o n en t (for in sta n ce, a n ew tub e). In m o st in sta n c es, the d en tist w ill not a sse m b le o r in stall his o w n X -ray m ach ine. H o w e v e r , if he c h o o s e s to d o s o , he b eco m e s a “ m anu factu rer” a ccord in g to the d efinition in the standard. T h u s, he is su b je c t to the requ irem en ts for m anu factu rers in clu d ing co m p letio n o f F orm F D 2579 “ R ep ort o f a s sem b ly o f a d ia g n o stic X -ray s y s t e m .” T h is form m ust b e co m p leted by the p erson w h o a sse m b le s th e u nit, w h eth er it is th e co m p a n y rep resen t a tiv e, th e d en tist, or h is e m p lo y e e .2 T h e a ssem b ler o f an X -ray m a ch in e, acco rd in g to the standard, m ust n o tify the Bureau o f R a d iological H ealth if he fin d s e v id e n c e o f nonco m p lia n ce in the sy stem or its co m p o n e n ts. H e m ust a lso report any k n ow n or su sp e c te d radia tion a cc id en t arising from op eration o f an X -ra y m a ch in e, ev e n if there is n o d efec t or nonco m p lia n ce.
■ V a r i a n c e : A t tim e s, the d en tist m ay id en tify a n eed for sp ecia lized eq u ipm en t that d o e s n ot m eet all co n d itio n s o f th e standard. W hen su ch o c c a sio n s a rise, th e d en tist m ay req u est the m anu fac turer to obtain a variance from o n e o r m ore p rovi sio n s o f th e standard.
THE AUTHORS
JOHNSON
BARONE
Dr. Johnson is a dental X-ray specialist, Medi cal Branch, Division of Training and Medical Ap plications, and Dr. Barone is chief of the X-ray Products Branch, Division of Compliance, Bureau of Radiological Health, Rockville, Md 20852. Address requests for reprints to Dr. Johnson.
Johnson— Barone: FEDERAL X-RAY REGULATIONS ■ 811
Upgrading equipment T h e regu lation s e ffe c t the upgrading o f eq u ipm en t by: — requiring that an X -ray m ach in e m ad e b efo re A u g 1, 1974, that has b een altered b y in stallation o f a certified com p o n en t, w ill th ereafter h ave to u se o n ly certified rep lacem en t co m p o n e n ts; and — proh ibitin g th e a sse m b ly o f u ncertified c o m p o n e n ts in to X -ray m ach in es re a ssem b led and so ld after A u g 1, 1979, fiv e y ears after th e stan dard’s e ffe c tiv e d ate. U n c ertified co m p o n en ts w ill h a v e to b e replaced in su ch m ach in es. T h e fiv e -y e a r grace p eriod for ap p lication o f the standard to reassem b led eq u ip m en t a llo w s tim e to p ro d u ce ad eq u ate in v en tories o f certified c o m p o n en ts. F urth erm ore, it is estim a ted that it tak es ap p roxim ately fiv e years for eq u ip m en t to m o v e in to th e u se d X -ray m arket from h osp ital radiol o g y d ep artm en ts and oth er high w ork load f a c ilitie s .1
Frequently asked questions and the answers T h e fo llo w in g se ctio n con ta in s q u estio n s w h ich h a v e freq u en tly b een a sk ed b y d en tists. T h e D iv i sio n o f C o m p lia n ce, B ureau o f R a d iologica l H e a lth h as an sw ered th e se q u estio n s u sin g th e F ed er a l P erform an ce Standard and th e regulation co n ce rn in g P L 90-602 as au th oritative s o u r c e s .1 ■ D o e s th e standard ap ply to u sed eq u ipm en t p u rch a sed years ago? T h e standard ap p lies o n ly to X -ra y eq u ipm en t m anu factu red after A u g 1, 1974. ■ A re d en tists required to p u rch ase n ew X -ray eq u ip m en t that com p lies w ith th e standard and to d iscard o ld equipm ent? N o . T h er e is n o p rovision o f th e standard that requ ires th e p urch ase o f n ew eq u ip m en t. D e n tists m ay co n tin u e to u se eq u ip m en t m ade b efore A u g 1, 1974, e v e n though this eq u ip m en t m ight n ot c o m p ly w ith th e standard. S u ch eq u ip m en t, h o w e v e r , m ay b e su bject to state or lo c a l radiation co n tro l regulations. ■ H a s the F o o d and D ru g A d m in istration ad op ted n ew regulations w ith r e sp e c t to upgrad ing X -ray eq u ipm en t in u se to m ee t the standard? Y e s , b u t o n ly to th e e x te n t that su ch upgrading in v o lv e s th e a ssem b ly o f certified com p o n en ts in to ex istin g X -ray m ach in es. C o m p o n en ts in stalled in ex istin g eq u ip m en t d o n ot h a v e to b e 812 «JADA, Vol. 95, October 1977
certified if there are n o certified c o m p o n e n ts al ready in the sy stem . T h e regulation a lso w ill pro hibit the a sse m b ly o f n o n certified c o m p o n e n ts in to eq u ip m en t m o v ed , rea ssem b led , and so ld after A u g 1, 1979. ■ C an X -ra y eq u ip m en t m anufactured prior to A u g 1, 1974, b e m o v ed from o n e dental o ffic e to an oth er after th e e ffe c tiv e date o f th e standard w ith o u t b ein g upgraded to m eet th e standard? Y e s . U n c er tifie d X -ra y eq u ip m en t re a sse m b led in an oth er lo c a tio n after A u g 1, 1974, is n o t su b ject to th e standard u n le ss th e re a ssem b ly o c cu rs after A u g 1, 1979, and in v o lv e s a ch a n g e in ow n ersh ip . ■ It has b een stated that th e fed eral g o v e r n m en t has ad o p ted a standard o n the u se o f diag n o stic X -ra y eq u ip m en t. Is that correct? N o . T h e standard a p p lies o n ly to th e p erfor m an ce o f eq u ip m en t, n ot to its u se. A s in th e p a st, ju d g m en t o f th e freq u en cy and e x te n t o f radiographic ex a m in a tio n s is th e d e n tis t’s r e sp o n si b ility. ■ C an eq u ip m en t m ade prior to th e stan d ard ’s effe c tiv e date b e repaired w ith ou t h avin g step s taken to bring th e eq u ipm en t into co m p lia n ce? Y e s . T h ere is n o requirem ent for certifica tio n after serv icin g or repairing su ch eq u ipm en t. ■ W hat resp o n sib ilities w o u ld a d en tist assu m ^ under th e standard if h e replaced th e tu b e in a certified tu b e-h o u sin g a ssem b ly ? T h e standard d efin es su ch a ctio n as co n stitu t ing th e m anufacture o f a n ew tu b e-h o u sin g a s sem b ly . T h u s, the d en tist w o u ld a ssu m e th e re sp o n sib ilities o f a m anufacturer, in clu d in g re sp o n sib ility for certifyin g th e a sse m b ly for c o m p lia n ce w ith th e standard. S u ch certifica tio n w o u ld h a v e to b e m ade e v e n if th e tu b e w ere id en tica l to th e part it replaced. ■ W hat is th e d en tist’s resp o n sib ility for k eep ing certified eq u ip m en t in co m p lia n ce w ith the standard? It is up to th e d en tist to m aintain h is X -ra y eq u ip m en t a ccord in g to th e sch ed u le furnished b y th e m anufacturer, to en su re co m p lia n ce w ith th e standard fo r th e life o f the eq u ipm en t. F a ilu re to fo llo w th e m anufacturer’s m ain ten an ce in stru c tio n s co u ld re lie v e th e m anufacturer o f r e sp o n si bility for co n tin u ed c o m p lia n c e .1 In a d d ition , the p ractition er m ay b e required to co m p ly w ith state X -ra y eq u ip m en t regulations, w h ich in turn m ust b e co m p a tib le w ith the F ed era l P erform an ce Standard. ■ W hat a ctio n sh ou ld th e d en tist tak e if h e pur c h a se s a n e w X -ra y m ach ine and it is fo u n d to be
o u t o f co m p lia n ce after installation? T h e first step sh ould b e to n otify th e a ssem b ler or m anu factu rer. I f th e m ach in e is n ot brought into co m p lia n ce , th e d en tist sh ould inform the lo ca l or state radiation con trol a g en cy an d/or the n ea rest F o o d and D ru g A d m in istration o ffic e. ■ M u st le a se d or im ported d en tal X -ray m a ch in es m ee t th e standard? Y e s , if th e y w er e m anufactured after A u g 1, 1974. ■ M a y an a sse m b le r refu se to c o n n e c t eq u ip m ent to a u se r ’s p o w e r sou rce? Y e s . A s part o f his in stru ction s to a sse m b le rs, th e m anu factu rer m u st sp ec ify m inim um p o w er req u irem en ts for a particular u n it.2 C o n n ec tio n o f th e unit m ay b e refu sed if th e required p o w e r is n ot av ailab le.
Summary T h e d en tist sh ould k eep in m ind that th e F ed era l P erform an ce Standard is d esig n ed to p ro tec t the p ub lic and the p ro fessio n from h ealth h azard s and from in a d eq u a cies in m anu factu re. It o ffe rs m any ad van tages to the d en tist w h o u se s X -r a y eq u ip m ent. T h e standard d o e s n o t regulate th e d e n tist’s d ia g n o stic u se o f X radiation, but it a ssu re s him o f p urchasing reliab le, prop erly fu n ctio n in g eq u ip m ent w ith an in crea sed le v e l o f radiation p ro tec tion.
1. A practitioner's guide to the diagnostic X-ray equipment stan dard. Rockville, Md, Bureau of Radiological Health, Division of Compliance, Sept 1974. 2. Regulations for the administration and enforcement of the radiation control for Health and Safety Act of 1968. Rockville, Md, Bureau of Radiological Health, Jan 1976.
Johnson— Barone: FEDERAL X-RAY REGULATIONS ■ 813
What the federal X-ray regulations mean to the dentist
Orlen N. Johnson, DDS, MS G regory J. Barone, PhD, Rockville, Md
T h e F ed era l P erform an ce Standard for D ia g n o s tic X -ray E q u ip m en t, w h ich b eca m e e ffe c tiv e A u g 1, 1974, w a s issu e d by th e F o o d and D ru g A d m in istration u nder authority o f the R adiation C ontrol for H ea lth and S a fe ty A c t o f 1968 (P u b lic L aw 90-602). T h e a ct requ ires the S ecretary o f H ea lth , E d u ca tio n , and W elfare to con d uct, a radiation con trol program that in clu d es th e d ev elo p m en t and ad m in istration o f eq u ipm en t perform ance standards to red u ce hum an ex p o su re to electro n ic p rod uct radiation. T h is resp o n sib ility has b een d ele g a te d to th e F D A ’s B ureau o f R ad iological H ealth . A lth ou gh th e standard is in tend ed prim arily to p rotect p atien ts from u n n ec essa r y ex p o su re to X rad iation , it a lso o ffers d irect ad van tages to d en tists. In e s s e n c e , th e standard requ ires that X -ray eq u ip m en t b e cap ab le o f p rovid in g m ore reliable d iagn ostic inform ation w ith an in creased level o f radiation p ro tectio n . T h e p ro v isio n s o f the standard are q uite varied. T h e y in clu d e requ irem en ts for lim iting the X -ray field s iz e , for uniform ity and reprodu cibility o f X -ray ex p o su r e , for in d ication and accu ra cy o f 810 ■ JADA, Vol. 95, O ctober 1977
m ach in e fa cto rs su ch as tube k ilo v o lta g e (k V p ), tub e current (m a), and ex p o su re tim e, and fo r b eam q uality. A ls o , the standard sp e c ifie s that m anu factu rers m ust p rovid e ad eq uate inform a tion to both th e p u rch aser-u ser o f th e eq u ip m en t and th e in staller. T w o gen era l p oin ts sh ould be m ade about the standard. F irst, it is an eq u ipm en t p erform an ce standard; it ca n n o t require eq u ipm en t d esign fe a tu res. S e c o n d , the standard d o e s not regulate d ia g n o stic X -r a y eq u ipm en t u sers. It n eith er re quires d en tists to p ractice rad iology in certain w a y s n or p roh ibits them from using X -ray eq u ip m ent for a d esired p urpose. T h erefo re, m o st prac ticing d en tists n eed not be k n o w led g ea b le ab ou t the d eta ils o f th e standard. T h e s e are o f co n cern o n ly to d en tists w h o install or repair their o w n X -ray eq u ip m en t. T h e standard a p p lies to X -ra y eq u ip m en t m an ufactured after A u g 1, 1974. It d o es not require that d en tal X -ra y m ach in es in u se b efo re that d ate be m o d ified , upgraded, or d isca rd ed . A n old X -ra y m ach in e n eed not b e replaced if it is fu n c tioning properly.
T h e standard requires m anufacturers to certify b y m ean s o f a label that their X -ray eq u ipm en t, m anufactured after A u g 1, 1974, co m p lie s w ith the standard. T h e individual co m p o n e n ts o f d en tal X -ray sy stem s that m ust b e certified include the co n trol, the tube h ou sin g a sse m b ly and highv o lta g e gen erator, and the beam lim iting d ev ic e. A sse m b ler s m ust certify that th e X -ray m achine has b een assem b led in acco rd a n ce w ith th e m anu factu rer’s in stru ctions. A fter A u g 1, 1979, on ly certified X -ray eq u ip m en t m ay be in stalled , w h eth er it is n ew or u sed .
The d e n tis t’s respon sibilitie s T h e standard is prim arily d irected at m anufactur e r s, w h o m ust p rod uce X -ray eq u ip m en t that p er form s in a p rescribed w a y . H o w e v e r , eq u ipm en t o w n ers h ave resp on sib ilities in three areas: m ain ten a n c e, a sse m b ly , and varian ce from the stan dard. ■ M a i n t e n a n c e : A cco rd in g to th e standard, eq u ipm en t m anufacturers are required to furnish p urch asers w ith a sch ed u le o f m ain ten an ce step s n e ce ssa r y to k eep the sy stem in co m p lia n ce, as w ell as w ith in stru ctions regarding p rocedu res and p recaution s to b e fo llo w ed b eca u se o f unique featu res o f the eq u ipm en t. It is th e d en tist’s re sp o n sib ility, h o w e v er , to h ave h is X -ray eq u ip m ent m aintained accord in g to the sc h ed u le fur n ished b y the m anufacturer, to en su re com p lian ce w ith the standard for the life o f th e eq uipm ent. F ailu re to fo llo w the m anu factu rer’s m ainten an ce in stru ctions cou ld reliev e th e m anufacturer o f re sp o n sib ility for con tin u ed co m p lia n ce. M an u fac turers m ust repair, rep lace, or refund the c o s t o f certified com p o n en ts that fail, through n o fault o f the u ser, to com p ly w ith the stan d ard .1 I f eq u ip m ent m ainten an ce is perform ed u nder a serv ic e co n tract, the con tract sh ould in clu d e a p rovision to k eep the unit in co m p lian ce w ith the standard by strict ad h eren ce to th e m ain ten an ce s c h e d u le .1 ■ A s s e m b l y : T h e in terco n n ectio n o f major co m p o n en ts to form a d iagn ostic X -ray sy stem and the adjustm ent and testin g o f th e sy stem are th e final step s in the X -ray eq u ip m en t m anufactur ing p ro ce ss. T h e standard r e co g n iz es this fa ct by d efining the installer or assem b ler o f certified co m p o n en ts as a “ m an u factu rer.”
A cco rd in g to the standard, the m anufacturer m ust m eet requ irem en ts o f th e standard w h eth er he in stalls an en tire sy stem (a co m p lete X -ray m ach ine) or adds or rep la ces a sin gle certified co m p o n en t (for in sta n ce, a n ew tub e). In m o st in sta n c es, the d en tist w ill not a sse m b le o r in stall his o w n X -ray m ach ine. H o w e v e r , if he c h o o s e s to d o s o , he b eco m e s a “ m anu factu rer” a ccord in g to the d efinition in the standard. T h u s, he is su b je c t to the requ irem en ts for m anu factu rers in clu d ing co m p letio n o f F orm F D 2579 “ R ep ort o f a s sem b ly o f a d ia g n o stic X -ray s y s t e m .” T h is form m ust b e co m p leted by the p erson w h o a sse m b le s th e u nit, w h eth er it is th e co m p a n y rep resen t a tiv e, th e d en tist, or h is e m p lo y e e .2 T h e a ssem b ler o f an X -ray m a ch in e, acco rd in g to the standard, m ust n o tify the Bureau o f R a d iological H ealth if he fin d s e v id e n c e o f nonco m p lia n ce in the sy stem or its co m p o n e n ts. H e m ust a lso report any k n ow n or su sp e c te d radia tion a cc id en t arising from op eration o f an X -ra y m a ch in e, ev e n if there is n o d efec t or nonco m p lia n ce.
■ V a r i a n c e : A t tim e s, the d en tist m ay id en tify a n eed for sp ecia lized eq u ipm en t that d o e s n ot m eet all co n d itio n s o f th e standard. W hen su ch o c c a sio n s a rise, th e d en tist m ay req u est the m anu fac turer to obtain a variance from o n e o r m ore p rovi sio n s o f th e standard.
THE AUTHORS
JOHNSON
BARONE
Dr. Johnson is a dental X-ray specialist, Medi cal Branch, Division of Training and Medical Ap plications, and Dr. Barone is chief of the X-ray Products Branch, Division of Compliance, Bureau of Radiological Health, Rockville, Md 20852. Address requests for reprints to Dr. Johnson.
Johnson— Barone: FEDERAL X-RAY REGULATIONS ■ 811
Upgrading equipment T h e regu lation s e ffe c t the upgrading o f eq u ipm en t by: — requiring that an X -ray m ach in e m ad e b efo re A u g 1, 1974, that has b een altered b y in stallation o f a certified com p o n en t, w ill th ereafter h ave to u se o n ly certified rep lacem en t co m p o n e n ts; and — proh ibitin g th e a sse m b ly o f u ncertified c o m p o n e n ts in to X -ray m ach in es re a ssem b led and so ld after A u g 1, 1979, fiv e y ears after th e stan dard’s e ffe c tiv e d ate. U n c ertified co m p o n en ts w ill h a v e to b e replaced in su ch m ach in es. T h e fiv e -y e a r grace p eriod for ap p lication o f the standard to reassem b led eq u ip m en t a llo w s tim e to p ro d u ce ad eq u ate in v en tories o f certified c o m p o n en ts. F urth erm ore, it is estim a ted that it tak es ap p roxim ately fiv e years for eq u ip m en t to m o v e in to th e u se d X -ray m arket from h osp ital radiol o g y d ep artm en ts and oth er high w ork load f a c ilitie s .1
Frequently asked questions and the answers T h e fo llo w in g se ctio n con ta in s q u estio n s w h ich h a v e freq u en tly b een a sk ed b y d en tists. T h e D iv i sio n o f C o m p lia n ce, B ureau o f R a d iologica l H e a lth h as an sw ered th e se q u estio n s u sin g th e F ed er a l P erform an ce Standard and th e regulation co n ce rn in g P L 90-602 as au th oritative s o u r c e s .1 ■ D o e s th e standard ap ply to u sed eq u ipm en t p u rch a sed years ago? T h e standard ap p lies o n ly to X -ra y eq u ipm en t m anu factu red after A u g 1, 1974. ■ A re d en tists required to p u rch ase n ew X -ray eq u ip m en t that com p lies w ith th e standard and to d iscard o ld equipm ent? N o . T h er e is n o p rovision o f th e standard that requ ires th e p urch ase o f n ew eq u ip m en t. D e n tists m ay co n tin u e to u se eq u ip m en t m ade b efore A u g 1, 1974, e v e n though this eq u ip m en t m ight n ot c o m p ly w ith th e standard. S u ch eq u ip m en t, h o w e v e r , m ay b e su bject to state or lo c a l radiation co n tro l regulations. ■ H a s the F o o d and D ru g A d m in istration ad op ted n ew regulations w ith r e sp e c t to upgrad ing X -ray eq u ipm en t in u se to m ee t the standard? Y e s , b u t o n ly to th e e x te n t that su ch upgrading in v o lv e s th e a ssem b ly o f certified com p o n en ts in to ex istin g X -ray m ach in es. C o m p o n en ts in stalled in ex istin g eq u ip m en t d o n ot h a v e to b e 812 «JADA, Vol. 95, October 1977
certified if there are n o certified c o m p o n e n ts al ready in the sy stem . T h e regulation a lso w ill pro hibit the a sse m b ly o f n o n certified c o m p o n e n ts in to eq u ip m en t m o v ed , rea ssem b led , and so ld after A u g 1, 1979. ■ C an X -ra y eq u ip m en t m anufactured prior to A u g 1, 1974, b e m o v ed from o n e dental o ffic e to an oth er after th e e ffe c tiv e date o f th e standard w ith o u t b ein g upgraded to m eet th e standard? Y e s . U n c er tifie d X -ra y eq u ip m en t re a sse m b led in an oth er lo c a tio n after A u g 1, 1974, is n o t su b ject to th e standard u n le ss th e re a ssem b ly o c cu rs after A u g 1, 1979, and in v o lv e s a ch a n g e in ow n ersh ip . ■ It has b een stated that th e fed eral g o v e r n m en t has ad o p ted a standard o n the u se o f diag n o stic X -ra y eq u ip m en t. Is that correct? N o . T h e standard a p p lies o n ly to th e p erfor m an ce o f eq u ip m en t, n ot to its u se. A s in th e p a st, ju d g m en t o f th e freq u en cy and e x te n t o f radiographic ex a m in a tio n s is th e d e n tis t’s r e sp o n si b ility. ■ C an eq u ip m en t m ade prior to th e stan d ard ’s effe c tiv e date b e repaired w ith ou t h avin g step s taken to bring th e eq u ipm en t into co m p lia n ce? Y e s . T h ere is n o requirem ent for certifica tio n after serv icin g or repairing su ch eq u ipm en t. ■ W hat resp o n sib ilities w o u ld a d en tist assu m ^ under th e standard if h e replaced th e tu b e in a certified tu b e-h o u sin g a ssem b ly ? T h e standard d efin es su ch a ctio n as co n stitu t ing th e m anufacture o f a n ew tu b e-h o u sin g a s sem b ly . T h u s, the d en tist w o u ld a ssu m e th e re sp o n sib ilities o f a m anufacturer, in clu d in g re sp o n sib ility for certifyin g th e a sse m b ly for c o m p lia n ce w ith th e standard. S u ch certifica tio n w o u ld h a v e to b e m ade e v e n if th e tu b e w ere id en tica l to th e part it replaced. ■ W hat is th e d en tist’s resp o n sib ility for k eep ing certified eq u ip m en t in co m p lia n ce w ith the standard? It is up to th e d en tist to m aintain h is X -ra y eq u ip m en t a ccord in g to th e sch ed u le furnished b y th e m anufacturer, to en su re co m p lia n ce w ith th e standard fo r th e life o f the eq u ipm en t. F a ilu re to fo llo w th e m anufacturer’s m ain ten an ce in stru c tio n s co u ld re lie v e th e m anufacturer o f r e sp o n si bility for co n tin u ed c o m p lia n c e .1 In a d d ition , the p ractition er m ay b e required to co m p ly w ith state X -ra y eq u ip m en t regulations, w h ich in turn m ust b e co m p a tib le w ith the F ed era l P erform an ce Standard. ■ W hat a ctio n sh ou ld th e d en tist tak e if h e pur c h a se s a n e w X -ra y m ach ine and it is fo u n d to be
o u t o f co m p lia n ce after installation? T h e first step sh ould b e to n otify th e a ssem b ler or m anu factu rer. I f th e m ach in e is n ot brought into co m p lia n ce , th e d en tist sh ould inform the lo ca l or state radiation con trol a g en cy an d/or the n ea rest F o o d and D ru g A d m in istration o ffic e. ■ M u st le a se d or im ported d en tal X -ray m a ch in es m ee t th e standard? Y e s , if th e y w er e m anufactured after A u g 1, 1974. ■ M a y an a sse m b le r refu se to c o n n e c t eq u ip m ent to a u se r ’s p o w e r sou rce? Y e s . A s part o f his in stru ction s to a sse m b le rs, th e m anu factu rer m u st sp ec ify m inim um p o w er req u irem en ts for a particular u n it.2 C o n n ec tio n o f th e unit m ay b e refu sed if th e required p o w e r is n ot av ailab le.
Summary T h e d en tist sh ould k eep in m ind that th e F ed era l P erform an ce Standard is d esig n ed to p ro tec t the p ub lic and the p ro fessio n from h ealth h azard s and from in a d eq u a cies in m anu factu re. It o ffe rs m any ad van tages to the d en tist w h o u se s X -r a y eq u ip m ent. T h e standard d o e s n o t regulate th e d e n tist’s d ia g n o stic u se o f X radiation, but it a ssu re s him o f p urchasing reliab le, prop erly fu n ctio n in g eq u ip m ent w ith an in crea sed le v e l o f radiation p ro tec tion.
1. A practitioner's guide to the diagnostic X-ray equipment stan dard. Rockville, Md, Bureau of Radiological Health, Division of Compliance, Sept 1974. 2. Regulations for the administration and enforcement of the radiation control for Health and Safety Act of 1968. Rockville, Md, Bureau of Radiological Health, Jan 1976.
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