Bracco`s Rb-82 Generator
Contents
1. LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator Directions for Eluting Section 2 4 Was previously section 2 6 e Adds a new warning about additives particularly calcium ions which may cause the release of substantial amounts of Sr 82 and or Sr 85 regardless of any other considerations NOTE For example Lactated Ringer s solution which contains large amounts of calcium ions should NEVER be used for Rb 82 elution e Adds a new instruction to maintain an on going record of all elution volumes This refers not only to patient doses but to all eluate that goes through the generator including that used for column washing and strontium level testing o E a AN 1 CardioGen 82 Rubidium Rb 82 Generator Prescribing Information Princeton NJ Bracco Diagnostics Inc February 2012 BRACCO LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator Ongoing Compliance Program The adherence of sites to the new quality control provisions of the revised CardioGen 82 PI must be monitored by Bracco as per FDA Sites are required to submit daily to Bracco QC documentation re column wash Sr testing calibration and Accounting of total elution volume passed through the generator column Bracco instituted an on line electronic data entry system to eliminated paper fax reporting Site training certification etc measures are required FDA expects Bracco to take action if sites are not compli2. 2 CardioGen 82 Rubidium Rb 82 Generator Infusion System User s Guide AN BRACCO LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator ist Elution The Generator Column Wash 1 Label elution test vial with VV current date time and initial of technologist performing test 2 Place elution test vial into the vial shield 3 Attach a 18 20 gauge needle to the patient administration set 4 Insert the needle into the shielded elution test vial septum 5 Insert a vent needle into the shielded elution test vial septum make sure it does not extend below the 50 ml fill point 6 Setthe patient dose to 99 mCi 7 Setthe patient volume to 50 ml 8 Confirm the infusion mode is set to automatic infusion 9 Confirm the syringe pump is properly filled 10 Start infusion by pressing the Inject Start Stop button 11 observe ALARA principles 12 Allow for adequate decay and discard the eluate vial according to department radiation safety regulations 13 Label Infusion System printout with date infusion time user initials and W Save printout for volume tracking Ee AN BRACCO 2 CardioGen 82 Rubidium Rb 82 Generator Infusion System User s Guide Rev 20 October 2012 LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator 1st Elution The Generator Column Wash Control Panel Settings Mode Automatic Switch Infusion Elution 99 ml Volume Patient Volume Dose Dose Flow Rate 50 ml
3. Listing of Isotopes AtomLab Dose Calibrators 1 7 d Y 6 Biodex Medical Systems Supplemental Alphabetical Listing of Isotopes AtomLab 400 and AtomLab 500 Dose Calibrators Rev 4 20 09 1 6 BRACCO 7 Capintec User s Manual July 2007 Appendix Il A2 9 8 Standard Operating Procedures for the Training and Certification of Individual Using CardioGen 82 2012 LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 idis CardioGen 82 QC Preparation Aseptic techniques should be employed throughout each procedure e Waterproof gloves are to be worn Survey the waste bottle and empty the contents every morning in accordance with department radiation safety regulations Allow 10 minutes between elutions Elute only with additive free 0 996 sodium chloride injection USP 2 CardioGen 829 Rubidium Rb 82 Generator Infusion System User s Guide N BRACCO LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 ides CardioGen 82 QC Procedures Three Step QC Procedure W S C 1st Elution Generator Column Wash W 2nd Elution Sr 82 and Sr 85 Level Testing S 3rd Elution Infusion System Calibration C 2 CardioGen 829 Rubidium Rb 82 Generator Infusion System User s Guide AN BRACCO LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator CardioGen 82 Infusion System QC 1st Elution Generator Column Wash W This prepares the column for use Performed with a 50 mL elution Performed daily
4. System Fluid System Design POSITRON ETA DIVERGENCE DETECTOR VALVE PRESSURE SYRINGE TRANSDUCER u GENERATOR SHIELD 2 CardioGen 829 Rubidium Rb 82 Generator Infusion System User s Guide N BRACCO LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator CardioGen 82 Infusion System Shielding Photo courtesy of RbM Services oS BRACCO LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator CardioGen 82 Infusion System Syringe Pump Photo courtesy of RbM Services AN BRACCO LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator CardioGen 82 Infusion System Valve Shield Assembly Photo courtesy of RbM Services oS BRACCO LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator CardioGen 82 Infusion System Display Control Panel Photo courtesy of RbM Services N BRACCO LIFE FROM INSIDE Cardiogen 82 Nuclear Rubidium Rb 82 Generator pj February 2 2012 Cardiogen 82 Rubidium Rb 82 Generator Why was CardioGen recalled Early Summer 2011 2 individuals entering the U S triggered gamma ray emissions sensors that detected radiation that was analyzed to have come from strontium 82 Sr 82 and strontium 85 Sr 85 Weeks before these 2 individuals had undergone CardioGen 82 MPI at 2 different clinical user sites one in Las Vegas and the other in Sarasota MN IM AN BRACCO 15 LIFE FROM INSIDE
5. min AN BRACCO LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 E ad CardioGen 82 Infusion System QC 2nd Elution Sr 82 and Sr 85 Level Testing S Measurement of Sr 82 Sr 85 levels in the eluate Measured as the ratio of Sr 82 or Sr 85 to Rb 82 activity uCi mCi Performed daily prior to patient administration and at additional daily tests after reaching any ONE of the Alert Limits see Prescribing Information Additional daily tests every 750 mL elution volume 1 CardioGen 829 Rubidium Rb 82 Generator Prescribing Information Princeton NJ Bracco Diagnostics Inc February 2012 AN 2 CardioGen 82 Rubidium Rb 82 Generator Infusion System User s Guide BRACCO LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator 2nd Elution Sr 82 and Sr 85 Level Test DB E om ER 7 8 9 Allow 10 min to elapse for isotope regeneration Label elution test vial with S current date time and initial of technologist performing test Place elution test vial into the vial shield Attach an 18 20 gauge needle to the patient administration set Insert the needle into the shielded elution test vial septum Insert a vent needle into the shielded elution test vial septum make sure it does not extend below the 50 ml fill point Set the patient dose to 99 mCi Set the patient volume to 50 ml Confirm the infusion mode is set to automatic infusion 10 Confirm the syringe pump is
6. 2 Rubidium Rb 82 Generator Infusion System Calibration QC Sample A Microsoft Excel 17 2003 Workshee oU AN BRACCO LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator Volume Tracking Infusion System Printouts Record each generator ELUTION VOLUME P e from the Infusion System printout Mud R including waste and test volumes and Se keep a record of the cumulative generator am pate Bae volumes on the volume tracking Satan oi worksheets n Track volumes for all Daily QC and Patient ue infusions vel es n Preserve Printouts by photocopy or digital sie copy TI Retain according to Bracco 5yrs and or Department Policy which ever is more a i AN BRACCO LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator Generator Volume Tracking Sample A Microsoft Excel 17 2003 Workshee LL uu AN BRACCO LIFE FROM INSIDE Nuclear Cardiooen 82 Rubidium Rb 82 Generator Cardiac PET Advantages 4 un Cardiogen 82 Rubidium Rb 82 Generator PET for Cardiac Perfusion Imaging Advantages Short lived isotopes allow fast rest stress protocols High spatial and contrast resolution that allows improved detection of small perfusion defects Decreases false negatives thus increasing sensitivity High temporal resolution Allows fast dynamic imaging of tracer kinetics e Attenuation correction is routine 13 e Super
7. 2 only with an infusion system specifically designed for use with the generator and capable of accurate measurement and delivery of doses of rubidium Rb 82 chloride injection The recommended adult 70 kg dose of rubidium Rb 82 chloride injection is e 1480 MBq 40 mCi with a range of 1110 2220 MBq 30 60 mCi infused intravenously at a rate of 50 mL minute not to exceed a total volume of 100 mL e Do not exceed a single dose of 2220 MBq 60 mCi Use the lowest dose necessary to obtain adequate cardiac visualization consistent with the dosing goal of as low as reasonably achievable ALARA e S tS AN 1 CardioGen 82 Rubidium Rb 82 Generator Prescribing Information Princeton NJ Bracco Diagnostics Inc February 2012 BRACCO 5 LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator Prescribing Information Dosage Forms and Strengths section 3 CardioGen 82 is a closed system used to produce rubidium Rb 82 chloride injection for intravenous use CardioGen 82 consists of strontium Sr 82 adsorbed on a hydrous stannic oxide column with an activity of 90 150 millicuries Sr 82 at calibration time mm AN 1 CardioGen 829 Rubidium Rb 82 Generator Prescribing Information Princeton NJ Bracco Diagnostics Inc February 2012 BRACCO LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator Technical Aspects Contains Sr 82 and Sr 85 in a lead shielded hydrous stannic oxide column Sr 82 hal
8. Cardiogen 82 Nuclear Rubidium Rb 82 Generator pj 2014 Meeting of Mid Atlantic States Radiation Control Programs Brian Cherundc Sr Clinical Applican Bracco Diagnostics Inc Cardiogen 82 Rubidium Rb 82 Generator Describe CardioGen 82 Indication and Technical Aspects Review the Product Recall and Back to Market Objectives Review the Updated Prescribing Information Review CardioGen 82 Daily Quality Control Identify advantages of Cardiac PET OO So cS BRACCO LIFE FROM INSIDE Nuclear Cardiooen 82 Rubidium Rb 82 Generator CardioGen 82 Indication and Technical Aspects Cardiogen 82 Rubidium Rb 82 E ad Indication and Usage CardioGen 82 is a closed system used to produce rubidium Rb 82 chloride injection for intravenous use Rubidium Rb 82 chloride injection is a radioactive diagnostic agent indicated for Positron Emission Tomography PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease CardioGen 82 is not indicated for use with pediatric patients e Contraindications None 1 CardioGen 829 Rubidium Rb 82 Generator Prescribing Information Princeton NJ Bracco Diagnostics Inc February 2012 CN LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator Dosage and Administration Use CardioGen 8
9. Cardiogen 82 Rubidium Rb 82 Generator Why was CardioGen recalled Homeland Security notified the Department of Energy Department of Energy officials notified Bracco Bracco reported the 2 incidents as expedited AE reports to the FDA Bracco met with FDA on July 22 and presented the information it had to date which indicated product misuse at the 2 sites steps it was taking and would take to address the issue and the FDA inspection findings and information about the clinical value of CardioGen _ IM AN BRACCO LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator Why was CardioGen recalled Subsequent to the meeting Bracco voluntarily recalled and suspended distribution of CardioGen 82 while Further investigating the root causes of these two reports of unexpected radiation exposure from CardioGen 82 And began a 6 month process of near constant interaction with various divisions of the FDA and to a lesser extent with the NRC and agreement states E Fm AN BRACCO LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator CardioGen 82 Reintroduction Plan Test the recalled generators Investigate patients at risk for excessive Sr 82 Sr 85 exposure Re validate the manufacturing process Update the prescribing information Develop and implement QC monitoring program cS BRACCO 18 LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator Recall
10. Generator Testing Observations The 113 recalled generators that were tested were between 28 54 days from the date of calibration Not all returned generators were testable some had been allowed to dry out others were gt 2 months beyond calibration These generators reflected a wide range of field usage conditions for both patient dose and elution volume They also reflected rigorous transport conditions not only original shipping to individual sites and use in mobile PET vehicles but also the return to LANL shipment procedure Results None of the 113 returned testable generators showed excessive Sr breakthrough i e none were defective Mf cS BRACCO 19 LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator Clinical Assessments after Recall FDA required Bracco to perform clinical assessments of the scope and severity of Sr 82 Sr 85 exposure to patients receiving CardioGen 82 Accordingly FDA directed that two types of clinical studies be done An investigation of high risk patients from the two clinical user sites Las Vegas and Sarasota A more general survey of patients from all other clinical user sites Please refer to www cardiogen com for updates regarding the clinical studies RU uie AN BRACCO 20 LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator The Root Cause from the FDA s Safety Announcement of Jan 12 2012 The preliminary informat
11. ant such as Retraining additional knowledge assessments Termination as a CardioGen 82 customer Monitoring data is reported monthly to FDA amp NRC amp agreement states 1 y cS BRACCO 30 LIFE FROM INSIDE Nuclear Cardiooen 82 Rubidium Rb 82 Generator Cardiogen 82 Rubidium Rb 82 Generator Dose Calibrator QC The NRC or NRC Agreement States requires that instruments be calibrated in accordance with nationally recognized standards or the manufacturer s instructions Calibration Tests include Accuracy Linearity Geometry Constancy 3 Nuclear Regulatory Commission NRC Chapter 1 of Title 10 Energy of the CFR Part 35 60 cS 4 Academic Affairs Committee SNMTS 2003 Performance and responsibility guidelines JNMT 31 4 222 229 BRACCO LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator Dose Calibrator Settings for Rb 82 For Rb 82 assays Determine if the dose calibrator has a Rb 82 pre set channel f there is no setting for Rb 82 use the setting for Co 60 and a mathematical correction factor Program dose calibrator for Rb 82 as recommended by the manufacturer Biodex AtomLab 100 8 82 AtomLab 400 500 8 75 Capintec 5047 Check user manual for setting specifics The facility must have a dose calibrator capable of reading microcuries uCi and out to 2 decimal places 5 Biodex Medical Systems Supplemental Alphabetical
12. e the shielded vial to the dose calibrator for assay Assay the eluate vial at 3 min and 45 sec and record the dose calibrator reading Label Infusion System printout with date infusion time user initials and C Save printout for volume tracking Correct the dose assay for decay to the End Of Elution EOE Multiply the dose calibrator reading by the appropriate decay factor Calculate the calibration ratio using the calibration worksheet provided Initial calibration of a new generator Day 1 should be within 0 95 and 1 05 Daily calibration should be within 0 90 and 1 10 If calibration exceeds limits calculate a new calibration factor Enter the new calibration factor into the Infusion System and repeat the calibration procedure Diligent record keeping and retention of the calibration worksheet must be in compliance with Bracco policies as well as in accordance with individual departmental policies Allow for adequate decay and discard the elute and vial according to department radiation safety regulations Additional times are available E A cS BRACCO 2 CardioGen 82 Rubidium Rb 82 Generator Infusion System User s Guide Rev 20 October 2012 LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator 3rd Elution Calibration Procedure Control Panel Settings Mode Automatic Switch Infusion Elution 99ml Volume Patient Volume Patient 30 60mCi Dose AN BRACCO LIFE FROM INSIDE Cardiogen 8
13. en 82 2013 Nordion Sr 82 Fact Sheet Retrieved from http www nordion com documents products Sr 82 Can pdf Radionuclide Data Sheet Retrieved from http www ehs ucsd edu rad radionuclide Sr 85 pdf 11 Di Carli M 2004 Advances in positron emission tomography JNC 11 6 719 732 12 Bateman T et al 2002 PET MPI Making Transition to the Clinical Routine Applied Imaging Applications in Nuclear Cardiology 3 1 1 6 13 Merhige M 2002 PET Myocardial Perfusion Imaging A New Standard for the Management of Coronary Artery Disease Applied Imaging Applications in Nuclear Cardiology 1 1 2 6 cS BRACCO NA LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator THANK YOU QUESTIONS LIFE FROM INSIDE
14. erformed at least daily 2 CardioGen 82 Rubidium Rb 82 Generator Infusion System User s Guide N BRACCO LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator 3rd Elution Calibration Procedure 1 ok a ong 7 8 9 Allow 10 min to elapse for isotope regeneration Label elution test vial with C current date time and initial of technologist performing test Place elution test vial into the vial shield Attach 18 20 gauge needle to the patient administration set Insert the needle into the shielded elution test vial septum Insert a vent needle into the shielded elution test vial septum make sure it does not extend below the 50 ml fill point Set the patient dose between 30 60 mCi use typical patient dose Set the patient volume limit 20 50ml Study volume is not to exceed 200 ml Confirm the infusion mode is set to automatic infusion 10 Confirm the syringe pump is properly filled 11 Start infusion by pressing the Inject Start Stop button LUE du cS 2 CardioGen 82 Rubidium Rb 82 Generator Infusion System User s Guide Rev 17 January 2012 BRACCO 1 CardioGen 829 Rubidium Rb 82 Generator Prescribing Information Princeton NJ Bracco Diagnostics Inc February 2012 LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator 3rd Elution Calibration Procedure 12 13 14 19 16 17 18 19 20 When the infusion light goes out start a timer Tak
15. f life is 25 days parent isotope Sr 85 half life is 65 days unintended byproduct e The daughter is Rb 82 chloride Half life 75 seconds e Rb 82 kinetics Potassium analog After IV injection Rb 82 rapidly clears the blood Activity in myocardium within first minute Defects visualized 2 7 minutes after injection High extraction fraction at high flow rates Must be used with the Infusion System Same quantity dose for rest and stress imaging On demand availability 1 CardioGen 829 Rubidium Rb 82 Generator Prescribing Information Princeton NJ Bracco Diagnostics Inc February 2012 CN LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator CardioGen 82 Infusion System Provides automated dose delivery systeme Two shielding vaults CardioGen 82 Waste container A scintillator for determining dose activity Elute with additive free 0 9 Sodium Chloride Injection USP only Quality control Daily column wash Rb 82 Sr 82 and Sr 85 level testing daily prior to patient administration and additionally daily every 750 mL after detection of an Alert Limit Daily calibration 1 CardioGen 82 Rubidium Rb 82 Generator Prescribing Information Princeton NJ Bracco Diagnostics Inc February 2012 N 2 CardioGen 82 Rubidium Rb 82 Generator Infusion System User s Guide BRACCO LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator CardioGen 82 Infusion
16. injections at clinical sites where generator eluate testing appeared insufficient 1 CardioGen 82 Rubidium Rb 82 Generator Prescribing Information Princeton NJ Bracco Diagnostics Inc February 2012 AA LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator CardioGen 82 Labeling Revisions Additional warnings re strontium breakthrough potential New Boxed Warning Warns of unintended radiation exposure to Sr 82 amp Sr 85 Instructs user to record cumulative eluate volume which may trigger an alert or product expiration see below Establishes new Alert Limits and requires additional testing if and when any of these limits are reached Establishes new Expiration Limits Update of WARNINGS AND PRECAUTIONS section Section 5 1 Unintended Sr 82 and Sr 85 exposure P y 1 CardioGen 829 Rubidium Rb 82 Generator Prescribing Information Princeton NJ Bracco Diagnostics Inc February 2012 KCN LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator Old and New Limits Breakthrough limits 0 02 yu Ci Sr 82 mCi Rb 82 or 0 2 uCi Sr 85 mCi Rb 82 These remain a part of federal regulations 10 CFR 35 204 as well as a part of the Prescribing Information Section 11 1 cS 1 CardioGen 82 Rubidium Rb 82 Generator Prescribing Information Princeton NJ Bracco Diagnostics Inc February 2012 BRACCO LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generato
17. ion from the investigations suggests that improper usage of CardioGen 82 at certain clinical sites is responsible for the exposure of some patients to more radiation than is typically associated with a CardioGen 82 scan This increased radiation exposure was due to the administration of CardioGen 82 generator eluates that contained excessive concentrations of strontium 82 Sr 82 and strontium 85 Sr 85 This excessive release of Sr 82 and Sr 85 in generator eluates is known as strontium breakthrough FDA believes it is unlikely that this excessive exposure posed significant risks to patients though exposure to any excessive radiation is undesirable ee ar AN BRACCO 21 LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator Return to Market Requirements from FDA e Successful Conduct of Quality and Clinical Root Cause Investigations previous slides Revalidate Manufacturing Process Develop new Product Labeling with additional safety measures Implement new QC user monitoring program to be run by Bracco UU o AN BRACCO 22 LIFE FROM INSIDE Cardiooen 82 Nuclear Rubidium Rb 82 Generator o Committed to You Cardiogen 82 Rubidium Rb 82 Generator New statement in revised PI reflects FDA findings In WARNINGS AND PRECAUTIONS Section 5 1 2nd sentence Unintended exposure to strontium radiation has occurred in some patients who received rubidium Rb 82
18. ior attenuation correction techniques Decreases false positives thus increasing specificity e Lower radiation exposure 11 Di Carli M 2004 Advances in positron emission tomography JNC 11 6 719 732 12 Bateman T et al 2002 PET MPI Making Transition to the Clinical Routine Applied Imaging Applications in Nuclear Cardiology 3 1 1 6 13 Merhige M 2002 PET Myocardial Perfusion Imaging A New Standard for the Management of BRACCO Coronary Artery Disease Applied Imaging Applications in Nuclear Cardiology 1 1 2 6 LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator References 1 10 Ti 12 13 CardioGen 829 Rubidium Rb 82 Generator Prescribing Information Princeton NJ Bracco Diagnostics Inc February 2012 CardioGen 829 Rubidium Rb 82 Generator Infusion System User s Guide Rev 20 October 2012 Nuclear Regulatory Commission Regulation Title 10 Chapter I Code of Federal Regulations Part 35 60 Academic Affairs Committee SNMTS 2003 Performance and responsibility guidelines JNMT 31 4 222 229 Biodex Medical Systems Supplemental Alphabetical Listing of Isotopes AtomLab Dose Calibrators 1 7 Biodex Medical Systems Supplemental Alphabetical Listing of Isotopes AtomLab 400 and AtomLab 500 Dose Calibrators Rev 4 20 09 1 6 Capintec CRC 25R User s Manual Rev 8 2007 Standard Operating Procedures for the Training and Certification of Individual Using CardioG
19. level worksheet Sr 82 content must not be more than 0 01 uCi mCi of Rb 82 22 Calculate the level of Sr 85 using the Sr 82 Sr 85 level worksheet Sr 85 content must not be more than 0 1 uCi mCi of Rb 82 23 If levels are above the allowable limits discontinue use of the generator immediately and contact Bracco Diagnostics Inc 24 Diligent record keeping and retention of the worksheet must be in compliance with Bracco policies as well as in accordance with individual departmental policies 25 Allow for adequate decay and discard the eluate vial according to department radiation safety regulations o dom AN 2 CardioGen 82 Rubidium Rb 82 Generator Infusion System User s Guide Rev 20 October 2012 BRACCO LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator 2nd Elution The Sr 82 and Sr 85 Level Test Control Panel Settings Mode Automatic Switch Infusion Elution 99 ml Volume Patient Volume 99 mCi Patient Dose Dose Rate 1mCi sec Flow Rate 50 ml min AN BRACCO LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator Sr Level QC Worksheet Sample A Microsoft Excel 17 2003 Workshee oU AN BRACCO LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator CardioGen 82 Infusion System QC 3rd Elution Infusion System Calibration C Validates the Infusion System measured activity with the dose calibrator assay of the eluate P
20. properly filled 11 Start infusion by pressing the Inject Start Stop button a cS 2 CardioGen 82 Rubidium Rb 82 Generator Infusion System User s Guide Rev 20 October 2012 BRACCO LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator 2nd Elution Sr 82 and Sr 85 Level Test Collect and assay a 50 ml sample of Rb 82 12 When the infusion light goes out start a timer 13 Take the shielded vial to the dose calibrator for assay 14 Assay the eluate vial at 3 min and 45 sec and record the dose calibrator reading 15 Correct the dose assay for decay to the End Of Elution EOE e Multiply the dose calibrator reading by the appropriate decay factor 16 Set shielded vial aside to measure for Sr 82 Sr 85 levels at 60 min post EOE 17 Label Infusion System printout with date infusion time user initials and S Save printout for volume tracking Additional times are available I F AN 2 CardioGen 82 Rubidium Rb 82 Generator Infusion System User s Guide Rev 20 October 2012 BRACCO LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator 2nd Elution Sr 82 and Sr 85 Level Test 18 Perform a dose calibrator background check prior to assay 19 Assay the eluate vial at 60 minutes post EOE allow eluate to stabilize 100 to 200 seconds before recording 20 Record the dose calibrator reading in uCi out to two decimal places 21 Calculate the level of Sr 82 using the Sr 82 Sr 85
21. r CardioGen 82 Labeling Revisions New Product Expiration Limits Sr 82 level exceeds 0 01 uCi Sr 82 mCi Rb 82 or Sr 85 level exceeds 0 1 uCi Sr 85 mCi Rb 82 or Atotal elution volume of 17 L has passed through the generator column or 42 days post calibration date NOTE The Expiration Limits for Sr 82 and Sr 85 levels are Ve the legal breakthrough limits continuing to provide a wide safety margin 1 CardioGen 829 Rubidium Rb 82 Generator Prescribing Information Princeton NJ Bracco Diagnostics Inc February 2012 LAS LIFE FROM INSIDE Cardiogen 82 Rubidium Rb 82 Generator CardioGen 82 Labeling Revisions New product Alert Limits Sr 82 level exceeds 0 002 uCi Sr 82 mCi Rb 82 or Sr 85 level exceeds 0 02 uCi Sr 85 mCi Rb 82 or Atotal elution volume of 14 L has passed through the generator column These are now the limits at which the clinical site must monitor additional generator elution volume and perform another test for Sr 82 Sr 85 levels each time an additional 750 ml has been eluted from the generator on a given alert day NOTE The Alert Limits for Sr 82 and Sr 85 levels are 1 10 the legal breakthrough limits which are established in 10 CFR 35 204 this provides a wide margin of safety at the onset of increased vigilance Oe ECO E RM AN 1 CardioGen 82 Rubidium Rb 82 Generator Prescribing Information Princeton NJ Bracco Diagnostics Inc February 2012 BRACCO 28
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