Check Applicators and Transfer Tubes aging, integrity and suitability
Contents
1. 113 Fax 31 318 557 208 oncosupport nucletron com Copyright 2013 Nucletron B V All rights reserved www nucletron com gPOL0007 3 Ay Nucletron Important User Notice case such a transfer tube becomes disconnected from the applicator while the source or check cable is inside the applicator the capsule may become stuck in the space between the two ball bearings upon retraction of the cable 5 Consequences Unintended disconnection of the transfer tube and applicator and possible failure to automatically retract the source cable from the transfer tube caused by The use of damaged applicators or transfer tubes The use of kinked or contaminated transfer tubes The use of applicators and transfer tubes beyond its technical lifetime The use of unsuitable transfer tubes Such an unintended disconnection will most likely result in an interruption of treatment and a disruption of the workflow In a worst case scenario inadvertent irradiation of patients or staff could result 6 Resolution To minimize the probability of the Consequences described in the previous paragraph from occurring these are the steps that can be taken Please check your applicators and transfer tubes regularly and always prior to use regarding aging integrity cleanness and suitability The following parts should be removed from clinical use e The referenced GYN Transfer tubes produced before 2007 since they have known deficiencies e Transfer tubes a2. applicators and transfer tubes with microSelectron and Flexitron afterloaders The User Manuals for all specific parts contain clear guidelines on life expectancy cleaning inspection and suitability The increase in incidents has given rise to the assumption that this information is not always known and therefore instructions are not always followed as intended It is Elekta s responsibility as a medical device manufacturer to bring such information to the clinical user s attention if safety related problems could occur as a consequence of the information being unknown This Important User Notice is a reminder of the recommended process for checking your Applicators and Transfer Tubes regularly and always prior to use regarding aging integrity cleanness and suitability and to remove parts with unacceptable wear or damage from clinical use and dispose of them properly Next to these checking procedures for all applicators and transfer tubes another reminder is included in this Important User Notice regarding certain types of gynecological transfer tubes as referenced above Transfer tube connectors have a mechanism to ensure that the check cable or source cable cannot pass through the connector in case an applicator is correctly connected In the referenced Gynecological Transfer Tubes that were produced before 2007 this mechanism comprises of two steel ball bearings In FCO IUN 799701 VID 01 Nucletron B V Page 3 of 11 Tel 31 318 557
3. to prevent the Problem described from occurring these are steps that can be taken Make sure to inspect transfer tubes applicators and accessories on a regular basis and always prior to each use according to the instructions in the applicable user manual If a part has unacceptable wear or damage of the kind described in the user manual then it is recommended to remove it from clinical use Please pay attention to the specified life expectancy of applicators and transfer tubes which are the limits to which the components were tested Elekta recommends to only use applicators accessories and transfer tubes that are within their specified life expectancy and to replace any applicators accessories and transfer tubes that are beyond the specified life expectancy as stated in the user manual GYN Transfer tubes produced before 2007 have known deficiencies and are past their life expectancy should be removed them from clinical use Finally please make sure to only use transfer tubes specified for your specific afterloader and applicator Technical Reference CLM 1643523 CLM 1658652 CLM 1569261 FPR 325929 These are actual complaint cases registered by Elekta in which incorrect or worn applicators and or transfer tubes were the cause of issues such as described under the Problem header above Contact If you have any queries about this Notice please contact your local Elekta office FCO IUN 799701 VID 01 Nu
4. B V Page 11 of 11 Tel 31 318 557 113 Fax 31 318 557 208 oncosupport nucletron com Copyright 2013 Nucletron B V All rights reserved www nucletron com gPOL0007 3
5. Important User Notice Check Applicators and Transfer Tubes aging integrity and suitability Product microSelectron and Flexitron Date 17 January 2014 FCO IUN 799701 01 amp S Nucletron Ay Nucletron Important User Notice We are providing the information in this FCO to notify you of a possible safety issue that may exist on your equipment and to inform you of action you can take to safeguard both your staff and your patients We ask that you please read and understand the content of this notice and recommend implementation of the measures provided We also need you to acknowledge this FCO by signing and returning the statement on the FCO Action Notification Report We advise you to insert this Notice in the applicable copy of the User Manual Check Applicators and Transfer Tubes aging integrity and suitability Product microSelectron and Flexitron Date 17 January 2014 FCO IUN 799701 01 Scope All users of microSelectron and Flexitron Problem Unintended disconnection of the transfer tube and or applicator and possible failure to retract the source cable from the transfer tube caused by e The use of damaged applicators or transfer tubes e The use of kinked or contaminated transfer tubes e The use of parts beyond their technical lifetime e The use of unsuitable transfer tubes Clinical impact Possible inadvertent irradiation of patient and hospital staff Solution To take every precaution
6. cletron B V Page 2 of 11 Tel 31 318 557 113 Fax 31 318 557 208 oncosupport nucletron com Copyright 2013 Nucletron B V All rights reserved www nucletron com gPOL0007 3 Ay Nucletron Important User Notice 1 Safety reference The recommendations in this user notice fall under the process of checking your applicators and transfer tubes regularly and always prior to use regarding aging integrity and suitability As part of this process Elekta recommends to remove parts from clinical use that have unacceptable wear or damage to them as revealed by your inspection 2 Scope This Important User Notice is applicable to all users of microSelectron and Flexitron afterloaders specifically relating to the use of applicators accessories and transfer tubes Additionally Gynecological Transfer Tubes with the following part numbers produced before 2007 revision 00 01 and 02 should be removed from clinical use and properly disposed of as they have known deficiencies and are also outside their expected life window e GYN Transfer Tube keyed for Channel 1 111002 revision 00 01 02 GYN Transfer Tube keyed for Channel 2 111003 revision 00 01 02 e GYN Transfer Tube keyed for Channel 3 111004 revision 00 01 02 3 Related Documents Reference Revision Description 4 Problem Description During the past months Elekta has experienced an increasing number of incidents related to the use of old damaged or unsuitable
7. e inspections for applicators amp accessories before use FCO IUN 799701 VID 01 Nucletron B V Page 5 of 11 Tel 31 318 557 113 Fax 31 318 557 208 oncosupport nucletron com Copyright 2013 Nucletron B V All rights reserved www nucletron com gPOL0007 3 Ay Nucletron Important User Notice e Inspect applicators for any indication of unacceptable deterioration dullness cracking staining corrosion discoloration or bending Inspect joints and connections on play strength or other forms of degradation Do not attempt to repair the product Transfer Tubes inspections before use e All parts to be used must be clean e Visually inspect parts for indication of kinking weakening bending corrosion discoloration or general deterioration e Check that no other obstructions are present e Check the secure connection with the suitable applicator Transfer Tubes regular inspections e Check the reference length by performing a source position check or measure the length with a tape measure e Check that the source positioning accuracy is within specification To prevent damage of the transfer tubes do not apply excessive forces to the transfer tube Excessive force can change the length of a transfer tube To prevent kinking ensure that the transfer tubes are not bent tightly 6 4 Check suitability Different Transfer Tube Sets are suitable for the different type of afterloaders and should never be used on a different after
8. knowledge and accept the recommendations given and ensure they are implemented By refusing to implement the recommendations the customer assumes full responsibility and liability for all matters including costs losses claims and expenses resulting whether directly or indirectly from not implementing such recommendations Further the customer will hold Elekta harmless from all matters including costs losses claims and expenses resulting whether directly or indirectly from not implementing such recommendations Failure to sign and return the acknowledgement may affect any follow up actions necessary for us to take and may require Elekta to report to the Regulatory Authorities in your country Classification Important User Notice FCO Ref IUN 799701 VID 01 FCO vopi description Check Applicators and Transfer Tubes aging integrity cleanness and suitability Scope All users of microSelectron and Flexitron Hospital Device Serial No Location or e g linac if applicable Site No Acknowledgement by customer This notification to be signed by the customer acknowledge that have read and understood this FCO and accept implementation of any given recommendations Name Title Signature Date New installation confirmation This notification to be signed by the installing Elekta or Representative employee Name Title Signature Date FCO IUN 799701 VID 01 Nucletron
9. loader then specified in the User Manual e microSelectron Classic e microSelectron V2 and Digital e Flexitron Additionally Transfer Tubes are different for different applicator types and should never be used on a different applicator than specified in the User Manual e Steel e Titanium e CT MR e Bronchial applicators e Needles e 4F Catheters e 5F Catheters e 6F Catheters Please find the overview of correct combinations on the next page FCO IUN 799701 VID 01 Nucletron B V Page 6 of 11 Tel 31 318 557 113 Fax 31 318 557 208 oncosupport nucletron com Copyright 2013 Nucletron B V All rights reserved www nucletron com gPOL0007 3 Ay Nucletron Important User Notice Stainless Steel CT MR Titanium applicators applicators applicators Metal Needies Catheters 4F Catheters 5F 114805 111816 114850 111861 137030 137031 111827 111838 111872 111883 411041 114021 411071 111084 111054 111061 411140 111600 111614 FCO IUN 799701 VID 01 Nucletron B V Tel 31 318 557 113 Fax 31 318 557 208 oncosupport nucletron com Copyright 2013 Nucletron B V All rights reserved www nucletron com Bronchial applicators Catheters 6F 137094 137035 191031 111044 111628 Page 7 of 11 gPOL0007 3 Ay Nucletron Important User Notice 7 Appendix example applicator sterilization test method and results The exemplary excerpt below is from the 84 page test rep
10. nd accessories have a 3 year life expectancy based on 300 sterilization cycles e microSelectron Transfer Tubes have a 2 year life expectancy e Flexitron Transfer Tubes have a 3 year life expectancy e For all other accessories please refer to the applicable user manual for the life expectancy Applicators transfer tubes and accessories that are beyond the life expectancy are recommended for frequent inspection and replacement consideration Elekta cannot assume liability for these products if used past their life expectancy 6 2 GYN Transfer Tubes produced before 2007 Gynecological Transfer Tubes with the above listed parts numbers 111002 111003 111004 and revisions 00 01 02 should be removed from clinical use You can check the revision number which is engraved on the indexer connector of the transfer tube and compare it to the numbers given A visual way to determine if this is one of the affected transfer tubes is to check the number of ball bearings inside the transfer tube connector Gynecological Transfer Tubes that have connectors with two ball bearings should be removed from clinical use 6 3 Regular inspections It is the responsibility of the user to inspect transfer tubes applicators and accessories on a regular basis and always prior to each use according to the instructions in the applicable User Manual Parts that exhibit unacceptable wear or damage are recommended to be removed from clinical use Applicabl
11. ort of the Vaginal CT MR Multi Channel applicator product part number 110 750 The lifetime expectancy tests performed simulate 300 sterilization cycles that in a moderate use scenario 2 treatments per week results in 3 years of expected life 2 treatments wk x 52wk y x 3 300 FCO IUN 799701 VID 01 Nucletron B V Page 8 of 11 Tel 31 318 557 113 Fax 31 318 557 208 oncosupport nucletron com Copyright 2013 Nucletron B V All rights reserved www nucletron com gPOL0007 3 Sy Nucletron Important User Notice 16 Life time requirements ai life expectancy for the reusable parts mentioned in a Evaluate the shelf life of the single use parts mentioned in Note 9 Material _ PPSU Radel R 5100 Rationale 10 PPSU Radel R 5100 Rationale 10 PPSU Radel R 5100 Rationale 10 PPSU Radel R 5100 Test 1 NT15 white 110 773 Perineal Bar Set 110 774 PPSU Radel R 5100 Rationale 10 110 776 NT15 white 110 778 110 778 Adapter Set for Applicator Clamp 110 784 Titanum Grade Testi 110 783 NT15 white 110 771 Set of Fixation Screws PPSU Radel R 5100 Rationale 10 NT15 white 110 780 Sleeve for Titanium Intrauterine Tubes 110 781 PPSU Radel R 5100 110 782 NT15 white Validation of the life expectancy of 3 years is performed by means the following test Test 1 Pass Fail Criteria FCO IUN 799701 VID 01 Nucletron B V Page 9 of 11 Tel 31 318 557 113 Fax 31 318 557 208 oncosup
12. port nucletron com Copyright 2013 Nucletron B V All rights reserved www nucletron com gPOL0007 3 Ay Nucletron Important User Notice Set of Vaginal CT MR Multi Channel Components 40mm 110 766 Adapter Set for Applicator Clamp 110 778 Autoclave Maximum life expectancy is three years One whole aaah sn sterilization This means maximal 2 cycles per week 2 cycles x 52 weeks x 3 years 300 cycles 1 autoclave sterilization cycle at 134 C lasts 3 minutes Total sterilization time is 300 cycles x 3 minutes 900 minutes Autoclave the parts of the applicator for a period of 30 minutes at 2 atm and 134 degrees Celsius the autoclave test 35 times 35 x 30 1050 minutes FCO IUN 799701 VID 01 Nucletron B V Page 10 of 11 Tel 31 318 557 113 Fax 31 318 557 208 oncosupport nucletron com Copyright 2013 Nucletron B V All rights reserved www nucletron com gPOL0007 3 S Nucletron FCO Action Notification Report Please complete the details below and sign the appropriate acknowledgement section e Existing installations Acknowledgement by the customer e New installations New installation confirmation by the installing Elekta or Representative employee Please return this report to your local Elekta Office or Representative as soon as possible and within 30 days at the latest The information in this FCO has been provided to address a safety issue and therefore the customer is expected to ac
13. pplicators and that have unacceptable wear and damage to them e Transfer tubes that were not intended for your specific afterloader and applicator Applicators accessories and transfer tubes that are beyond their specified life expectancy as specified in the user manual are recommended for frequent inspection and replacement consideration 6 1 Life expectancy This section further clarifies the life expectancy of applicators and transfer tubes All medical devices are subject to a stringent set of regulations most of them related to patient and staff safety As part of these regulations all claims that a manufacturer makes about products must be supported by filed test evidence For applicators the category of tests that leads most directly to the life expectancy is the number of sterilization cycles For transfer tubes multiple parameters apply among which repeated connection disconnection tests and tests that verify the stability of the length of the transfer tube over time FCO IUN 799701 VID 01 Nucletron B V Page 4 of 11 Tel 31 318 557 113 Fax 31 318 557 208 oncosupport nucletron com Copyright 2013 Nucletron B V All rights reserved www nucletron com gPOL0007 3 Ay Nucletron Important User Notice An example of test evidence for one of the applicators is included in the appendix Based on this evidence Elekta can claim the following life expectancy figures for different products e Resterilizable applicators a
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