URGENTE AVVISO DI SICUREZZA - Ministero Salute...2) Push all needle tips to the same depth as the deepest (base plane) needle. The following needle depth verification procedures can

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Spett.le Responsabile U.O. di Fisica Sanitaria e/o Radioterpia URGENTE AVVISO DI SICUREZZA Prodotto interessato : SPOT PRO FSCA-FPR234774 Avviso riguardante l’uso di “SPOT PRO” Monza 01 luglio 2008 Alla cortese attenzione : Tutti gli utilizzatori di “SPOT PRO” Dettaglio del sistema interessato : Tutte le versioni di SPOT PRO Descrizione del problema : Un errata posizione della profondità degli aghi può dar luogo ad un sovradosaggio agli organi a rischio e/o un sottodosaggio al volume “bersaglio” Avviso per le azioni da intraprendere dagli utilizzatori : L’utilizzatore deve sempre verificare la profondità degli aghi in relazione alla base prostatica. Per ulteriori dettagli si richiama l’allegato “Customer Information Bulletin” n.555.000.50 CIB-00 Trasmissione del “Field Safety Notice” Il presente avviso deve essere diffuso a tutti coloro che necessitano sapere della disponibilità della revisione di cui sopra, sia all’interno della propria organizzazione sia a qualsiasi altra organizzazione potenzialmente interessata al riguardo. Vi preghiamo di voler prestare la massima attenzione al presente avviso ed alle successive azioni intraprese per un adeguato periodo di tempo affinché ci si possa assicurare della effettiva miglioria data dall’azione correttiva indicata.

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Ufficio da contattare : Nuclital Srl Viale Elvezia no. 52 20052 MONZA (Milan) Tel. : +39 039 322848 / 323148 Fax : +39 039 323913 e-mail : [email protected] Il sottoscritto conferma che il presente avviso è stato inoltrato agli Uffici Competenti. Confidando di aver provveduto a fornire le corrette informazioni. Distinti saluti,

Nucletron BV Guido Ligthart Senior Qualità Engineer

© Nucletron Proprietary Information 555.00050 CIB - 00

Customer Information Bulletin

Title

Needle depth verification during clinical procedure of FIRST

Scope

All Spot-pro users

Target Group

Customers and Nucletron application specialists

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Table Of Contents

1 Document History .....................................................................................................................22 Where To Include ......................................................................................................................23 Related Documents...................................................................................................................24 Subject....................................................................................................................................... 25 Identification..............................................................................................................................26 Consequences...........................................................................................................................27 Resolution ................................................................................................................................. 3

1 Document History

Revision Who Reason for Change Changes00 AKN First issue Not applicable

2 Where To Include

• Nucletron strongly advises to insert this bulletin in any printed copy of the “SPOT Pro v3.0 usermanual” (part no. 091.925ENG).

3 Related Documents

Reference Revision Description091.925ENG * SPOT Pro v3.0 user manual

* Latest version (available via the Nucletron Extranet)

4 Subject

The Spot-pro planning software is a real-time planning system for treatment of the prostate with seeds.During the procedure, the physician is responsible for its proper clinical use and the prescribed radiation dose. It is therefore necessary that the physician or independent medical personnel trained in the intended application verify any data or information generated by this system.

This document is intended to give advice to the physician or independent medical personnel for verification of the needle depth in relation to the base plan.

5 Identification

• This Bulletin is applicable for prostate Brachytherapy procedures involving afterloading radioactive sources using the Spot-pro system.

6 Consequences

An incorrect verification of the needle depth can result in an overdose in Organs at risk and/or an under dose in the target volume.

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7 Resolution

Preliminary information

The information presented here is assuming that all needles of the pre-plan are implanted into the prostate before implanting seeds. It is strongly recommended that, at the end of implementation of the needles and before the delivery of the seeds, the position of the needles are checked and verified.

More than one method of needle position verification should be used before delivering seeds. The results of these verifications should be checked against each other.

Before beginning to implant the needles, a pre-plan can be made, and a printout should be done of at least a page in the associated report which indicates the retraction distance of the fore-most seed tip of each needle relative to the base plane.

Just prior to implanting needles, a strategy for needle tip position should be chosen and followed consistently during the implant.

The choices are:

1) Push each needle tip to the depth of the tip of the fore-most seed, as called for in the plan.2) Push all needle tips to the same depth as the deepest (base plane) needle.

The following needle depth verification procedures can be used:

Verification relative to a reference needle

The first needle implanted should be a centrally located needle in which the foremost seed tip is to be implanted to the base plane. We shall call this the “reference needle”. This needle must be carefully placed under image guidance, and its tip position must be verified against the visible base plane of the prostate as viewed in the live transverse view as well as in the live sagittal view (see Figure 1).

Figure 1 When transversal array of the ultrasound probe is placed in the base plane, the needle can be identified by its reflection.

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This needle can be used as a reference needle for depth, and all other needles implanted can be verified for depth against this needle, taking into account the strategy chosen for depth of needle tips. This reference needle should be marked as such in the printout of the plan.

If a strategy is followed of only inserting each needle tip to the depth intended for the foremost seed tip, then for any one needle, its free length behind the template must be the free length of the reference needle plus the retraction distance for the needle indicated in the printout of the plan.The retraction distance is defined as the distance between the base plane and the centre of the first seed in the needle (see Figure 2).

The same amount of shift between the reference needle and a needle with e.g. a retraction distance of 5 mm, can then be applied at the connector end of the needle (see Figure 3)

Figure 2 The retraction distance is defined as the distance between the base plane and the centre of the first seed in the needle.

Figure 3 Needle placed according to the first seed in that needle.

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If a strategy is followed of inserting all needles to the same depth, then each needle should have the same free length behind the template as that of the reference needle (see Figure 4).

While positioning a needle for depth, if a discrepancy relative to the reference needle is found as compared to what is expected, this must be resolved before proceeding to the next needle. If the reference needle tip position has shifted relative to the base plane, it must be re-positioned correctly, and the positions of the other needles implanted thus far must be re-checked.

Verification on ultrasound image

As each needle is inserted, its tip should be positioned by visualizing it in the ultrasound image relative to the superior surface of the prostate and the superior surface of the contours of the prostate, as viewed in the live image of the SPOT screen (needle navigator) (see Figure 5).

If the superior surface of the prostate does not match that of the contours of the prostate, the position of the ultrasound probe must be adjusted so that they do match each other before finalizing the position of the needle tip.

If a strategy of only inserting each needle tip to the depth intended for the foremost seed tip, then while inserting any one needle, if the live sagittal image is shown on the SPOT screen, the SPOT

Figure 4 Needles placed on the same depth.

Figure 5 Live sagittal image.

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indicates how deep to push the needle by showing a purple cartoon of the selected needle superimposed on the live sagittal ultrasound image.

The needle must be pushed to the depth indicated by SPOT, and then rotated by hand. The tip can be visualized by viewing the rotating tip in the live ultrasound image, and checked to see if it comes up to the end of the cartoon. To see the rotating tip, it may be necessary to make fine adjustments to the probe angle through the appropriate SPOT controls of the ECRM.

If a strategy is followed of inserting all needles to the same depth, then when inserting any needle which has a non-zero retraction distance, the tip of the needle must be pushed beyond the cartoon needle tip shown on the live sagittal image by the amount of the retraction distance.

The SPOT screen shows a trail of dots straight out beyond the cartoon of the needle tip, and there is 2.5 mm spacing between each dot. The user can calculate how many dots are equal to the retraction distance. In this way he knows how deep to push the needle. The user must always keep in mind that the superior surface of the prostate should match the tip of the cartoon of the needle -- if it does not, the user must re-position the ultrasound probe until it does before finalizing the depth of the needle tip.

Figure 6 The pre-planed needle (purple cartoon) has a retraction distance of 5 mm.

Figure 7 A retraction distance of 10 mm; the distance between the base plane and the centre of the first seed!The Purple cartoon represents the whole needle.

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Verification of final implant in 3D

It is possible to proceed with the loading of the needles without making a final acquisition which includes the needles. The verification of the needle placement is then verified based on the live ultrasound image or/and spot software, Sagittal and Transversal. It is not always clear on the live 2D ultrasound images to define the exact base plane. A 3D image can be acquired in the SPOT-pro software to verify the needle positions in 3D (see Figure 8).

Verification on a fluoroscopy image

Once the needles are all inserted, their position can be checked with a fluoroscopy. The transversal array of the probe needs to be positioned in the base plane. This means that the base plane should be visible on the live transversal ultrasound image during fluoroscopy. On the fluoroscopy the transversal array is visible. The needle tip positions can therefore be verified. One should take into account the diversion of the fluoroscopy image and therefore place the transversal array in the center of the fluoroscopy field (see Figure 1).

Figure 8 The 3D cube can be shaped in any direction and oblique plane.

Figure 9 A) The transversal probe array is placed in the base plane of the prostate. The needle positions can be checked in relation to the base plane. When the balloon is correctly placed in the inferior part of the bladder it can be used as an alternative reference point.