The technologist's role in Intraoperative Radiation Therapy (IORT): experience of Città di Castello Hospital (Pg) Italy.

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1 The technologist's role in Intraoperative Radiation Therapy (IORT): experience of Città di Castello Hospital (Pg) Italy. RT Technologist Massimo Angelini Department of Radiotherapy (*), ASL n.1 Umbria, Città di Castello Hospital, Italy. * What is IORT? Intra-operative Radiation Therapy (IORT) or more precisely, in our case: Intra-operative Electron Radiation Therapy (IOERT) with mobile accelerator is a technique where a high single-dose of radiation is delivered to the tumor bed during surgery, immediately after tumor removal and directly on the anatomical area that contained the neoplasia, a possible location of sub-clinical disease or macroscopic residue.

2 What is IOERT? The radiation beam is produced by an electron accelerator specifically conceived and designed to work directly in the Operating Room (OR), on the same operating table where the surgery is carryed out. What is IOERT? IOERT minimizes the amount of tissue that is exposed to radiation. This is because normal tissues can be moved out of the way and shielded during surgery. uterus bladder applicator Rectum IOERT, bladder and other tissues are moved by the surgeon and the applicator allows the radiation to reach the tumor bed on the anterior wall of the sacrum

3 What is IOERT? * In our Radiotherapy Department in Città di Castello Hospital, ASL n.1 Umbria, Italy, we use NOVAC7 a new generation of mobile Linear Accelerator High versatility but a high level of concentration required! * The gantry can be rotated between - 45 to + 45

4 High versatility but a high level of concentration required! The gantry can be tilted between - 45 to High versatility but a high level of concentration required! The arm can be rotated between - 45 to + 45 to the right or the left The arm can be tilted between 30 to +60, upward or downward

5 High versatility but a high level of concentration required! * With a remote control the technologist moves the Novac through the operating theatre. The collimator is placed on the tumor bed by the radiation oncologist. With a hard docking maneuver the technologist joins the gantry with the collimator. High versatility but a high level of concentration required! The remote control is used to drive the accelerator: By holding the red button on the handle the movement is activated. Three safety switches for enabling or disabling arm, gantry or wheel movements. Speed selector, three speeds (slow, medium, fast) can be selected for the movement of the arm, the gantry or the wheels. Motor selector: by turning the dial you can either activate the gantry, the arm or the wheels. Command lever : the joystick allows you to control all the movements. Emergency button everything comes to a stop!

6 Difficulties the RT Technologist has to deal with! 1) Ensuring all the necessary tools are available 1) Ensuring all the necessary tools are available when required. APPLICATOR DISK Difficulties the RT Technologist has to deal with! 1) Ensuring all the necessary tools are available Protection disks are used during breast surgery. The disk is needed to protect the chest wall and the lung from radiation. The breast tissue to be irradiated, is positioned on the disk by the surgeon.

7 * Difficulties the RT Technologist has to deal with! 2) Correct positioning of accelerator 2) Driving the accelerator among many obstacles in the operating room without contaminating the sterile environment! You must be careful as the space where the accelerator to be moved into could be limited! is * Difficulties the RT Technologist has to deal with! 2) Driving the accelerator in the operating room! Hard docking: approach maneuver of the Novac 7 (mobile accelerator) at the operating table. Too many cooks spoil the broth! At this stage decisions are up to the RT technologist. Risky manouvers should be avoided! Don't rush!

8 * Difficulties the RT Technologist has to deal with! 2) Driving the accelerator in the operating room! Hard docking: approach maneuver of the Novac 7 (mobile accelerator) at the operating table. Different views to show the logistical challenges * Difficulties the RT Technologist has to deal with! 2) Driving the accelerator in the operating room! Hard docking: approach maneuver of the Novac 7 (mobile accelerator) at the operating table. Different views to show the logistical challenges

9 * Difficulties the RT Technologist has to deal with! 2) Driving the accelerator in the operating room! Hard docking: approach maneuver of the Novac 7 (mobile accelerator) at the operating table. Different views to show the logistical challenges * Difficulties the RT Technologist has to deal with! 2) Driving the accelerator in the operating room! Hard docking: approach maneuver of the Novac 7 (mobile accelerator) at the operating table. X-ray barriers Different views to show the logistical challenges

10 Difficulties the RT Technologist has to deal with! 3)Avoiding the lengthening of surgery time 3)Not lengthening the surgery time because of technical failures. * This requires a lot of concentration! * Difficulties the RT Technologist has to deal with! 3)Avoiding the lengthening of surgery time The hard docking must be fast and efficient! Wrong maneuvers can cause serious harm to the patient!

11 * What are the problems for the Technologist in IOERT? We need to minimize any possibility of error or delay in the procedure. We must try to predict what the possible problems might be. HOW? NO!!! Short summary of our research method * We decided to check out the technical procedure through the FMEA method! Failure Modes and Effects Analysis (FMEA) is a procedure used to analyse potential failure modes within a system, to classify the severity and to determine the effects of failures in the system. FMEA can be used in health services too!

12 * Short summary of our research method Through clinical audits we've heard the views of professionals involved in various capacities in the procedure. The multidisciplinary meetings have proved extremely useful for getting to know all the possible problems from different perspectives. Anaesthesist OR Nurse Surgeon Technologist Radiation Oncologist Medical physicist What is the FMEA method? FAILURE MODES consist of any errors or defects in: a process, design, or item, especially those, that affect the patient potentially or actually. cause... and effect If this is the situation, it s possible (and easy) to predict

13 What is the FMEA method? EFFECT ANALYSIS refers to the study of the consequences of those failures. THE FAILURE the effect!!! This is the outcame * FMEA METHOD TO IDENTIFY THE CRITICAL ELEMENTS Qualitative detection scale of FM (1st stage) In order to quantify IOERT risk, the process has been divided into ten basic activities: 1. Turning on the accelerator 2. Positioning the patient previous to anesthetics 3. Positioning the bed 4. Choosing the applicator 5. Hard docking 6. Placing X-Ray X barriers 7. Carrying out therapy 8. Removing X ray barriers 9. Removing accelerator 10. Turning off accelerator

14 * FMEA METHOD TO IDENTIFY THE CRITICAL ELEMENTS Qualitative detection scale of FM (2nd stage) Disclosure of the problems encountered in relation to activities (two examples following) that characterize the IOERT process. Activity 4: choosing the applicator 1. Unsuitable diameter 2. Applicator diameter not corresponding to the connection 3. Applicator not available 4. Applicator not-sterile Activity 5: hard docking 1. Misplaced surgical bed 2. Patient misplaced 3. Error handling of machine 4. Wrong selection on remote control 5. Contamination of the sterile environment FMEA METHOD TO IDENTIFY THE CRITICAL ELEMENTS Through the qualitative analysis of the process we identified possible ways of error failure mode (FM) potentially causing harm to the patient and/or to the operators. Each FM has been assessed (weighted) using a quantitative analysis by assigning each FM its Risk Probability Index (RPI), RPI is the product of three indexes: severity, probability and significance.

15 The pros of the new FMEA METHOD. This FMEA method helped us make a realistic IOERT CHECK LIST!!! The pros of the new FMEA METHOD. After applying the check list with the FMEA method, the technologist is able to check the mechanical apparatus of the equipment used and he/she can set up the equipment and the operating room suitably for the IOERT procedure.

16 The pros of the CHECK LIST. Two of the most important issues were: a) the need to integrate all the various skills,, because of the large number of people involved, b) the need to have several automatic tools to facilitate teamwork. * The pros of the new method The operator must, at various stages, follow the points shown in the check-list reminder. The check-list is built in a logical time sequence,, so that in the tension of the surgical session no steps are left out. The same check-list is binding not only for technologists,, but also for the team which must provide maximum collaboration.

17 The pros of the new method. Every step of the IOERT process can be carried out, according to a correct time sequence; You can make sure in advance that all the equipment needed for IOERT is available; Checks can be quickly carried out without forgetting anything; All the technologists of the department will be able to follow the same procedures. What problems are solved by implementing the check list? It avoids delays in the preparation of the equipment, needed for carrying out the procedure; It will reduce stress for the technologist and the whole team; It reduces the overall time for IOERT treatment; It increases patient safety.

18 What are the cons? Our group didn t find any disadvantages in using this check-list!!! We didn t find any disadvantage in using the checklist! We performed a total of 384 IOERT treatments on breast, prostate, rectum, pancreas tumors, lymph nodes and on soft tissue sarcomas. The checklist optimizes the IOERT procedure and therefore the time of surgery is shorter.

19 RECOMMENDATIONS 1 The technologist must refer to a check list of all items for IOERT phases before and during surgery. 2 Preparation of all the tools that will be critical to the success of the radiotherapy must be ensured. CONCLUSIONS 1 Team work as in all health activities, is particularly important as regards to IOERT activities. 2 The efficacy of this approach is also confirmed in all the activities ranging from the clinical phases to the surgery.

20 CONCLUSIONS We've had no negative reports during our IOERT procedures!! N a z a r B o n c u k

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