Implicazioni medico legali_Minini

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Dr. Minini Corso GLUP TV - 22-23 marzo 2013

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Implicazioni medico legali_Minini

  1. 1. Implicazioni medico-legali: come fare cosa fare Dott. Gianfranco Minini
  2. 2. La divulgazione mediatica ha indotto nella opinionepubblica la percezione che l’errore medico siafrequente e non giustificabile in un’epoca in cui si puòcurare tutto e si deve guarire sempre.
  3. 3. Da “Obiettivo-Risarcimento”… non hai i soldi per tutto questo?Non preoccuparti, rischiamo le nostre competenze; cipaghi solo in caso di risarcimento ottenuto.Per le spese di perizia, visite e terapie, puoi beneficiaregratuitamente del nostro servizio di anticipo spese …
  4. 4. L’incidenza dei risarcimenti in campioni di strutture a rischio – USADiscipline Richieste Richieste di risarcimento/ di risarcimento/ 100 letti* 1000 ricoveri*Chirurgia 9,67 2,62Ortopedia 14,85 4,11Ginecologia 10,29 1,67Media 9,80 2,59 *Medical Claims survey 2010 realizzata da Marsh su 74 ospedali pubblici
  5. 5. - Le richieste di risarcimento sono lievitate del 250% in 15 anni.- In 20 anni di attività ogni medico ha circa l’80% di probabilità di ricevere un avviso di garanzia o una richiesta di risarcimento danni
  6. 6. Secondo un’indagine dell’Ordine dei Medici di Roma edell’Università Federico II di Napoli, c’è stato unaumento dell’8% del tasso di rischio clinico ogni 100medici, mentre il costo assicurativo medio permedico è salito del 23,86%.
  7. 7. Attualmente si può ritenere, senza tema di smentita, cheogni anno circa il 10% dei medici italiani, vengaraggiunto da una nuova richiesta di risarcimento oda una denuncia.Siccome l’iter giudiziario dura mediamente 8 anni,possiamo affermare che l’80% dei medici italiani (nelcaso dei chirurghi la percentuale supera il 90%) passeràsicuramente un quarto della propria esistenzalavorativa a districarsi tra le carte legali. Primatoinvidiabile, irraggiungibile anche per le categorie chedovrebbero essere più avvantaggiate in questacompetizione come gli spacciatori, i ladri o gli assassini.Oggi i medici devono fare conto con questa realtà!
  8. 8. Piero Calamandrei, illustre giurista, sostiene che ilprocesso, anche civile, costituisce già di per sé unagrave pena per chi lo subisce, a prescindere dalrisultato che detto processo potrà avere
  9. 9. Dati ENPAM: 2001 2010medici pensionati < 65 a. 2,5% 27,4%
  10. 10. Movimento per i Diritti del Malato:- 93% delle denunce vengono archiviate per mancanza di reato
  11. 11. Responsabilità Professionale Medicina Difensiva
  12. 12. Concetto di “cautela giudiziaria”La medicina difensiva consiste nell’operare scelteterapeutiche condizionate dall’osservanzagiurisprudenziale più che dai propri convincimentiscientifici
  13. 13. I concetti cardine della responsabilità medica- Negligenza: omissione volontaria di una attività imposta da un dovere di diligenza (ricomprende disaccortezza e disattenzione).- Imprudenza: attività compiuta senza quelle cautele suggerite da ordinarie regole.- Imperizia: difetto delle necessarie cognizioni ordinariamente richieste.
  14. 14. commissivaUna condotta colposa può essere o omissiva
  15. 15. Decreto Balduzzi (n 158 – 13.09.2012, art. 3) il medico che segue le linee guida non potrà essere imputato di colpa lieve
  16. 16. CASSAZIONE: “SE IL MEDICO HA SEGUITO LELINEE GUIDA LA COLPA LIEVE NON È PENALE”La Corte di Cassazione ha depenalizzato la colpa lievedei camici bianchi. La decisione della suprema corteprende l’avvio dall’articolo 3 della legge 189 dell’8novembre 2012 “responsabilità professionaledell’esercente le professioni sanitarie”
  17. 17. Oggi nelle aule dei Tribunali si èprogressivamente giunti ad unatteggiamento giurisprudenzialea favore delle posizioni dei Pazienti
  18. 18. - Danno patrimoniale- Danno morale- Danno biologico- Danno psichico e psicologico- Danno esistenziale
  19. 19. GOOD CLINICAL PRACTICE / STANDARD OF CARE - Linee guida - Percorsi assistenziali - Protocolli diagnostico-terapeutici
  20. 20. - LINEE GUIDA: è essenziale fare riferimento ai livelli di evidenza e forza delle raccomandazioni.- Tali livelli condizionano l’uso nella pratica clinica.- La loro applicabilità deve essere supportata dall’ utilizzo di criteri validati a livello internazionale.
  21. 21. Esistono tre criteri per definire la qualità metodologicadelle linee guida:1) multidisciplinarità del gruppo di lavoro2) processo esplicito di ricerca bibliografica3) grading delle evidenze
  22. 22. CONSENSO
  23. 23. - la responsabilità del danno deriva dall’inadempimento dell’informazione- l’onere di dimostrare di avere informato esaustivamente il paziente ricade sul medico
  24. 24. “Non vi è chi non veda come il consenso(rectius: la sua acquisizione) rappresentaelemento essenziale del rapporto tra il medico eil suo assistito, ad esso e alle sue caratteristichedi espressione subordinandosi la validitàdell’atto e la conformità delle obbligazioni alcontratto assunto; di tutto ciò dovendosi forniredimostrazione probatoria, il cui onere incombedi fatto sul professionista” (Norelli e Mazzeo, 1998)
  25. 25. “Il perimetro del consenso non può ritenersi didimensioni sconfinate né uguale per tutti, perchél’informazione che esso racchiude deve esserepersonalizzata alle peculiarità psicologiche delpaziente, al suo stato di malattia e allepossibilità della terapia in un’armonica sintesi” (Buccelli et al., 2002)
  26. 26. La responsabilità civile è distinta in: scaturisce da qualsiasi rapportocontrattuale obbligatorio precostituito (contratto, legge, ecc.) oextracontrattuale non presuppone alcun rapporto(o aquiliana) preesistente, ma deriva da un atto illecito posto in violazione del generale principio del “neminem laedere”
  27. 27. •RecommendationsPhysicians should:- Obtain specialized training for each mesh placement techmique, and be aware of its risks.- Be vigilant for potential adverse events from the mesh, especially erosion and infection.- Watch for complications associated with the tools used in transavginal placement, especially bowel, bladder and blood vessel perforations.- Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complications.- Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).- Provide patient with a written copy of the patient labeling from the surgical mesh manufacturer, if available. Additional patient information s can be found on the following FDA Consumer website.
  28. 28. AUGS Transvaginal Mesh Informed Consent ToolkitQuestion 1: Are you planning to use mesh in my surgery?While the 2011 Safety Communication focuses on the transvaginal placement of mesh for prolaspse repair, it is prudent to discussmesh-related issues even if you are planning to implant mesh for stress urinary incontinence or abdominally for prolapsed repair.Question 2: Why do you think I am a good candidate for mesh?The answer to this question certainly has to be tailored to each individual patient. However, a fair starting point in this discussionwould be to state that your anticipate that the benefits of using mesh outwight the potential risks associated with it. If the patienthas an anterior compartment defect, you can refr to a number of studies that show a decreased rate of anatomic recurrence withmesh use in cystocele repair. If the patient has had prior surgery to repair pelvic organ prolapse, you can likewise refet to literatureshowing the benefit of mesh versus native tissue repair in that clinical situation.Question 3: Why are you choosing surgical mesh for my repair?The patient should understand that surgical mesh is an option. It may be recommended, but it is never the only choice. If, afterdiscussing the pros and cons of mesh, the patient would rather not use mesh, she may choose a native tissue repair. Usually, mesh isused with the goal of increasing the durability of a repair (i.s., decreasing the risk of prolapse recurrence). The most commonclinical scenarios in which the risk of failure appears to be increased include: recurrent prolapse (prior failed surgery), prolapse ofthe anterior compartment, advanced prolapse (stage III or IV), and age (< 60 years). Certain kinds of procedures, such assacrocolpopexy, require the use of graft or mesh, and no native-tissue forms of these procedures are available. There may be otherparticular scenarios in which the surgeon may recommend the use of mesh.
  29. 29. Question 4: What are the alternatives to transvaginal surgical mesh repair for POP, including non-surgical options?Non-surgical options that shouls be discussed for POP repair include expectant management (“wait and watch”) and conservativemanagement (pelvic floor muscle exercises and/or pessary). Surgeons may want to divide the other surgical alternatives into twocategories: surgical options that they perform and other surgical options that exist, but that they do not perform. The options forpatients who do not desire future coital function include reconstructive and obliterative techniques. There are many options forpatients who desire to preserve possible coital function. However, these options can be divided into a few basic categories for sakeof simplicity: transvaginal native tissue repairs (i.e. colporrhaphy, sacrospinous and uterosacral ligament suspension),transabdominal native tissue repairs (i.e. paravaginal defect repairs and uterosacral ligament suspension), and transabdominalsurgical mesh repair (i.e. sacral colpopexy). It should be noted that the abdominal procedures can be performed via laparotomy orlaparoscopy. Also mention uterine-sparing procedures vs. pelvic reconstruction with hysterectomy in patients with uterovaginalprolapse.Question 5: What are the pros and cons of using surgical mesh in my particular case? How likely is it thatmy repair could be successfully performed without using surgical mesh?Refer to question 2 & 3 to answer this question, and mention relative paucity of data regarding there issue. Also, a surgeon’s ownpersonal experience and patient outcomes with various procedures will be helpful to add here. There is almost no clinical scenariowhere the repair cannot be performed without using surgical mesh; it is more a question of the degree and speed of possiblerecurrence that must be discussed. Since there are very few RCTs with greater than one year of follow-up, it can be challenging togive an evidence-based response to the second half of this questions. There is one RCT of the anterior compartment comparingcolporrhaphy to transvaginal mesh with three-year follow-up. This study shows a lower rate of anatomic “recurrence” with themesh but the difference in symptomatic bulge failed to each statistical significance. Of course, the one con that always exists withmesh that does not exist with native tissue repairs is mesh erosion/exposure.
  30. 30. Question 6: Will my partner be able to feel the surgical mesh during sexual intercourse? What if thesurgical mesh erode through my vaginal wall?Unless there is exposure or erosion of the mesh, your patient and her partner should not be able to feel the mesh. However, changesto the vaginal (scar tissue, decreased elasticity, vaginal lenght and caliber) that can affect sexual sensation can occur after anysurgery for pelvic organ prolapse. Tell the patient that if the mesh erodes through the vaginal wall, her partner may feel it.Depending on a number of factors, different options exist for the managemet of mesh erosion. In some cases (small, asymptomaticerosion), expectant management can be employed. In other cases, conservative management, usually in the form of vaginalestrogen therapy, can be used. Some physicians advocate surgical revision of any mesh exposure, but in one trial only one-third ofthe mesh exposure case needed revision during 12 months of follow-up.Question 7: If you plan to use surgical mesh, how often have you implanted this particular product?This response should be determined from the experiences of the surgeon. The surgeon may wish to create several versions of thisdocument to reflect the experiences with each of the specific procedures offered.Question 8: What results have your other patients had with this product?If surgeon have collected data to answer this question, then the question can be answered based on that data. Otherwise, it may beuseful to ask patients who have had mesh procedures in your practice if they would be willing to discuss their experience withpatients who care candidates for the same surgery. Alternatively, you can ask them to prepare a written statement of theirexperience that they are willing tho share with others.
  31. 31. Question 9: What can I expect to feel after surgery and for how long?Data fron the surgeon’s practice will be helpful in answering this question. A simple chart review can reveal the average hospitallength of stay and amount of narcotic pain medication necessary for the average patient. Otherwise, since this is a relativelysubjective issue, resources from question 8 may be useful.Question 10: Which specific side effects should I report to you after surgery?Standard postoperative precautions should be followed (asking the patient to call with fever, chills, worseningpain, etc.), but with specific regard to mesh, the patient should be aware of symptoms of mesh erosion. Theseinclude vaginal bleeding or discharge beyond the usual 6-8 week postoperative period. They should also reportani complaints from their partners regarding any sense of encountering a foreign body in the vagina (scratchingsensation with [or abrasions on the penis after] intercourse). Patients also should be alerted to the possibility ofneuropathic pain or scar tissue/retraction; although these conditions are not limited to patients with mesh repairs,they still warrant specific discussion.Question 11: What if the mesh surgery doesn’t correct my problem?Each surgeon should have a plan regarding management of recurrent prolapse after pelvic reconstructive surgery. The patientshould be aware that if a uterine-sparing procedure is performed, that ii is no guarantee that a hysterectomy may not be needed inthe future. She should also be aware that sometimes when one compartment is treated, a new prolapse can develop in the othercompartment. The patient should be aware of whether you tend to treat your own recurrences or if you are likely to refer them outto a different surgeon.
  32. 32. Question 12: If I develop a complication, will you treat or will I be referred to a specialist experiencedwith surgical mesh complications?You should provide an honest appraisal of your experience in managing mesh-related and other potential complications. It isworthwhile to inform patients that subspecialty referral may be warranted (Urology, Colorectal, or other colleague with greaterexperience in these issues) in some cases, but that you will remain involved until any problems have been throughly addressed.Question 13: If I have a complication related to the surgical mesh, how likely is it that the surgical meshcould be removed and what could be the consequences?Different clinical scenarios should be discussed with the patient with regard to this question. If there in asn early complication thatis prompty diagnosed (such as a visceral perforation during mesh placement), the wole mesh can be removed. If there is a vaginalmesh exposure later on, she should know that most of these can be treated with removel of the section of exposed mesh. However,she should know that if complications arise lonf after tissue ingrowth (beyond 12 weeks), it is quite difficult, and in some casesimpossible, to remove the mesh in its entirety. If the mesh is removed, there is a chance that prolapse could recur or that symptoms,such as pain and dyspareunia, might persist.Question 14: If you plan to use surgical mesh, is there patient information that comes with the product?Package labeling, as described by the FDA, is not consistent or always available at this point; a variety of patient information andpamphlets exists, some of which has been assembled for use on this site. The instructions for Use (IFUs) that come with thedevices are likely to be of little use to the patient.Manufacturers are being encouraged to be more consistent about supplying patient-based literature that can be sent with the patientafter implantation.
  33. 33. Guidelines for Providing Privileges and Credentials to Physicians for Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
  34. 34. For surgeons who do not currently placetransvaginal mesh for pelvic organ prolapsebut wish to begin performing this procedure: 1. Documenting Knowledge - general knowledge - specific knowledge 2. Documenting Surgical Skills 3. Documenting Experience 4. Internal Audits
  35. 35. For surgeons who currently have privileges intransvaginal placement of surgical mesh forpelvic organ prolapse a) Continuing medical education in female pelvic reconstructive surgery should be documented annually b) A minimum of 30 surgical cases for pelvic organ prolapse (any route, with or without transvaginal mesh) be performed each year c) Demonstrate experience and privileges in non-mesh vaginal repair of prolapse d) Annual internal audits should be performed e) Prior to adoption of a new transvaginal mesh technology or device, the surgeon should be proctored on no fewer than 5 procedures.
  36. 36. Frequenti motivi “minori” di contenzioso - Dolore pelvico/dolore arti inferiori - Difficoltà alla deambulazione - Comparsa di incontinenza/urgenza - Evacuazione difficoltosa - Disuria - Erosioni/perdite vaginali -…
  37. 37. Problema dei Consulenti Tecnici d’ Ufficio NONcompetenti su questioni altamente specialistiche
  38. 38. Negli USA esiste il diritto di rivalsa del medicoassolto, verso chi ha denunciato.In Italia è prevista la possibilità di contro-denuncia per “temerarietà” dell’azione legale.

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