{"id":49846,"date":"2024-05-28T09:41:10","date_gmt":"2024-05-28T07:41:10","guid":{"rendered":"https:\/\/clariscience.com\/blog\/uncategorized\/la-valutazione-biologica-dei-dispositivi-medici-in-10-punti"},"modified":"2024-11-08T15:43:38","modified_gmt":"2024-11-08T14:43:38","slug":"biological-evaluation","status":"publish","type":"post","link":"https:\/\/clariscience.com\/en\/blog\/regulatory-affairs\/biological-evaluation","title":{"rendered":"Biological Evaluation of Medical Devices in 10 Points"},"content":{"rendered":"\t\t
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La valutazione biologica dei dispositivi medici consiste nella valutazione dei potenziali rischi biologici<\/strong> derivanti dall\u2019uso di dispositivi medici<\/strong> allo scopo di verificarne la sicurezza per i pazienti e gli utilizzatori.<\/strong><\/p>\n

La valutazione biologica \u00e8 un aspetto cruciale dello sviluppo dei dispostivi medici, e pertanto andrebbe affrontata per la prima volta nella fase di <\/span>verifica della progettazione<\/strong> di un dispositivo, per poi <\/span>proseguire nel corso del suo intero ciclo di vita.<\/strong>
<\/p>\n

Un approccio ampiamente riconosciuto alla valutazione biologica dei dispositivi medici \u00e8 descritto nello <\/span>Standard Internazionale ISO 10993-1: 2018 \u201cBiological evaluation of medical devices \u2014Part 1: Evaluation and testing within a risk management process\u201d<\/strong>, giunto ormai alla sua 5\u00b0 edizione.<\/span><\/p>\n

La norma \u00e8 supportata da altre 21 parti, pi\u00f9 tecniche e dedicate all\u2019approfondimento di specifici test chimico-fisici o biologici, che nel complesso costituisco la cosiddetta serie ISO 10993<\/em><\/strong>.<\/p>\n

Vediamo ora in 10 punti<\/strong> in cosa consiste valutazione biologica ai sensi della ISO 10993-1<\/strong>:<\/p>\n

    \n
  1. SCOPO e AMBITO DI APPLICAZIONE.<\/strong> La norma ha lo scopo di descrivere <\/span>i principi generali<\/strong> che regolano la <\/span>valutazione biologica dei dispositivi medici nell’ambito di un processo di gestione del rischio<\/strong>; questo processo di gestione del rischio prevede <\/span>l\u2019identificazione dei pericoli biologici<\/strong>, la <\/span>stima dei rischi biologici associati<\/strong> e la <\/span>determinazione della loro accettabilit\u00e0<\/strong>. L’allegato B della norma fornisce indicazioni su questo processo. La valutazione biologica ai sensi della ISO 10993-1 si applica a tutti i <\/span>dispositivi medici o materiali<\/strong> di questi che si prevede possano entrare <\/span>in contatto diretto o indiretto con:<\/strong>\n
      \n
    • il corpo del paziente durante l’uso previsto;<\/strong><\/li>\n
    • il corpo dell’utilizzatore, se il dispositivo medico \u00e8 destinato alla protezione<\/strong> (es. guanti chirurgici, mascherine e altro).<\/li>\n<\/ul>\n<\/li>\n


      <\/p>\n

    • CHI EFFETTUA LA VALUTAZIONE BIOLOGICA?<\/strong> La valutazione biologica deve essere <\/span>pianificata, effettuata e documentata da professionisti competenti, adeguatamente qualificati per formazione ed esperienza<\/strong>, che siano in grado di interpretare i requisiti della norma ISO 10993-1 e giudicare l’esito della valutazione per ciascun dispositivo medico, prendendo in considerazione tutti i fattori rilevanti per il dispositivo stesso, quali, ed esempio, la sua destinazione d\u2019uso, la revisione della letteratura scientifica\/tossicologica pertinente, la precedente esperienza clinica ecc.<\/span><\/li>\n


      <\/p>\n

    • QUAL \u00c8 IL PUNTO DI PARTENZA?<\/strong> La valutazione biologica in accordo alla ISO 10993-1 inizia con la categorizzazione dei dispositivi medici in base alla natura e alla durata <\/strong>del loro contatto previsto con il corpo umano <\/strong>durante l’uso. La categorizzazione dei dispositivi medici facilita la selezione dei pericoli biologici, o endpoints biologici<\/strong>, da considerare nella valutazione. La gamma di possibili pericoli biologici \u00e8 ampia e pu\u00f2 includere effetti a breve termine <\/strong>come tossicit\u00e0 acuta, irritazione della pelle, degli occhi e delle mucose, emolisi e trombogenicit\u00e0, nonch\u00e9 effetti tossici a lungo termine o specifici <\/strong>come effetti tossici subcronici e cronici, sensibilizzazione con conseguente allergia, genotossicit\u00e0, cancerogenicit\u00e0 (tumorogenicit\u00e0) ed effetti sulla riproduzione o sullo sviluppo, compresa la teratogenicit\u00e0.<\/li>\n


      <\/p>\n

    • QUALI ENDPOINTS VALUTARE? <\/strong>L’ Allegato A <\/strong>della norma fornisce, in una matrice, gli<\/strong> endpoint biologici ritenuti rilevanti nella valutazione di biocompatibilit\u00e0 dei dispositivi<\/strong> in base alla loro categoria di contatto corporeo e alla durata dell’esposizione clinica<\/strong>. Questa matrice, tuttavia, non deve essere interpretata come una rigida check-list, n\u00e9 tantomeno come una serie di test da eseguire, ma come un consiglio sugli endpoint che il professionista competente dovrebbe prendere in considerazione nella valutazione del rischio. Per particolari dispositivi medici, esiste la possibilit\u00e0 che, rispetto gli endpoint indicati, sia opportuno includerne ulteriori, o escluderne alcuni.<\/li>\n


      <\/p>\n

    • PROCESSO DI VALUTAZIONE BIOLOGICA.<\/strong> Il processo di valutazione biologica suggerito dalla ISO 10993-1 si basa su un approccio sistematico<\/strong>. Questo approccio comprende la revisione e la valutazione dei dati esistenti<\/strong> provenienti da tutte le fonti, inclusa una serie di informazioni fisico-chimiche preliminari, e, ove necessario, la selezione e l\u2019esecuzione di test aggiuntivi<\/strong>, consentendo cos\u00ec di effettuare una valutazione completa delle risposte biologiche<\/strong> al dispositivo medico<\/strong>, per poter trarre conclusioni circa la sua sicurezza d\u2019uso<\/strong>. Analizziamo pi\u00f9 in pi\u00f9 nel dettaglio questi step nei prossimi punti.<\/li>\n


      <\/p>\n

    • RACCOLTA DI INFORMAZIONI PRELIMINARI CHIMICO-FISICHE.<\/strong> La raccolta di informazioni fisiche e chimiche sul dispositivo medico o sui suoi componenti, nota anche come caratterizzazione del materiale<\/strong>, \u00e8, secondo la ISO 10993-1, un passaggio obbligatorio preliminare di ogni valutazione biologica, che dovrebbe precedere qualsiasi test biologico. Tale caratterizzazione riguarda, come minimo, le sostanze chimiche costituenti del dispositivo medico<\/strong>, gli additivi previsti<\/strong> e gli eventuali ausiliari di processo<\/strong> utilizzati nella sua fabbricazione, potenzialmente presenti come residui nel dispositivo finale. Vanno inoltre considerati i materiali di imballaggio (packaging)<\/strong> che entrano in contatto diretto o indiretto con il dispositivo medico, i quali hanno il potenziale di trasferire sostanze chimiche al dispositivo medico e quindi indirettamente al paziente o all\u2019utilizzatore.<\/li>\n


      <\/p>\n

    • RACCOLTA DI ALTRI DATI<\/strong>. Altri dati utili alla valutazione biologica dei dispositivi sono:\n
        \n
      • altri test pre-clinici gi\u00e0 effettuati<\/strong> sul dispositivo o sui materiali costituenti, compresi eventuali test di biocompatibilit\u00e0<\/strong> precedentemente svolti<\/strong>;<\/li>\n
      • i dati clinici disponibili<\/strong>, inclusi i risultati di indagini cliniche;<\/li>\n
      • dati derivanti dell’esperienza post-commercializzazione <\/strong>di propri dispositivi medici o di dispositivi simili (la storia dell\u2019uso sicuro<\/strong>).<\/li>\n<\/ul>\n<\/li>\n


        <\/p>\n

      • GAP ANALYSIS E SELEZIONE DEI DATI\/TEST MANCANTI.<\/strong> La valutazione delle informazioni disponibili, incluse quelle appositamente raccolte, esposte nei due punti precedenti, consente quindi un’analisi delle possibili lacune (gap analysis) <\/strong>per il completamento dell’analisi dei rischi, e quindi l’identificazione di ulteriori set di dati necessari<\/strong> per analizzare la sicurezza biologica del dispositivo. Se sono necessari test per endpoint specifici, la selezione di eventuali test in vitro o in vivo  deve essere opportunamente motivata. <\/strong><\/li>\n


        <\/p>\n

      • VALUTAZIONE COMPLESSIVA DELLA SICUREZZA BIOLOGICA E CONCLUSIONI.<\/strong> I valutatori esperti sono quindi tenuti alla valutazione dei rischi biologici<\/strong> del dispositivo medico attraverso l’uso dei dati esistenti, i risultati di eventuali test aggiuntivi richiesti o specifici razionali<\/strong>, e ad esprimere le proprie conclusioni circa la sicurezza biologica<\/strong>, ovvero assenza di rischi biologici inaccettabili nel contesto dell’uso previsto.<\/li>\n


        <\/p>\n

      • QUANDO RIPETERE LA VALUTAZIONE BIOLOGICA?<\/strong> La valutazione biologica deve essere ripetuta, se, durante il ciclo di vista del dispositivo, si verifica una delle seguenti condizioni:<\/li>\n<\/ol>\n

        a) qualsiasi cambiamento nella fornitura o nelle specifiche dei materiali utilizzati <\/strong>nella fabbricazione del prodotto;<\/p>\n

        b) qualsiasi modifica nella formulazione, lavorazione, confezionamento primario o sterilizzazione<\/strong> del prodotto;<\/p>\n

        c) qualsiasi cambiamento riguardo allo stoccaggio<\/strong>, ad es. cambiamenti nella durata di conservazione e\/o nel trasporto;<\/p>\n

        d) qualsiasi cambiamento nella destinazione d’uso del prodotto<\/strong>;<\/p>\n

        e) qualsiasi evidenza che il prodotto possa produrre effetti biologici avversi se utilizzato sull’uomo<\/strong>.<\/p>\n


        Come detto, la valutazione biologica di un dispositivo medico si inserisce nel contesto pi\u00f9 ampio della valutazione dei rischi; data la natura delle informazioni da considerare, che spaziano da quelle relative ai materiali costituenti il dispositivo ed il suo packaging, al processo produttivo\/di sterilizzazione, alla modalit\u00e0 di interazione del dispositivo col corpo umano, al suo uso clinico, sarebbe opportuno che essa venisse affidata ad un team multidisciplinare<\/strong>, in cui non possono mancare specifiche competenze in ambito tossicologico<\/strong> per la corretta interpretazione e valutazione dei dati. Potrebbe dunque essere opportuno avvalersi anche di esperti esterni alla propria organizzazione nell\u2019ottica di valutare correttamente la sicurezza biologica del proprio dispositivo, oltre che di ottimizzare i tempi e i costi dell\u2019intero processo di valutazione biologica.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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        The biological evaluation of medical devices involves assessing potential biological risks arising from the use of these devices<\/strong> to verify their safety for patients and users.<\/strong><\/p>

        \u00a0<\/p>

        Biological evaluation is a crucial aspect of medical device development and should therefore be addressed for the first time during the design verification phase<\/strong> of a device, continuing throughout its entire lifecycle.<\/strong><\/p>

        A widely recognized approach to the biological evaluation of medical devices is described in International Standard ISO 10993-1: 2018<\/strong> “Biological evaluation of medical devices \u2014 Part 1<\/strong>: “Evaluation and testing within a risk management process,<\/strong>” now in its 5th edition.<\/p>

        The standard is supported by 21 other parts, which are more technical and dedicated to in-depth specific chemical-physical or biological tests, collectively forming the so-called ISO 10993 series.<\/strong><\/p>

        Let\u2019s now look at the biological evaluation according to ISO 10993-1 in 10 points:<\/strong><\/p>

        1.PURPOSE AND SCOPE:<\/strong> The standard aims to describe the general principles<\/strong> governing the biological evaluation of medical devices within a risk management process.<\/strong> This process includes identifying biological hazards<\/strong>, estimating associated biological risks, and determining their acceptability.<\/strong> Annex B of the standard provides guidance on this process. The biological evaluation according to ISO 10993-1 applies to all medical devices or materials<\/strong> expected to come into direct or indirect contact with:<\/strong><\/p>

        • the patient’s body during the intended use;<\/strong><\/li>
        • the user\u2019s body, if the medical device is intended for protection (e.g., surgical gloves, masks, etc.).<\/strong><\/li><\/ul>

          2. WHO PERFORMS THE BIOLOGICAL EVALUATION?:<\/strong> The biological evaluation must be planned, conducted, and documented by competent professionals, suitably qualified by training and experience,<\/strong> who can interpret the requirements of ISO 10993-1 and judge the outcome of the evaluation for each medical device, considering all relevant factors such as its intended use, review of pertinent scientific\/toxicological literature, previous clinical experience, etc.<\/p>

          3.WHAT IS THE STARTING POINT?:<\/strong> The biological evaluation according to ISO 10993-1 begins with the categorization of medical devices based on the nature and duration of their expected contact with the human body<\/strong> during use. Categorization facilitates the selection of biological hazards or biological<\/strong> endpoints<\/strong> to consider in the evaluation. The range of possible biological hazards is broad and may include short-term effects like acute toxicity, skin, eye, and mucosal irritation, hemolysis, and thrombogenicity, as well as long-term or specific toxic effects<\/strong> such as subchronic and chronic toxic effects, sensitization leading to allergy, genotoxicity, carcinogenicity (tumorigenicity), and effects on reproduction or development, including teratogenicity.<\/p>

          4.WHICH ENDPOINTS TO EVALUATE?:<\/strong> Annex A<\/strong> of the standard provides a matrix of biological endpoints deemed relevant in the biocompatibility evaluation of devices based on their body contact category and duration of clinical exposure.<\/strong> However, this matrix should not be interpreted as a rigid checklist or a series of tests to perform, but rather as guidance on the endpoints that the competent professional should consider in the risk evaluation. For specific medical devices, it may be appropriate to include additional endpoints or exclude some.<\/p>

          5.BIOLOGICAL EVALUATION PROCESS:<\/strong> The biological evaluation process suggested by ISO 10993-1 is based on a systematic approach.<\/strong> This includes reviewing and evaluating existing data<\/strong> from all sources, including preliminary physicochemical information, and, if necessary, selecting and conducting additional tests<\/strong> to enable a comprehensive assessment of the biological responses to the medical device,<\/strong> thus allowing conclusions to be drawn about its safety for use.<\/strong> We will analyze these steps in more detail in the following points.<\/p>

          6.COLLECTION OF PRELIMINARY PHYSICOCHEMICAL INFORMATION:<\/strong> According to ISO 10993-1, the collection of physical and chemical information about the medical device or its components, known as material characterization<\/strong>, is a mandatory preliminary step in any biological evaluation that should precede any biological testing. This characterization should minimally cover the constituent chemicals of the medical device, any intended additives, and any process aids<\/strong> used in its manufacture that may be present as residues in the final device. Packaging materials<\/strong> that come into direct or indirect contact with the medical device should also be considered, as they have the potential to transfer chemicals to the medical device and thus indirectly to the patient or user.<\/p>

          7.COLLECTION OF OTHER DATA:<\/strong> Other useful data for the biological evaluation of devices include:<\/p>

          • other pre-clinical tests<\/strong> already performed on the device or its constituent materials, including any previously conducted biocompatibility tests;<\/li>
          • available clinical data,<\/strong> including the results of clinical investigations;<\/li>
          • data from the post-market experience<\/strong> of similar devices (the history of safe use).<\/li><\/ul>

            8.GAP ANALYSIS AND SELECTION OF MISSING DATA\/TESTS:<\/strong> The evaluation of the available information, including that specifically collected as outlined in the previous two points, enables a gap analysis for completing the risk analysis<\/strong> and identifying additional sets of data necessary to analyze the biological safety of the device.<\/strong> If tests for specific endpoints are required, the selection of any in vitro or in vivo tests must be adequately justified.<\/strong><\/p>

            9.OVERALL EVALUATION OF BIOLOGICAL SAFETY AND CONCLUSIONS<\/strong>: Expert evaluators are required to assess the biological risks<\/strong> of the medical device using existing data, the results of any required additional tests, and specific rationales,<\/strong> and to express their conclusions regarding biological safety<\/strong>, i.e., the absence of unacceptable biological risks in the context of the intended use.<\/p>

            10.WHEN TO REPEAT THE BIOLOGICAL EVALUATION?:<\/strong> The biological evaluation must be repeated if, during the device’s lifecycle, any of the following conditions occur:<\/p>

            • change in the supply or specifications of materials used<\/strong> in the product\u2019s manufacture;<\/li>
            • any modification in formulation, processing, primary packaging, or sterilization<\/strong> of the product;<\/li>
            • any change regarding storage<\/strong>, e.g., changes in shelf life and\/or transport;<\/li>
            • any change in the<\/strong> intended use of the product;<\/strong><\/li>
            • any evidence that the product may produce adverse biological effects when used on humans.<\/strong><\/li><\/ul>

              As mentioned, the biological evaluation of a medical device fits within the broader context of risk evaluation; given the nature of the information to be considered, which ranges from those related to the materials constituting the device and its packaging, to the manufacturing\/sterilization processes, to the mode of interaction of the device with the human body, to its clinical use, it would be advisable for this evaluation to be entrusted to a multidisciplinary team,<\/strong> including specific expertise in toxicology<\/strong> for the correct interpretation and evaluation of the data. It may also be beneficial to engage external experts to ensure a proper assessment of the biological safety of the device, as well as to optimize the time and costs of the entire biological evaluation process.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

              Biological evaluation is a crucial aspect of medical device development. It should first be addressed during the design verification phase of a device and then continue throughout its entire lifecycle.<\/p>\n","protected":false},"author":267,"featured_media":45478,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"episode_type":"","audio_file":"","podmotor_file_id":"","podmotor_episode_id":"","cover_image":"","cover_image_id":"","duration":"","filesize":"","filesize_raw":"","date_recorded":"","explicit":"","block":"","powered_cache_disable_cache":false,"powered_cache_disable_css_optimization":false,"powered_cache_disable_js_optimization":false,"footnotes":""},"categories":[532],"tags":[575],"class_list":["post-49846","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatory-affairs","tag-magazine-en"],"acf":[],"yoast_head":"Biological Evaluation of Medical Devices in 10 Points | Clariscience Magazine<\/title>\n<meta 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