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"tienePdf" => "en" "tieneTextoCompleto" => "en" "tieneResumen" => array:2 [ 0 => "en" 1 => "es" ] "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "455" "paginaFinal" => "461" ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Formación atípica de agujero macular después de terapia Anti-VEGF para la degeneración macular vinculada a la edad: ¿coincidencia o consecuencia?" ] ] "contieneResumen" => array:2 [ "en" => true "es" => true ] "contieneTextoCompleto" => array:1 [ "en" => true ] "contienePdf" => array:1 [ "en" => true ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:8 [ "identificador" => "fig0020" "etiqueta" => "Fig. 4" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr4.jpeg" "Alto" => 1073 "Ancho" => 905 "Tamanyo" => 119322 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0020" "detalle" => "Fig. " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Seventy-six years old female patient with age-related macular degeneration. OCT image of the left eye showing (A) thickened RPE raised by a nonuniform, slightly hperreflective formation and intraretinal cysts; (B) regression of choroidal neovascularization and macular hole formation 2 months after the sixth intravitreal ranibizumab injection.</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Z. Kayaarasi Ozturker, S. Akca Bayar, E. Yaman Pinarci, R.A. Kurt, I. Akkoyun, G. Yilmaz" "autores" => array:6 [ 0 => array:2 [ "nombre" => "Z." "apellidos" => "Kayaarasi Ozturker" ] 1 => array:2 [ "nombre" => "S." "apellidos" => "Akca Bayar" ] 2 => array:2 [ "nombre" => "E." "apellidos" => "Yaman Pinarci" ] 3 => array:2 [ "nombre" => "R.A." "apellidos" => "Kurt" ] 4 => array:2 [ "nombre" => "I." "apellidos" => "Akkoyun" ] 5 => array:2 [ "nombre" => "G." "apellidos" => "Yilmaz" ] ] ] ] ] "idiomaDefecto" => "en" "Traduccion" => array:1 [ "es" => array:9 [ "pii" => "S0365669120304482" "doi" => "10.1016/j.oftal.2020.08.011" "estado" => "S300" "subdocumento" => "" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:1 [ "total" => 0 ] "idiomaDefecto" => "es" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0365669120304482?idApp=UINPBA00004N" ] ] "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2173579421000645?idApp=UINPBA00004N" "url" => "/21735794/0000009600000009/v1_202109010611/S2173579421000645/v1_202109010611/en/main.assets" ] "en" => array:13 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Editorial</span>" "titulo" => "Medical devices and the pendulum’s law" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "453" "paginaFinal" => "454" ] ] "autores" => array:1 [ 0 => array:3 [ "autoresLista" => "J. Carlos Pastor" "autores" => array:1 [ 0 => array:4 [ "nombre" => "J." "apellidos" => "Carlos Pastor" "email" => array:1 [ 0 => "pastor@ioba.med.uva.es" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] ] "afiliaciones" => array:2 [ 0 => array:3 [ "entidad" => "Departamento de Oftalmología, Hospital Clínico Universitario de Valladolid, Valladolid, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "IOBA-Universidad de Valladolid, Valladolid, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "La ley del péndulo en los productos sanitarios" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Not many colleagues will be familiar with the EU MDR: European Union Medical Devices Regulation,<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> which should have come into force last year, but did so on 27 May last due to a postponement decided by the health authorities because of the pandemic. Regulation 2017/745 was drafted by the European Parliament and approved by the Council of Europe on 5 April 2017. It is mandatory and aims to improve the safety of the medical devices we use every day, which are given the so-called “CE marking”.</p><p id="par0010" class="elsevierStylePara elsevierViewall">In recent years we have witnessed a number of scandals with certain products (not only ophthalmological) that have left serious consequences in many patients and have frightened more than one ophthalmologist who had to endure them. All of said products bore the CE mark, which means that they had been assessed by the so-called “notified bodies”, in accordance with ISO standards, and their applications were subsequently approved by a country of the Union, allowing them to display the CE mark which for many of us had a meaning equivalent to a guarantee of safety.</p><p id="par0015" class="elsevierStylePara elsevierViewall">But, due to several factors that came into play, this was not the case. On the one hand, the permissiveness of some notified bodies, a fact known to companies with less scruples who filed their applications with them because they were more tolerant in their verifications. In addition, a certain laxity on the part of the public administrations of some countries (not ours). And finally, industry corporatism in certain countries (and once again, not precisely ours) which endeavoured to cover up situations that their companies were aware of in order to preserve the reputation of the sector. All of these factors have led to situations that we all remember and that many patients will suffer for the rest of their lives.</p><p id="par0020" class="elsevierStylePara elsevierViewall">The series of calamities is long and covers all fields. I will only mention a few: intraocular lenses that in 2018 had to be recalled for causing toxic syndromes after implantation, or phakic lenses that were recalled in 2014 for causing an excessive loss of endothelial cells. Something similar happened with an implant to reduce intraocular pressure that also had to be withdrawn from the market. In addition, the problems with highly toxic inner limiting membrane or anterior lens capsule dyes, not to mention the famous story of liquid perfluorocarbons, which we have already written enough about and which I will not dwell on.</p><p id="par0025" class="elsevierStylePara elsevierViewall">The field of contact lenses and disinfection and cleaning solutions has been another problem generator. Examples include a contact lens cleaning and disinfection solution that had high residual levels of peroxide in some batches and was recalled in 2017; or the contact lens care solution that in 2007 was linked to an increased frequency of Acanthamoeba infections, and many others. No one should feel particularly concerned as there are products from almost every company and I have selected these just to give a few examples. All existing health alerts can be consulted on the website of our Spanish Agency for Medicines and Health Products (AEMPS) which has always acted diligently as soon as problems were reported. Incidentally, Spain is one of the few European countries where healthcare professionals are obliged by law to report adverse effects. This explains the absence of such reporting elsewhere.</p><p id="par0030" class="elsevierStylePara elsevierViewall">Within this long list of mishaps, the IOBA are going to dedicate, shortly, a “special issue” to a product called AlaSil, from the Alamedics company. It was a “light” silicone, which was recommended to replace the intraocular liquids used in vitrectomies to “contain intraocular haemorrhages”. Of course, we were unable to find a single scientific paper to support this claim and, upon analysis of the compound, it turns out to be, unsurprisingly, a cocktail of low molecular weight compounds (LWMC). Recently, a purely chemical study has been published on the different silicone oils, where the high concentration of LWMC<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> appears to be one of the most serious problems. It is a little sad to think that the members of the ISO Standards Committee did not issue a warning about this product which would have prevented it from being marketed. Instead, the company producing it received an innovation prize from the Bavarian government.<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">But the law of the pendulum is unavoidable. From the aforementioned EU-MDR (regulation 2017/245) onwards, all companies will have to submit a clinical evaluation plan to the health authorities for any medical device (Class I, Class IIa, Class IIb and Class III). They will be required to conduct clinical research in the form of a clinical development plan (i.e. as close as possible to a clinical trial), a post-marketing clinical follow-up and, depending on the product, a periodic safety summary every one or two years, which will have to be updated.</p><p id="par0040" class="elsevierStylePara elsevierViewall">It will not be easy for many companies to comply with these requirements, and the mechanism to be developed will have to include some corrective factors to avoid some biases that can be surmised. But it is clear that the European Parliament has become aware of the severity of the problem and has at least taken action. It is certainly a step forward so that surgeons of any speciality, when they get their hands on a CE-marked product, will not be beset by doubts about it safety. That would be the last straw.</p><p id="par0045" class="elsevierStylePara elsevierViewall">Not many months ago, a German chemist suggested in a publication that ophthalmologists should become experts in certain chemical matters in order to better select our products and thus protect our patients.<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a></p><p id="par0050" class="elsevierStylePara elsevierViewall">In a letter to the editor of the journal<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> I tried to explain to the author that we ophthalmologists had enough to learn to diagnose correctly, successfully cover our surgical learning curve without harming many patients, periodically audit our results to improve them, console patients when we fail and assume that, like any human being, we make mistakes and show our faces. It would be too much to expect from us to learn chemistry and legislation to use safe products in our daily practice. Fortunately, the European Council seems to agree with us.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Funding</span><p id="par0055" class="elsevierStylePara elsevierViewall">The author declares that this work has not received any funding, has no commercial interest and does not use patient data.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Conflicts of interest</span><p id="par0060" class="elsevierStylePara elsevierViewall">The authors declare no conflicts of interest.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:3 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Funding" ] 1 => array:2 [ "identificador" => "sec0010" "titulo" => "Conflicts of interest" ] 2 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:2 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Carlos Pastor J. La ley del péndulo en los productos sanitarios. Arch Soc Esp Oftalmol. 2021;96:453–454.</p>" ] 1 => array:2 [ "etiqueta" => "☆☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0010">Expert and Vicepresident of the European Commission Joint Research Center for Ocular Medical Devices.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:5 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "<a target="_blank" href="https://eur-lex.europa.eu/legalcontent/ES/TXT/PDF/?uri=CELEX:02017R0745-20170505&from=EN">https://eur-lex.europa.eu/legalcontent/ES/TXT/PDF/?uri=CELEX:02017R0745-20170505&from=EN</a>. [Accessed 3 Jul 2021]." ] ] ] 1 => array:3 [ "identificador" => "bib0010" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Benchmarking different brands of silicone oils" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "J.H. Dresp" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1007/s00417-020-04809-2" "Revista" => array:7 [ "tituloSerie" => "Graefes Arch Clin Exp Ophthalmol." "fecha" => "2021" "volumen" => "259" "numero" => "1" "paginaInicial" => "13" "paginaFinal" => "20" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/32623577" "web" => "Medline" ] ] ] ] ] ] ] ] 2 => array:3 [ "identificador" => "bib0015" "etiqueta" => "3" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "<a target="_blank" href="https://www.kfw.de/KfW-Group/Newsroom/Latest-News/Pressemitteilungen-Details_304320.html">https://www.kfw.de/KfW-Group/Newsroom/Latest-News/Pressemitteilungen-Details_304320.html</a>, [Accessed 3 Jul 2021]." ] ] ] 3 => array:3 [ "identificador" => "bib0020" "etiqueta" => "4" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Benchmarking different brands of perfluorocarbon liquids" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "J.H. Dresp" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1007/s00417-020-04964-6" "Revista" => array:6 [ "tituloSerie" => "Graefes Arch Clin Exp Ophthalmol." "fecha" => "2021" "volumen" => "259" "paginaInicial" => "21" "paginaFinal" => "27" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/33245429" "web" => "Medline" ] ] ] ] ] ] ] ] 4 => array:3 [ "identificador" => "bib0025" "etiqueta" => "5" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Safety of perfluorocarbon liquids cannot be the retinologist’s responsibility" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "J.C. Pastor" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1007/s00417-021-05111-5" "Revista" => array:6 [ "tituloSerie" => "Graefes Arch Clin Exp Ophthalmol." 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