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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EDespite advancements in medical device technology over the past several decades, safety issues remain a problem in diabetes technology, including glucose meters and insulin pumps. This article explores diabetes technology with specific topics including past and present devices, the evaluation of diabetes technology, and the US perspective on the evaluation of diabetes devices.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EDiabetes Mellitus\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInsulin\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EExclusive Article - For home page\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EDiabetes Mellitus\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EEndocrinology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EDiabetes \u0026amp; Metabolic Syndrome\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInsulin\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EExclusive Article - For home page\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EDespite advancements in medical device technology over the past several decades, safety issues remain a problem in diabetes technology, including glucose meters and insulin pumps. John C. Pickup, BM, PhD, King\u0027s College London School of Medicine, London, United Kingdom, introduced a session exploring diabetes technology with a discussion of past and present devices.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EEarly continuous subcutaneous insulin infusion (CSII) safety data from the 1980s suggested pump use resulted in less hypoglycemia and less increase in diabetic ketoacidosis compared with injection therapy. A 1980s survey showed that 25% of CSII pumps malfunctioned; 29% from drive failure and 14% from battery issues. In addition, 81% of patients reported infusion setting problems, of which 53% were due to blockage.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EModern insulin pump therapy is more complex and sophisticated. Some features include an alarm for malfunctions, software to aid assessment, and wireless connectivity to adjust settings. Although this complexity translates into greater opportunities for adverse events (AEs), clinical experience with pumps has greatly increased. In terms of safety, some premarket regulations have been developed, yet postmarket surveillance for safety and efficacy of insulin pumps is limited and is often not available to the public.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EDespite the more advanced technology in modern insulin pumps, pump failures and AEs still occur frequently. In a survey of 640 new pumps from 4 different insulin pump manufacturers, 36% of pumps were reported to have any defect, 16% reported a complete pump failure, and 6.5% reported mechanical defects that required replacement [Guilhem I et al. \u003Cem\u003EDiabetologia\u003C\/em\u003E 2009]. In a 10-year retrospective study of AEs reported to the United States Food and Drug Administration (FDA), 1594 AEs related to insulin pumps were reported between 1996 and 2005 and 13 deaths were documented [Cope JU et al. \u003Cem\u003EPediatrics\u003C\/em\u003E 2008]. However, this study lacked a matched control group and FDA verification of the accuracy and completeness of the reported AEs.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EIn a study of nonmetabolic complications of CSII, 96 patients with type 1 diabetes mellitus (T1DM) using a CSII for \u22656 months completed a questionnaire about demographics, infusion set type and duration, pump model, and frequency of complications. The rates of kinking, blockage, leaking, and malfunction are shown in \u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E.\u003C\/p\u003E\u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/13813\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/13813\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/13813\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-7\u0022 class=\u0022first-child\u0022\u003EPatient Survey: Insulin Pump Complications\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-8\u0022\u003EInfusion-site complications such as lipohypertrophy (26.1%), infection (17.4%), bleeding or bruising (14.1%), pain or soreness (5.4%), and irritation or itchiness (5.4%) were reported. Interestingly, a common cause of CSII AEs is ultimately due to patient error, poor patient training, or patient compliance, such as accidental damage to the pump, poor infusion set connection, or missed bolus.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003ELutz Heinemann, PhD, Science \u0026amp; Consulting, D\u00fcsseldorf, Germany, provided the European perspective on evaluating diabetes technology. A CE mark, required for market approval of a medical device in the European Union (EU), is provided by a Notified Body that is accredited to assess safety and performance, but not clinical effectiveness. However, a new framework for EU regulatory approval has been proposed, and a vote of the European Parliament is anticipated end of October 2013. One proposed change is basing approval on the associated risk of a medical device, such as insulin pumps, and \u003Cem\u003Ein vitro\u003C\/em\u003E diagnostics, such as blood glucose meters.\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003ESome limitations of the current system, according to Prof. Heinemann, include the quality of the postmarketing surveillance system required of the manufacturer after obtaining a CE mark, the time required to identify an issue, and the type of event that prompts a physician to report it. Another limitation is that devices are not being withdrawn from the market even though they do not meet regulatory requirements\u2014about 20% to 50% of blood glucose meters fall into this category.\u003C\/p\u003E\u003Cp id=\u0022p-11\u0022\u003EQuality management systems by manufacturers are required and regulated by government authorities. The public cannot access reports or reviews of medical devices in the EU. Regulatory agencies perform regular manufacturing inspections; however, smaller companies are less likely to be inspected because of their size.\u003C\/p\u003E\u003Cp id=\u0022p-12\u0022\u003ESafety issues associated with insulin pumps are the accuracy of the insulin infusion, bolus calculators (duration of insulin action), infusion catheters (for patients, not usually for manufacturers), and timing of occlusion alarms. Safety issues associated with insulin pens are the lack of independent head-to-head comparisons (most studies are a single manufacturer study of their device), and whether the accuracy is reduced in daily life.\u003C\/p\u003E\u003Cp id=\u0022p-13\u0022\u003EThe European Associate for the Study of Diabetes (EASD) is also addressing the issue of market approval and surveillance of diabetes devices. Some steps include holding an EASD diabetes technology meeting, a diabetes technology study group, supporting a registry of insulin pumps in Sweden, and the development of a statement proposing a new methodology for evaluating insulin pumps.\u003C\/p\u003E\u003Cp id=\u0022p-14\u0022\u003EDavid B. Sacks, MB, ChB, National Institutes of Health, Bethesda, Maryland, USA, provided the US perspective on the evaluation of diabetes devices. The FDA classifies medical devices based on their associated risk. Class I (low risk) devices are exempt from formal review, and most Class II (moderate risk) devices, which include insulin pumps, are cleared by the FDA for clinical use. Class III (high risk) devices must undergo clinical trials by the manufacturer to establish safety and efficacy.\u003C\/p\u003E\u003Cp id=\u0022p-15\u0022\u003EThe steps to obtain FDA approval of a Class II medical device are the submission of a premarket notification, also called a 510(k), that establishes the new device is at least as safe and effective as a similar device in clinical use, followed by FDA evaluation of the intended use, performance, and labeling of the device. The FDA can require postmarketing surveillance by the manufacturer if the device is likely to cause serious AEs if it fails, will be used in a pediatric population, will be implanted \u0026gt;1 year, or is intended as a life-sustaining or life-supporting device. Reports of AEs are reviewed by the FDA, and are followed-up if they are serious or a pattern emerges.\u003C\/p\u003E\u003Cp id=\u0022p-16\u0022\u003EAll postmarketing surveillance reports in the United States are available to the general public. The Manufacturer and user Facility Device Experience, one such database, is a searchable list of manufacturers, device brand names, and date of reported events. Alerts from the reporting system or by a manufacturer may lead to product recalls.\u003C\/p\u003E\u003Cp id=\u0022p-17\u0022\u003ENotably, the number of serious and fatal medical device AEs rose about 17% per year between 2001 and 2009 (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). The greatest proportion of the serious AEs reported between 2005 and 2009 occurred with insulin pumps, and blood glucose test systems were the third most common cause.\u003C\/p\u003E\u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/13\/17\/32\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Serious AE Associated With Medical Devices\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-2129749867\u0022 data-figure-caption=\u0022Serious AE Associated With Medical Devices\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/13\/17\/32\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/13\/17\/32\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/13\/17\/32\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/13812\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-18\u0022 class=\u0022first-child\u0022\u003ESerious AE Associated With Medical Devices\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EReproduced with permission from DB Sacks, MB, CHB.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-19\u0022\u003EMedical devices, particularly those used routinely in diabetes, are more complex and sophisticated, but AEs and device recalls remain and must be addressed.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2013 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/13\/17\/32.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nznlop\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nznlop\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_tables.js?nznlop\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}