9月20日，F(xiàn)DA正式出臺(tái)了舉世矚目的醫(yī)療器械監(jiān)管規(guī)則，要求相關(guān)產(chǎn)品須標(biāo)注唯一識(shí)別碼（UDI）。UDI規(guī)則實(shí)施后，器械產(chǎn)品將更容易被跟蹤、監(jiān)控，及加快召回。
UDI系統(tǒng)具有提高醫(yī)療器械不良事件報(bào)告的信息質(zhì)量潛力，這將有助于FDA更快捷的找出產(chǎn)品問題、更好的定向回應(yīng)以及提高病人的安全。FDA與醫(yī)療行業(yè)、臨床社區(qū)、病人和大眾消費(fèi)群體都有緊密的合作。
醫(yī)學(xué)、法學(xué)博士Jeffrey Shuren（FDA器械和輻射健康中心主任）表示：“UDI是提高病人安全的標(biāo)志，讓我們的醫(yī)療設(shè)備監(jiān)控系統(tǒng)更加現(xiàn)代化，同時(shí)更促進(jìn)了醫(yī)療設(shè)備的創(chuàng)新步伐”。
UDI系統(tǒng)包括兩個(gè)核心部分。第一部分是器械的唯一識(shí)別編號(hào)，由GHTF（全球協(xié)調(diào)組）進(jìn)行全球唯一賦碼。這些編號(hào)包括了批號(hào)、型號(hào)、生產(chǎn)日期、有效期等信息，以號(hào)碼、可掃描的條形碼及英文文本的形式出現(xiàn)，由器械制造商管理。第二部分是可公開查詢的數(shù)據(jù)庫(kù)，里面可檢索除病人信息外的其他數(shù)據(jù)，由FDA管理。
一旦該新規(guī)則全面實(shí)施，市場(chǎng)上流通的產(chǎn)品將可被快速、高效地識(shí)別。這意味著兩個(gè)方面：
1.患者的電子病歷上將顯示使用了哪一個(gè)設(shè)備。這將提高不良反應(yīng)事件的報(bào)告質(zhì)量，加快產(chǎn)品召回，保障病人安全。這也有助于醫(yī)療保險(xiǎn)的結(jié)算。
2.器械產(chǎn)品的分銷網(wǎng)絡(luò)將納入數(shù)據(jù)庫(kù)。出現(xiàn)問題后，庫(kù)存產(chǎn)品亦可迅速召回。另一方面，也可防止假冒偽劣產(chǎn)品流入市場(chǎng)。FDA表示，分銷網(wǎng)絡(luò)的數(shù)據(jù)將是全球性的。
2007版的《聯(lián)邦食品藥品化妝品法》修正案當(dāng)中，已明確將UDI納入監(jiān)管日程。因會(huì)導(dǎo)致部分廠家的合規(guī)成本驚人，政商兩方展開了多年的拉鋸，于2012年7月份發(fā)布了120天征求意見稿，而后繼續(xù)推遲。
FDA在最終版規(guī)則中作出了一定的讓步。大多數(shù)高風(fēng)險(xiǎn)植入設(shè)備將首先開展UDI監(jiān)管，如心臟起搏器和除顫器。低風(fēng)險(xiǎn)的產(chǎn)品將免除部分或全部UDI，如繃帶等大包裝產(chǎn)品將共同使用一個(gè)UDI編碼。（詳細(xì)規(guī)則請(qǐng)點(diǎn)擊https://www.federalregister.gov/articles/2013/09/24/2013-23059/unique-device-identification-system）
UDI實(shí)施后，醫(yī)療器械監(jiān)管將進(jìn)入信息化、溯源化的新時(shí)代。國(guó)家藥監(jiān)局CFDA將于2015年全面實(shí)施的藥品電子監(jiān)管，與UDI規(guī)則有異曲同工之處。不同之處在于一個(gè)是藥品，一個(gè)是更為復(fù)雜的醫(yī)療器械，且UDI系統(tǒng)可公開查詢。
英文信息：
Today, the U.S. Food and Drug Administration announced a final rule2 for the unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices.
The UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA has worked closely with industry, the clinical community and patient and consumer groups in the development of this rule.
“UDI represents a landmark step in improving patient safety, modernizing our postmarket surveillance system for medical devices, and facilitating medical device innovation,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
The UDI system consists of two core items. The first is a unique number assigned by the device manufacturer to the version or model of a device, called a unique device identifier. This identifier will also include production-specific information such as the product’s lot or batch number, expiration date, and manufacturing date when that information appears on the label.
The second component is a publicly searchable database administered by the FDA, called the Global Unique Device Identification Database (GUDID) that will serve as a reference catalogue for every device with an identifier. No identifying patient information will be stored in this device information center.
The FDA plans to phase in the UDI system, focusing first on high-risk medical devices. Many low-risk devices will be exempt from some or all of the requirements in the final rule.
Once fully implemented, the UDI system rule is expected to have many benefits for patients, the health care system and the device industry. It will enhance the ability to quickly and efficiently identify marketed devices when recalled, improve the accuracy and specificity of adverse event reports and provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion. It will also offer a clear way of documenting device use in electronic health records and clinical information systems.
“A consistent and clear way to identify medical devices will result in more reliable data on how medical devices are used. In turn, this can promote safe device use by providers and patients as well as faster, more innovative, and less costly device development,” said Shuren.
The FDA issued the proposed rule3 requesting input from industry, the clinical community and patient and consumer groups on July 10, 2012.
The UDI system builds on current device industry standards and processes, and reflects substantial input from the clinical community and the device industry during all phases of its development. In addition, the FDA worked to reduce the burden on industry by building upon systems already in place. The UDI system is a key component of the National Medical Device PostMarket Surveillance System4 proposed in September 2012.
In general, high-risk medical devices (Class III) will be required to carry unique device identifiers on their label and packaging within one year and this number and corresponding device information must be submitted to the new database. Manufacturers will have three years to act for most Class II (moderate risk) devices. Manufacturers of Class I devices not exempt from UDI requirements will have five years to act.
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