FDA803不良事件管理法規(guī)

1、Code of Federal RegulationsTitle 21, Volume 8Revised as of April 1, 2015CITE: 21CFR803TITLE 21-FOOD AND DRUGSCHAPTER I-FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H-MEDICAL DEVICES PART 803MEDICAL DEVICE REPORTINGSubpart A-General ProvisionsSec. 803.1 What does thi

2、s part cover? 803.1 的內(nèi)容(a) This part establishes（建立） the requirements for medical device（裝置） reporting for device user facilities, manufacturers（生產(chǎn)商）, importers（進(jìn)口商）, and distributors（經(jīng)銷商）. If you are a device user facility, you must report deaths and serious injuries that a device has or may have c

3、aused or contributed to, establish and maintain adverse event files, and submit summary annual reports. If you are a manufacturer or importer, you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device malfunctions, and you m

4、ust establish and maintain adverse event files. If you are a manufacturer, you must also submit specified followup. These reports help us to protect the public health by helping to ensure that devices are not adulterated or misbranded and are safe and effective for their intended use. If you are a m

5、edical device distributor, you must maintain records (files) of incidents, but you are not required to report these incidents. 本部分建立用戶、制造商、進(jìn)口商和分銷商的醫(yī)療器械產(chǎn)生不良事件報(bào)告的要求。如果你是一個(gè)用戶，您必須針對(duì)設(shè)備或器械造成的死亡和嚴(yán)重傷害進(jìn)行報(bào)告，建立和維護(hù)不良事件文件，并提交摘要年度報(bào)告。如果您是一個(gè)制造商或進(jìn)口商，您必須對(duì)死亡和嚴(yán)重傷害（事件）報(bào)告，您的設(shè)備已經(jīng)或可能造成或促成，您必須報(bào)告某些設(shè)備故障，您必須建立和維護(hù)不良事件文件。如果你是一個(gè)制

6、造商，還必須提交指定的隨訪。這些報(bào)告可以幫助我們通過幫助確保設(shè)備不摻假或冒牌的，是安全和有效的使用保護(hù)公眾健康。如果你是一個(gè)醫(yī)療設(shè)備經(jīng)銷商，你必須保持記錄（文件）的事件，但你不需要報(bào)告這些事件。(b) This part supplements and does not supersede other provisions of this chapter, including the provisions of part 820 of this chapter.這一部分的補(bǔ)充，不能取代本章其他規(guī)定，包括本章820部分的規(guī)定。(c) References in this part to regu

7、latory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.在本部分中提到的聯(lián)邦法規(guī)的法規(guī)部分是第一章我的標(biāo)題21，除非另有說明。Sec. 803.3 How does FDA 美國食品藥品管理局define the terms used in this part?803.3 FDA如何定義這一部分所使用的術(shù)語？Some of the terms we use in this part are specific to medical device

8、reporting and reflect the language used in the statute (law). Other terms are more general and reflect our interpretation of the law. This section defines the following terms as used in this part:（這部分中，我們使用的術(shù)語是指特定的醫(yī)療設(shè)備，并規(guī)定了申報(bào)是語言）我們在這部分使用的術(shù)語是特定于醫(yī)療設(shè)備的報(bào)告，反映了在法規(guī)中使用的語言（法律）。其他條款更為普遍，反映了我們對(duì)法律的解釋。本節(jié)定義了下列術(shù)語：

9、Act means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., as amended.法案意味著聯(lián)邦食品、藥物和化妝品法案，21 U.S.C. 301 et seq.，修訂。Ambulatory surgical facility (ASF) means a distinct entity that operates for the primary purpose of furnishing same day outpatient surgical services to patients. An ASF m

10、ay be either an independent entity (i.e., not a part of a provider of services or any other facility) or operated by another medical entity (e.g., under the common ownership, licensure, or control of an entity). An ASF is subject to this regulation regardless of whether it is licensed by a Federal,

11、State, municipal, or local government or regardless of whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the ASF must report that event regardless of the nature or location of the medical service provided by the ASF.門診手術(shù)設(shè)施（ASF）

12、是一個(gè)獨(dú)立的實(shí)體，用于向患者提供當(dāng)日門診手術(shù)服務(wù)的主要目的。ASF可以是一個(gè)獨(dú)立的實(shí)體（即，不是一個(gè)部分提供服務(wù)或任何其他設(shè)備）或其他醫(yī)療單位操作（例如，共同的所有權(quán)，在執(zhí)照，或一個(gè)實(shí)體控制）。ASF是受這一規(guī)定無論是授權(quán)由聯(lián)邦，州，市，或當(dāng)?shù)卣虿还芩怯梢粋€(gè)公認(rèn)的認(rèn)證機(jī)構(gòu)認(rèn)證。如果一個(gè)不良事件符合報(bào)告標(biāo)準(zhǔn)，ASF必須無論由ASF提供醫(yī)療服務(wù)的性質(zhì)或位置報(bào)告事件。Become aware means that an employee of the entity required to report has acquired information that reasonably sugge

13、sts a reportable adverse event has occurred.覺察意味著要求報(bào)告實(shí)體員工獲得信息的合理建議報(bào)告的不良事件的發(fā)生。(1) If you are a device user facility, you are considered to認(rèn)為 have "become aware（意識(shí)到）" when medical personnel, as defined（定義） in this section（部分）, who are employed by or otherwise formally affiliated with your fa

14、cility, obtain information about a reportable event.如果您是設(shè)備用戶，你被認(rèn)為是有“意識(shí)”當(dāng)醫(yī)務(wù)人員，本節(jié)中定義的，誰是受雇于或正式的附屬設(shè)施，獲得有關(guān)報(bào)告的事件信息。(2) If you are a manufacturer, you are considered to have become aware of an event when any of your employees becomes aware of a reportable event that is required to be reported within 30 ca

15、lendar days or that is required to be reported within 5 work days because we had requested reports in accordance with 803.53(b). You are also considered to have become aware of an event when any of your employees with management or supervisory responsibilities over persons with regulatory, scientifi

16、c, or technical responsibilities, or whose duties relate to the collection and reporting of adverse events, becomes aware, from any information, including any trend analysis, that a reportable MDR event or events necessitates remedial action to prevent an unreasonable risk of substantial harm to the

17、 public health.（制造商發(fā)現(xiàn)疑是不良事件時(shí)，不管是什么渠道，必須在30天內(nèi)匯報(bào)，按照803.53（b）需要5個(gè)工作日內(nèi)的應(yīng)及時(shí)上報(bào)，如果你確定是不良事件的，必須對(duì)收集到的信息進(jìn)行分析，并對(duì)不良事件采取補(bǔ)救措施。）不良事件申報(bào)原則如果你是一個(gè)制造商，你認(rèn)為已經(jīng)意識(shí)到一個(gè)事件時(shí)，你的任何員工知道成為一個(gè)可報(bào)告事件，必須在30天內(nèi)報(bào)告或 需要報(bào)告的5個(gè)工作日內(nèi)，因?yàn)槲覀円蟮膱?bào)告按照803.53（b）。你也被認(rèn)為是一個(gè)事件，當(dāng)你的員工與管理或監(jiān)督責(zé)任的人與監(jiān)管，科學(xué)，或技術(shù)的責(zé)任，或其職責(zé)涉及的不良事件的收集和報(bào)告，意識(shí)到，從任何信息，包括任何趨勢分析，這一報(bào)告的MDR事件需要補(bǔ)救措施

18、防止對(duì)公眾健康的重大損害的不合理的危險(xiǎn)。(3) If you are an importer, you are considered to have become aware of an event when any of your employees becomes aware of a reportable event that is required to be reported by you within 30 days.（進(jìn)口商發(fā)現(xiàn)不良事件，需要在30天內(nèi)匯報(bào)）如果你是一個(gè)進(jìn)口商，你認(rèn)為已經(jīng)意識(shí)到一個(gè)事件時(shí)，你的任何員工知道成為一個(gè)可報(bào)告事件，需要報(bào)告的30天之內(nèi)你。Caused o

19、r contributed means that a death or serious injury was or may have been attributed to a medical device, or that a medical device was or may have been a factor in a death or serious injury, including events occurring as a result of:（造成死亡或嚴(yán)重傷害的，或是由器械（設(shè)備）造成，或可能由器械造成，包括事件發(fā)生的結(jié)果：）造成或造成死亡或嚴(yán)重傷害的原因，或可能已被歸因于醫(yī)

20、療設(shè)備，或醫(yī)療設(shè)備是或可能是一個(gè)因素死亡或嚴(yán)重受傷，包括發(fā)生的結(jié)果：(1) Failure; 失敗(2) Malfunction; 故障(3) Improper or inadequate design; 設(shè)計(jì)缺陷(4) Manufacture; 制造(5) Labeling; or 標(biāo)簽信息錯(cuò)誤(6) User error. 用戶使用錯(cuò)誤什么樣的情況定義為不良事件Device user facility means a hospital, ambulatory surgical facility, nursing home（療養(yǎng)院）, outpatient （用戶可以是醫(yī)院、門診、護(hù)理院）設(shè)

21、備用戶設(shè)施指一家醫(yī)院，門診手術(shù)設(shè)施，護(hù)理院，門診diagnostic facility, or outpatient treatment facility as defined in this section, which is not a physician's office, as defined in this section. School nurse offices and employee health units are not device user facilities.（診斷設(shè)備，或本節(jié)定義的門診設(shè)施，不是指醫(yī)生的辦公室，科研機(jī)構(gòu)和員工的及安康單位不屬于用戶）診斷設(shè)

22、施，或本節(jié)所定義的門診治療設(shè)備，這不是醫(yī)生的辦公室，在本節(jié)中定義的。學(xué)校的護(hù)士辦公室和員工的療養(yǎng)院不是設(shè)備的用戶設(shè)施。Distributor means any person (other than the manufacturer or importer) who furthers the marketing of a device from the original place of manufacture to the person who makes final delivery or sale to the ultimate user, but who does not repack

23、age or otherwise change the container, wrapper, or labeling of the device or device package. If you repackage or otherwise change the container, wrapper, or labeling, you are considered a manufacturer as defined in this section.（分裝者亦屬于生產(chǎn)商）經(jīng)銷商是指任何人（除了制造商或進(jìn)口商）誰能從生產(chǎn)到最終交付的人或銷售給最終用戶的原始位置設(shè)備的營銷，但誰不重新包裝或改變?nèi)?/p>

24、器，包裝或標(biāo)簽的裝置或器件封裝。如果你重新包裝或改變?nèi)萜?，包裝或標(biāo)簽，你是一個(gè)制造商在本節(jié)中定義。Expected life of a device means the time that a device is expected to remain functional after it is placed into use. Certain implanted devices have specified "end of life" (EOL) dates. Other devices are not labeled as to their respective EOL

25、, but are expected to remain operational through activities such as maintenance, repairs, or upgrades, for an estimated period of time.設(shè)備的預(yù)期壽命意味著一個(gè)設(shè)備被放置在使用后將保持功能的時(shí)間。某些植入物指定了“植入期限”（EOL）日期。其他設(shè)備都沒有標(biāo)記為各自的停產(chǎn)，但預(yù)計(jì)將通過活動(dòng)，如維修、修理或升級(jí)保持運(yùn)行，為估計(jì)時(shí)間。FDA, we, or us means the Food and Drug Administration.Five-day repor

26、t means a medical device report that must be submitted by a manufacturer to us under 803.53, on FDA Form 3500A or an electronic equivalent approved under 803.14, within 5 work days.五天的報(bào)告意味著醫(yī)療設(shè)備報(bào)告，必須提交由制造商，我們在，在FDA或批準(zhǔn)在803.14電子版，5個(gè)工作日內(nèi)。（制造商在發(fā)現(xiàn)設(shè)備的設(shè)計(jì)缺陷應(yīng)在5個(gè)工作日內(nèi)按照FDA803.53規(guī)定按照表3500A或者在803.14批準(zhǔn)的電子版格式申報(bào)）制造商

27、在發(fā)現(xiàn)設(shè)計(jì)缺陷申報(bào)期限Hospital means a distinct entity that operates for the primary purpose of providing diagnostic, therapeutic (such as medical, occupational, speech, physical), surgical, and other patient services for specific and general medical conditions. Hospitals include general, chronic disease, reha

28、bilitative, psychiatric, and other special-purpose facilities. A hospital may be either independent (e.g., not a part of a provider of services or any other facility) or may be operated by another medical entity (e.g., under the common ownership, licensure, or control of another entity). A hospital

29、is covered by this regulation regardless of whether it is licensed by a Federal, State, municipal or local government or whether it is accredited by a recognized accreditation organization.（ If an adverse event meets the criteria for reporting, the hospital must report that event regardless of the n

30、ature or location of the medical service provided by the hospital.如果不良事件符合報(bào)告標(biāo)準(zhǔn)，醫(yī)院必須報(bào)告該事件，不管醫(yī)療機(jī)構(gòu)提供的醫(yī)療服務(wù)的性質(zhì)或位置。）Human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device means an HCT/P as defined in 1271.3(d) of this chapter that does not meet the criteria in 1271.10(a) and

31、 that is also regulated as a device.（生物制品也屬于醫(yī)療器械）Importer means any person who imports a device into the United States and who furthers the marketing of a device from the original place of manufacture to the person who makes final delivery or sale to the ultimate user, but who does not repackage or

32、otherwise change the container, wrapper, or labeling of the device or device package. If you repackage or otherwise change the container, wrapper, or labeling, you are considered a manufacturer as defined in this section.任何進(jìn)口商在進(jìn)口產(chǎn)品在交付使用時(shí)，必須保證是原始設(shè)備，任何重新包裝或分裝的，也是按照制造商管理Malfunction means the failure of

33、 a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. The intended performance of a device refers to the intended use for which the device is labeled or marketed, as defined in 801.4 of th

34、is chapter.故障是指設(shè)備的故障，以滿足其性能規(guī)格或以其他方式執(zhí)行。性能規(guī)格包括所有的索賠，在標(biāo)簽的設(shè)備。設(shè)備的預(yù)期性能是指在本章801.4中所定義的用于該設(shè)備被標(biāo)記或銷售的用途。Manufacturer means any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure. The term includes any person who eith

35、er:制造商指任何制造、準(zhǔn)備、傳播、化合物、組裝或處理某設(shè)備的化學(xué)、物理、生物或其他過程的人。這個(gè)詞包括任何一個(gè)人：(1) Repackages or otherwise changes the container, wrapper, or labeling of a device in furtherance of the distribution of the device from the original place of manufacture;重新包裝或改裝的產(chǎn)品應(yīng)在標(biāo)簽上注明原廠(2) Initiates specifications for devices that are m

36、anufactured by a second party for subsequent distribution by the person initiating the specifications;（因?yàn)橹匦掳b后，包裝規(guī)格（劑量？）發(fā)生變化）為隨后由該規(guī)范的人發(fā)起的后續(xù)發(fā)行裝置所制造的設(shè)備的規(guī)格；？(3) Manufactures components or accessories that are devices that are ready to be used and are intended to be commercially distributed and intended

37、 to be used as is, or are processed by a licensed practitioner or other qualified person to meet the needs of a particular patient; or（生產(chǎn)商制造的零件或配件，是是耗材，或是定制的由醫(yī)護(hù)人員使用的設(shè)備或滿足特定的患者？）制造設(shè)備或附件，是準(zhǔn)備使用的設(shè)備，并打算是商業(yè)分布，并打算使用，或由執(zhí)業(yè)或其他合格的人處理，以滿足特定病人的需要；或？(4) Is the U.S. agent of a foreign manufacturer.是美國代理的外國制造商Manuf

38、acturer or importer report number. Manufacturer or importer report number means the number that uniquely identifies each individual adverse event report submitted by a manufacturer or importer. This number consists of the following three parts:制造商或進(jìn)口商報(bào)告號(hào)碼不良事件報(bào)告的編號(hào)。制造商或進(jìn)口商報(bào)告號(hào)碼是指制造商或進(jìn)口商提交的每一個(gè)單獨(dú)的不良事件報(bào)告

39、的數(shù)量。此號(hào)碼由以下三部分組成：(1) The FDA registration number for the manufacturing site of the reported device, or the registration number for the importer. If the manufacturing site or the importer does not have an establishment registration number, we will assign a temporary MDR reporting number until the site

40、 is registered in accordance with part 807 of this chapter. We will inform the manufacturer or importer of the temporary MDR reporting number;美國食品藥品管理局注冊號(hào)為該設(shè)備的制造地點(diǎn)，或進(jìn)口商的注冊號(hào)碼。如果制造現(xiàn)場或進(jìn)口商沒有設(shè)立登記號(hào)碼，我們將分配一個(gè)臨時(shí)的MDR報(bào)告數(shù)直至網(wǎng)站與本章807部分按照注冊。我們將通知制造商或進(jìn)口商臨時(shí)MDR報(bào)告數(shù)；申報(bào)的注冊碼，注冊碼的解釋(2) The four-digit calendar year in whic

41、h the report is submitted; and提交報(bào)告的四位數(shù)字日歷年；及(3) The five-digit sequence number of the reports submitted during the year, starting with 00001. (For example, the complete number will appear as follows: 1234567-1995-00001.)年提交的報(bào)告的五位序列號(hào)，從00001開始。（例如，完整的號(hào)碼將顯示如下：1234567-1995-00001。）報(bào)告編號(hào)方式MDR means medical

42、 device report.MDR是指醫(yī)療器械報(bào)告。MDR reportable event (or reportable event) means:MDR報(bào)告的事件（或可報(bào)告事件）的手段：(1) An event that user facilities become aware of that reasonably suggests that a device has or may have caused or contributed to a death or serious injury; or（用戶意識(shí)到器械已經(jīng)或可能造成導(dǎo)致死亡或嚴(yán)重傷害）一個(gè)事件，用戶設(shè)施的意識(shí)，合理地表明，一

43、個(gè)設(shè)備已經(jīng)或可能造成或?qū)е滤劳龌驀?yán)重傷害；或(2) An event that manufacturers or importers become aware of that reasonably suggests that one of their marketed devices:（制造商意思到設(shè)備需要合理改進(jìn)）一個(gè)事件，制造商或進(jìn)口商意識(shí)到，合理的建議，他們的一個(gè)銷售設(shè)備：(i) May have caused or contributed to a death or serious injury, or可能造成或?qū)е滤劳龌驀?yán)重傷害，或(ii) Has malfunctioned and

44、 that the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.（設(shè)備再次發(fā)生故障，制造商發(fā)現(xiàn)可能導(dǎo)致死亡或嚴(yán)重傷害。應(yīng)當(dāng)定義為不良事件）發(fā)生故障，裝置或類似裝置銷售由制造商或進(jìn)口商將可能引起或?qū)е滤劳龌驀?yán)重傷害，如果故障再次發(fā)生。報(bào)告手段（醫(yī)療單位匯報(bào)流程）Medical personnel means

45、 an individual who:醫(yī)務(wù)人員指個(gè)人（發(fā)現(xiàn)（不良事件的）醫(yī)務(wù)人員）(1) Is licensed, registered, or certified by a State, territory, or other governing body, to administer health care;具有國家、地區(qū)或其他管理機(jī)構(gòu)的許可、注冊、認(rèn)證，以管理醫(yī)療；（該人員所屬單位，（發(fā)生不良事件的醫(yī)療機(jī)構(gòu)）(2) Has received a diploma or a degree in a professional or scientific discipline;在專業(yè)或科學(xué)學(xué)科的

46、學(xué)位或?qū)W位；（發(fā)現(xiàn)的人對(duì)該產(chǎn)品的專業(yè)程度）(3) Is an employee responsible for receiving medical complaints or adverse event reports; or負(fù)責(zé)接受醫(yī)療投訴或不良事件報(bào)告的員工；或（指單位負(fù)責(zé)人）(4) Is a supervisor of these persons.是這些人的主管Nursing home means:護(hù)理機(jī)構(gòu)(1) An independent entity (i.e., not a part of a provider of services or any other facility)

47、 or one operated by another medical entity (e.g., under the common ownership, licensure, or control of an entity) that operates for the primary purpose of providing:一個(gè)獨(dú)立的實(shí)體（即，不是一個(gè)部分提供服務(wù)或任何其他設(shè)備）或一個(gè)由另一個(gè)醫(yī)療單位（例如，共同的所有權(quán)，在執(zhí)照，或一個(gè)實(shí)體控制），經(jīng)營為主要目的：(i) Skilled nursing care and related services for persons who re

48、quire medical or nursing care;(ii) Hospice care to the terminally ill; or(iii) Services for the rehabilitation of the injured, disabled, or sick.（一）對(duì)需要醫(yī)療或護(hù)理的人提供熟練的護(hù)理及相關(guān)服務(wù)；（二）臨終關(guān)懷的臨終關(guān)懷；或（三）為受傷、傷殘或生病的康復(fù)服務(wù)。(2) A nursing home is subject to this regulation regardless of whether it is licensed by a Federa

49、l, State, municipal, or local government or whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the nursing home must report that event regardless of the nature or location of the medical service provided by the nursing home.無論是聯(lián)

50、邦政府、州政府、市政府、地方政府，還是認(rèn)可認(rèn)證機(jī)構(gòu)的認(rèn)證，都要受此規(guī)定的監(jiān)管。如果一個(gè)不良事件符合報(bào)告標(biāo)準(zhǔn)，該護(hù)理之家必須報(bào)告該事件，不論其提供的醫(yī)療服務(wù)的性質(zhì)或位置。（無論機(jī)構(gòu)大小，均需要申報(bào)）Outpatient diagnostic facility. (1) Outpatient diagnostic facility means a distinct entity that:門診診斷設(shè)備。（1）門診診斷設(shè)施指的是一個(gè)不同的實(shí)體：(i) Operates for the primary purpose of conducting medical diagnostic tests on

51、patients,(ii) Does not assume ongoing responsibility for patient care, and(iii) Provides its services for use by other medical personnel.（一）經(jīng)營醫(yī)療診斷測試的主要目的是對(duì)病人進(jìn)行診斷，（二）不承擔(dān)對(duì)病人護(hù)理的持續(xù)責(zé)任，以及（三）提供其他醫(yī)務(wù)人員使用的服務(wù)。(2) Outpatient diagnostic facilities include outpatient facilities providing radiography, mammography,

52、 ultrasonography, electrocardiography, magnetic resonance imaging, computerized axial tomography, and in vitro testing. An outpatient diagnostic facility may be either independent (i.e., not a part of a provider of services or any other facility) or operated by another medical entity (e.g., under th

53、e common ownership, licensure, or control of an entity). An outpatient diagnostic facility is covered by this regulation regardless of whether it is licensed by a Federal, State, municipal, or local government or whether it is accredited by a recognized accreditation organization. If an adverse even

54、t meets the criteria for reporting, the outpatient diagnostic facility must report that event regardless of the nature or location of the medical service provided by the outpatient diagnostic facility.門診診斷設(shè)施包括門診設(shè)施提供照相、攝影、超聲、心電圖、磁共振成像、計(jì)算機(jī)斷層掃描，并在體外測試。門診診斷設(shè)備可以是獨(dú)立的（即不是一個(gè)部分提供服務(wù)或任何其他設(shè)備）或其他醫(yī)療單位操作（例如，共同的所有權(quán)

55、，在執(zhí)照，或一個(gè)實(shí)體控制）。本規(guī)例所涵蓋的門診診斷設(shè)備，不論其是否由聯(lián)邦、州、市、或地方政府授權(quán)，或是否由認(rèn)可認(rèn)可機(jī)構(gòu)認(rèn)可。如果一個(gè)不良事件符合標(biāo)準(zhǔn)報(bào)告，門診診斷設(shè)施必須報(bào)告，事件的性質(zhì)或位置的醫(yī)療服務(wù)提供的門診診斷設(shè)施。Outpatient treatment facility means a distinct entity that operates for the primary purpose of providing nonsurgical therapeutic (medical, occupational, or physical) care on an outpatient b

56、asis or in a home health care setting. Outpatient treatment facilities include ambulance providers, rescue services, and home health care groups. Examples of services provided by outpatient treatment facilities include the following: Cardiac defibrillation, chemotherapy, radiotherapy, pain control,

57、dialysis, speech or physical therapy, and treatment for substance abuse. An outpatient treatment facility may be either independent (i.e., not a part of a provider of services or any other facility) or operated by another medical entity (e.g., under the common ownership, licensure, or control of an

58、entity). An outpatient treatment facility is covered by this regulation regardless of whether it is licensed by a Federal, State, municipal, or local government or whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the outpatien

59、t treatment facility must report that event regardless of the nature or location of the medical service provided by the outpatient treatment facility.門診治療設(shè)備是一個(gè)獨(dú)立的實(shí)體，用于提供非手術(shù)治療的主要目的（醫(yī)療、職業(yè)、或物理）護(hù)理門診的基礎(chǔ)上，或在家庭健康護(hù)理的環(huán)境。門診治療設(shè)施包括救護(hù)車服務(wù)提供者、救援服務(wù)和家庭醫(yī)療保健組。通過門診處理設(shè)施提供服務(wù)的例子包括：心臟除顫、化療、放射治療、疼痛控制、透析、演講或物理治療，和藥物濫用的治療。門診治療設(shè)備可以是獨(dú)立的（即不是一個(gè)部分提供服務(wù)或任何其他設(shè)備）或其他醫(yī)療單位操作（例如，共同的所有權(quán)，在執(zhí)照，或一個(gè)實(shí)體控制）。一個(gè)門診治療設(shè)施，無論是由聯(lián)邦，州，市，或當(dāng)?shù)卣蚴欠袼?/p>