Information destinée aux établissements de santé                           Cette action de sécurité est enregistrée à l’ANSM sous le n° R2327421. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité.L'ANSM a été informée de la mise en œuvre d’un retrait de lots effectué par la société BD.Les utilisateurs concernés ont reçu le courrier ci-joint.                                    Téléchargez le courrier de la société BD (30/11/2023)                                             Téléchargez le courrier de la société BD (30/11/2023)

Information for healthcare establishments This safety action is registered with the ANSM under the number R2327421. If you have any questions, please contact the issuer of the security action directly. The ANSM has been informed of the implementation of a batch withdrawal carried out by the company BD. Affected users have received the attached letter.                                    Download the letter from the BD company (30/11/2023) Download the letter from the BD company (30/11/2023)

Information destinée aux établissements de santé

Set de biopsie – Bard Mission Disposable Core Biopsy Kit – BD

Set de biopsye – Bard Mission 一次性核心活检套件 – BD

Cette action de sécurité est enregistrée à l`ANSM sous le n° R2327421. Pour toute question, merci de vous adresser directement à l`émetteur de l`action de sécurité.L`ANSM a été informée de la mise en œuvre d`un retrait de lots effectué par la société BD.Les utilisateurs concernés ont reçu le courrier ci-joint.

Téléchargez le courrier de la société BD (30/11/2023)

This security action is registered with the l`ANSM under No. R2327421. If you have any questions, please contact the `issuer of the security action directly. The `ANSM has been informed of the implementation of `a batch withdrawal carried out by the BD company. Affected users have received the attached letter.

Download the letter from the BD company (30/11/2023)

该安全行动在法国国家药品和保健品安全检测局第 R2327421 号下注册。如有任何疑问,请直接与安全行动的发行人联系。法国国家药品和保健品安全检测局已获悉BD实施了批量撤回。受影响的用户已收到随附的信件。

下载碧迪医疗公司的来信 (30/11/2023)

Information destinée aux pharmacies d'usage intérieur                           Cette action de sécurité est enregistrée à l’ANSM sous le n° R2326619. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité.L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Olympus.Les utilisateurs concernés ont reçu le courrier ci-joint.                                    Téléchargez le courrier de la société Olympus (30/11/2023)                                             Téléchargez le courrier de la société Olympus (30/11/2023)

Information for pharmacies for indoor use This security action is registered with the ANSM under the number R2326619. If you have any questions, please contact the issuer of the security action directly. The ANSM has been informed of the implementation of a security action carried out by the company Olympus.The users concerned have received the attached letter.                                    Download the Olympus Company Letter (30/11/2023) Download the Olympus Company Letter (30/11/2023)

Information destinée aux pharmacies d'usage intérieur

Video laparoscope Endoeye HD II – Olympus

视频腹腔镜 Endoeye HD II – Olympus

Information destinée aux pharmacies d`usage intérieur

Cette action de sécurité est enregistrée à l`ANSM sous le n° R2326619. Pour toute question, merci de vous adresser directement à l`émetteur de l`action de sécurité.L`ANSM a été informée de la mise en œuvre d`une action de sécurité effectuée par la société Olympus.Les utilisateurs concernés ont reçu le courrier ci-joint.

Téléchargez le courrier de la société Olympus (30/11/2023)

Information for Pharmacies for Indoor `Use

This security action is registered with the `ANSM under No. R2326619. If you have any questions, please contact the `issuer of the security action directly. L`ANSM has been informed of the implementation of `a security action carried out by the company Olympus.The users concerned have received the attached letter.

Download the letter from the Olympus company (30/11/2023)

此安全操作在 法国国家药品和保健品安全检测局 的编号 R2326619 下注册。如有任何疑问,请直接与安全行动的发行人联系。法国国家药品和保健品安全检测局已获悉奥林巴斯公司实施的安全行动的实施情况,受影响的用户已收到所附信件。

下载奥林巴斯公司的来信 (30/11/2023)

Information destinée aux pharmacies d'usage intérieur                           Cette action de sécurité est enregistrée à l’ANSM sous le n° R2324772/R2324432. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité.L'ANSM a été informée de la mise en œuvre d’une action effectuée par la société BD Switzerland Sàrl.Les utilisateurs concernés ont reçu le courrier ci-joint.                                    Téléchargez le courrier de la société BD Switzerland Sàrl (30/11/2023)                                             Téléchargez le courrier de la société BD Switzerland Sàrl (30/11/2023)

Information for pharmacies for indoor use This security action is registered with the ANSM under the number R2324772/R2324432. If you have any questions, please contact the issuer of the security action directly. The ANSM has been informed of the implementation of an action carried out by the company BD Switzerland Sàrl.The users concerned have received the attached letter.                                    Download the letter from BD Switzerland Sàrl (30/11/2023) Download the letter from BD Switzerland Sàrl (30/11/2023)

Pompe à perfusion – BD Alaris Pump Sets and Extension infusion sets – BD Switzerland

Pompe à 灌注 – BD Alaris 泵组和扩展输液器 – BD 瑞士

Cette action de sécurité est enregistrée à l`ANSM sous le n° R2324772/R2324432. Pour toute question, merci de vous adresser directement à l`émetteur de l`action de sécurité.L`ANSM a été informée de la mise en œuvre d`une action effectuée par la société BD Switzerland Sàrl.Les utilisateurs concernés ont reçu le courrier ci-joint.

Téléchargez le courrier de la société BD Switzerland Sàrl (30/11/2023)

This security action is registered with the l`ANSM under No. R2324772/R2324432. If you have any questions, please contact the `issuer of the security action directly. The `ANSM has been informed of the implementation of an action ` carried out by the company BD Switzerland Sàrl.The users concerned have received the attached letter.

Download the letter from BD Switzerland Sàrl (30/11/2023)

此安全行动在法国国家药品和保健品安全检测局注册,编号为 R2324772/R2324432。如有任何疑问,请直接与安全行动的发行人联系。法国国家药品和保健品安全检测局已获悉BD瑞士Sàrl公司所采取的行动的实施情况,受影响的用户已收到所附信件。

下载 碧迪医疗 Switzerland Sàrl 的来信(2023 年 11 月 30 日)

Information destinée aux établissements de santé                           Cette action de sécurité est enregistrée à l’ANSM sous le n° R2327407. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité.L'ANSM a été informée de la mise en œuvre d’un retrait de lot effectué par la société Cair LGL.Les utilisateurs concernés ont reçu le courrier ci-joint.                                    Téléchargez le courrier de la société Cair LGL (30/11/2023)                                             Téléchargez le courrier de la société Cair LGL (30/11/2023)

Information for healthcare establishments This safety action is registered with the ANSM under the number R2327407. If you have any questions, please contact the issuer of the security action directly. The ANSM has been informed of the implementation of a batch withdrawal carried out by the company Cair LGL. Affected users have received the attached letter.                                    Download the Cair LGL Company Letter (30/11/2023) Download the Cair LGL Company Letter (30/11/2023)

Raccords ambrés pour préparation de chimiothérapie – Chemocair - Amber-colored male luer lock – Cair LGL

Amber Fittings for Chemotherapy Preparation – Chemocair - Amber-colored male luer lock – Cair LGL

用于化疗准备的琥珀色配件 – Chemocair - 琥珀色公鲁尔锁 – Cair LGL

Cette action de sécurité est enregistrée à l`ANSM sous le n° R2327407. Pour toute question, merci de vous adresser directement à l`émetteur de l`action de sécurité.L`ANSM a été informée de la mise en œuvre d`un retrait de lot effectué par la société Cair LGL.Les utilisateurs concernés ont reçu le courrier ci-joint.

Téléchargez le courrier de la société Cair LGL (30/11/2023)

This security action is registered with the l`ANSM under No. R2327407. If you have any questions, please contact the `issuer of the security action directly. L`ANSM has been informed of the implementation of `a batch withdrawal carried out by the company Cair LGL. Affected users have received the attached letter.

Download the letter from Cair LGL (30/11/2023)

此安全操作在法国国家药品和保健品安全检测局第 R2327407 号下注册。如有任何疑问,请直接与安全行动的发行人联系。法国国家药品和保健品安全检测局获悉Cair LGL实施了批次召回。受影响的用户已收到随附的信件。

下载 Cair LGL 的来信(2023 年 11 月 30 日)

Information destinée aux patients, professionnels de santé et aux prestataires de santé à domicile                           Cette action de sécurité est enregistrée à l’ANSM sous le n° R2326180L'ANSM a été informée par la société Medtronic de la mise en œuvre d’une action de sécurité concernant des capteurs de glucose Guardian 4, pouvant être utilisés dans un système en boucle fermée hybride avec la pompe à insuline Minimed 780G.En raison d’un défaut de test lors de procédures de production, certains lots de capteurs Guardian 4 pourraient transmettre à la pompe des mesures de glucose incorrectes. Ce problème est susceptible de causer des administrations d’insuline inadaptées lorsque les capteurs sont utilisés en boucle fermée hybride (provoquant des hyperglycémies ou des hypoglycémies).Les capteurs Guardian 4 des lots concernés ne doivent plus être utilisés et font l’objet d’un rappel. En France, ce sont les lots F1923, G0323, G1723, G2023, HG6Z7N5, HG7038Y, HG70JSU, HG75TSX, HG75XA1 et HG76RYY. Les patients doivent demander à leur prestataire de santé le remplacement des capteurs des lots impactés et ne plus les utiliser. Medtronic a transmis un courrier avec la marche à suivre aux prestataires de santé à domicile, ainsi qu’un courrier à transmettre aux patients concernés. Les professionnels de santé ont également reçu un courrier d’information.Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité.                                    Courrier d’information de Medtronic pour les professionnels de santé (29/11/2023)                                             Courrier d’information de Medtronic pour les professionnels de santé (29/11/2023)                                             Courrier d’information de Medtronic pour les patients (29/11/2023)                                             Courrier d’information de Medtronic pour les patients (29/11/2023)                                             Courrier d’information de Medtronic pour les prestataires de santé à domicile (29/11/2023)                                             Courrier d’information de Medtronic pour les prestataires de santé à domicile (29/11/2023)                                             Formulaire de Medtronic pour les professionnels de santé et prestataires de santé (29/11/2023)                                             Formulaire de Medtronic pour les professionnels de santé et prestataires de santé (29/11/2023)

Information for Patients, Healthcare Professionals and Home Health Care Providers This safety action is registered with the ANSM under the number R2326180L ANSM has been informed by Medtronic of the implementation of a safety action concerning Guardian 4 glucose sensors, which can be used in a hybrid closed-loop system with the Minimed 780G insulin pump. Due to a test failure during production procedures, some batches of Guardian 4 sensors could transmit incorrect glucose readings to the pump. This problem is likely to cause inappropriate insulin delivery when sensors are used in a hybrid closed-loop (causing hyperglycemia or hypoglycemia). The Guardian 4 sensors in the affected lots should no longer be used and are being recalled. In France, these are lots F1923, G0323, G1723, G2023, HG6Z7N5, HG7038Y, HG70JSU, HG75TSX, HG75XA1 and HG76RYY. Patients should ask their healthcare provider to replace the sensors in the affected batches and stop using them. Medtronic sent a letter with instructions to home health care providers, as well as a letter to be sent to affected patients. Healthcare professionals have also received an information letter. If you have any questions, please contact the issuer of the security action directly.                                    Medtronic Newsletter for Healthcare Professionals (11/29/2023) Medtronic Newsletter for Healthcare Professionals (11/29/2023) Medtronic Patient Information Letter (11/29/2023) Medtronic Patient Information Letter (11/29/2023) Information Letter from Medtronic for Home Health Care Providers (11/29/2023) Medtronic Information Letter for Home Health Providers (11/29/2023) Medtronic Form for Healthcare Professionals and Healthcare Providers (11/29/2023) Medtronic Form for Healthcare Professionals and Healthcare Providers (11/29/2023)

Information destinée aux patients, professionnels de santé et aux prestataires de santé à domicile

Information for Patients, Healthcare Professionals and Home Health Care Providers

面向患者、医疗保健专业人员和家庭医疗保健提供者的信息

Appareils de mesure du glucose en continu – Guardian 4 Sensor – Medtronic Minimed

Continuous Glucose Monitors – Guardian 4 Sensor – Medtronic Minimed

连续血糖监测仪 – Guardian 4 传感器 – Medtronic Minimed

Cette action de sécurité est enregistrée à l`ANSM sous le n° R2326180L`ANSM a été informée par la société Medtronic de la mise en œuvre d`une action de sécurité concernant des capteurs de glucose Guardian 4, pouvant être utilisés dans un système en boucle fermée hybride avec la pompe à insuline Minimed 780G.En raison d`un défaut de test lors de procédures de production, certains lots de capteurs Guardian 4 pourraient transmettre à la pompe des mesures de glucose incorrectes. Ce problème est susceptible de causer des administrations d`insuline inadaptées lorsque les capteurs sont utilisés en boucle fermée hybride (provoquant des hyperglycémies ou des hypoglycémies).Les capteurs Guardian 4 des lots concernés ne doivent plus être utilisés et font l`objet d`un rappel. En France, ce sont les lots F1923, G0323, G1723, G2023, HG6Z7N5, HG7038Y, HG70JSU, HG75TSX, HG75XA1 et HG76RYY. Les patients doivent demander à leur prestataire de santé le remplacement des capteurs des lots impactés et ne plus les utiliser. Medtronic a transmis un courrier avec la marche à suivre aux prestataires de santé à domicile, ainsi qu`un courrier à transmettre aux patients concernés. Les professionnels de santé ont également reçu un courrier d`information.Pour toute question, merci de vous adresser directement à l`émetteur de l`action de sécurité.

Courrier d`information de Medtronic pour les professionnels de santé (29/11/2023)

Courrier d`information de Medtronic pour les patients (29/11/2023)

Courrier d`information de Medtronic pour les prestataires de santé à domicile (29/11/2023)

Formulaire de Medtronic pour les professionnels de santé et prestataires de santé (29/11/2023)

This safety action is registered with the `ANSM under the number R2326180L`ANSM has been informed by Medtronic of the implementation of `a safety action concerning Guardian 4 glucose sensors, which can be used in a hybrid closed-loop system with the Minimed 780G insulin pump. Due to`a test defect during production procedures, some batches of Guardian 4 sensors may transmit incorrect glucose readings to the pump. This problem is likely to cause inappropriate insulin delivery when sensors are used in a hybrid closed loop (causing hyperglycaemia or hypoglycemia). The Guardian 4 sensors in the affected lots should no longer be used and are subject to``a recall. In France, these are lots F1923, G0323, G1723, G2023, HG6Z7N5, HG7038Y, HG70JSU, HG75TSX, HG75XA1 and HG76RYY. Patients should ask their healthcare provider to replace the sensors in the affected batches and stop using them. Medtronic has sent a letter with instructions to home health care providers, as well as` a letter to be forwarded to affected patients. Health professionals also received an information letter`. If you have any questions, please contact the `issuer of the security action directly.

Medtronic Newsletter`Information for Healthcare Professionals (29/11/2023)

Medtronic Patient Newsletter`Information (11/29/2023)

Medtronic Newsletter`Information for Home Health Providers (11/29/2023)

Medtronic Formulary for Healthcare Professionals and Healthcare Providers (11/29/2023)

该安全措施已在法国国家药品和保健品安全检测局注册,R2326180L号法国国家药品和保健品安全检测局已获美敦力告知实施了有关 Guardian 4 葡萄糖传感器的安全措施,该传感器可用于带有 Minimed 780G 胰岛素泵的混合闭环系统。由于生产过程中的测试失败,某些批次的 Guardian 4 传感器可能会将不正确的葡萄糖读数传输到泵。当传感器在混合闭环中使用时,这个问题可能会导致胰岛素输送不适当(导致高血糖或低血糖)。受影响批次中的 Guardian 4 传感器不应再使用,并且正在召回。在法国,这些是拍品 F1923、G0323、G1723、G2023、HG6Z7N5、HG7038Y、HG70JSU、HG75TSX、HG75XA1 和 HG76RYY。患者应要求其医疗保健提供者更换受影响批次的传感器并停止使用它们。美敦力向家庭医疗保健提供者发送了一封信,其中包含指示,以及一封发送给受影响患者的信。医护人员也收到了一封信息信。如有任何疑问,请直接与安全行动的发行人联系。

美敦力医疗保健专业人员通讯(2023 年 11 月 29 日)

美敦力患者信息信(2023 年 11 月 29 日)

美敦力家庭健康提供者信息信 (11/29/2023)

美敦力医疗保健专业人员和医疗保健提供者处方集 (11/29/2023)

Information destinée aux pharmacies d'usage intérieur                           Cette action de sécurité est enregistrée à l’ANSM sous le n° R2322654. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité.L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Olympus Medical Systems Corp.Les utilisateurs concernés ont reçu le courrier ci-joint.                                    Téléchargez le courrier de la société Olympus Medical Systems Corp (29/11/2023)                                             Téléchargez le courrier de la société Olympus Medical Systems Corp (29/11/2023)

Information for pharmacies for indoor use This security action is registered with the ANSM under the number R2322654. If you have any questions, please contact the issuer of the security action directly. The ANSM has been informed of the implementation of a security action carried out by the company Olympus Medical Systems Corp. The users concerned have received the attached letter.                                    Download the letter from Olympus Medical Systems Corp (29/11/2023) Download the letter from Olympus Medical Systems Corp (29/11/2023)

Insufflateur – UHI-4 – Olympus

吹气机 – UHI-4 – Olympus

Cette action de sécurité est enregistrée à l`ANSM sous le n° R2322654. Pour toute question, merci de vous adresser directement à l`émetteur de l`action de sécurité.L`ANSM a été informée de la mise en œuvre d`une action de sécurité effectuée par la société Olympus Medical Systems Corp.Les utilisateurs concernés ont reçu le courrier ci-joint.

Téléchargez le courrier de la société Olympus Medical Systems Corp (29/11/2023)

This security action is registered with the `ANSM under No. R2322654. If you have any questions, please contact the `issuer of the security action directly. The `ANSM has been informed of the implementation of `a security action carried out by the company Olympus Medical Systems Corp. The users concerned have received the attached letter.

Download the letter from Olympus Medical Systems Corp (29/11/2023)

此安全操作在法国国家药品和保健品安全检测局的编号R2322654下注册。如有任何疑问,请直接与安全行动的发行人联系。法国国家药品和保健品安全检测局已获悉奥林巴斯医疗系统公司实施了安全行动,受影响的用户已收到所附信件。

下载奥林巴斯医疗系统公司的来信(2023 年 11 月 29 日)

Information destinée aux établissements de santé                           Cette action de sécurité est enregistrée à l’ANSM sous le n° R2325103. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité.L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Olympus Medical Systems Corp.Les étapes de séchage décrites dans l'addendum doivent également être effectuées après la désinfection et le rinçage final de ce modèle d'endoscope. Ainsi, toutes les méthodes de retraitement compatibles avec ce dispositif sont concernées par cette modification.Les utilisateurs concernés ont reçu le courrier ci-joint.                                    Téléchargez le courrier de la société Olympus Medical Systems Corp. (29/11/2023)                                             Téléchargez le courrier de la société Olympus Medical Systems Corp. (29/11/2023)

Information for health establishments This safety action is registered with the ANSM under the number R2325103. If you have any questions, please contact the issuer of the security action directly. The ANSM has been informed of the implementation of a safety action carried out by the company Olympus Medical Systems Corp.The drying steps described in the addendum must also be carried out after the disinfection and final rinsing of this endoscope model. Thus, all reprocessing methods compatible with this device are affected by this change. Affected users have received the attached letter.                                    Download Olympus Medical Systems Corp. Company Letter (11/29/2023) Download Olympus Medical Systems Corp. Company Letter (11/29/2023)

Vidéoscope gastro-intestinal Evis Exera III – GIF-1TH190 – Olympus Medical Systems Corp.

Evis Exera III胃肠道视频内窥镜 – GIF-1TH190 – Olympus Medical Systems Corp.

Cette action de sécurité est enregistrée à l`ANSM sous le n° R2325103. Pour toute question, merci de vous adresser directement à l`émetteur de l`action de sécurité.L`ANSM a été informée de la mise en œuvre d`une action de sécurité effectuée par la société Olympus Medical Systems Corp.Les étapes de séchage décrites dans l`addendum doivent également être effectuées après la désinfection et le rinçage final de ce modèle d`endoscope. Ainsi, toutes les méthodes de retraitement compatibles avec ce dispositif sont concernées par cette modification.Les utilisateurs concernés ont reçu le courrier ci-joint.

Téléchargez le courrier de la société Olympus Medical Systems Corp. (29/11/2023)

This security action is registered with the l`ANSM under No. R2325103. If you have any questions, please contact the `issuer of the security action directly. The `ANSM has been informed of the implementation of `a safety action carried out by Olympus Medical Systems Corp.The drying steps described in the `addendum must also be carried out after the disinfection and final rinsing of this model of `endoscope. Thus, all reprocessing methods compatible with this device are affected by this change. Affected users have received the attached letter.

Download the letter from Olympus Medical Systems Corp. (29/11/2023)

此安全操作在 法国国家药品和保健品安全检测局 的编号下注册,编号为 R2325103。如有任何疑问,请直接与安全行动的发行人联系。法国国家药品和保健品安全检测局已获悉奥林巴斯医疗系统公司实施了安全行动,附录中描述的干燥步骤也应在对该内窥镜型号进行消毒和最终冲洗后进行。因此,与此设备兼容的所有再处理方法都会受到此更改的影响。受影响的用户已收到随附的信件。

Date Issued: November 28, 2023 The U.S. Food and Drug Administration (FDA) is warning patients and health care providers to carefully monitor Philips DreamStation 2 continuous positive airway pressure (CPAP) machines for signs of overheating. The FDA recently received medical device reports (MDRs) associated with thermal issues such as fire, smoke, burns, and other signs of overheating while people are using Philips DreamStation 2 CPAP machines. The agency observed a recent increase in reports about these thermal issues with DreamStation 2 CPAP machines. Between August 1, 2023, and November 15, 2023, the FDA received more than 270 reports of problems associated with the device, compared with fewer than 30 MDRs received in the previous three years. Consumers should be aware some DreamStation 2 CPAP machines were distributed as replacements for recalled DreamStation 1 CPAP machines. Based on the currently available evidence, the agency does not believe the safety issue with the DreamStation 2 is related to the foam used in the machine. This is a developing situation, and to date, reports gathered and analyzed by the FDA indicate that the thermal issues reported for the DreamStation 2 CPAP machines may be related to an electrical or a mechanical malfunction of the machine, which may cause it to overheat in certain situations. Recommendations for Patients, Caregivers, and Health Care Providers Follow the manufacturer’s instructions in the user manual , including: place the CPAP machine on a firm, flat surface keep the CPAP away from carpet, fabric, or other flammable materials carefully clean the CPAP machine empty the CPAP machine’s water reservoir let the CPAP machine’s heater plate and water tank cool for approximately 15 minutes before removing the tank to reduce the risk of burns. You could be burned if you touch the heater plate, come in contact with the heated water, or touch the humidifier water tank pan. place the CPAP machine on a firm, flat surface keep the CPAP away from carpet, fabric, or other flammable materials carefully clean the CPAP machine empty the CPAP machine’s water reservoir let the CPAP machine’s heater plate and water tank cool for approximately 15 minutes before removing the tank to reduce the risk of burns. You could be burned if you touch the heater plate, come in contact with the heated water, or touch the humidifier water tank pan. Inspect and examine the CPAP machine before and after each use for unusual smells or changes in its appearance. Some problems may only be noticeable when the machine is running, so pay attention to any differences in the CPAP machine as you prepare for bed, before you fall asleep. Unplug the CPAP machine and do not use it if: you smell burning, smoke, or any unusual odors, there is a change in the appearance of the CPAP machine, there are unexplained changes to the CPAP machine’s performance, water is spilled into the CPAP machine, you hear unusual sounds coming from the CPAP machine. you smell burning, smoke, or any unusual odors, there is a change in the appearance of the CPAP machine, there are unexplained changes to the CPAP machine’s performance, water is spilled into the CPAP machine, you hear unusual sounds coming from the CPAP machine. If you are unable to use your CPAP device due to these issues, discuss your individual health situation with a health care provider, such as your primary care physician or sleep doctor. At this time, if you are not experiencing these issues, then the FDA does not recommend discontinuing use of these machines. Report any concerns about the CPAP machine to the FDA , including unusual smells, sounds, or changes in appearance, and report any concerns to Philips . Report any concerns about the CPAP machine to the FDA , including unusual smells, sounds, or changes in appearance, and report any concerns to Philips . Device Description The Philips DreamStation 2 CPAP machine delivers positive airway pressure for treatment of obstructive sleep apnea. It is used at home and in clinical settings. FDA Actions The FDA is working with the company to better understand the issue(s) related to the DreamStation 2 CPAP machine and the possible underlying cause(s) and will update the public with new information, as appropriate. The FDA is also in ongoing discussions with the company about mitigation strategies for this safety issue and will update the public accordingly. Reporting Problems with Your Device If you think there may be a problem with your CPAP machine, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form. If you think there may be a problem with your CPAP machine, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Questions? If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100. If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100. Additional Resources FDA Press Release FDA Press Release BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET (function(){var g=function(e,h,f,g){     this.get=function(a){for(var a=a+"=",c=document.cookie.split(";"),b=0,e=c.length;b<e;b++){for(var d=c[b];" "==d.charAt(0);)d=d.substring(1,d.length);if(0==d.indexOf(a))return d.substring(a.length,d.length)}return null};     this.set=function(a,c){var b="",b=new Date;b.setTime(b.getTime()+6048E5);b="; expires="+b.toGMTString();document.cookie=a+"="+c+b+"; path=/; "};     this.check=function(){var a=this.get(f);if(a)a=a.split(":");else if(100!=e)"v"==h&&(e=Math.random()>=e/100?0:100),a=[h,e,0],this.set(f,a.join(":"));else return!0;var c=a[1];if(100==c)return!0;switch(a[0]){case "v":return!1;case "r":return c=a[2]%Math.floor(100/c),a[2]++,this.set(f,a.join(":")),!c}return!0};     this.go=function(){if(this.check()){var a=document.createElement("script");a.type="text/javascript";a.src=g;document.body&&document.body.appendChild(a)}};     this.start=function(){var t=this;"complete"!==document.readyState?window.addEventListener?window.addEventListener("load",function(){t.go()},!1):window.attachEvent&&window.attachEvent("onload",function(){t.go()}):t.go()};};               try{(new g(100,"r","QSI_S_ZN_6FpQ8uiCQiPh6SN","https://zn6fpq8uicqiph6sn-fdawebcx.gov1.siteintercept.qualtrics.com/SIE/?Q_ZID=ZN_6FpQ8uiCQiPh6SN")).start()}catch(i){}})(); END WEBSITE FEEDBACK SNIPPET BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET

Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating: FDA Safety Communication

仔细监控飞利浦 DreamStation 2 CPAP 机器是否有过热迹象：美国食品药品监督管理局安全沟通

The U.S. Food and Drug Administration (FDA) is warning patients and health care providers to carefully monitor Philips DreamStation 2 continuous positive airway pressure (CPAP) machines for signs of overheating.

The FDA recently received medical device reports (MDRs) associated with thermal issues such as fire, smoke, burns, and other signs of overheating while people are using Philips DreamStation 2 CPAP machines. The agency observed a recent increase in reports about these thermal issues with DreamStation 2 CPAP machines. Between August 1, 2023, and November 15, 2023, the FDA received more than 270 reports of problems associated with the device, compared with fewer than 30 MDRs received in the previous three years.

Consumers should be aware some DreamStation 2 CPAP machines were distributed as replacements for recalled DreamStation 1 CPAP machines. Based on the currently available evidence, the agency does not believe the safety issue with the DreamStation 2 is related to the foam used in the machine. This is a developing situation, and to date, reports gathered and analyzed by the FDA indicate that the thermal issues reported for the DreamStation 2 CPAP machines may be related to an electrical or a mechanical malfunction of the machine, which may cause it to overheat in certain situations.

Recommendations for Patients, Caregivers, and Health Care Providers

Follow the manufacturer`s instructions in the user manual , including: place the CPAP machine on a firm, flat surface keep the CPAP away from carpet, fabric, or other flammable materials carefully clean the CPAP machine empty the CPAP machine`s water reservoir let the CPAP machine`s heater plate and water tank cool for approximately 15 minutes before removing the tank to reduce the risk of burns. You could be burned if you touch the heater plate, come in contact with the heated water, or touch the humidifier water tank pan.

place the CPAP machine on a firm, flat surface

keep the CPAP away from carpet, fabric, or other flammable materials

let the CPAP machine`s heater plate and water tank cool for approximately 15 minutes before removing the tank to reduce the risk of burns. You could be burned if you touch the heater plate, come in contact with the heated water, or touch the humidifier water tank pan.

Inspect and examine the CPAP machine before and after each use for unusual smells or changes in its appearance. Some problems may only be noticeable when the machine is running, so pay attention to any differences in the CPAP machine as you prepare for bed, before you fall asleep.

Unplug the CPAP machine and do not use it if: you smell burning, smoke, or any unusual odors, there is a change in the appearance of the CPAP machine, there are unexplained changes to the CPAP machine`s performance, water is spilled into the CPAP machine, you hear unusual sounds coming from the CPAP machine.

you smell burning, smoke, or any unusual odors,

there is a change in the appearance of the CPAP machine,

there are unexplained changes to the CPAP machine`s performance,

you hear unusual sounds coming from the CPAP machine.

If you are unable to use your CPAP device due to these issues, discuss your individual health situation with a health care provider, such as your primary care physician or sleep doctor.

At this time, if you are not experiencing these issues, then the FDA does not recommend discontinuing use of these machines.

Report any concerns about the CPAP machine to the FDA , including unusual smells, sounds, or changes in appearance, and report any concerns to Philips .

The Philips DreamStation 2 CPAP machine delivers positive airway pressure for treatment of obstructive sleep apnea. It is used at home and in clinical settings.

The FDA is working with the company to better understand the issue(s) related to the DreamStation 2 CPAP machine and the possible underlying cause(s) and will update the public with new information, as appropriate.

The FDA is also in ongoing discussions with the company about mitigation strategies for this safety issue and will update the public accordingly.

If you think there may be a problem with your CPAP machine, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA`s user facility reporting requirements should follow the reporting procedures established by their facilities.

If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.

美国食品和药物管理局 (美国食品药品监督管理局) 警告患者和医疗保健提供者仔细监测飞利浦 DreamStation 2 持续气道正压通气 (CPAP) 机器是否有过热迹象。

美国食品药品监督管理局最近收到了与人们使用飞利浦 DreamStation 2 CPAP 机器时出现火灾、烟雾、烧伤和其他过热迹象等热问题相关的医疗设备报告 (医疗器械R)。该机构观察到最近关于 DreamStation 2 CPAP 机器的这些热问题的报告有所增加。在 2023 年 8 月 1 日至 2023 年 11 月 15 日期间,美国食品药品监督管理局收到了 270 多份与该设备相关的问题报告,而前三年收到的医疗器械报告不到 30 份。

消费者应注意,一些 DreamStation 2 CPAP 机器是作为召回的 DreamStation 1 CPAP 机器的替代品分发的。根据目前可用的证据,该机构认为 DreamStation 2 的安全问题与机器中使用的泡沫无关。这是一个发展中的情况,迄今为止,美国食品药品监督管理局收集和分析的报告表明,DreamStation 2 CPAP机器报告的热问题可能与机器的电气或机械故障有关,这可能导致其在某些情况下过热。

对患者、护理人员和医疗保健提供者的建议

按照用户手册中制造商的说明进行操作,包括: 将 CPAP 机器放在坚固、平坦的表面上 使 CPAP 远离地毯、织物或其他易燃材料 仔细清洁 CPAP 机器 清空 CPAP 机器的储水器 让 CPAP 机器的加热板和水箱冷却约 15 分钟,然后再取出水箱以降低烫伤风险。如果您触摸加热板、接触热水或触摸加湿器水箱盘,您可能会被烫伤。

将 CPAP 机器放在坚固、平坦的表面上

使 CPAP 远离地毯、织物或其他易燃材料

让 CPAP 机器的加热板和水箱冷却约 15 分钟,然后再取下水箱,以降低烫伤风险。如果您触摸加热板、接触热水或触摸加湿器水箱盘,您可能会被烫伤。

每次使用前后检查和检查 CPAP 机器是否有异常气味或外观变化。有些问题可能只有在机器运行时才会显现出来,因此在准备就寝时,在入睡前注意 CPAP 机器的任何差异。

如果出现以下情况,请拔下 CPAP 机器的插头并请勿使用:您闻到燃烧、冒烟或任何异常气味,CPAP 机器的外观发生变化,CPAP 机器的性能有无法解释的变化,水溅入 CPAP 机器,您听到 CPAP 机器发出异常声音。

您闻到燃烧、烟雾或任何异常气味,

CPAP 机器的性能发生了无法解释的变化,

您会听到 CPAP 机器发出异常声音。

如果您由于这些问题而无法使用 CPAP 设备,请与医疗保健提供者讨论您的个人健康状况,例如您的初级保健医生或睡眠医生。

目前,如果您没有遇到这些问题,那么美国食品药品监督管理局不建议停止使用这些机器。

向美国食品药品监督管理局报告有关 CPAP 机器的任何疑虑,包括异常气味、声音或外观变化,并向飞利浦报告任何问题。

飞利浦 DreamStation 2 CPAP 呼吸机可提供气道正压通气,用于治疗阻塞性睡眠呼吸暂停。它用于家庭和临床环境。

美国食品药品监督管理局的行动

美国食品药品监督管理局正在与该公司合作,以更好地了解与DreamStation 2 CPAP机器相关的问题以及可能的根本原因,并将酌情向公众提供新信息。

美国食品药品监督管理局也在与该公司讨论这一安全问题的缓解策略,并将相应地向公众提供最新信息。

如果您认为您的 CPAP 机器可能存在问题,美国食品药品监督管理局鼓励您通过 MedWatch 自愿报告表报告问题。

受美国食品药品监督管理局用户设施报告要求约束的设施雇用的医疗保健人员应遵循其设施制定的报告程序。

如果您有任何疑问,请致电 DICE@美国食品药品监督管理局.HHS.GOV 联系工业和消费者教育部 (DICE),或致电 800-638-2041 或 301-796-7100。

美国食品药品监督管理局新闻稿

The last day for submitting an application for a certificate of free sale to export a medical device will be Wednesday 13 December 2023. The last day for submitting an application for a certificate of free sale to export a medical device will be Wednesday 13 December 2023. Any application received after that will be considered received on Tuesday 2 January 2024.

The last day for submitting an application for    a certificate of free sale to export a medical device  will be Wednesday 13 December 2023. 
 Any application received after that will be considered re

提交出口医疗器械自由销售证书申请的最后一天是2023年12月13日星期三。
 在此之后收到的任何申请将被视为重新

Last day for submission of applications for certificates of free sale to export medical devices is 13 December 2023

提交出口医疗器械自由销售证明书申请的截止日期为2023年12月13日

The last day for submitting an application for a certificate of free sale to export a medical device will be Wednesday 13 December 2023.

Any application received after that will be considered received on Tuesday 2 January 2024.

提交出口医疗器械自由销售证书申请的最后一天是2023年12月13日星期三。

在此之后收到的任何申请将被视为在 2024 年 1 月 2 日星期二收到。

For Immediate Release: November 28, 2023      Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a drug safety communication warning that the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan), can cause a rare but serious reaction that can be life-threatening if not diagnosed and treated quickly. This reaction is called Drug Reaction with Eosinophilia and Systemic Symptoms. It may start as a rash, but can quickly progress, resulting in injury to internal organs, the need for hospitalization, and even death. As a result, the agency is requiring warnings about this risk to be added to the prescribing information and patient Medication Guides for these medicines. Today, the FDA issued a drug safety communication warning that the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan), can cause a rare but serious reaction that can be life-threatening if not diagnosed and treated quickly. This reaction is called Drug Reaction with Eosinophilia and Systemic Symptoms. It may start as a rash, but can quickly progress, resulting in injury to internal organs, the need for hospitalization, and even death. As a result, the agency is requiring warnings about this risk to be added to the prescribing information and patient Medication Guides for these medicines. Today, the FDA issued a drug safety communication warning that the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan), can cause a rare but serious reaction that can be life-threatening if not diagnosed and treated quickly. This reaction is called Drug Reaction with Eosinophilia and Systemic Symptoms. It may start as a rash, but can quickly progress, resulting in injury to internal organs, the need for hospitalization, and even death. As a result, the agency is requiring warnings about this risk to be added to the prescribing information and patient Medication Guides for these medicines. Today, the FDA issued a safety communication regarding reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies. The reports were received from clinical trials and/or postmarketing adverse event data sources. Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, the FDA is investigating identified risk of T-cell malignancy with serious outcomes including hospitalization and death. For more information, visit the FDA’s website . On Monday, the FDA published the FDA Voices: “ FDA Protects Patients from Harmful Drugs Through the Drug Supply Chain Security Act ,” by Jaqueline Corrigan-Curay, Office of the Center Director, Center for Drug Evaluation and Research (CDER) and Jill Furman, Office of Compliance, CDER. Since 2013, the FDA has been implementing the Drug Supply Chain Security Act, a law known as DSCSA. This law gives the FDA more regulatory tools to detect and help ensure the removal of dangerous drugs from the supply chain, such as those that may be counterfeit, stolen, contaminated, or otherwise harmful. By fully implementing DSCSA, together with industry and other stakeholders, we will create a more secure pharmaceutical supply chain that will assure the continued distribution of safe prescription drugs for the benefit of public health. On Monday, the FDA announced the availability of a Small Entity Compliance Guide (SECG) to help explain the actions a small entity must take to comply with recent changes made to “Milk and Cream Products and Yogurt Products; Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt.” The final rule, which was published on June 11, 2021 and modified on Dec. 15, 2022 and April 14, 2023, amends and modernizes the standard of identity for yogurt by allowing for technological advances in yogurt production while preserving the basic nature and essential characteristics of yogurt. On Monday, the FDA announced its withdrawal as a member of the Global Harmonization Working Party (GHWP), which the agency joined in December 2021. The FDA will continue its outreach to global partners and its efforts to ensure alignment of medical device international harmonization by primarily working with the International Medical Device Regulators Forum (IMDRF). In 2024, the FDA, as chair of IMDRF, will continue to work collaboratively to reach consensus on common goals, foster global regulatory convergence, and leverage resources to make safe and effective medical devices available globally. On Monday, the FDA approved nirogacestat (Ogsiveo, SpringWorks Therapeutics Inc.) for adult patients with progressing desmoid tumors who require systemic treatment. This is the first approved treatment for desmoid tumors. Full prescribing information is available here . On Monday, the FDA approved nirogacestat (Ogsiveo, SpringWorks Therapeutics Inc.) for adult patients with progressing desmoid tumors who require systemic treatment. This is the first approved treatment for desmoid tumors. Full prescribing information is available here . On Monday, the FDA issued another update to the Outbreak Advisory on the outbreak investigation of Listeria monocytogenes linked to peaches, plums, and nectarines (stone fruit). The advisory was updated to include the names of known retailers who received the recalled fruit including Publix , Wal-Mart & Sam’s Club , Albertsons Company, ALDI , and Sprouts Farmers Market . On Monday, the FDA issued another update to the Outbreak Advisory on the outbreak investigation of Listeria monocytogenes linked to peaches, plums, and nectarines (stone fruit). The advisory was updated to include the names of known retailers who received the recalled fruit including Publix , Wal-Mart & Sam^s Club , Albertsons Company, ALDI , and Sprouts Farmers Market . On Monday, the FDA issued another update to the Outbreak Advisory on the outbreak investigation of Listeria monocytogenes linked to peaches, plums, and nectarines (stone fruit). The advisory was updated to include the names of known retailers who received the recalled fruit including Publix , Wal-Mart & Sam^s Club , Albertsons Company, ALDI , and Sprouts Farmers Market . On Monday, the FDA issued another update to the Outbreak Advisory on the outbreak investigation of Listeria monocytogenes linked to peaches, plums, and nectarines (stone fruit). The advisory was updated to include the names of known retailers who received the recalled fruit including Publix , Wal-Mart & Sam^s Club , Albertsons Company, ALDI , and Sprouts Farmers Market . On Monday, the FDA issued another update to the Outbreak Advisory on the outbreak investigation of Listeria monocytogenes linked to peaches, plums, and nectarines (stone fruit). The advisory was updated to include the names of known retailers who received the recalled fruit including Publix , Wal-Mart & Sam^s Club , Albertsons Company, ALDI , and Sprouts Farmers Market . On Wednesday, Nov. 22, the FDA issued the final guidance “ COVID-19: Developing Drugs and Biological Products for Treatment or Prevention .” The guidance provides updated recommendations that reflect the evolving scientific knowledge and the current state of the pandemic. This supersedes the guidance of the same name initially issued on May 12, 2020, and reissued on February 22, 2021. On Wednesday, Nov. 22, the FDA published the FDA Voices: “ VAERS: A Critical Part of the National Vaccine Safety System ,” by Peter Marks, M.D., Ph.D., Director of the Center for Biologics Evaluation and Research and Daniel Jernigan, M.D., MPH, Director of the National Center for Emerging and Zoonotic Infectious Diseases, CDC. VAERS is an early-warning monitoring system for vaccine safety. It allows patients, pharmaceutical companies, medical personnel and other users to report concerns about medical events that occurred after someone received a vaccination. VAERS has a proven track record of successfully helping to identify safety issues. On Wednesday, Nov. 22, the FDA issued an update to the advisory for the Investigation of Elevated Lead Levels in Cinnamon Applesauce Puree . As of November 22, 2023, there have been 52 reports of adverse events potentially linked to recalled product submitted to FDA. To date, confirmed complainants are less than 1 to 4 years of age. The Nov. 22 advisory stated that at the time, the FDA was aware that recalled WanaBana Apple Cinnamon Puree was still on the shelves at several Dollar Tree stores in multiple states. The FDA is working with the firm to ensure an effective recall. This product should not be available for sale and consumers should not purchase or consume this product as it is potentially contaminated with lead, which can be harmful to health, particularly for children. This investigation is ongoing and the FDA will update the advisory as information becomes available. On Tuesday, Nov. 21, the FDA issued a Safety Alert to consumers not to eat, and restaurants and food retailers not to sell, and to dispose of oysters illegally harvested from Milford Approved area in Connecticut on 11/12/2023 and 11/15/2023 by original certified dealer Seaview Fisheries, CT-084-SS, AQ, and labeled as lots L466B and 466A because they may be contaminated. The oysters were directly distributed to a distributor in RI. Oysters were distributed further to a distributor and retailers in DE, FL, IL, MD, NJ, NY, PA, and TX and may have been distributed further from these states. On Tuesday, Nov. 21, the FDA announced the ninth in the ongoing series of webinars exploring food safety culture will take place on Dec. 6, 2023, from 12 noon to 1 p.m. ET. This webinar “ Food Safety Culture: Storytelling to Shape, Reinforce, and Inspire ” will focus on the importance of storytelling in building and reinforcing a strong food safety culture. The webinar series Collaborating on Culture in the New Era of Smarter Food Safety is in partnership with Stop Foodborne Illness , a non-profit public health organization. On Tuesday, Nov. 21, the FDA announced the ninth in the ongoing series of webinars exploring food safety culture will take place on Dec. 6, 2023, from 12 noon to 1 p.m. ET. This webinar ^ Food Safety Culture: Storytelling to Shape, Reinforce, and Inspire ^ will focus on the importance of storytelling in building and reinforcing a strong food safety culture. The webinar series Collaborating on Culture in the New Era of Smarter Food Safety is in partnership with Stop Foodborne Illness , a non-profit public health organization. Related Information FDA Newsroom ### The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.    Inquiries    Media:    FDA Office of Media Affairs     888-INFO-FDA                    Consumer:  888-INFO-FDA      Inquiries    Media:    FDA Office of Media Affairs     888-INFO-FDA                    Consumer:  888-INFO-FDA         (function(){var g=function(e,h,f,g){     this.get=function(a){for(var a=a+"=",c=document.cookie.split(";"),b=0,e=c.length;b<e;b++){for(var d=c[b];" "==d.charAt(0);)d=d.substring(1,d.length);if(0==d.indexOf(a))return d.substring(a.length,d.length)}return null};     this.set=function(a,c){var b="",b=new Date;b.setTime(b.getTime()+6048E5);b="; expires="+b.toGMTString();document.cookie=a+"="+c+b+"; path=/; "};     this.check=function(){var a=this.get(f);if(a)a=a.split(":");else if(100!=e)"v"==h&&(e=Math.random()>=e/100?0:100),a=[h,e,0],this.set(f,a.join(":"));else return!0;var c=a[1];if(100==c)return!0;switch(a[0]){case "v":return!1;case "r":return c=a[2]%Math.floor(100/c),a[2]++,this.set(f,a.join(":")),!c}return!0};     this.go=function(){if(this.check()){var a=document.createElement("script");a.type="text/javascript";a.src=g;document.body&&document.body.appendChild(a)}};     this.start=function(){var t=this;"complete"!==document.readyState?window.addEventListener?window.addEventListener("load",function(){t.go()},!1):window.attachEvent&&window.attachEvent("onload",function(){t.go()}):t.go()};};               try{(new g(100,"r","QSI_S_ZN_6FpQ8uiCQiPh6SN","https://zn6fpq8uicqiph6sn-fdawebcx.gov1.siteintercept.qualtrics.com/SIE/?Q_ZID=ZN_6FpQ8uiCQiPh6SN")).start()}catch(i){}})();



For Immediate Release:
November 28, 2023




FDA Roundup: November 28, 2023

美国食品药品监督管理局综述：2023 年 11 月 28 日

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

Today, the FDA issued a drug safety communication warning that the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan), can cause a rare but serious reaction that can be life-threatening if not diagnosed and treated quickly. This reaction is called Drug Reaction with Eosinophilia and Systemic Symptoms. It may start as a rash, but can quickly progress, resulting in injury to internal organs, the need for hospitalization, and even death. As a result, the agency is requiring warnings about this risk to be added to the prescribing information and patient Medication Guides for these medicines.

Today, the FDA issued a safety communication regarding reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies. The reports were received from clinical trials and/or postmarketing adverse event data sources. Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, the FDA is investigating identified risk of T-cell malignancy with serious outcomes including hospitalization and death. For more information, visit the FDA`s website .

On Monday, the FDA published the FDA Voices: ` FDA Protects Patients from Harmful Drugs Through the Drug Supply Chain Security Act ,` by Jaqueline Corrigan-Curay, Office of the Center Director, Center for Drug Evaluation and Research (CDER) and Jill Furman, Office of Compliance, CDER. Since 2013, the FDA has been implementing the Drug Supply Chain Security Act, a law known as DSCSA. This law gives the FDA more regulatory tools to detect and help ensure the removal of dangerous drugs from the supply chain, such as those that may be counterfeit, stolen, contaminated, or otherwise harmful. By fully implementing DSCSA, together with industry and other stakeholders, we will create a more secure pharmaceutical supply chain that will assure the continued distribution of safe prescription drugs for the benefit of public health.

On Monday, the FDA announced the availability of a Small Entity Compliance Guide (SECG) to help explain the actions a small entity must take to comply with recent changes made to `Milk and Cream Products and Yogurt Products; Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt.` The final rule, which was published on June 11, 2021 and modified on Dec. 15, 2022 and April 14, 2023, amends and modernizes the standard of identity for yogurt by allowing for technological advances in yogurt production while preserving the basic nature and essential characteristics of yogurt.

On Monday, the FDA announced its withdrawal as a member of the Global Harmonization Working Party (GHWP), which the agency joined in December 2021. The FDA will continue its outreach to global partners and its efforts to ensure alignment of medical device international harmonization by primarily working with the International Medical Device Regulators Forum (IMDRF). In 2024, the FDA, as chair of IMDRF, will continue to work collaboratively to reach consensus on common goals, foster global regulatory convergence, and leverage resources to make safe and effective medical devices available globally.

On Monday, the FDA approved nirogacestat (Ogsiveo, SpringWorks Therapeutics Inc.) for adult patients with progressing desmoid tumors who require systemic treatment. This is the first approved treatment for desmoid tumors. Full prescribing information is available here .

On Monday, the FDA issued another update to the Outbreak Advisory on the outbreak investigation of Listeria monocytogenes linked to peaches, plums, and nectarines (stone fruit). The advisory was updated to include the names of known retailers who received the recalled fruit including Publix , Wal-Mart & Sam`s Club , Albertsons Company, ALDI , and Sprouts Farmers Market .

On Wednesday, Nov. 22, the FDA issued the final guidance ` COVID-19: Developing Drugs and Biological Products for Treatment or Prevention .` The guidance provides updated recommendations that reflect the evolving scientific knowledge and the current state of the pandemic. This supersedes the guidance of the same name initially issued on May 12, 2020, and reissued on February 22, 2021.

On Wednesday, Nov. 22, the FDA published the FDA Voices: ` VAERS: A Critical Part of the National Vaccine Safety System ,` by Peter Marks, M.D., Ph.D., Director of the Center for Biologics Evaluation and Research and Daniel Jernigan, M.D., MPH, Director of the National Center for Emerging and Zoonotic Infectious Diseases, CDC. VAERS is an early-warning monitoring system for vaccine safety. It allows patients, pharmaceutical companies, medical personnel and other users to report concerns about medical events that occurred after someone received a vaccination. VAERS has a proven track record of successfully helping to identify safety issues.

On Wednesday, Nov. 22, the FDA issued an update to the advisory for the Investigation of Elevated Lead Levels in Cinnamon Applesauce Puree . As of November 22, 2023, there have been 52 reports of adverse events potentially linked to recalled product submitted to FDA. To date, confirmed complainants are less than 1 to 4 years of age. The Nov. 22 advisory stated that at the time, the FDA was aware that recalled WanaBana Apple Cinnamon Puree was still on the shelves at several Dollar Tree stores in multiple states. The FDA is working with the firm to ensure an effective recall. This product should not be available for sale and consumers should not purchase or consume this product as it is potentially contaminated with lead, which can be harmful to health, particularly for children. This investigation is ongoing and the FDA will update the advisory as information becomes available.

On Tuesday, Nov. 21, the FDA issued a Safety Alert to consumers not to eat, and restaurants and food retailers not to sell, and to dispose of oysters illegally harvested from Milford Approved area in Connecticut on 11/12/2023 and 11/15/2023 by original certified dealer Seaview Fisheries, CT-084-SS, AQ, and labeled as lots L466B and 466A because they may be contaminated. The oysters were directly distributed to a distributor in RI. Oysters were distributed further to a distributor and retailers in DE, FL, IL, MD, NJ, NY, PA, and TX and may have been distributed further from these states.

On Tuesday, Nov. 21, the FDA announced the ninth in the ongoing series of webinars exploring food safety culture will take place on Dec. 6, 2023, from 12 noon to 1 p.m. ET. This webinar ` Food Safety Culture: Storytelling to Shape, Reinforce, and Inspire ` will focus on the importance of storytelling in building and reinforcing a strong food safety culture. The webinar series Collaborating on Culture in the New Era of Smarter Food Safety is in partnership with Stop Foodborne Illness , a non-profit public health organization.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation`s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Inquiries    Media:    FDA Office of Media Affairs     888-INFO-FDA                    Consumer:  888-INFO-FDA

今天,美国食品和药物管理局(FDA)提供了该机构新闻的概览摘要:

今天,美国食品药品监督管理局发布了一项药物安全沟通警告,抗癫痫药物左乙拉西坦(Keppra,Keppra XR,Elepsia XR,Spritam)和氯巴占(Onfi,Sympazan)可引起罕见但严重的反应,如果不及时诊断和治疗,可能会危及生命。这种反应称为具有嗜酸性粒细胞增多和全身症状的药物反应。它可能从皮疹开始,但可以迅速进展,导致内脏器官损伤、需要住院治疗,甚至死亡。因此,该机构要求将有关这种风险的警告添加到这些药物的处方信息和患者用药指南中。

今天,美国食品药品监督管理局发布了关于接受BCMA或CD19靶向自体CAR T细胞免疫疗法治疗的患者中T细胞恶性肿瘤(包括嵌合抗原受体CAR阳性淋巴瘤)报告的安全性通报。这些报告来自临床试验和/或上市后不良事件数据源。尽管这些产品的总体益处继续超过其批准用途的潜在风险,但美国食品药品监督管理局正在调查已确定的T细胞恶性肿瘤风险,包括住院和死亡等严重后果。欲了解更多信息,请访问美国食品药品监督管理局的网站。

周一,美国食品药品监督管理局发布了美国食品药品监督管理局的声音:`美国食品药品监督管理局通过药物供应链安全法案保护患者免受有害药物的侵害`,作者是药物评估和研究中心(CDER)中心主任办公室Jaqueline Corrigan-Curay和CDER合规办公室的Jill Furman。自2013年以来,美国食品药品监督管理局一直在实施《药品供应链安全法》,即DSCSA。该法律为美国食品药品监督管理局提供了更多的监管工具,以检测并帮助确保从供应链中移除危险药物,例如那些可能是假冒、被盗、污染或其他有害药物的药物。通过与行业和其他利益相关者一起全面实施DSCSA,我们将创建一个更安全的药品供应链,确保持续分销安全的处方药,以造福公众健康。

周一,美国食品药品监督管理局宣布提供小型实体合规指南(SECG),以帮助解释小型实体必须采取的行动,以遵守最近对`牛奶和奶油产品以及酸奶产品;最终规则:撤销低脂酸奶和脱脂酸奶的标准,并修改酸奶的标准。 最终规则于 2021 年 6 月 11 日发布,并于 2022 年 12 月 15 日和 2023 年 4 月 14 日进行了修改,通过允许酸奶生产中的技术进步,同时保留酸奶的基本性质和基本特征,对酸奶的身份标准进行了修订和现代化。

周一,美国食品药品监督管理局宣布退出全球协调工作组 (GHWP) 的成员资格,该机构于 2021 年 12 月加入该工作组。美国食品药品监督管理局将继续与全球合作伙伴联系,并主要与国际医疗器械监管机构论坛(IMDRF)合作,努力确保医疗器械国际协调一致。2024年,美国食品药品监督管理局作为I医疗器械射频的主席,将继续合作,就共同目标达成共识,促进全球监管趋同,并利用资源在全球范围内提供安全有效的医疗器械。

周一,美国食品药品监督管理局批准nirogacestat(Ogsiveo,SpringWorks Therapeutics Inc.)用于需要全身治疗的进行性硬纤维瘤成年患者。这是第一个获批的硬纤维瘤治疗方法。完整的处方信息可在此处获得。

周一,美国食品药品监督管理局发布了关于与桃子、李子和油桃(核果)有关的单核细胞增生李斯特菌爆发调查的疫情咨询的另一次更新。该公告已更新,包括收到召回水果的已知零售商的名称,包括Publix,沃尔玛和山姆会员店,Albertsons公司,ALDI和Sprouts农贸市场。

11月22日星期三,美国食品药品监督管理局发布了最终指南`COVID-19:开发用于治疗或预防的药物和生物制品`。 该指南提供了最新的建议,反映了不断发展的科学知识和大流行的当前状态。这取代了最初于 2020 年 5 月 12 日发布并于 2021 年 2 月 22 日重新发布的同名指南。

11月22日星期三,美国食品药品监督管理局发布了美国食品药品监督管理局的声音:`VAERS:国家疫苗安全系统的关键部分`,作者是生物制品评估和研究中心主任Peter Marks,医学博士,博士和CDC国家新兴和人畜共患传染病中心主任Daniel Jernigan,医学博士,公共卫生硕士。VAERS是疫苗安全的预警监测系统。它允许患者、制药公司、医务人员和其他用户报告对某人接种疫苗后发生的医疗事件的担忧。VAERS在成功帮助识别安全问题方面有着良好的记录。

11月22日星期三,美国食品药品监督管理局发布了关于调查肉桂苹果酱中铅含量升高的咨询的最新情况。截至 2023 年 11 月 22 日,已向美国食品药品监督管理局提交了 52 份可能与召回产品相关的不良事件报告。迄今为止,已确认的投诉人不到1至4岁。11月22日的公告称,当时,美国食品药品监督管理局知道召回的WanaBana苹果肉桂泥仍在多个州的几家Dollar Tree商店的货架上。美国食品药品监督管理局正在与该公司合作,以确保有效召回。本产品不应出售,消费者不应购买或食用本产品,因为它可能被铅污染,这可能对健康有害,尤其是对儿童。这项调查正在进行中,美国食品药品监督管理局将在获得信息时更新公告。

11月21日星期二,美国食品药品监督管理局向消费者发出安全警报,禁止食用,餐馆和食品零售商不得出售,并处置2023年11月12日和2023年11月15日从康涅狄格州米尔福德批准地区非法收获的牡蛎,由原始认证经销商Seaview Fisheries,CT-084-SS,AQ,并标记为批次L466B和466A,因为它们可能受到污染。牡蛎直接分发给罗德岛的经销商。牡蛎进一步分发给德州、佛罗里达州、伊利诺伊州、医疗器械、新泽西州、纽约州、宾夕法尼亚州和德克萨斯州的分销商和零售商,并且可能已经从这些州进一步分发。

11 月 21 日星期二,美国食品药品监督管理局宣布,正在进行的探索食品安全文化的系列网络研讨会中的第九场将于美国东部时间 2023 年 12 月 6 日中午 12 点至下午 1 点举行。本次网络研讨会`食品安全文化:讲故事以塑造、加强和启发`将重点介绍讲故事在建立和加强强大的食品安全文化方面的重要性。`在更智能的食品安全新时代开展文化合作`系列网络研讨会与非营利性公共卫生组织`停止食源性疾病`合作。

美国食品药品监督管理局新闻编辑室

美国食品药品监督管理局是美国卫生与公众服务部下属的一个机构,通过确保人类和兽药、疫苗和其他人用生物制品以及医疗器械的安全性、有效性和安全性来保护公众健康。该机构还负责我国食品供应、化妆品、膳食补充剂、发出电子辐射的产品的安全和保障,并负责监管烟草制品。

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