Съобщение относно безопасността на място за медицинско изделие (извън САЩ)

Philips Respironics

Информация за лекарите и други доставчици на медицински грижи

Philips Respironics обяви известие за доброволно изтегляне (само за САЩ)/съобщение относно безопасността на място (извън САЩ) за непрекъснати и периодични вентилатори (определени CPAP, BiLevel PAP и вентилаторни устройства) поради два проблема, свързани със звукопоглъщаща пяна от базиран на полиестер полиуретан (PE-PUR), използвана в тези устройства: 1) пяната от PE-PUR може да се разгради на частици, които може да навлязат във въздушните пътища на устройството и да бъдат погълнати или вдишани от потребителя, и 2) пяната от PE-PUR може да отделя като газ определени химикали. Влошаването на качеството на пяната може да се ускори от използването на неодобрени методи за почистване, като например озон (вижте Съобщение, свързано с безопасността, на FDA относно използването на почистващи препарати с озон), а изпускането на газ може да възникне по време на първоначалната работа и може евентуално да продължи по време на целия полезен живот на устройството.

 

За повече информация относно това съобщение относно безопасността на място, включително списък на засегнатите устройства, моля, посетете нашата главна страница за съобщението относно безопасността на място.

 

Philips работи неуморно по отстраняването на този проблем чрез замяна на засегнатите устройства. Известие за изтегляне (само за САЩ)/съобщение относно безопасността на място (извън САЩ) с незабавните действия, които трябва да се предприемат, е било изпратено до дистрибуторите и лечебните заведения, които са директен клиент на Philips, за тяхна собствена употреба, както и за ангажимент с пациентите. При това има вероятност Вашите пациенти да се свържат с Вас за указания и ние сме ангажирани да Ви предоставим информация и инструменти, за да проведете информирана дискусия с тях и да направите Вашата клинична препоръка. Моля, вижте ЧЗВ по-долу и PDF файл с клинична информация тук.

 

През последните 40 години сме центрирали нашия бизнес около ангажимента ни за грижи за пациентите с решения, които са насочени към подобряване живота на хората с респираторни и сънни затруднения. Признаваме важността за осигуряването на безопасна и ефективна терапия.

 

Ангажирани сме да се придържаме към най-високите стандарти за качество и безопасност на продуктите в усилията си да направим това, което е правилно за Вас и за пациентите, които са се доверили да се грижите за тях.

 

Ангажирани сме да разрешим този проблем и да предоставим прозрачна текуща комуникация, докато преминаваме през следващите стъпки.

 

Ангажирани сме да Ви предоставяме информация и ресурси за Вашето собствено разбиране, но също и за да Ви помогнем да комуникирате ефективно и ефикасно с Вашите пациенти.

При други запитвания или за да говорите със специалист по поддръжката, можете също да се обадите на 0800-15575 (пон-пет: 9-18).

 

Искрено се извиняваме за този пробив. Изцяло сме ангажирани да подкрепяме Вас и Вашите пациенти през целия този процес. 

За пациенти и потребители съобщението относно безопасността на място също съветва: 

 

  • За пациенти на засегнатите BiLevel PAP и CPAP устройства Philips продължава да препоръчва те да преустановят използването на BiLevel PAP и CPAP устройствата и да се консултират с лекарите, за да се определят най-подходящите възможности за продължаване на лечението на базата на ползите от продължаване на терапията и потенциалните идентифицирани рискове. 

 

  • Съответните органи в Европейския съюз/Обединеното кралство обаче са предоставили тяхното указание, както следва:
    • Моля, свържете се с Вашия лекар или доставчик на медицински грижи, преди да правите каквито и да било промени по Вашата предписана терапия.
    • Макар че рисковете, идентифицирани в съобщението относно безопасността на място, да са довели до това Philips да препоръчва преустановяване на използването, важно е пациентите да се консултират с лекарите си, за да определят най-подходящите възможности за продължаване на лечението.
    • Заедно със своите лекари пациентите трябва да определят дали ползата от продължаване на терапията с устройството надхвърля идентифицираните рискове.  

 

  • За пациенти на засегнатите животоподдържащи механични вентилаторни устройства, не преустановявайте и не променяйте предписаната терапия, без да се консултирате с лекари, както и инструкциите за модифицирано продължаване на употребата.

Въпроси и отговори

Are affected devices safe for use? Should affected devices be removed from service?

The field safety notice advises patients and customers to take the following actions:

 

  • For patients using BiLevel PAP and CPAP devices: Please contact your physician or care provider before making any changes to your prescribed therapy. While the risks identified in the field safety notice have resulted in Philips recommending discontinued use, it is important that patients consult with their physicians to determine the most appropriate options for continued treatment. Together with their physicians, patients should determine if the benefit of continuing therapy with the device outweighs the risks identified.
  • For patients using life-sustaining mechanical ventilator devices: DO  NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps.

 

Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods.

 

Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after five years of use.

What is the safety hazard associated with this issue? Has Philips received any reports of patient harm due to this issue?

The field safety notice informs customers and users of potential impacts on patient health and clinical use related to this issue. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material.  High heat and high humidity environments may also contribute to foam degradation in certain regions.

 

Philips continues to monitor reports of potential safety issues through our post-market surveillance activities as required by medical device regulations and laws in the markets in which we operate.

 

In the event of exposure to degraded foam:

 

  • The potential risks of degraded foam exposure include:
    • Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and toxic carcinogenic affects.
  • To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection.

 

In the event of exposure to chemical emissions:

 

  • The potential risks of exposure due to chemical emissions from affected foam include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects.
  • To date, Philips has not received reports of patient impact or serious harm as a result of this issue.

When will the correction for this issue begin? How long will it take to address all affected devices?

The company will replace the current sound abatement foam with a new material that is not affected by this issue.

 

At this time, the company is working to address all affected devices within the scope of this correction as expeditiously as possible.

 

Philips will provide further clarity on projected dates for implementation of the correction to begin when this information is available.

 

The process for preparing the corrections indicated in the field safety notice has begun.

 

This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction.

 

Philips is notifying regulatory agencies in the regions and countries where affected products are available.

 

As each country authorizes regulatory agency approvals, our global repair and replacement program for affected devices will be operational.

 

We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction.

Are affected devices continuing to be manufactured and/or shipped?

At this time, affected devices are on manufacturing and ship hold as the company prepares to implement the repair / replacement program for affected devices, to install new sound abatement foam material not affected by the reported issues.

Is this a recall? Have regulatory authorities classified the severity of this action?

The issuance of the notification is a field safety notice in the European Union and U.K., according to regulatory agency criteria.

 

This field safety notice has not yet been classified by European Union / U.K. regulatory agencies.

How will Philips address this issue? Are affected devices being replaced and/or repaired? Are customers entitled to warranty replacement, repair, service or other mitigations?

We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible.

 

As a result of extensive ongoing analysis, on June 14, 2021, the company issued a field safety notice for specific affected Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.

 

The notification informs customers and users of potential impacts on patient health and clinical use related to this issue. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material.

 

Philips is notifying customers and users of affected devices that the company will replace the current sound abatement foam with a new material that is not affected by this issue. Affected devices currently will be either replaced with a new or refurbished unit that incorporates the new material, or repaired to replace the sound abatement foam in customer units. The new material will also replace the current sound abatement foam in future products.

 

Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods.

 

Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after five years of use.

 

The company has dedicated significant resources to address this issue, and has developed a comprehensive plan for this correction, and has already begun this process. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction.

 

Philips deeply regrets the inconveniences caused by this issue, and we are dedicating significant time and resources to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority.

 

For more information on the field safety notice, as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update.

Are there any steps that customers, patients, users and/or clinicians should take regarding this issue?

Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets).

 

The field safety notice advises patients and customers to take the following actions:

 

  • For patients using BiLevel PAP and CPAP devices: Please contact your physician or care provider before making any changes to your prescribed therapy. While the risks identified in the field safety notice have resulted in Philips recommending discontinued use, it is important that patients consult with their physicians to determine the most appropriate options for continued treatment. Together with their physicians, patients should determine if the benefit of continuing therapy with the device outweighs the risks identified.
  • For patients using life-sustaining mechanical ventilator devices: DO  NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps.
  • Register affected devices on the field safety notice website, www.philips.com/SRC-update.
    • The website provides current information on the status of the field safety notice and how to receive permanent corrective action to address the two issues.
    • The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process.

 

The company has developed a comprehensive plan for this correction, and has already begun this process.

 

Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods.

 

Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after five years of use.

 

Philips deeply regrets the inconveniences caused by this issue, and we are dedicating significant time and resources to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority.

 

For more information on the field safety notice, as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update.

What is the cause of this issue? Was it a design, manufacture, supplier or other problem?

Based on Philips analysis, the root cause of this issue is related to the sound abatement foam currently used in specific identified products of the Sleep & Respiratory Care portfolio.

How did this happen, and what is Philips doing to ensure it will not happen again?

Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue.

 

The products were designed according to, and in compliance with, appropriate standards upon release.  As new standards are developed, they require assessment of product characteristics according to quality and regulatory processes.  Philips Quality Management System has been updated to reflect these new requirements.

 

However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. The foam degradation and chemical emission issues were discovered as part of our Quality Management System processes, and are being corrected in accordance with appropriate regulatory requirements.

 

Philips has been in full compliance with relevant standards upon product commercialization.

What is meant by "high heat and humidity" being one of the causes of this issue?

Philips has determined that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone), and certain environmental conditions involving high humidity and temperature.

 

The environmental conditions that may be one of the causes of this issue refer to the climate and regional temperatures of the countries where the devices are used and stored. 

 

This factor does not refer to heat and humidity generated by the device for patient use.

Do affected units exhibit features that customers / users should watch out for? Particles or other visible issues?

Users should consult with their physicians as directed in the field safety notice.

Can Philips replace products under warranty or repair devices under warranty?

Affected devices may be repaired under warranty.

 

Philips will provide further information regarding warranty replacement procedures during this issue when it is available.

In those regions where Philips provides both patient care and devices, will new patients be set up with devices? Will existing patient devices that fail be replaced?

At this time, Philips is unable to set up new patients on affected devices. Philips may work with new patients to provide potential alternate devices.

 

Philips may repair / replace ventilator units that patients are reliant on in emergency situations such as device failure during required treatment, to ensure continuity of care.

 

Philips CPAPs cannot be replaced during ship hold.

Is Philips certain that this issue is limited to the listed devices? Is there any possibility others are affected?

Philips has completed our analysis in accordance with our Quality Management System and identified all affected products, which are included in our notifications to regulatory agencies and customers.

 

No further products are affected by this issue.

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