Author 丨Ji Yuanyuan
Editor 丨 Xu Xu
Figure Source 丨 Figure worm
Recently, the U.S. FDA issued a notice to Philips, requiring it to clearly inform patients and suppliers within 45 days that the company is fully recalling Respironics ventilators, continuous positive airway pressure ventilation (CPAP) and dual-level positive airway pressure ventilation (BiPAP) machines, and asking Philips to ensure that patients and suppliers are aware of the potential risks to public health posed by polyester polyurethane (PE-PUR) anechoic foam used in these devices.
As for the reason for the notice, the US FDA said that it was because the philips recall notice was far from strong and effective. Previously, in January 2022, Philips Medical said that the recall of ventilators worldwide had been expanded to 5.2 million units. The cost of the recall increased by 225 million euros ($256 million).
Jeff Shuren, director of the FDA Center for Equipment and Radiation Health Medicine, said: "A large number of relevant patients and durable medical equipment suppliers have been disappointed in the implementation of the Philips recall process, and even some people do not know the news of the recall, nor have they received information about the next steps of the recall process.
To this end, the US FDA has decided to take the necessary executive orders to explicitly require Philips to strengthen communication with patients and the public, effectively communicate the information of the recalled equipment and the serious risks that may occur if the equipment continues to be used, and require Philips to ensure that these medical device users are aware of important information about the recall.
The FDA ordered this time, some insiders believe that this means that Philips Medical's ventilator recall has evolved from "active recall" to "mandatory recall". In this regard, Philips medical related people said in an interview with the 21st Century Business Herald reporter that Philips' recall actions are all voluntary recalls. "The Company is deeply sorry for the impact of the Philips Wellcome product recall on patients, healthcare organizations and stakeholders. We have strengthened our equipment production, service and repair capabilities and are fully committed to repairing or replacing equipment for patients as soon as possible. The person in question said.
Ventilator recall caused Philips medical losses of more than 5 billion yuan
According to Philips' financial report for the fourth quarter and full year of 2021, philips Group's total sales for the full year will be about 17.2 billion euros in 2021, and net profit is expected to be about 2.1 billion euros, accounting for about 12% of sales. Total sales in the fourth quarter were around 4.9 billion euros, about 350 million euros lower than previously expected. This is mainly due to tight global supply chains and the costs incurred by Philips Wellcome's large-scale equipment recalls.
According to the report, the recall of several respiratory equipment such as ITS CPAP and BiPAP caused Philips to lose 719 million euros (about 5.048 billion yuan) in net revenue in 2021. According to relevant statistics, the number of respiratory devices recalled by Philips worldwide has expanded to 5.2 million units.
According to Philips' ventilator recall notice in June last year, polyester polyurethane foam for sound suppression has been found in more than 20 devices, which may decompose over time, resulting in serious problems such as external respiratory irritation and internal organ damage if inhaled by patients. Previously, Philips and the US FDA had received more than 1,200 related complaints from around the world, and at least 100 patients had been injured as a result.
Philips subsequently expanded the recall to include older equipment, which led to a surge in the number of ventilators it recalled worldwide to 5.2 million.
Philips Medical related people said in an interview with the 21st Century Business Herald reporter that Philips Wellcome launched a voluntary recall notice for some sleep and respiratory treatment products worldwide on June 14, 2021. Since then, Philips Wellcome has conducted comprehensive testing and research on PE-PUR foam with accredited testing laboratories and qualified third-party experts to further evaluate the particles that PE-PUR foam may degrade into, as well as the potential health risks to patients posed by certain chemicals that may be released.
"In December 2021, based on ISO 18562 guidelines, based on an external medical team and an audit of the assessment by Philips Wellcome, Philips Wellcome published an update on the test results and assessment of the VOC emissions of the first generation of DreamStation equipment. It can be determined that the extent to which the first-generation DreamStation devices have been exposed to vovolutionic compounds identified to date generally do not pose a long-term health hazard to patients. Said the above-mentioned person.
How to ensure the safety and quality of products of multinational enterprises in China?
In fact, according to relevant statistics, before the incident, Philips and the US FDA had received more than 1,200 complaints related to the problem from around the world, including even at least 100 patient injury reports. According to incomplete statistics from the State Food and Drug Administration, Philips conducted at least 34 product recalls in the Chinese market in 2021, of which 17 were tertiary recalls. This has also brought the safety and security issues behind Philips medical devices to a close concern.
Philips Medical stressed that Philips' recalls are all voluntary recalls. Philips has a strict and sound quality management system, in the research and development, design, production, listing and other aspects, are in strict compliance with the global and local market medical device laws and regulations, is committed to providing customers with safe and reliable products. Philips' quality management system is continuously updated according to the latest industry standards and continuously monitors, evaluates and tests products after listing in accordance with the appropriate review and analysis processes to identify and determine whether certain potential risks may exist. Philips always adheres to the fair and transparent face and resolution of possible potential product risks, and takes various proactive measures, including voluntary recalls, to ensure that high-quality, safe and effective health technologies are always provided to customers and patients.
"In China, we proactively notify affected customers and users through multiple channels to implement corrective actions against affected devices. Philips will provide new materials to replace the current sound-deadening foam with a view to addressing all affected devices covered by this recall program as quickly as possible and addressing the issue as thoroughly and effectively as possible. We reported to the relevant government departments at the first time, maintained close communication with them, implemented the recall plan under their supervision and guidance, and reported the implementation process of the recall and corrective measures to the Shanghai Municipal Drug Administration at the frequency of one report per month. The person concerned said.
Philips said in its full-year financial report that the company is on track to complete repairs to all recalled equipment in the fourth quarter of 2022. However, in addition to equipment repairs, philips may face problems in the future due to the many class-action lawsuits and personal injury lawsuits against the company due to the recall of equipment, and Philips also said that it is not yet possible to estimate the potential financial impact.
However, Philips CEO Francis van Houten said in a statement that there is still good demand for Philips' innovative products and solutions in the future, and the order volume is expected to reach a record high. "Based on good customer demand and growing market orders, Philips expects to resume its growth rate and margin expansion trajectory in 2022." Fransvan Houten said.
This issue is edited by Feng Zhanpeng Intern Lin Xiying
