Philips recently reached agreement on a consent decree with the U.S. Department of Justice, representing the Food and Drug Administration (FDA), related to compliance with current good manufacturing practice requirements arising from past inspections focusing primarily on Philips’ Emergency Care and Resuscitation (ECR) facilities in Andover, MA and Bothell, WA, in and before 2015.
The decree also provides for increased scrutiny, for a period of time, of the compliance of the other patient care businesses at Philips facilities with the Quality System Regulation.
Under the decree, Philips is required to suspend the manufacture and distribution of external defibrillators manufactured at these facilities, subject to certain exceptions, until FDA certifies through inspection the facilities’ compliance with the Quality System Regulation.
Philips will continue the manufacture and distribution of certain automated external defibrillator (AED) models, service of AED and MRx devices, and provide consumables and the relevant accessories, to ensure uninterrupted availability of these highly reliable life-saving devices in the U.S. Additionally, to meet the needs of global customers, Philips will also continue to export defibrillators including the FRx and FR3 AEDs once certain requirements have been met.
I reached out to Philips and asked them to discuss what the injunction means for Philips monitor/defibrillator customers.
Carla Kriwet, Chief Business Leader Connected Care & Health Informatics at Royal Philips has said that Philips is committed to delivering high quality, innovative products and solutions, is prepared to fulfill the terms of the decree, and hopes to resume the suspended defibrillator production in the course of 2018.
Philips officials also told me defibrillators currently in use by customers are recommended by Philips to remain in use, and should not be taken out of service because there is no reason to believe they pose a risk to patients.
The full consent decree is currently posted on Philips’ website, along with information for users of Philips external defibrillators, describing how these products are impacted by the consent decree. Customers with questions not answered on Philips’ website, can also contact Philips at + 1 800 263 3342 or via this link: https://www.usa.philips.com/healthcare/about/news/public-web-site-consent-decree
Matt Penzone, Sr. Field Marketing Manager for Emergency Care & Resuscitation at Philips North America then graciously answered the following questions about the consent decree and what it means for the EMS Industry
What is a consent decree?
The consent decree is a court order issued by a federal judge with terms agreed to in advance by the Philips and the US Government. This consent decree concerns quality systems compliance following FDA inspections of the Andover, MA and Bothell, WA Emergency Care & Resuscitation (ECR) manufacturing facilities in and before 2015. Philips takes this matter extremely seriously and we’re committed to fulfilling the terms of the decree, building on the actions we have taken since 2015 to address these issues.
What does it mean for Philips?
At this time, under the terms of the Consent Decree and subject to limitations and conditions, Philips is permitted to continue to manufacture and ship HeartStart Home and HeartStart OnSite automated external defibrillators in order to meet public health needs. Under certain conditions, Philips may also manufacture and ship HeartStart FR3 devices.
It’s important to note that we will continue to provide necessary consumables and accessories for defibrillator products without restriction and may continue to service existing devices, including the HeartStart MRx. We will also continue participation in clinical trials and sustain our ongoing R&D efforts into new Resuscitation solutions.
Are the Philips devices subject to this action safe to use?
Yes, it is important to understand that Philips defibrillators can remain in use by customers, enjoy strong reliability records and should not be taken out of service, as Philips has no reason to believe they pose a risk to patients.
Has there been any increase in the number of complaints with your devices within the affected businesses, whether for performance or safety?
No. There has been no increase in complaints for devices within the affected businesses for performance or safety. We intend to remain the world’s leading supplier of defibrillators and make continued investments so that Philips products demonstrate the strong reliability our customers are accustomed to.
Does this impact the availability of other Philips products?
No, the primary impact of the consent decree on product availability relates to Philips’ AED products. Because the HeartStart MRx ended production in earlier in 2017, the consent decree chiefly affects our AED products. Other consumer health products and medical devices manufactured by other Philips businesses at the Andover, MA and Bothell, WA sites, like Lumify Ultrasound, are not affected by the decree.
So what’s next for Philips?
We’re engaged in some exciting new projects to evolve and complement our existing offerings that we feel will help emergency responders play an even larger role in this evolving healthcare environment. Philips is fully committed to our AED and ALS defibrillator portfolio and to the EMS market, so we’re eager to help advance Mobile-Integrated Health efforts and adoption of new, powerful technology like Lumify Point-of-Care Ultrasound.
Speaking of ultrasound, how is that going to help EMS?
Ultrasound is a powerful diagnostic tool but historically, the size, complexity and price have limited adoption outside the hospital. Now for the first time, Lumify is making high-quality, ultra-mobile Ultrasound a reality. It’s versatile enough to be used in a variety scenarios and can helps care providers make diagnosis that impact treatment and transportation decisions. Just like with 12-Lead ECG acquisition & interpretation, a learning curve will exist but the huge benefits to patients will see Ultrasound become a standard of care in the near future.