MPO’s Most-Read Stories This Week—May 20

Philips’ past troubles kept it foremost in the minds of MPO website visitors this past week. 

Driving a significant portion of digital traffic was the company’s fine for breaking the law, and its latest sleep therapy recall update.

The Securities and Exchange Commission’s (SEC) announced that Philips must pay more than $62 million to resolve charges it violated the Foreign Corrupt Practices Act (FCPA). The FCPA charges stem from conduct related to medical diagnostic equipment sales in China. According to the SEC, Philips China used special price discounts with distributors that created a risk that excessive distributor margins may be used to fund improper payments to government employees. The SEC also found employees, distributors, or sub-dealers of Philips’ Chinese subsidiaries engaged in improper conduct to influence hospital officials to draft technical specs in public tender to favor Philips’ products.
 
Amid news of the fine, Philips provided an update about the comprehensive test and research program its Respironics subsidiary is conducting to assess possible health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in some sleep therapy and ventilator devices under the June 2021 recall/safety notice. Philips said the risk assessments were completed for the CPAP/BiPAP sleep therapy devices under the recall—the first generation DreamStation, System One, and DreamStation Go devices—representing about 95% of the registered devices worldwide. These assessments build on past updates in December 2021, June 2022, and December 2022.
 
Tests and analyses have also been completed for first-gen DreamStations exposed to ozone cleaning. According to Philips, the test and research program was conducted together with five independent, certified testing labs, and results were reviewed and assessed by third-party qualified experts, Philips Respironics, and an external medical panel. Philips concluded from its tests that results indicate the exposure to volatile organic compound (VOC) emissions is “unlikely to result in an appreciable harm to health in patients.” The company said results indicate exposure to particulate matter (PM) emissions from degraded foam in the devices—including possible respirable and non-respirable particulates—isn’t likely to result in appreciable harm to health as well.

Also garnering pageviews this past week was Biomeric’s mrger with Precision Concepts Medical, a preview of GE Healthcare’s new innovations being showcased at the European Society for Therapeutic Radiology and Oncology 2023 Congress, and preliminary data from HAGAR’s clinical study of its non-invasive glucose monitoring device, GWave. All results fell within the A Zone on the Clarke Error Grid Analysis (EGA), and blood glucose levels ranged from 70-140, the data show.

1. HAGAR Releases Preliminary Study Results for its Non-Invasive Glucose Monitoring System

2. Philips to Pay Over $62M to Resolve FCPA Charges

3. GE Healthcare Presents New Innovations at ESTRO 2023 Congress

4. Philips Says Tests on 95% of Recalled Devices Suggest Unlikely Harm to Health

5. Biomerics to Merge With Precision Concepts Medical