Philips is facing regulatory scrutiny after an inspection by the U.S. Food and Drug Administration (FDA) at its Suzhou, China facility revealed multiple compliance issues concerning its computed tomography (CT) and ultrasonography systems. During the October 2023 inspection, the FDA identified that the devices were “adulterated” within the context of the Federal Food, Drug, and Cosmetic Act, indicating non-conformance with good manufacturing practice requirements. Specifically, Philips failed to validate an injection molding process necessary for manufacturing a data cable used in its Incisive CT machines. This lack of validation led to the cable being redesigned following 64 complaints regarding cable connection issues, which were linked to potential delays in diagnosis due to ECG gating signal errors.
Further compounding the regulatory challenges for Philips, the FDA found that the company had not reported three specific field corrections associated with the Incisive CT machines to the agency as required. These corrections were important as they were intended to reduce risks to patient health, including a cable connection failure that could delay diagnoses and software defects that could result in reversed or upside-down images or image artifacts, potentially leading to misdiagnoses. The FDA’s warning letter to Philips noted that these omissions in reporting were serious and outlined the need for a more in-depth review by Philips, extending beyond the initial two-year period they had examined. This situation reflects a broader issue of oversight and reporting within Philips’ operations, as evidenced by similar issues with other devices, including the company’s sleep and respiratory devices, which are also under scrutiny.
Adding to the oversight failures, the FDA’s letter disclosed that Philips did not correctly manage the control over its product, services, suppliers, contractors, and consultants. This was evident in the insufficient validation of the injection molding process used by Philips’ supplier for the custom-manufactured data cables. Although Philips responded to the initial FDA findings by halting the distribution of the problematic cables and requalifying the supplier to meet validation requirements, the agency found these measures inadequate. The FDA criticized Philips for its limited range in reviewing and ensuring the quality and compliance of its parts and processes, suggesting that this could be indicative of more systemic problems within the company’s quality management systems.
In response to the FDA’s findings and the subsequent warning letter, Philips has stated its commitment to addressing the issues raised and to enhancing its processes to prevent future occurrences. The company has undertaken to extend the review timeframe for field safety notices and to reassess all parts supplied to its Suzhou facility. Philips also aims to improve its Advanced Product Quality Plan process and has updated its protocols for managing product corrections and removals. Despite these efforts, the ongoing challenges highlight the importance of strict quality control and regulatory compliance in the manufacturing of medical devices, particularly those that are necessary for diagnostic accuracy. Philips’ experience serves as a cautionary tale for the medical device industry, emphasizing the need for continuous oversight and adherence to regulatory standards to ensure patient safety and trust in medical technologies.
