Preventing costly recalls with quality management systems

In the dynamic world of medical technology, ensuring the safety, reliability, and effectiveness of medical devices is key. This article explores how robust technical documentation, accurate verification and validation, and a well-implemented quality management system can prevent costly recalls and enhance patient safety.

Introduction

In the fast-evolving landscape of medical technology, the stakes are incredibly high. Every medical device placed into the hands of healthcare providers and patients carries with it a promise of safety, reliability, and effectiveness. However, this promise is only as strong as the foundation of quality on which it is built. The frequent recalls of medical devices not only underscore the potential risks to patient safety but also expose the substantial costs and reputational damage that manufacturers can suffer.

This article is written for stakeholders across the medical device industry—from design engineers and quality assurance specialists to regulatory professionals and top-level management. It explores why robust technical documentation, meticulous verification and validation, and a thoroughly implemented quality management system are not merely regulatory checkpoints, but the backbone of market success and patient safety.

Through the lens of recent real-world recall incidents, we will discuss how rigorous adherence to standards like ISO 13485, the European MDR, and the US QSR can prevent the kind of oversights that lead to these costly mistakes. We will dissect few critical failures that led to recall-examples and highlight how proactive compliance could have altered the course of events. Our goal is to not only inform but to inspire a culture of quality that transcends the minimum requirements—transforming quality management from a statutory obligation to a strategic asset.

NOTE: It is important to note, that IMT has not been part of the development projects in the examples below and has not been part of remediation. IMT also does not have any insights into these projects within mentioned companies. We used only publicly available information to analyse the recall cases and draw conclusions of the article. We are fully aware that one is always smarter in hindsight, therefore these examples shall be used only as an information for education of medical device manufacturers. See also the Disclaimer below.

Examples

The yearly numerous recalls of medical devices worldwide highlight the risks for patients and cause enormous costs (e. g. court settlements, compensations, global programs to remediate the affected devices) for medical device manufacturers.

Some recent examples include:

Example 1: the recall of multiple masks containing magnets from Philips [1], ResMed [2] or Sleepnet Corporation [3]

Example 2: the recalls of Philips ventilators, CPAP and BIPAP machines due to issues with foam [4] used in these devices to reduce sound and vibration leading to a temporary ban of products [5]

Example 3: Sterility issues with Medical Devices processed at Steril Milano Facilities [6]

Prevention

If we look at these recalls retrospectively, many of them would have been prevented by complete and thorough technical documentation, validation and verification activities based on a quality management system continuously maintained and adhered to.

Usability and Risk Management

The potential for serious patient harm sparked the recalls of magnet-containing masks (Example 1), which could deactivate pacemakers and implantable defibrillators. This serious oversight highlights two crucial areas in the technical documentation that, if properly addressed, might have circumvented the recalls:

Usability File: Before a medical device reaches the market, a detailed usability specification must be created which includes also the intended patient population as well as procedural descriptions for every stage of device interaction with the patient. For instance, when preparing and fitting a (magnet-containing) mask, the placement of the harness might bring it into close proximity with or on a patient’s chest—where pacemakers or defibrillators are implanted. This scenario should have automatically triggered an evaluation for potential electromagnetic interference, ensuring that such a critical risk is recognized and mitigated early in the design process.
Risk Management File: This document should include a comprehensive assessment of all possible risks associated with a device. The risk of magnets affecting pacemakers and other critical implantable devices, as well as their interactions in MR (Magnetic Resonance) environments, should be evaluated thoroughly. The risk management process serves not only as a checkpoint but also as a proactive measure to safeguard the patient against foreseeable device interactions.

Validation

In major product recall in June 2021, Philips Respironics had to recall ventilators and few other respiratory devices (CPAP, BIPAP) due to the degradation of foam used in these devices to reduce sound and vibration. If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. This issue underpins the importance of rigorous verification and validation processes, including state-of-the-art biocompatibility testing of all materials that can potentially come into contact with human tissues:

Biocompatibility Testing proactively applied: Although the affected products were released before the current ISO standards (ISO 18562-1:2024 and 18562-2:2024) were published, which specifically address particulate matter emissions from medical devices, a proactive validation approach considering the life expectancy of the products could have identified the degradation issue sooner. Regular assessments and updates to testing protocols in line with emerging standards can serve as a critical check to catch such defects before they pose a risk to patients, thereby preventing recalls and ensuring ongoing compliance with safety norms. In this case it could have at least prevented recalls of devices manufactured from the time between the publication of the initial version of the standard in 2017 and today.

Quality Management System

A striking example of the consequences of neglecting quality management system protocols came to light with the FDA's findings regarding Steril Milano:

Integrity of Records: In a communication of the FDA concerning the recall in the third case, the FDA stated: “<…>The FDA became aware that Steril Milano falsified graphs and parameters of sterilization certificates for a variety of FDA-regulated products, dating back to 2016.<…>”.

Under ISO 13485, medical device manufacturers are required to maintain stringent controls over documentation to prevent such falsifications. This includes implementing robust verification processes for all data and reports related to device safety and efficacy. A diligent and transparent quality management system is not merely a regulatory requirement but a fundamental component that maintains trust and integrity in the medical device industry. Ensuring the accuracy and honesty of every piece of data not only upholds regulatory standards but also protects patient lives and the manufacturer's reputation.

Conclusion

The documentation and protocols mandated by standards like ISO 13485, the European Medical Device Regulation (MDR), and the US Quality System Regulation (QSR) serve as critical foundations for safeguarding patient safety and ensuring the efficacy of medical devices in the marketplace. These regulations are designed not only to guide medical device manufacturers in producing products that meet strict safety criteria but also to mitigate risks that could lead to adverse patient outcomes and costly recalls.

However, the effectiveness of these regulatory frameworks extends beyond mere compliance on paper. To truly prevent recalls, avoid additional costs, and protect against damage to reputation, these standards must be fully integrated into the daily operations and culture of the organizations. This means that the principles of the quality management systems need to be 'lived'—actively practiced, regularly reviewed, and consistently enforced within every level of the organization.

When these standards are lived, they empower manufacturers to detect potential safety issues before products reach the market, thereby reducing the likelihood of costly post-market corrections and recalls. Moreover, robust adherence to these standards can enhance the trust of consumers and regulatory bodies in the brand, which is crucial for long-term success and market presence. In contrast, superficial compliance can lead to significant oversight, which might not only result in financial loss but also in irreversible damage to a company’s reputation and, more importantly, to patient health.

Therefore, it is imperative for medical device manufacturers to foster a culture where quality management and regulatory compliance are seen as integral to their business strategy and operational execution. This holistic approach will ensure that the documentation, verification, and validation processes are not just procedural formalities but are effective tools for promoting patient safety and product reliability.

Regulatory Affairs and Quality Management

Are you looking for a partner to find answers to your regulatory affairs or quality management system challenges?

Don’t delay your project or risk costly product recalls – contact our experts today.

Disclaimer

This article's analysis of product recall incidents is for informational purposes only. Despite efforts to ensure accuracy and reliability, we do not guarantee the completeness, accuracy, or timeliness of the information. The insights and suggestions are based on our interpretation and are not definitive advice. This analysis is speculative, not accounting for all possible factors, and may not apply in all situations. Readers should conduct their own research and consult professionals before making decisions or taking actions based on this article. The publisher disclaims any liability for actions taken as a result of reading this article. For accurate information on the recalls, refer to official statements from the involved companies and relevant regulatory authorities.