The real reason why post-market safety surveillance must become a top priority

Lessons from Class I recalls of life-saving medical devices

A cardiac defibrillator locks-up after delivering the first shock causes delay in treatment, which can result in serious injury or death.

A needle-free closed system used to deliver chemotherapy drugs could release tiny plastic particles in a patient’s blood stream which can cause blockage.

A pacemaker fails due to an unpredictable circuit error which can result in a life-threatening situation.

These are just a few examples of Class I recalls¹ recently announced by the FDA in a span of just a few weeks.

A Class I recall of a medical device is the most serious type of recall, where a product-related issue can cause injury or death. Such recalls happen at a fairly high rate and cover a broad range of products from manufacturers both large and small. Rarely do they get any public attention, but they expose patients to unacceptable risk. In some cases, patients may need to go through a second surgery to remove the affected devices already implanted. In many other cases, however, these devices are left alone and doctors are advised to regularly monitor the patients.

Just like any real-life situation, there are known-unknowns, and there are unknown-unknowns!

One challenge is that medical devices are approved or cleared by the FDA with only limited amount of safety data from carefully controlled clinical trials. During the design phase, engineers consider many risks based on their current level of knowledge and technical judgment. There are risks they know about, and risks they know they don’t know about. They design, build and test the product based on risks they know and include a reasonable amount of cushion for risks they don’t fully understand. But there are many potential risks they don’t know about until the product is used across a wide range of patient population and varying circumstances.

There are known-unknowns. But there are also unknown-unknowns

Donald Rumsfeld, Former US Secretary of Defense

As a result, there is a lot of uncertainty about the safety performance of a medical device at the time of FDA approval or clearance.  

Medical device manufacturers are required to monitor complaints and report them to the FDA when patients and users experience device-related malfunctions and injuries. Manufacturers are also required to analyze their complaints data over time to detect potential safety signals and trends.

Sometimes, manufacturers have to voluntarily recall specific lots or units when the potential risk due to the reported events is high.

Recalling a product is not an easy decision for any organization. Yet it must be done, not only because of regulatory requirements, but also to protect patients and brand reputation.

When such decisions are being debated in the board rooms, business leaders are generally surprised and they often ask:

How could we have prevented this from happening?

This question needs to be the main focus of a strong post-market safety surveillance system.

There is a reason why regulatory authorities, especially in the European Union, are now requiring medical device manufacturers to implement a post-market surveillance system and submit regular safety update and trend reports.

But if we focus only on reporting requirements, we are going to fall short in understanding the real goal of medical device safety surveillance.

A truly effective system of surveillance helps us detect and verify safety signals so that we can take timely action before patients are exposed to unintended harm.  

Signal detection, risk reduction and creating a feedback channel are the three main deliverables of a safety surveillance system

Signal detection is the first real deliverable of surveillance. It involves both quantitative and qualitative analysis to know the unknown high risk. It is like shining a bright light on our blind spots to uncover areas of vulnerability.

The second deliverable of surveillance is to facilitate a timely decision for risk reduction mitigate the recently uncovered risk. This is often difficult in light of competing organizational priorities and limited resources. It becomes a chicken-or-the-egg situation, because a signal is not a confirmed trend and most organizations are not willing to divert cross-functional resources from more important projects. 

Even if prompt actions are taken when emerging safety signals are uncovered, we are still talking about a reactive approach. The defective, or potentially risky, product is already in the market. To be truly effective, the safety surveillance process needs to also drive action at the front end of design and development. 

A third deliverable of surveillance is to create a feedback channel for the R&D function to update their risk management files and use this information as an input for future new products. This is what is meant by the total lifecycle approach to risk management, which integrates newly uncovered risks with the product development process. In this way, a virtuous cycle of innovation is established to continuously improve patient safety with each new generation of new products.

Consider blind spot and lane departure monitoring sensors, which now come standard on many automobile models. The number of automobile crashes, injuries and deaths have been significantly reduced due to these features. The Insurance Institute of Highway Safety (IIHS) and Highway Loss Data Institute (HLDI) recently estimated that automobiles equipped with these technologies had nearly 25% fewer incidents of police-reported crashes with injuries compared to vehicles that did not have these features.

FDA is now taking a much more proactive and aggressive position on medical device safety. Recent statements from the FDA leadership, and the release of a Medical Device Safety Action Plan² demonstrate a serious commitment to be first among the world to identify and act upon safety signals related to medical devices. The intent is to move from passive surveillance from adverse event reporting data, to active surveillance from real-world data analyzed through the National Evaluation System for health Technology (NEST)³.

Ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.

Scott Gottlieb, Former FDA Commissioner

The regulatory environment is becoming increasingly focused on patient safety in a comprehensive, holistic way, not just as a matter of compliance.

Leaders who lament that post-market surveillance is a non-value added activity to be done to satisfy the regulators, need to take another look at the changing industry and regulatory environment. Medical device industry must quickly adapt to the world of value-based care, where provider reimbursement will be increasingly based on outcomes rather than fee for service. This will significantly impact how medical devices are selected by providers and payors, who will now require better results on safety and performance.

The real goal of a medical device safety surveillance system is to become a driver of innovation by enabling an effective, integrated risk management throughout the organization. It is no longer an exercise to simply satisfy regulatory requirements. Signal detection, risk reduction and integration with R&D must become a core competence.

1. FDA: Medical Device Recalls

2. FDA: Medical Device Safety Action Plan

3. FDA: National Evaluation System for health Technology (NEST)