Why we need a stronger focus on medical device safety

3 emerging trends driving a new focus on patient safety

Rising cost of healthcare, increasing public awareness of injuries and deaths related to medical devices, and a rapidly changing regulatory environment are driving the need for better safety performance. 

Ask any medical device manufacturer, and you will hear “of course, patient safety is our highest priority”. Ask how they measure the safety performance of their products, and you will likely hear about “low rates” and “no significant trends”.

The prevailing business model is that as long as our products are safe and effective, and we are not under any enforcement actions by the FDA, we are good on patient safety. No need to do anything else. Doctors love our products, and that’s our competitive advantage.

It is true that healthcare providers have been the most important stakeholder for the industry since they strongly influence the decision to use a specific medical device. Patients trust the doctor’s decision and generally do not ask for a specific brand. Unlike pharmaceuticals, where heavy direct-to-consumer marketing by the industry is increasingly driving patient choice, medical devices decisions are still heavily controlled by the healthcare provider.

There are three recent trends that are going to significantly change this dynamic in the marketplace.

As Quality and Regulatory professionals, we can help our organizations recognize these trends and stay ahead of the curve by making patient safety a strategic choice. 

1. Rising cost of healthcare is driving increased scrutiny on the contribution of device related issues on total cost of care

When a patient experiences injury, either directly or indirectly due to a device related issue, there is added cost in billions of dollars for monitoring, hospitalization, surgeries, imaging, post-acute care and physician services. However, it is very difficult to estimate these costs due to limitations in the claims data. As a result, there has been no direct financial accountability for the industry.

Well, things are about to change!

Recently, Office of the Inspector General (OIG) issued a report¹ following an investigation on behalf of the Centers for Medicare & Medicaid Services (CMS), which provides an estimate of costs related to replacement of recalled or prematurely failed medical devices. After “complex and labor-intensive auditing” of claims and other data sources, they estimated that such procedures from only 7 cardiac devices cost Medicare around $1.5 billion over a 10-year period between 2005 and 2014. They also estimated around $140 million in beneficiary copayment and deductible liabilities.

 With tens of thousands of device related injuries and deaths reported each year, the cost burden on the healthcare system is significant. It is inevitable that these costs will become more transparent, especially in light of the OIG report and possible CMS plans to update the claims form for better data collection. What happens when your device is “black listed” due to a poor safety record and can’t be reimbursed?

Patient safety must become a strategic choice, not just a tagline. Products with a superior patient safety performance will have a competitive advantage in faster regulatory approvals and in eligibility for reimbursement. Recently FDA has announced a new Safer Technology Program (STeP)² to support innovations that improve the safety profile of medical devices.

2. Public awareness of device related injuries and deaths is rising due to social media influencers and highly acclaimed reports and documentaries

Nothing causes more lasting damage to a reputable brand than public perception of poor safety. There is a tipping point, and public confidence once lost is hard to regain.

When John Oliver does a long segment about medical device safety on his popular show, Last Week Tonight with John Oliver, you know that this is now a mainstream issue. The Bleeding Edge, a highly acclaimed Netflix documentary, also created a lot of public buzz through highly emotional, heart-wrenching personal stories. Statistics about injury and death are one thing, but personal testimony from people about pain and suffering caused by devices such as vaginal mesh, Essure® permanent birth control and hip replacement, hit much closer to home. These stories make us relate to the human element beyond the numbers and have a powerful effect.

What the industry may consider “isolated” events, can turn into a movement in the age of Social Media. Case in point is the Advocating Safety in Healthcare E-Sisters (ASHES), a non-profit organization which first started as a Facebook page, Essure Problems, and soon became a powerful voice against the permanent birth control procedure. This device was taken off the market in the EU, and FDA also came out with additional requirements for the post-market clinical study. There is a real possibility that your device may end up in the crosshairs of intense public scrutiny even when all your internal post-market analysis is indicating that injury rates are “low” and “within acceptable range”. To an individual patient, such statistics are irrelevant because of the personal harm they have already experienced.

MedTech can no longer afford to be content with passive monitoring of device related adverse events. Traditional post-market surveillance approaches are no longer sufficient to ensure that you will be able to take timely action and manage the substantial, lasting damage to your brand equity caused by a single event. Your post-market surveillance system needs to be robust at detecting and confirming potential safety signals, not simply monitoring a “trend”. Further, the process needs to be integrated with your R&D organization to ensure all potential vulnerabilities are proactively addressed in designing new products.

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.

3. Regulatory environment is rapidly changing to drive increasing focus on public safety and transparency

FDA has taken steps to improve transparency of adverse events reporting and rigor around the 510(k) review process. The agency has signaled a renewed focus on safety by publishing a Medical Device Safety Action Plan³ which highlights 5 key actions for protecting patients and promoting public health.

In a significant move to improve transparency, FDA has ended the Alternate Summary Reporting (ASR) program after more than 20 years, which allowed manufacturers to report certain “well-known and well-characterized” device related events in a summary format instead of the individual reports otherwise required by regulations. There was a lot of noise in the media about millions of injuries and malfunctions “hidden” in these ASRs since the data was not included in the publicly available MAUDE database due to incompatible formats. In particular, safety concerns around breast implants and surgical staplers widely reported in the media led to additional FDA inquiry and actions related to these devices.

In general, it is common knowledge that adverse events are under-reported and MAUDE data is not fully indicative of injury rates seen in practice. Additionally, the 510(k) process is widely criticized as a “loop hole” which allows manufacturers to receive clearance of their device by showing “substantial equivalence” to another predicate device, which may be decades old or may have a poor post-market safety record. In response, FDA has taken several steps to improve the rigor by requiring more information in the submission and by eliminating nearly 1500 cleared devices for use as predicates to demonstrate substantial equivalence.

In short, the FDA is raising the bar on medical devices! More data to demonstrate safety and effectiveness is expected before new devices can be approved or cleared.

FDA is focused on the Safety Action Plan and they have already taken several steps in this direction. As an example, the re-organization of the CDRH to integrate both pre-market and post-market functions in one place is nearly complete. This has two implications for device manufacturers – one, poor safety performance post-market will influence new product approval or clearance; and second, FDA may take targeted enforcement actions against manufacturers with poorly performing devices in the market. FDA is building new capabilities to obtain and monitor Real World Data (RWD) through the National Evaluation System for Health Technology (NEST)⁴ program, which has recently received additional funding. This national evaluation system will link and synthesize data from different sources across the medical device landscape, including clinical registries, electronic health records and medical billing claims. The idea is to generate evidence that will help the agency “strike the right balance between assuring safety and fostering device innovation and patient access”.

Another major change in the global regulatory landscape is the revised medical device regulation in the European Union (EU-MDR and EU-IVDR) with a very heavy emphasis on risk management with the goal of improving patient safety.

In conclusion

MedTech should expect both regulatory and market pressure to improve safety performance of medical devices. Rising healthcare costs will drive increased scrutiny by payors, increasing public awareness of poor safety will rapidly erode brand equity, and renewed regulatory focus on public safety will affect how fast you can get your product out in the market. Those with a strong focus on patient safety throughout the product lifecycle, from design to launch to post-market, will have a significant competitive advantage.

It’s time for patient safety to become a strategic imperative for MedTech.  

1. OIG report: Shortcomings of device claims data complicate and potentially increase Medicare costs for recalled and prematurely failed devices

2. FDA: Safer Technologies Program (STeP) for medical devices

3. FDA: Medical Device Safety Action Plan

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