Navigating Medical Device Evaluation Challenges

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  • Sep 05, 2019

From Patient Safety & Quality Healthcare

Evaluating the clinical, cost, and safety benefits of medical devices is more important than ever. Unfortunately, it’s more difficult than ever as well due to factors such as incredibly complex care delivery, the sheer volume of medical devices on the market, an explosion in scientific knowledge, healthcare fragmentation, and the tendency to rely on vendor marketing materials for information. In this Q&A, Gina Thomas, RN, MBA, chief nursing advisor at Lumere, offers her perspective on how healthcare organizations can manage these challenges.

Q: Why is it more critical now than ever to evaluate medical device safety, cost, and efficacy?

Gina Thomas: Over the past few years, health systems have become more adept at avoiding readmissions, improving quality scores, and lowering costs, driven in part by pressures from risk-based payment models. Yet, the U.S. remains a country with the highest GDP and medical errors being the number three cause of death. Healthcare organizations continue to be under intense financial pressures; therefore, managing costs (even at this granular level) of device analysis will be required.

While I’ve heard some healthcare leaders suggest that overuse, underuse, and misuse of medical devices is a separate issue from patient safety, I find this argument to be fundamentally flawed. Key examples of this exist in the expansion of robotic surgery utilization, where clinical evidence and careful patient selection is critical. Patient safety and outcomes-oriented expertise is essential as robotic technology continues to evolve. In the same way that an organization would never set a target of reducing catheter-related infections from five to three, we must strive for zero harm resulting from device safety issues.

Q: Can you effectively evaluate medical devices by looking at one factor, or must you consider the role of all three? Why?

Thomas: The value equation makes it imperative to examine safety, efficacy, and cost holistically and to treat them with equal weight. Analyzing only the cost of a medical device can lead to an ill-informed clinical decision that negatively impacts the patient. Similarly, a clinician may agree to use a certain medical device based on efficacy and/or cost-effectiveness but miss out on recently reported safety issues, potentially leading to more interventions, longer hospitalization, and higher costs in the long run.

Q: How have health systems traditionally evaluated the safety and quality of medical devices?

Thomas: Health systems have often relied on three informational sources: clinician expertise and experience; manufacturer-provided product materials; and their own quality, biomedical, and research departments. However, there are challenges and shortcomings associated with each.

While clinician expertise is extremely valuable, it inherently will not represent the full body of clinical evidence, cost information, and adverse event reporting. As clinicians face pressure to see more patients in less time, they have less capacity than ever to keep up with the flood of available information. Compounding this is a lack of access to necessary data. A recent study found that while the vast majority of surveyed physicians believe that access to cost data drives better care decisions, only 40% of surveyed physicians are currently given access to this data. Charge data is often more readily available than actual acquisition costs. In some situations, physicians only receive extremely generalized cost benefits (e.g., being told a device leads to “better reimbursement” or “decreased length of stay”) that at best lack sufficient detail and at worst can be dangerously misleading.

Additionally, manufacturer-provided materials provide great information about functionality, features, and benefits, but are not a substitute for objective data. Finally, quality, biomed, and research departments are often inundated with requests, and the generalists who address them do not have the deep expertise to translate the data into clinical practice or indication.

Q: What information/data sources are required to comprehensively assess the safety and quality of medical devices?

Thomas: Unbiased, objective data sources that can present a broad view are critical complements to clinical expertise and associated guidelines. Disparate groups of decision-makers must have access to these “sources of truth” to ensure the clinical decisions are well informed. Done well, this means hosting a recurring departmental meeting wherein various departments (clinical leadership, service line, supply chain, value analysis, safety and quality, etc.) share details about top-of-mind projects and present data that is relevant to real-world practice. Ideally, these conversations occur within a patient unit with real patient application. This keeps the patient at the center of efficient, evidence-based discussions.

Organizations should also utilize resources to proactively monitor publicly reported adverse event trends and send alerts to service line and physician leaders. This empowers organizations to remain ahead of a manufacturer notification of adverse events or product recalls (which are often delayed by several months). Consider the recent debacle concerning Allergan breast implants: Significant adverse events have been reported since mid-2017. Questions were raised to the FDA about product safety in March 2019, but it wasn’t until the end of July that FDA asked Allergan to voluntarily recall specific implants.

Q: How should the different members of the healthcare team use this data when assessing medical devices? How should other healthcare leaders leverage this financial or business leaders use it?

Thomas: Knowledge sharing between clinicians and financial or business leaders is paramount when reviewing clinical indications or use cases. This step ensures financial and business leaders understand why a clinician is requesting a particular device. This process also presents an opportunity for clinicians to access valuable cost data that they may not otherwise receive. When assessing medical devices, business and clinical leaders should establish and agree upon a common and consistent set of patient safety and quality requirements, which may include factors such as indications, contraindications, efficacy, recently reported adverse events (either broadly or in their own organization), and any changes in technique that may pose harm to a healthcare worker or a patient. Any concerns about the interpretation of the data should be raised in real time. Once there is a clear understanding of use, safety, and evidence, the cost impact is easier to apply.

Q: Is this data easily accessible to physicians, and do they even have time to review it?

Thomas: The safety, efficacy, and quality data that physicians have access to may not always be easy to extract. Consider the recent outcry for enhanced transparency of the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. Many physicians find the database difficult to navigate, and tracked events are not summarized. While each reported event can be viewed, trends or root causes aren’t summarized for ease of understanding.

It is also time-consuming to digest the available evidence. A practicing physician would need to read 20 articles a day, 365 days a year to keep up! Additionally, physicians in many organizations feel they can’t access cost data when they request it.

Q: How can patient safety and quality professionals play a more strategic role in decision-making?

Thomas: Many studies have shown that interprofessional collaborative care can lead to better, less costly outcomes. A huge opportunity exists for patient safety and quality teams to position themselves as expert counterparts to clinicians and establish more proactive collaborative working relationships. The first step is to act as an active participant in governance processes as well as to establish safety as a priority every day by proactively asking what safety concerns people have.

The following questions can encourage ongoing involvement with clinical decision-makers:

  • Could I help research any of the following for you?
  • What safety information have you considered for this request or initiative?
  • Where did that information come from?
  • Have you considered whether we have had any incidents in our organization with this particular product that would warrant a change? Was there an industry event that has initiated broad, far-reaching change?
  • What’s the impact of this decision (e.g., innovation, improved outcomes, regulatory concerns, cost, etc.)?

Recent issues surrounding paclitaxel-coated balloons and stents for patients with peripheral artery disease provide a timely opportunity to leverage these questions with clinicians. In March, the FDA issued initial guidance to healthcare providers to generally limit the use of these devices until additional safety analyses could be performed. After a detailed review of all available data, the FDA concluded there was evidence of a late mortality signal in patients, but the data was insufficient to confirm whether this was true of all paclitaxel-coated devices.

In an August 7 update to healthcare providers, the FDA recommended that these devices remain on the market, but encouraged providers to consider alternative treatment options until longer-term data becomes available. Essentially, the FDA has left decision-making up to providers and patients.

Q: What recommendations do you have for evaluating new medical technologies that may not have much (or any) clinical evidence available?

Thomas: In addition to the questions I mentioned above, a number of factors should be considered, such as the organization’s appetite for risk, an understanding of what makes this product different from comparable or legacy products, and exploring if and how other organizations have evaluated the device. Here are several helpful questions:

  • Does the unknown risk outweigh the unknown benefit? What’s the magnitude of the risk?
  • Are the physician and organization willing to take that risk?
  • What are the differences in device design and material?
  • Does the patient understand that the device has limited clinical evidence to support the positive outcome intended?
  • Have there been successful uses documented outside of clinical evidence such as guidelines or other forms such as case studies and presentations?
  • What milestones can we agree to that would help in the evaluation in lieu of a significant body of evidence to demonstrate positive outcomes?

Gina Thomas is chief nursing advisor at Lumere, a Chicago-based analytics company that offers evidence-based solutions and services that empower physicians and health systems to reduce costly, unwarranted variation in drugs and medical devices.