In a recent Q&A with MedTech Intelligence, John Cherf, M.D., MPH, MBA, chief medical officer of Lumere shares his perspective on the challenges facing healthcare stakeholders in the journey to improve patient safety.
MedTech Intelligence: What is the impact of medical device complications to the healthcare industry in terms of both care quality and financial burden?
John Cherf, M.D.: Medical device complications are harmful to patients, society and the financial well being of hospitals. Every year, over 600,000 patients are admitted to hospitals for device complications, costing health systems nearly $12 billion. However, the true costs to a hospital extend beyond the initial admission. Fifteen to twenty percent of patients with device complications will be readmitted for various reasons, and the cost of those readmissions are typically significantly more expensive than the cost of the initial index admission. Additionally, a patient going through extensive revision and diagnostic processes following a device complication is likely to adversely impact patient satisfaction scores, leading to potential adverse impact to the institution.
MTI: The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database contains publicly available information about adverse events. Why is it so difficult for health systems to use it to reach conclusions about the safety of medical devices?
Cherf: The MAUDE database contains medical device reports submitted by voluntary reporters including patients, attorneys, manufacturers and users (e.g., hospitals ASCs, outpatient facilities). This construct has limitations. It is an inherently passive system that relies on the accuracy of non-standardized reporting. The early reporting of adverse events may be understated until publicity or general awareness about an alleged product defect occurs. If you look at the MAUDE homepage, you’ll see that the agency is very upfront about some of these limitations.
MTI: Are manufacturer-initiated recalls and FDA warnings insufficient for identifying potential safety issues? Can you provide a specific example?
Cherf: Recalls are often not issued until significant damage has already occurred. For example, an in-depth analysis reveals stark differences between surgical stapler-related adverse events reported by two vendors. In 2016, 59% of one vendor’s stapler-related adverse events were considered ‘serious’ (i.e., resulted in patient injury or death). Alternatively, the other vendor’s staplers had a 41% serious adverse event rate. The vast majority of reported serious adverse events were leakage. Data also showed differences in how the two devices malfunctioned: The first vendor’s powered staplers had a higher proportion of adverse events that stemmed from the devices failing to fire, whereas overall the second vendor’s staplers were more prone to incorrect staple formation.
MTI: Given the current state and challenges you’ve outlined, should other healthcare industry stakeholders be involved or are there other ways to improve monitoring patient safety concerns? How can hospitals and physicians better serve as a strong line of defense for assessing the safety of devices? How can they develop a better understanding of the available scientific research and safety data?
Cherf: Given what I’ve outlined, the onus shifts to physicians and health systems to identify and protect their patients from harmful medical devices. Ultimately, physicians and hospitals are responsible for the quality and safety of the care they provide.
Lumere’s analysis of data from over 500 hospitals shows that organizations have historically approved 83% of requests to introduce new devices, often with limited analysis. Hospitals need to develop staff proficient in understanding scientific research and safety data, implement procedures to monitor safety incidences specifically related to devices, and pay physicians for time spent reviewing devices.
MTI: Last fall, the FDA announced “transformative new steps” to modernize the 510(k)program to “advance the review of the safety and effectiveness of medical devices.” What impact will these changes have?
Cherf: The FDA’s proposal disallows manufacturers from referencing an old technology when seeking new product approvals. By eliminating references to older devices, it seems likely that medical device manufacturers will simply increase how quickly they bring new products to market.
This maneuvering introduces new problems—while new healthcare technology is nearly always more expensive, it is frequently no better at improving patient outcomes. As the FDA itself suggested in the press release announcing these proposed changes, “old” certainly does not always equate to “harmful.” In fact, a 2017 study published in The British Medical Journal made clear that newer hip implants are no more effective than older-generation products. We observed a similar phenomenon with newer knee implants.
MTI: What recommendations would you have for device manufacturers as they look to work more effectively with both the FDA and health systems to lessen the impact of device complications?
Cherf: I would tell device manufacturers to simply continue to embrace transparency and collaboration. There should be an open dialogue between manufacturers and providers. With the right information, we can put aside preconceived ideas, engage in healthy discussions, and collaboratively develop the optimal solutions for our patients.
The brief discussion of MAUDE leaves out that certain kinds of reporting is mandatory for hospitals, not voluntary. None-the-less under reporting is believed to be substantial.
The dis-allowance of using old predicates for 510(k)s is based on the assumption that newer is always better. We have many examples where the opposite is true.
What is entirely overlooked here is the responsibility of the manufacturer to conduct risk management of the product during development, manufacturing, and post-production to identify and address issues before release and in early release stages. Risk management has been a requirement of regulators for many years, yet manufacturers have often conducted inadequate review of the device risks during development and have failed to take sufficient action to reduce the risk to people. The ISO 14971 standard that defines medical device risk management has been in place for nearly 20 years, but we in the industry still don’t have it right. If it was strictly followed, risks would be reduced as would injuries and deaths.
It is similar to the Boeing 737 MAX8 situation where reviews of the safety systems analysis revealed incorrect steps in the analysis and failure to followup after design changes were made. We encounter the same situation in the medical device industry. Schedule and cost get in the way of developing safe and effective devices.