Controlling device cost
Medical devices that don’t work as designed are an increasing problem in health care, causing pain and frustration for patients and additional cost to an already expensive system. Orthopedic surgery is an increasingly prominent specialty in this arena, and has three of the top 10 cost increases for all healthcare procedures over the last decade.
Beth Israel Deaconess Medical Center orthopedist Charles Day, MD, MBA, Chief of Hand and Upper Extremity Surgery, recently named by Boston Magazine as one of the ‘Top Docs’ in Hand Surgery, was invited to speak on upper extremity Patient Reported Outcome (PRO) instruments by the US Food and Drug Administration as it reexamines how it reviews and approves these devices.
“Companies are spending a lot of money on devices that may not work in the long term and result in poor outcomes for patients,” says Day, who spoke in a recent conference on “Minimum Clinical Important Difference: Defining Outcome Metric for Orthopedic Devices.”
The purpose was to bring together orthopedists, industry representatives, PRO experts, and the government representatives to discuss the current state of orthopedic device approval utilizing PROs and how best to gather patient-reported outcome measures in order to improve the entire process.
“Patient-reported outcomes are a significant part of that process,” says Day. “Without tools that accurately measure how well or not devices and treatments work, it’s hard to judge the clinical impact of a new device.”
Day notes orthopedic procedures have grown increasingly expensive but not necessarily effective. The most recent example is the Depuy metal-on-metal replacement where hip joints can develop abnormal tumors and, either fail or require a second replacement surgery. The device was approved under a process that assumed it was substantially the same as a previous model on the market, allowing it to bypass the traditional safety and efficacy testing protocols.
Also troubling is that the process can be influenced through non-scientific measures, citing the example of a knee meniscus implant – the Menaflex Collagen Scaffold – that was pushed through from political pressure of congressmen who received campaign contributions from the manufacturer. The FDA recalled that device, admitting to the mistake.
Day views a properly running system as one where orthopedists choose the best devices for their patients based on the best available data, monitor and track those devices in their own patients and report any adverse findings to a federally regulated database.
“Without outcome measurement tools to aid in reporting complications and device efficacy and without registries in which to report findings, devices are essentially not monitored until failure, resources are already wasted, and unfortunately, hundreds of patients can be hurt along the process,” says Day.