Avoidable medical complications plague American families physically, emotionally — and economically.
A poignant example of the damage caused not by accidents but by failures in the health care system was recently identified and carefully studied in the medical device space. An analysis by the Government Accountability Office (GAO) determined that physicians, hospitals and manufacturer failed to report to the FDA for more than 20 years the fact that a device used in hysterectomies, the power morcellator, was linked with deadly cancers.
Complications trigger not only a personal cost, but also a serious drain on our economy, in the form of higher health care prices and a burden on health insurance investments.
In our family, the power morcellator complication has meant more than $1-million in health care costs over the course of three years. Yes, we are fortunate enough to have good insurance. But these are costs that never should have happened.
Over 20 years, hundreds, if not thousands, of families have been harmed by the power morcellator, leading to untold millions in health care costs.
If a complication is a rarity and immediate steps are taken by practitioners and manufacturers to contain the damage, we might be able to accept them as part of healthcare being an imperfect science. But when a complication, like that caused by the power morcellator, goes unreported for over 20 years, repeatedly causing serious damage to lives and the economy, we must act to contain the damage.
The GAO report on power morcellators showed that complications associated with the use of flawed or dangerous medical devices are not being adequately reported to FDA by expert physicians, hospitals and manufacturers.
This failure is now an indisputable fact – and it is a systemic one that could affect any and all medical devices.
Many politicians today in this anti-regulatory climate are viewing pre-market regulation of drugs and medical devices as a burden that contributes to high costs. Yet this case shows that failing to regulate is hugely expensive.
If the Trump administration is serious about containing health care costs, a clear target is to demand that physicians promptly report problems their patients experience with medical devices. The Medical Device Guardians Act proposed in the 114th U.S. House of Representatives is the commonsense and cost neutral way to do so.
Fixing the adverse event reporting failure for medical devices will save American lives and dollars.
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