You’ve seen the headlines: Medical Device Maker Fined Millions in Penalties. FDA Critics Outraged Over New Medical Device Rule. Patient Dies from Medical Device Warning Gone Wrong.
No matter how you cut it, it seems clear that more aggressive oversight of medical devices is sorely needed. Annually, greater than 3,000 Americans die from issues related to medical device complications that include everything from dirty scopes that cause infection to downright defective devices (Think the 2010 Depuy Hip Recall). The cost to the country has soared into the billions. Government officials seem unconcerned with enforcing stricter regulations to protect their constituencies, largely due to the costs of implementing medical surveillance systems.
Why Aren’t Medical Devices Far Safer?
For starters, the United States does not track medical devices in the same way as, say, prescription drugs, which are coded with unique identifiers. Many medical experts agree that nearly all medical devices, not just the high-risk types, should be “tagged”. Additionally, the codes should be entered into patient health records in order to better analyze and sort out any future issues. Opponents fear the potentially prohibitive cost and the additional time and strain on healthcare teams when a patient needs surgery that, for example, requires multiple plates, screws, and miscellaneous hardware. Additionally, since it is unclear exactly where this information would be recorded (the US has not yet migrated to a health records system that allows patient information sharing across multiple medial facilities), questions arise as to how precise such a tracking system might be, and how data might be collectively analyzed.
Then again, similar systems already in place and working in healthcare facilities across Sweden, England, Wales and Australia have been able to detect some medical device flaws far more rapidly than in the United States.
The bottom line?
Medical devices are manufactured to save lives and to reduce or eliminate pain. Sadly, some, like the faulty defibrillators that affected 200,000+ patients and cost Medicare $287 million, cause untold harm.
The problem is, we don’t know which ones to avoid until it may be too late. Devising a system to track this data, although costly, holds out the potential to save millions of innocent lives.