Patient Safety
"Standards for devices exist, they just don’t make sense."
Diana Zuckerman
En Español | The FDA administration is the government agency that is responsible to protect the public by ensuring safety and effectiveness of some products such as drugs and medical devices, among others.
Medical devices require seldom rigorous evidence that they work well and safely, they can go from bandages to MRI scanners to smartphone apps to artificial hips.
Medical devices are classified by the FDA according to their level of risk to patients, being the Class I the category for low risk devices, such as oxygen masks, and Class III those with a high risk for the patient such a pace-makers.
The FDA Approval Methods:
Registration: Class I and low-risk Class II devices just need to register their product; they don’t have to go through an approval process nor proof any efficacy or safety. Example of this category are canes, dental floss, thermometers and plastic bandages.
Substantial Equivalence/501(k): Intermediate risk Class II have to show substantial equivalence to a product already in the market, products that have minor modifications are approved via this pathway.
Unfortunately it is also used for new devices with similar intended use and safety profile as other devices, even if it has a different mechanism or different material, such as screws or surgical mesh. Safety nor efficacy is required to be demonstrated, meaning that if a different material is used, one that can produce toxicity, it will be approved. More than 3,000 products are approved via this pathway each year.
Pre-market approval: Class III are required to demonstrate safety and efficacy of their products, through a clinical trial in which evidence is collected from humans, these are the 10% of devices that pose greater risk, usually used to support life, and are usually implanted. Examples are pacemakers, breast implants, heart valves, and external defibrillators. Fewer than 50 devices are approved by year, and are called “FDA approved.”
FDA Loopholes to Consider
90% of devices never have to provide clinical data, devices get tweaked and cleared for market without patient trials.
Device manufacturers can prove “substantial equivalence” with products manufactured before 1976 (grandfathered products) when there were no testing requirements.
Predicate devices that were problematic and removed from the market, may still be used to demonstrate “substantial equivalence” for new devices.
Devices may stay in the market even when manufacturers are aware of the problems.
The quality standards for the new devices subject for review, are flimsy.
Steps to Consider when Offered a Device
1. Ask your doctor for the brand name, product code, model and serial number.
2. Keep in mind that the FDA registration, clearance or approval says little if anything about whether a device actually works or is safe.
3. Review which regulatory pathway was taken.
Was a 510(k) clearance? What predicate device was used? Is the predicate still in the market?
Was there a pre-authorization? What was the “reasonable assurance” of the device safety and effectiveness?
4. Who funded the studies done, if any? What are the limitations and harms of the device?
5. Investigate the impact on survival, or all cause-mortality, rather than the surrogate marker results often used for approval.
6. Review the FDA Manufacturer and User Facility Device Experience database for adverse event reports from patients.
7. Calculate the true cost of medical device and failures, such as price of surgical implementation and visits to specialists for monitoring, and costs in the event of failure and removal.
8. Make a Google search to search for warnings from the public, if many law firms appear in the search that might be a sign for further investigation.
RESOURCES
FDA Adverse Event Reporting
National Advisory, Warning and Recalls
Food and Drug Administration (FDA)
International Drug Safety Advisory Sites
Canada: Health Canada (HC) – Advisories, Warnings and Recalls
UK: Medicines and Healthcare products Regulatory Agency (MHRA) – Drug Safety Update
Australia: Therapeutics Goods Administration (TGA) – Safety Alerts