Using a medical device that doesn’t have 510(k) clearance is like operating a vehicle without a license

While you CAN drive without a license, you may not be safe and competent to be on the road.  And, if caught, you may be subject to penalties.

During recent customer visits, we became aware that many blood banks don’t clearly understand the significance of the FDA 510(k) clearance for medical devices – including users of Safe-T-Vue temperature indicators.  In this VUEPOINT, we explain what the 510(k) is, why it matters, and how you can know if a product that you are using has been cleared by FDA 510(k).

What is the FDA Section 510(k)?

The purpose of the FDA is to oversee the safety of food and medical products in the US. Much of the FDA’s authority is derived from the Federal Food, Drug & Cosmetic Act. Section 510(k) of the act requires manufacturers to notify FDA prior to marketing a new, non-exempt medical device.  As a result, this premarket notification is called a 510(k) submission.  A 510(k) submission is made to the FDA to demonstrate that the medical device is substantially equivalent to another legally marketed medical device, called a predicate device.  Substantially equivalent means that the device is at least as safe and effective as the predicate device.  FDA reviews 510(k) submissions and determines if the medical device is substantially equivalent or not.  If the FDA determines that the device is substantially equivalent , then the device is considered “510(k) cleared”.

Screenshot of FDA website to Search Medical Device DatabaseThis FDA requirement applies to medical devices including temperature indicators for blood and is of critical importance.  510(k) clearance shows that the FDA has reviewed the data and found the device to be as safe and effective as another 510(k) cleared device already on the market.

Just because a product is being sold into the healthcare market, do not assume it has been cleared by FDA.  Ask your supplier – and make them prove it.

Think of the 510(k) like a driver’s license.

If a person operates a motor vehicle without a driver’s license, they are not only in violation of the law; you have a potentially unsafe driver milling about among those who are legally licensed.  The unlicensed driver may not have passed the required exam or worse, had his/her license revoked due to unsafe and/or violative performance.  An unlicensed driver may be perfectly capable of safely operating a motor vehicle, but if caught, will be subject to penalty.

How does this apply to medical devices like temperature indicators?

A product that has not been cleared by FDA under section 510(k) may not have been reviewed for safety and effectiveness and therefore, does not have the legal right to be in the market.  The product may be safe and could perform quite well, but then again it may be unsafe and not meet its stated performance criteria.   The 510(k) clearance gives you some assurance that the product has been reviewed by the FDA and determined to be as safe and as effective as other legally marketed devices.

What else can you do to assure that medical devices you are using in your lab are safe and effective?

Quality Audits

In addition to 510(k) clearance, credible suppliers have a quality plan to support the process and accuracy claims of their products.  For example, actual and statistical verification of Safe-T-Vue data supports the product claims.  As part of the quality plan, this data is reviewed by the company’s QC staff and annually by external auditors.

Origin of the Medical Device

The 510(k) authorizes the FDA to inspect manufacturing facilities, providing additional assurance that the product you are purchasing – and trusting – is manufactured within quality guidelines and best practices.  As an example, a product that has not met 510(k) clearance could be manufactured in a facility that also manufactures garments, without quality oversight.  Know where your product is manufactured and if that facility has been inspected by the FDA.

Summary

Going back to the driver’s license analogy, look to your suppliers of medical devices – including temperature indicators – to provide proof of their FDA 510(k) clearance.  If it is not clearly represented on the product packaging, website or literature – ask them.