There are many companies now offering kits for bleeding control and advanced trauma injuries. They offer tourniquets, chest seals, bandages, and other products put together in various bags, pouches, packs, and boxes. It's easy to be confused about who to choose when purchasing kits that you and those around you will rely upon in an emergency.
You need to know that the company you purchase your trauma kits are experienced, registered, and have the necessary processes to do it right. So when looking for someone to provide or make kits, ask these questions.
1. Are they registered with the Food and Drug Administration?
First, know that trauma kits are registered devices with the US Food and Drug Administration. They are listed on the FDA's Product Classification website as "First Aid Kits without Drug" (Product Code OHO listed here) or, if they do carry drugs like antibiotics, "First Aid Kits with Drug" (Product Code LRR listed here). This means that companies making trauma kits like "Stop The Bleed" kits need to be registered with the FDA.
You can check to see if the company making your kits has registered from the FDA's Establishment Registration website here. H&H Medical has been a registered entity with the FDA for over 20 years and our entire listing of products can be found by clicking here.
2. Do they have a quality program backing their products?
Why should you care about a quality program? First, a quality program is needed to be in compliance with the FDA's current Good Manufacturing Practices (cGMP). This demonstrates to you that the company making your kits are following documented processes and procedures and will ensure your kits are made the same way every time.
More importantly, a quality program ensures that the company making your kits will be with you in case something goes wrong. Can your kit maker handle a recall and help you through the process?
H&H Medical holds an ISO 13485:2016 quality certification, proving that we have independently audited processes to manage the entire kit process. We also track all the lot numbers of all the products we sell, ensuring that we will be with you every step of the way.
3. Do they stand behind the products they are selling?
Many companies creating trauma kits have experienced professionals working with them to create the kits. They understand the recommendations of different panels and have chosen products to match those recommendations. But do they know the products as much as the manufacturers?
We do because we are the manufacturers. Our kits include many proven H&H Medical products, including our SWAT-T Tourniquet, H-Bandage Compression Dressing, Bolin and H*VENT Chest Seals, and our TACgauze wound wrapping gauze. We have sponsored and participated in research studies (found here) supporting the effectiveness of many of our products.
And because we know our products, we know what products make sense for your specific needs. We can explain why one product might be preferred over another or why you may need more than one for specific situations. That's the strength of being the manufacturer.
4. Are they ready for UDI?
In 2020, the FDA will be mandating that all Class I products, including first aid and trauma kits, must have a Unique Device Identifier (UDI) barcode applied to all products. This means that the trauma kit you buy will need to have this unique barcode applied as well as the barcode information registered for uploading to the FDA.
H&H Medical is ready now for UDI. We have migrated many of our products over to having UDI codes on their packaging. We are also preparing to offer custom UDI codes for all of our kits including our custom kits we offer customers. And we will provide this to our customers at no charge.
Read more about our commitment to UDI here.
We take trauma seriously. Making emergency trauma products and kits is not just a job, it is a passion of ours. We believe in our products and our solutions are the best available. And we have the processes and procedures to support your needs well after we've sold you our kits. Give us a call at (804) 642-3663 or click on our "Contact Us" page for more information.