Vitamins, supplements, controlled medicinal substances, even the equipment used to clean hospitals—there’s a lot of items that go into the healthcare industry, and each of them carries their own specific storage and manufacturing guidelines.

Above and beyond being stored in the hospital or pharmacy itself, the way they’re stored inside your warehouse will be governed by strict federal regulations and will need to meet these safety requirements in order to be sold or distributed as needed. For anyone looking to learn more about these different guidelines and how they can affect your warehouse, we’ve provided a quick breakdown of many common medical industry guidelines and requirements:

 

Know the difference between regulated and non-regulated products

While nearly every product manufactured or sold in the United States today has to adhere to some kind of manufacturing and storage regulation, medical products are subject to stricter requirements than other non-medical products, even if they have similar materials and usage.

Things like cosmetics, vitamins, herbal supplements, beauty products like deodorant and shampoo, and other general-use body/health products will need to be handled appropriately (cold storage, sterile shelving, etc) but are not subject to the same strict demands from the FDA as medical products. Anything categorized by the FDA as a drug, medical/surgical devices, diagnostic tools, and the like do need special handling, and these handling methods will be provided by the manufacturer (storage temperature, security/labeling needs, etc) in the event that special care should to be taken.

 

Different classes of medical devices

As defined by the FDA, medical devices are “any item that is designed and intended for human use in the diagnosis or treatment of a disease, or an apparatus that can modify the anatomy or a physiological process”. This can be anything from an adhesive bandage to a scalpel used during surgery to an entire dialysis machine, and everything in between.

Without getting too far into the weeds in regards to the different individual devices this could include, it’s important to know the three different classes of device that the FDA breaks them down into:

 

  • Class 1 medical devices have the fewest controls and standards due to their relative safety and lack of potential danger to others. These devices will have the loosest requirements for storage, and will primarily focus on device registration and manufacturing process. These devices can typically be stored on normal warehouse shelving and wire shelving.
  • Class 2 devices meet the same standards as Class 1 equipment but include additional “special controls” such as labeling standards and monitoring rules, and include a range of products as diverse as surgical masks, syringes, and even certain powered wheelchairs.
  • Class 3 devices are extremely specialized and offer the strictest controls due to their sensitive manufacture and precise usage requirements, often involving life-sustaining products like pacemakers and other implants that require actual scientific review and approval. These will have the strictest storage and distribution standards and may require you to bring in outside supervision or consultation to make sure your facility is up to the needed FDA standards.

 

Sterile storage options

Above and beyond almost anything else, medical devices and pharmaceutical products need to be stored with regards to germ resistance and sterility. Even if your warehouse doesn’t deal solely with medical products, you need to make sure a special area is provided with sterile storage options like NSF shelving or specialized medical shelving to keep these products germ-free and safe as per FDA guidelines. Further storage options such as variable temperature and security precautions may be needed as well on a per-product basis.

 

Strict security

Finally, as mentioned above, many medical devices will require a high degree of security (even above and beyond what your warehouse currently offers) in order to keep these products properly stored and safe from misuse or theft. Use industrial lockers, security panels, and wire partitions where space allows in your warehouse to store these products in a way that minimizes theft or loss, particularly when it comes to controlled substances.

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