For medical manufacturers, ensuring compliance in the packaging of surgical instruments is essential for regulatory approval and product integrity. It requires careful planning from the earliest stages of design to comply with applicable regulations. Each component must support sterile and secure instrument delivery from manufacturing to the operating room.
Surgical instrument packaging should support sterile conditions. It also must offer sufficient protection to avoid damage during transportation and storage. The following design requirements can help you select materials that meet these criteria.
Manufacturers must follow strict labeling rules for the packaging of surgical instruments. Packaging designs should be in the design history file for each instrument to ensure compliance. Labeling requirements include:
Additionally, all labels should be designed to last for the customary use period of a surgical instrument.
The design and makeup of all packaging materials must allow for normal use over a predetermined shelf life. This period includes the time from manufacture through storage and to the end use in a medical facility. Any breakdown, whether it is in the label clarity or structural integrity of the outer packaging, could compromise the instrument and make it unusable.
End users should be able to easily open any packaging of surgical instruments. This generally means an easily identified opening process, such as seen with peel-pouches and sealed trays. In most cases, packages must indicate how to open them while maintaining sterility.
Packaging must be of sufficient strength to protect the enclosed surgical instruments. The level of protection required can vary significantly depending on the type of use.
For example, surgical instrument shipping cases must withstand harsh conditions found during transport. This is crucial to avoid damage during shipping. However, individual instrument peel packs usually require additional packaging materials during shipping and, therefore, can offer less protection.
Packaging should be suitable for the intended use and design of the surgical instrument. Some of the most common types of medical instrument packaging designs include:
Each one offers advantages for certain situations. For example, peel pouches are easy to open while maintaining sterility. They are ideal for single-use instruments. Plastic surgical trays are excellent for multiple instruments. Made from medical-grade plastics, they maintain sterility when properly opened.
Multiple agencies affect the types, materials, and designs of packaging for surgical instruments. Within the U.S. market, these include the Centers for Disease Control and Prevention and the Food and Drug Administration. Within Europe, individual states establish requirements with input and guidance from the European Medicines Agency.
Major CDC requirements focus on sterilization. In the Guideline for Disinfection and Sterilization in Healthcare Facilities, the CDC states that all packaging materials should support sterilization through breathability, ease of use, and their ability to seal out contaminants. They must also be compatible with sterilization procedures such as ethylene oxide.
The FDA is the main regulatory agency covering surgical instruments and medical device packaging. According to Quality System Regulations, 21 CFR Part 820. These largely cover labeling, material suitability, and general manufacturing best practices.
An additional concern of the FDA is that all materials are suitable for direct contact with surgical equipment. It requires manufacturers to use non-toxic, known, traceable materials for all medical devices and surgical instrument packaging.
ISO 13485:2016 covers best practices for the handling and packaging of medical devices, including surgical instruments. ISO 11607 applies to products requiring terminal sterilization. Following these guidelines ensures manufacturers meet current regulations.
The materials used for surgical instruments must meet all other criteria for safety and protection. They should also be lightweight and thin to help reduce transportation costs and demands on storage space. Three of the most commonly used materials are paper, foil, and plastic.
Medical-grade paper is lightweight and can be sterilized through most modern procedures. It also allows certain sterilization agents to penetrate primary packaging for terminal sterilization. Similarly, foil wrappers are commonly used to keep individual instruments sterile and organized. However, many foils are incompatible with ETO sterilization.
Many different types of plastics are compatible with surgical instrument packaging. Plastic films are typically used to seal paper pouches and trays. Thicker, medical-grade plastics are formed into plastic surgical instrument trays​ and packaging materials. These provide more physical protection and are an excellent way to keep essential surgical kits together in a single, sterilized container.
All manufacturers, logistics providers, and users should follow established best practices for handling and shipping surgical instruments. These establish the following steps for packaging surgical instruments:
All surgical instrument labels should have the initials of the person who performed the packaging process. This provides a straightforward way to track potential contamination during packaging.
Primary packaging has direct contact with a surgical instrument, while secondary packaging is an outer layer. They have different requirements when it comes to medical devices.
Primary packaging must be suitable for terminal sterilization where applicable. It also must be made from non-toxic, medical-grade materials. There is greater flexibility in secondary materials, such as those used for shipping. However, they still must meet labeling requirements and be able to withstand anticipated conditions during transport and storage.
Ready-Made Plastic Trays manufacturers stock and custom trays from medical-grade plastics. Our team can help you find the right trays for the packaging of surgical instruments. Contact us to request a free sample.