Proper medical implant packaging is important for maintaining the safety and integrity of implantable devices. Packaging failure can result in contamination or physical damage that can cause serious injury to patients. Manufacturers must comply with strict safety and performance regulations from trade groups and federal and international organizations.
Agencies That Oversee Medical Implant Packaging Regulations
Several agencies have established regulations and guidance for medical implant packaging best practices. The exact requirements will vary depending on the type of medical implant, where you are located, and where you are shipping implants to.
International Organization for Standardization
ISO standards offer guidance for medical device manufacturers to ensure that products are protected during shipping, handling, and storage. ISO 11607 is the primary standard covering medical device packaging. It has two main parts. The first covers the packaging design, construction, and testing, while the second covers proper assembly, sealing, and use.
Some additional ISO standards to be aware of for implant packaging include ISO 15223 and ISO 20417. These cover requirements for symbols used on labels and package inserts.
Food and Drug Administration
The FDA has strict rules for medical implant packaging that manufacturers operating within the United States must comply with. Best practices required by the FDA generally follow ISO guidance.
- Labeling: Strict labeling rules are established under 21 CFR Part 801. They cover labeling for the implant, its packaging, and any accompanying package inserts.
- Registration: Manufacturers must register with the FDA and list covered medical implants and packaging systems.
- Quality management systems: FDA inspections ensure that manufacturing facilities meet requirements for devices, including their packaging, labeling, and storage.
Regulations mandate situations where packaging must undergo pre-market testing and approval with a medical device.
European Union
The European Union sets standards for medical implants distributed in member states in Medical Device Regulation 2017/745. It requires that packaging that contains sterile devices must be designed so that a compromised seal is evident to the end user. Additionally, packaging must include the CE mark denoting European Conformity and a unique device identification system marking.
If you operate within the EU, it is important to note that member states may have additional regulations. You must also comply with the rules of other countries where your devices are used.
Essential Requirements for Medical Implant Packaging
Regulations establish several essential requirements covering packaging design, construction, and labeling. These ensure implant devices avoid damage during shipping and arrive at medical centers in good, sterile condition.
Sterility
This is a key component of all regulations that takes precedence over any other packaging features. Sterile implant packaging uses non-leaching materials that allow for an air and water-tight seal.
Sterile barrier systems use materials such as medical-grade paper, plastic films, and Tyvek to keep contaminants out of packaging. These materials have the advantage of being able to withstand standard sterilization processes.
Even the best packaging is only as good as the ability of the end user. That is why implant packaging must contain opening instructions that explain how to maintain sterility.
Security
Physical protection is another important component of regulations. Packaging should resist tears, punctures, and cracks to ensure that the device is safe for implantation when doctors open it. All implant packaging must be able to protect contents during handling, shipping, and storage.
Devices that are individually packaged in inflexible pouches or blister packs often require additional protection. Plastic compartmentalized trays are an ideal solution. They keep packs separate, making it easy to locate and identify components.
Material Suitability
Material compatibility must consider wide-ranging issues, such as the type of sterilization used, shipping and storage conditions, and the device composition. For example, some adhesives are not suitable for high-heat sterilization. Additionally, certain metals react with plastics, which can cause problems when implants come in direct contact with their packaging.
In general, materials should be chemical and heat resistant. Some device packaging best practices also require materials to be non-reactive and non-toxic. They should comply with regulations covering terminally sterilized devices.
Materials Used for Sterile Implant Packaging
Manufacturers use several materials for implant packaging, including plastic and foil, as well as paper and plastic pouches. Each one must meet the rigorous standards established by oversight agencies.
Medical Grade Plastics
Medical-grade plastic is one of the most commonly used materials for medical implant packaging. It provides physical security and is easily sterilized. Additionally, its lightweight nature and the ease with which it can be formed make it well-suited for a wide range of packaging needs.
Several types of medical-grade plastic exist to meet the needs of different implantable devices. These include:
- Acrylonitrile butadiene styrene: ABS resists abrasion, chemicals, and corrosion
- High impact polystyrene: HIPS is versatile and lightweight
- Polyethylene: HDPE is durable, rigid, and resists most chemicals
- Polypropylene: PP tolerates high temperatures used in sterilization
- Polyvinyl chloride: PVC is cost-effective, lightweight, strong, and compatible with a range of sterilization processes
An advantage of medical-grade plastics is that they are generally biocompatible. This provides an added layer of safety for manufacturers when packaging medical implant devices.
Paper and Plastic Pouches
Many manufacturers package smaller medical and dental implants in pouches. These are very lightweight and flexible. They are easy to open without compromising sterility, and transparent plastic makes it easy to verify contents against labels. However, paper and plastic pouches offer little physical protection for shipping and storage.
Foil Bags and Films
Metallic foils offer excellent protection against punctures and keep implants out of direct light that can degrade certain materials. Foil bags are compatible with many sterilization processes and make it very easy to spot a compromised seal. They also offer slightly better physical protection than paper pouches.
Plastic Trays for Secure Medical Implant Packaging
The medical implant packaging you choose is a critical part of the device design and approval process. It should be user-friendly while providing physical protection and a sterile environment. At Ready Made Plastic Trays, we design and manufacture custom trays to help you meet these requirements. We use sustainably sourced medical-grade plastics that ensure your implants are protected during shipping, handling, and storage. Contact us to request a sample.
