Medical Device vs. Medical Equipment
Any material selection process is guided by end-use requirements. In the healthcare industry there are important distinctions between “medical device” and “medical equipment” that you must understand before evaluating polymers and other materials. First, consider how the World Health Organization defines medical devices and equipment:
Medical device: “An article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose. Typically, the purpose of a medical device is not achieved by pharmacological, immunological or metabolic means.”
Medical equipment: “Medical devices requiring calibration, maintenance, repair, user training and decommissioning – activities usually managed by clinical engineers. Medical equipment is used for the specific purposes of diagnosis and treatment of disease or rehabilitation following disease or injury; it can be used either alone or in combination with any accessory, consumable or other piece of medical equipment. Medical equipment excludes implantable, disposable or single-use medical devices.”
In the United States, the definition of a medical device is clearer: If a product is labeled, promoted or used in a manner that satisfies section 201(h) of the Federal Food, Drug and Cosmetic Act (FFDCA), it is regulated by the FDA as a medical device and subject to regulatory controls. According to the FFDCA, a medical device is any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, component part or accessory which is a) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, b) Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or c) Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals, and which is not dependent upon being metabolized for the achievement of its primary intended purposes
Still unsure whether you are evaluating materials for a medical device or medical equipment? You can refer to the FDA’s Product Classification Database for help determining if your product is a device as defined by section 201(h) of the FFDCA. If you have additional questions or need further help with device determination, contact the FDA’s Office of Compliance. Note: Device Determination Officers only provide an informal device determination and do not determine device classification.
How OEMs and Design Engineers Can Select the Right Polymer With Confidence
As demand for plastic medical devices increases (thanks in large part to the growing need to improve performance and cut costs along with the viability of metal-to-plastic conversions, manufacturers and design engineers with limited plastics experience may struggle to make sense of the complicated world of polymers. There are dozens, if not hundreds, of polymers to choose from; selecting the right one is a delicate balancing act between performance requirements, manufacturability and cost. But while there are many different factors that need careful consideration at this stage, the first and most important is how the device will be used.
Medical device OEMs and design engineers can greatly narrow the field of polymer candidates by carefully defining end-use requirements up front and consulting their materials supplier early in the design process. Matching performance requirements with polymer capabilities is their area of expertise, and they can quickly steer you in the right direction and narrow your choices. This means less time spent evaluating materials, allowing you to focus on other mission-critical aspects of bringing a device to market.
Material Selection Based on Level of Body Contact
The more clearly defined your application is, the easier it will be to find the right material that satisfies performance and regulatory requirements. A key factor in this process is defining the level of body contact your application will be subjected to.
For applications having no contact with bodily fluids and tissues, design engineers can select from a wide variety of commodity, mid-range and high-performance polymers. In such cases, material selection will largely be driven by required performance properties, manufacturability and disinfection or sterilization requirements. For all other applications, the first and most important material consideration is biocompatibility — a general term used to describe the suitability of a material for exposure to the body or bodily fluids with an acceptable host response. Only a small number of specialty polymers are available as “medical grade” for applications subjected to biocompatibility testing. The choice of polymer will depend on the level and duration of body contact. .
The International Organization for Standardization provides widely adopted biocompatibility testing methodologies and programs (ISO 10993 test results are generally acceptable for applications in the United States; refer to other country-specific guidelines for biocompatibility testing outside of the US). The selected test program and biological endpoints depend on several factors, including time duration of contact with the device.
The above information is only a partial listing from the FDA guidance on ISO 10993. For the complete listing, please visit fda.gov.
How Your Polymer Supplier Can Provide Assurance and Confidence
Raw materials suppliers can help narrow your polymer choices depending on the type of medical device you are designing or manufacturing, but the ultimate assurance comes in the form of an FDA Master Access File (MAF). These documents may include formulation information, sterilization compatibility, recommended processing methods, ISO 10993 test results and other data that can help FDA reviewers assess the biocompatibility, safety and efficacy of the materials used in medical devices subject to 510(k) clearance and premarket approval.These file allow the FDA to review such information without the raw material or component supplier disclosing proprietary material information to the medical device manufacturer.
When an OEM is ready to submit a medical device for clearance, the materials supplier will issue a Letter of Access (LOA) granting the FDA permission to review any applicable files they have submitted. The LOA also provides the FDA reviewer with direct access to a representative from the raw materials company, who can answer questions and provide additional information as needed to assist in premarket approval and clearance (material formulation is sometimes considered confidential intellectual property, which can make it difficult for OEMs to answer material-related questions if their suppliers have not submitted Master Access Files to the FDA).
Raw materials suppliers are not required to submit Master Access Files, but many have done so to help bolster their customer’s confidence in using their materials for medical device applications. Well-documented records can also facilitate the design and regulatory application process for medical device OEMS, minimizing additional biocompatibility testing and thereby accelerating time to market.
With over 30 years of experience as a leading materials supplier to the healthcare industry, Syensqo understands the technical and regulatory support OEMs need to select medical-grade polymers with confidence. For this reason, we provide FDA Master Access Files for our entire portfolio of medical grade polymers which have been evaluated to ISO 10993 standards. We also provide global regulatory support for your medical device submissions.