Medical devices sold in the United States are subject to some of the most stringent manufacturing requirements in the world. Guidelines for every stage, from establishment registration to labeling, are detailed in U.S. Food & Drug Administration (FDA) regulations. Inspections are regularly conducted to enforce FDA regulations, and fiduciary penalties are levied for noncompliance.
In order to profitably manufacture medical devices with fasteners for sale in the U.S., companies must understand:
- The classification level of their device
- Regulations applying to their device
- The appropriate amount of torque for each fastener
- Reliable and reportable methods for torque delivery
- Reportable means of quality assessment
- Calibration and service needs of torque tools
To help manufacturers successfully create medical devices, we’ve prepared a short guide to appropriate torque verification devices and procedures for medical manufacturing.
Standards and Regulations Applying to Torque Application in Medical Manufacturing
The FDA would rather companies follow proper procedures than litigate against companies for noncompliance. As such, their standards and regulations are published freely online, easily accessible to legal and lay professionals. Manufacturers of medical devices must familiarize themselves with these regulations as applicable to their operations and proceed under their guidance.
In order to produce and sell medical devices in the U.S., manufacturers must:
- Register their establishment
- List their device with the FDA
- File a premarket notification or obtain a premarket approval
- Establish a quality assurance system
- Accurately label devices
- Create incident reporting procedures
To ensure your operation complies with FDA regulations, consult with qualified and experienced legal counsel. Legal counsel can register your establishment, list your devices, file notifications for approval, and detail appropriate labeling and incident reporting guidelines.
Your legal counsel will also help establish guidelines for your quality assurance system. However, in order to translate regulatory requirements into physical devices and practices, you’ll need to rely on the expertise of qualified engineers. Your engineers will determine proper torque values for each of your fasteners, in addition to reliable and reportable delivery methods. To make an informed decision about the devices and processes you’ll need, start with the basics—your product.
Classifications of Medical Devices
Medical devices are classified into three primary groups: Class I, II, and III. Manufacturing requirements are least stringent for Class I products and most stringent for Class III products. Devices are classified according to their intended and indicated uses, as well as any risk they pose. The greater a device’s potential to cause harm, the stricter the requirements which govern its creation.
You can determine the classification of your device by searching for its type in the FDA’s product database. Or, you can search for your device by its classification panel, which narrows your query to the appropriate medical specialty. Once you’ve determined your product’s classification, you’ll know which regulations apply to your manufacturing process.
Establishing Compliant Quality Assurance Systems
Instead of dictating manufacturing methods each company must use, the FDA has opened space for production innovation by stating certain qualities each system must know. Simply put, they’ve prescribed the ends, but not the means.
Depending on the specific nature of the devices a facility is manufacturing, the manufacturing process will be subject to different requirements. To understand the requirements your device is subject to, review the FDA’s Design Control Guidance. It includes topics such as appropriate practices for risk management, device reliability, and device durability.
Torque Control in Medical Manufacturing
If your medical device requires fasteners, you will need to determine, apply, and verify appropriate amounts of torque for each fastener. Depending on the classification of your device, more rigorous standards for repeatability may apply. Consult the product database to find the standards that apply to your product, then choose the proper tooling and verification devices to efficiently create your product within acceptable standards.
Choose your torque tools based on the needs of your product. Find the torque range you need your tools to deliver, the specificity stipulated by your engineers and legal counsel, and the rapidity needs of your assembly.
Torque Verification Devices for Medical Manufacturing
Hand tools, like break-over wrenches and cam-over wrenches, deliver small amounts of torque at slow to moderate speeds, with high specificity. Hand torque screwdrivers enhance the user experience during the fastening process. These tools deliver precise torque control and prevent a fastener or bolt from being tightened too much or too little. Hand torque screwdrivers are available in both preset and adjustable configurations.
DC control electric screwdrivers, while more expensive than hand tools, deliver precise torque amounts at high speeds. Multiple screwdrivers can be connected to the same automated control system and programmed to fasten complex sequences. This connectivity allows for simple data collection. The speed and efficiency of DC control electric screwdrivers make them ideal for high-paced production environments.
For sensitive medical devices under extremely strict manufacturing guidelines, clean room screwdrivers may be required. Clean room screwdrivers are designed to emit as little airborne particulate matter as possible, maintaining dust-free air for the most delicate assemblies.
Service and Calibration for Medical Manufacturing Torque Tools
To maintain compliance and repeatable product quality, torque tools must be regularly calibrated and serviced. The minimum calibration interval for most torque tools is six months. However, depending on the classification of your device, your quality assurance system may demand more frequent tool inspections, calibrations, and preventative maintenance. Some assemblies require testing before each use.
To calibrate and service your torque tools, you can invest in varying levels of calibration equipment and certification. If you want to fulfill further requirements, you can supplement your internal program with the aid of a certified service center. To begin building an internal calibration regimen, you will need to invest in torque testing equipment to diagnose your tool’s condition.
If you are calibrating tools in-house, you can hire or train certified technicians and procure calibration equipment. Alternatively, send your tools to qualified service centers, which can handle nearly any calibration need and often have expedited service programs. However you calibrate your tools, though, you’ll need to record the process and provide complete documentation for FDA inspections.
To successfully create and market medical devices in the United States, your operational procedures must be specific and impeccable, in compliance with every guideline. Knowing the regulations and how they apply to your products is essential for every manufacturer. Any device which requires fasteners must be built with the proper tools, to carefully designed specifications. The customers of your medical devices accept no less.
