Orthopedic devices play a crucial role in improving patient care. These devices come in various iterations like knee braces, neck collars, and joint replacement implants, and their main goal is to alleviate pain and enhance mobility for patients. However, this quality of life improvement is only possible if orthopedic implants and devices are manufactured and kept in sterile environments. As an orthopedic manufacturer, it’s imperative to learn the ins and outs of sterility and the role that cleanroom classifications can play in improving orthopedic manufacturing efficacy and safety.
Possible Orthopedic Device Complications
Orthopedic devices are particularly vulnerable to contamination due to the nature of their use. Whether you’re manufacturing internal or external devices, these items come into direct contact with bodily fluids and tissues during implantation or daily use. These products are instrumental in providing patients with a better quality of life, so ensuring sterility upon both first use and continuous, rigorous use is of utmost importance to the efficacy of the devices and prevention of adverse patient outcomes.
● Implant failure;
● Site or systemic infections;
● Allergic reactions to residues or impurities;
● Reduced efficacy and longevity of the device.
Surgeons and operating room (OR) staff also have a responsibility to practice sterile instrument wrapping techniques to prevent these mishaps. Ensuring sterility from initial manufacturing to patient dissemination safeguards both patients and product effectiveness.
Understanding Cleanroom Classifications
Implementation of rigorous cleanroom standards can significantly improve the safety, quality, and reliability of orthopedic device manufacturing processes. Cleanrooms are separate, controlled environments built with the purpose of minimizing contamination. Stringent protocols and devices like HEPA filters ensure low levels of airborne particles and potential contaminants.
There are various requirements for an orthopedic manufacturing cleanroom to become certified. Cleanroom classifications are set forth by the International Standards Organization (ISO) and are based on particle count. The ISO 146644-1 Cleanroom Standards include ISO-1 up to ISO-9. ISO-3 through ISO-8 correspond with the United States Federal Standard 209E’s Class 1 through Class 100,000. The higher the number, the more particles are in the cleanroom and the less clean the environment.
Medical device manufacturing cleanrooms are commonly at least ISO-8. These cleanrooms have a maximum particle count of 100,000 per cubic foot. However, the more sterile the environment, the better. Cleanroom setup is an initial investment but is imperative to meet regulations and ensure patient safety.
Implementing Stringent Manufacturing Protocols
Good manufacturing protocols for orthopedic devices are imperative to improve the efficacy and safety of products. A cleanroom setup should provide proper HEPA filtration systems, airflow, and design in line with the desired ISO classification. For example, ISO-7 requires certain design aspects, such as:
● Conventional T-bar grid ceilings;
● 99.997% HEPA filters;
● 60 air changes per hour;
● A 2’ x 4’ cleanroom light fixture;
● Modular or drywall walls;
● Sheet vinyl or VCT flooring.
Beyond cleanroom design, however, your manufacturing team is responsible for following strict protocols. This includes
proper garments and gowning techniques, best-practice material handling procedures, and rigorous surface disinfection.
● Pre-cleaning with sprays, water, or dry or wet wipes to remove debris;
● Main cleaning to eliminate all debris using a detergent and water;
● Rinsing with clean water and cloths, wipes, or mops;
● Disinfecting surfaces to eliminate bacteria and viruses not visible to the naked eye;
● Waiting a proper amount of time for heat or chemical disinfectants to work;
● Rinsing for the final time to remove disinfectant residues;
● Drying with clean cloths or air to prevent bacteria growth.
This level of detail is crucial to keeping orthopedic device manufacturing safe and efficient.
Improving Patient Safety and Product Efficacy
The quality of the devices you manufacture is important to your brand and patient safety. Adhering to regulations is simply not enough and is best to find ways to improve your cleanroom practices.
Group brainstorming can provide you with diverse perspectives, solving contamination issues you may not be aware of initially. For example, someone could notice a particle spike during certain times of day, and you can adjust workflow to minimize contamination. Working together with your team can also reduce biases and build camaraderie, making sure everyone is motivated to do their best and follow procedures.
Getting together with your manufacturing team can give you insight into potential contamination risks at each manufacturing stage and allow you to discuss hypothetical scenarios for improvement. Continuously striving to improve cleanroom protocols allows you to monitor situations, learn from incidents, implement ongoing training, and adapt your practices for maximum efficiency and safety.
Manufacturer Responsibility Moving Forward
Determining the required cleanroom classification for orthopedic device manufacturing has long-lasting effects on not only your organization but the industry as a whole. The safety and satisfaction of patients is always the top priority.
Keeping it clean in the manufacturing process is a small price to pay to ensure product efficacy through device improvements, staff changes, and societal shifts.
Amanda Winstead is a writer from the Portland area with a background in communications and a passion for telling stories. Along with writing she enjoys traveling, reading, working out, and going to concerts. If you want to follow her writing journey, or even just say hi you can find her on Twitter.