Group 8: Abdane Gutema, Chunyang Lu, Disha Patel, and Pleh Meh
A Mayfield head clamp is a surgical tool that secures a patient's head to the operating table during spinal or neurosurgery procedures. It uses three pins to immobilize the head. During delicate procedures involving the brain or spinal cord, the clamp's pins pierce the skull and apply a precise amount of pressure to hold the head firmly in place, preventing any movement (DeltaMed, n.d; Integra LifeSciences Corporation, 2021).
It works by using three pins, which penetrate the bone, to slowly but firmly fix the skull in place. The 3 pins are attached to an adjustable metal frame that can be positioned and locked onto the operating table. Once it is correctly applied to the patient, the head is supposed to remain completely still, allowing surgeons to work accurately without interference (Machts et al, 2024).
The Mayfield head clamp is made of high-performance composite and aluminium. It comes in 3 different rod distance ranges available for different surgery tables. According to product listings from Howell Medical Apparatus and Instruments Co., Ltd. (n.d.), a typical Mayfield skull clamp costs around $1960-2380.
The Mayfield head clamp is considered a critical device because the pins would penetrate the patient’s skin.
Since the Mayfield Head Clamp is a critical medical device, it should be decontaminated and sterilized under stringent conditions to ensure patient safety. According to Vanderbilt University Medical Center (2007), the process can be achieved in three major phases:
1. Point-of-use Pre-Cleaning and Transportation: The clamp must be wiped with a sterile, damp cloth immediately after surgery in order to get rid of the gross bioburden, such as blood, tissue, and bone dust. It should then be carefully dismantled. Skull pins, clamp frame, torque handle, and screws should be stored in a specific leak-proof container with enzymatic solution, so that the debris does not dry out while being transported to the Medical Device Reprocessing Department (MDRD).
2. Manual Cleaning and Decontamination in MDRD: Since the head clamp has complicated hinges, screw threads and sharp pins, it should be cleaned manually. The dismantled components should be placed in an enzymatic solution, cleaned with soft-bristled brushes to ensure that all the grooves and threads are burden-free. The sections should then be rinsed well using clean water. Lastly, parts are dried thoroughly with lint-free cloths or compressed air, in order to minimize corrosion.
3. Sterilization: Low-Temperature Sterilization is the most popular and most preferred method (Centers for Disease Control and Prevention, 2023). The heat and moisture used in steam are harmful to the temper of the skull pins. Steam autoclaving is not recommended by the majority of manufacturers (Integra LifeSciences Corporation, 2021), since the high temperature and moisture would cause erosion. One of the most prevalent approaches to low-temperature sterilization is the Hydrogen Peroxide Plasma, as used in the STERRAD®️ System (Advanced Sterilization Products, 2025). This sterilization process is capable of killing all microorganisms, including spores. The chemical does not leave any residue, while still being safe to use on the metals. Furthermore, an alternative to the STERRAD®️ System is Ethylene Oxide (EtO) gas. Compared to the STERRAD®️ System, EtO sterilization requires aerated EtO in the system and has a longer cycle time, making it less efficient for routine practice.
Before being assembled again and returned to the clinic, Mayfield Head Clamps must undergo a thorough inspection to ensure its functionality. The process begins with a visual check to confirm that all parts of the device is free of biological residue or corrosion (Integra LifeSciences Corporation, 2021, p.8). The skull pins are carefully examined for straightness, sharpness, thread integrity, and any damaged pins should be replaced. The torque-limiting handle should be tested to verify that it releases within its force specifications. The structural verification is essential to ensure positive patient outcomes. According to FDA reports, “[m]ore than 700 patients have been injured since 2009 when skull clamp systems used to immobilize the head moved or slipped during surgical procedures, the FDA has reported.” (Voelker, 2016). The clamp’s attachment point to its base is checked for stability, ensuring that it would hold firmly (Payne, 2016). Finally, the device is assembled and documented in the equipment maintenance log.