Facial Head Support
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Facial Head Support

The Facial Head Support is a single-use, non-sterile polyurethane foam device that supports a patient’s face and head during spinal surgery in the prone position. Anesthesiologists use it to hold the neck and spine in alignment while a T-shaped cut-out keeps the eyes, nose, and mouth clear.

Blue White Holdings, the manufacturer, is SAHPRA-licensed and ISO 13485-certified.

Blue and white polyurethane foam with a cut out T-shape opening in the middle for the patient’s eyes, nose and mouth. The Facial Head Support is used by anaesthesiologists in theatre for spinal operations. This disposable positioner assists in accurate neck and spinal alignment to provide facial/head support for when patients are undergoing spinal operational procedures in a prone position. The Polyurethane Foam is a widely used material. It is light, resist mildew and will not aggravate common allergies.

 

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Description

Patients undergoing spinal surgery lie face-down, in the prone position, for extended periods. That position puts the face, eyes, nose, and mouth at risk of pressure injury and makes it hard to keep the spine aligned without support. The Facial Head Support addresses both problems: anesthesiologists place it under the patient’s face and head to hold the neck and spine in alignment throughout the procedure, while the open T-shaped cut-out keeps the airway and eyes free of pressure and obstruction.

The device consists of two bonded polyurethane foam pieces: a 270mm x 240mm x 110mm blue base layer and a 270mm x 240mm x 60mm white top layer.

Polyurethane foam is lightweight, resists mildew, and does not aggravate common allergies. It is not classified as hazardous or as a mixture of dangerous substances.

Storage

  • Store finished products in a clean, dry, controlled area, away from direct sunlight, excessive heat, moisture, chemicals, sharp objects, and any source of contamination or foam deformation
  • Store in a manner that maintains product identification, batch traceability, and packaging integrity; do not store directly on the floor unless protected by suitable secondary packaging or shelving
  • Manage stock using First-Expired-First-Out (FEFO), or First-In-First-Out (FIFO) where no expiry date is allocated, to ensure controlled stock rotation
  • Segregate and handle damaged, dirty, compressed, wet, or otherwise non-conforming product in accordance with the non-conformance procedure

Handling

  • Ensure hands, work surfaces, and transport containers are clean and suitable for handling a medical device
  • Handle carefully to prevent compression marks, tearing, contamination, loss of labelling, packaging damage, or distortion of the cut-out area
  • Do not stack, crush, or expose the product to loads that may permanently deform the foam or compromise product performance
  • Do not release any product that has been dropped, contaminated, or damaged, or is suspected to be non-conforming; report it to Blue White Medical for assessment and disposition

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