Medical Warming Cabinets

Medical Warming Cabinets

What are they and how are they regulated?

A blanket warmer is known by many names, including; warming cabinet, blanket warming machine, and medical warmer as we refer to it. These units are often used to warm medical supplies like linens, blankets and sterile intravenous (IV) in a medical environment.

The warming cabinets have also been designed to bring the surgical fluids and solutions to the temperature levels required for the applications in the hospital and ambulatory treatments.

 

The top 5 uses for Medical Warming Cabinets

A warm blanket is an easy and safe method to increase patient comfort before and after surgery. This is just one of the many uses these devices serve. The five main use cases for warming cabinets are listed below:

 

  1. Blankets for patient comfort
  2. Irrigation solutions to maintain both the anatomic and physiologic integrity of intraocular tissues
  3. Intravenous fluids to deliver medications for blood transfusion or fluid replacement
  4. Injection fluids regulated at body temperature
  5. Blood to prevent hypothermia and safe infusion

 

South African Bureau of Standards

Albeit a medical device, the regulation is limited and the South African Bureau of Standards has no prescribed standards for these warming cabinets.

This is also true for global regulation, with the international EC.6.10 and EC.6.20 standards lacking any prescriptive requirements for this particular medical equipment. It is simply advised that manufacturers make a recommendation on the following:

 

  • Temperature set‐points
  • Temperature validation
  • High-temperature safety shut‐offs

 

As a manufacturer of medical equipment, we are frequently asked which ‘Class’ our Medical warmers are. This class level is often mistaken as an indicator of quality or licensing standard, when in fact, it does imply quality assurance at all. It does however stipulate the risk assigned to medical equipment.

 

The class matrix is divided into three categories, namely, class 1, class 2 and class 3. We have supplied the definitions of these below;

 

Class I Medical Devices

Class I medical devices have a low to moderate risk to the patient and/or user. Medical warmers fall within this category.

 

Class II Medical Devices

Class II medical devices are those devices that have a moderate to high risk to the patient and/or user.

 

Class III Medical Devices

Class III medical devices have a high risk to the patient and/or user and usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury.

 

As shown, these should not be used to determine the value of a product when planning an acquisition. Procurement officials should rather consider the following elements when evaluating the quality of a warming cabinet.

 

  1. The internal and external surfaces should be made from high-quality stainless steel for hygiene purposes.
  2. Medical warmers should have heat-resistant double glass to ensure energy saving as heat is retained more effectively. Glass doors are also recommended to prevent the unnecessary door opening due to the external view of the contents of the warmer.
  3. The walls and doors of the device must have double layers. Even though the wall thickness can vary between 20 and 25mm, the layers ensure effective temperature control.
  4. The air circulation must be distributed homogenously with a fan, which ensures even temperature distribution throughout the unit.
  5. A digital control must be present that displays the temperature with a visual and audio alarm notifying users of temperatures exceeding the set points. One of the most important elements is the automatic switch that powers down a device to prevent overheating.

 

 

All Minus40 warming cabinets includes these 5 elements and are made locally with a robust design that can withstand hard use in a hospital environment. One can expect a trouble-free lifetime of 15 to 20 years with the knowledge that the manufacturer is around the corner if help is required.