Clean or Sterile medical device: How clean does it need to be?

Medical devices often come into contact with patients, and users. Sometimes repeatedly. Addressing patient and user contact is a critical aspect of medical device development. Biocompatibility is a significant aspect of contact, but what about sterility? And if a device does not need to be sterile, then how clean does it need to be?

How Clean or Sterile Should my Medical Device Be?

The level of cleaning and disinfection needed depends on the use of the device. All reusable devices need to be able to be cleaned to some level, and that level depends on the risk of the device. In 1957, E.H Spaulding devised a method of classification that has been in use since. Although today’s knowledge of microorganisms is stretching the limits of this classification, it remains as the basis of classification today.  Many hospitals and health boards have a list of recommended practices which outline the requirements for reusable equipment.

The classification first aligns the criticality of the device. The criticality of the device is dependent on the contact: does the device comes in contact with mucous membranes, or sterile cavities, or only skin contact.

Based on the initial classification, a level of cleaning and disinfection is advised. The classifications are as follows:

Non-critical

Non-critical items are those that have skin contact only, or do not enter sterile body cavities or mucous membranes. Examples are stethoscopes, blood pressure cuffs, and patient lift slings.

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