Reprocessing of Flexidock Camera Probes - Disinfection policy guide

Grampians Region Infection Control Group

December 2008

Issues:

The devices have the potential to be used as both non critical and semi critical devices.

The level of disinfection required will differ depending on how the probe is used.

The manufacturer’s instructions recommend:

The manufacturer’s guidelines recommend procedures for processing semi critical items that are not consistent with either the AS/NZS 4187- 2003 Cleaning, disinfection and sterilising reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities Section 10.2.2 (1) or the CDNA Infection Control Guidelines 2004 Section 17.4. (2).The manufacturer recommends the use of alcohol, aldehydes or QUATS (quaternary ammonium compounds) –of this list only aldehydes are considered adequate for high level disinfection.

The manufacturer’s guidelines also recommend the use of sheaths to 'protect the hygiene of the patient" - this is contrary to AS/NZS: 4187, section 12.5 which states, “Sheathes/sleeves for instruments and equipment shall not be used as a substitute for cleaning, disinfection or sterilization procedures”. Section 17.2.2 of the CDNA Infection control guidelines 2004 also comment on the use of sheathes/sleeves.

Infection control guidelines[1],[2] recommend that devices in contact with intact nonsterile mucosa or non intact skin (semi critical items) be reprocessed using a high-level instrument grade disinfectant. For a chemical to be used as a high-level disinfectant or a sterilant it must be registered as such with the Therapeutics Goods Association (TGA).

Recommendations:

  1. The intended use ofeach probe/attachmentmust be documented and a risk assessment completed to identify if theattachment will be categorised as non critical and semi critical.
  2. Smaller agencies that do not have access to high level disinfection must limit the use of these devices to non critical sites/procedures only.
  3. All probes deemed to bein contact with intact skin only (non critical) can be processed using detergent and water then wipedover with alcohol.
  4. All probes, where there is risk of contact with intact nonsterile mucous membrane or non intact skin, must be processed using high level disinfection.

The high level disinfection method confirmed by the manufacturer as compatible with probes is:

Ortho-Phthalaldehyde (OPA)

(The devices have not been tested for compatibility with Steris or Sterrad and cannot be placed into a steam steriliser.)

The removable light diffusing tip on the dermatology probe cannot tolerate heat so cannot be processed in a thermal disinfector, but will tolerate soaking in OPA.

  1. Unless high level disinfection can be achieved thedevices must not be used on semi critical sites.
  2. Where probes are classified as non critical, contingencies must be in place to ensure high level disinfection is achieved in the event that one of the probes is accidentally used on non intact skin or mucous membrane – probe could be sent off-site to be processed appropriately.
  3. Sheaths MUST NOT be used as an alternative to thorough cleaning and appropriate level of disinfection.

CLEANING AND DISINFECTION GUIDELINES:

Camera control unit and docking station:

After every use, wipe over exterior surfaces with a damp cloth moistened with detergent and water, clean thoroughly. Dry surface then disinfectusing alcohol impregnated wipes.

Hand piece:

After every use, wipe over handpiece and hose with detergent and water, cleaning thoroughly. Dry surface then disinfectusing alcohol impregnated wipes.

Camera probes:

Camera probes –NON CRITICAL SITES only (not used on non intact skin or mucous membrane):

After every use, disassemble probe and clean thoroughly using detergent and water. Dry and thendisinfect all surfaces using alcoholimpregnated wipes.

Specific information for sites using probes for non critical sites only –

Dermatology probe: - must only be used for surface magnification where probe comes into contact with intact skin only,not to be used for non intact skin, open lesions, deep cavities or wounds.

Mouth/face probe: - for external use only or very superficial viewing of mouth and nose. Not to be used where there is a risk of contact with the mucous membrane of mouth and nose.

Otoscope probe: - disposable, single use speculae must be used for every patient.After removal of disposable speculae, the probe must be washed and disinfected using alcohol wipes.

Ophthalmoscope probe: - must not touch surface of eye, must be washed and disinfected after every use.

Camera probes – SEMI CRITICAL SITES(used on non intact skin or mucous membrane)must be disinfected using a high level disinfectant:

(THOSE AGENCIES THAT HAVE THE ABILITY TO PROCESS PROBES USING HIGH LEVEL DISINFECTION AND WHO CHOOSE TO APPLY THE PROBES FOR MORE COMPLEX, INVASIVE DIAGNOSIS) e.g. non intact skin/lesions, deep wounds, cleft palates, tonsils and intra oral lesions etc.

After every use, disassemble probe and clean thoroughly using detergent and water. Soak probe in high level disinfectant (OPA) for required timethen dry and store.

Note:The removable light diffusing tip on the dermatology probe cannot tolerate heat so cannot be processed in a thermal disinfector;it will tolerate soaking in OPA as above.

[1]Australian Government Department of Health and Aging [DoHA: 2004]: Communicable Diseases Network Australia [DoHA: 2004] Infection Control Guidelines for the prevention of transmission of infectious diseases in the health care setting (also available at

[2]AS/NZS 4187:2003 “Cleaning, disinfecting and sterilizating of reusable medical and surgical equipment, and the maintenance of associated environments in health care facilities”.