Guideline for Decontamination of nCountersonline Portable Limb Load Monitor

Dr. Sam John (PhD), for nCounters Engineering Rehabilitation

Purpose

The following document provides the cleaning procedure that minimises colonisation of microorganisms and antimicrobial activity (including fungal and bactericidal activity) and the risk of infection for patients using the nCountersonline Portable Limb Load Monitor (PLLM) device. The procedures described below are based on the guidance of the Australian Government, Therapeutic Goods Administration, Standards  AS/NZS 4815:2006, National Health & Medical Research Council and the Australian Commission on Safety and Quality in Healthcare. Full details can be found under the references section.

Disclaimer nCounters have no liability for any loss or damage to Biofeedback Devices Pty Ltd (T/A nCounters) products by the application of these cleaning and disinfecting protocols. nCounters have no liability for any loss or damage caused by cross-infection after the non or misapplication of these cleaning and disinfecting protocols

The content provided is for information purposes only and is not intended to replace advice from your doctor or other registered health professional. The information and references contained in this content are not intended to constitute a comprehensive guide concerning all aspects of infection control. All users are urged to always seek advice from a registered health care professional for answers to their infection control questions and to ascertain whether these disinfecting protocols as described are suitable in their circumstances.

Risk Assessment

The device comprises footpads placed under insoles and is connected with wires to a Control Unit attached to the legs above the ankle with a flexible velcro band. The leg-mounted unit communicates wirelessly with a portable feedback unit. The device is in contact (approximately 30 minutes on each patient) with intact skin and does not penetrate the skin, is not inserted into an open orifice, and is not in contact with the mucus membrane. The device is categorised as a non-critical reusable device, similar to Sphygmomanometers, Blood pressure cuffs or Stethoscopes.

Part

Contact with the body

Type/ Mode of infection transmission

Risk of transmission

Footpad

No direct contact with the body but is placed inside shoes during use.

Fungal or bacterial infections such as Athlete’s Foot

(Tinea Pedis), Plantar Warts, Paronychia, Onychomycosis (Toenail Fungus), Cellulitis

Medium

Insoles

No direct contact with the body but is placed inside shoes during use.

Fungal or bacterial infections such as Athlete’s Foot

(Tinea Pedis), Plantar Warts, Paronychia, Onychomycosis (Toenail Fungus), Cellulitis

Medium

Wires

Unrestricted placement and may touch the skin between the ankle and control unit during use.

Viral infections may spread by indirect contact between patients or between patients and healthcare providers. This can occur via surface contamination of equipment coming into contact with skin (and/or subsequent contact with mucous membrane)

Low

Control unit

Minimum contact with the patient may touch the skin (unbroken skin) at times during use.

Viral infections may spread by indirect contact between patients or between patients and healthcare providers. This can occur via surface contamination of equipment coming into contact with skin (and/or subsequent contact with mucous membrane)

Low

Flexible straps on the control unit

Is in continuous contact with the patient’s skin (unbroken skin) during use.

Viral infections may spread by indirect contact between patients or between patients and healthcare providers. This can occur via surface contamination of equipment coming into contact with skin (and/or subsequent contact with mucous membrane)

Low

Wireless feedback unit

Minimum contact with the patient may touch the skin (unbroken skin) at times during use.

Viral infections may spread by indirect contact between patients or between patients and healthcare providers. This can occur via surface contamination of equipment coming into contact with skin (and/or subsequent contact with mucous membrane)

Low

Flexible straps on feedback unit

Is in continuous contact with the patient’s skin (unbroken skin) during use.

Viral infections may spread by indirect contact between patients or between patients and healthcare providers. This can occur via surface contamination of equipment coming into contact with skin (and/or subsequent contact with mucous membrane)

Low

Cleaning Process

It is recommended that all surfaces of the unit are cleaned and decontaminated after each use. Hand hygiene must be performed following cleaning and decontaminated procedures. New nitrile gloves must be worn when performing general cleaning and decontamination and disposed appropriately after use.

Cleaning before/after each use

  • Perform cleaning starting from the least contaminated to the most contaminated parts.
    • Perform cleaning of all the surfaces starting with the monitor, followed by the control unit, wires and finally the footpads.
  • The monitor, control unit, straps and wires are at low risk of contamination.
    • These should be wiped down with Therapeutic Goods Administration (TGA) approved pH neutral detergent/disinfectant wipes and allow contact time recommended by the manufacturer before using.
  • Straps should be sprayed with decontaminating spray*
    • Decontaminating spray should be carefully applied to all areas of the straps and allowed to be thoroughly dry before storage*.
  • The foot pads are the most likely item to host pathogenic microorganisms as they are placed inside the shoe and are at moderate risk of contamination.
    • Care must be taken when disinfecting footpads and ensuring all parts are thoroughly wiped.

○ Footpads and insoles+ should be wiped down with TGA approved pH neutral detergent/disinfectant wipes after use and dried.

○ Footpads and insoles should be sprayed with decontaminating spray and dried before use*.

Cleaning following body fluid or blood spill/contamination

  • Perform cleaning starting from the least contaminated to the most contaminated parts.
    • Perform cleaning of all the surfaces starting with the monitor, followed by the control unit, wires and finally the footpads.
  • The monitor, control unit, and wires are at low risk of contamination.
    • If contaminated by blood or other body fluid, the surfaces should be wiped down with a TGA approved pH neutral detergent/disinfectant wipes.

○ If there is more blood or other body fluids repeat until there are no traces of body fluids and allow the contact time recommended by the manufacturer before using

  • Sweat contamination: If the footpads and insoles are wet from sweat, wipe down with TGA approved pH neutral detergent/disinfectant wipes after use.
    • Wiping Footpads and insoles should be followed by spraying with decontaminating spray and dried before subsequent use. *
  • Blood or mucus: The footpads and insoles are the most likely item to host pathogenic microorganisms as they are placed inside the shoe and pose a moderate risk of contamination.
    • If the insoles or foot pads have been in contact with broken skin, blood, or mucus it is recommended that these items are disposed of and replaced with new footpads and insoles.

*Alternately alcohol-based cleaning wipes may be used. May reduce the usable life of the insoles and erode the hydrophobic coating on insoles. +Where possible insoles should be disposed of after use and clinical staff discretion is recommended if reusing insoles.

References

Australian Government, Therapeutic Goods Administration (2022). Disinfectants for use against COVID-19 in the ARTG for legal supply in Australia, accessed June 2022.

Clinical Excellence Commission, 2022, COVID-19 Infection Prevention and Control Manual for acute and non-acute healthcare settings, v2.1, Sydney, Australia: Clinical Excellence Commission

National Health & Medical Research Council and the Australian Commission on Safety and Quality in Healthcare. (2019). Australian guidelines for the prevention and control of infection in healthcare.  Canberra, Australia:  Commonwealth of Australia.

Royal College of Nursing.  (2011). The selection and use of disinfectant wipes.  RCN guidance.  London, United Kingdom:  Royal College of Nursing.

Rutala, William Anthony, and David Jay Weber. “Guideline for disinfection and sterilization in healthcare facilities, 2008.” (2008).

Standards Australia/Standards New Zealand.  AS/NZS 4815:2006.  Office-based health care facilities.  Reprocessing of reusable medical and surgical instruments and equipment, and maintenance of the associated environment.  Sydney, Australia:  Standards Australia International Ltd and Standards New Zealand

Appendix – A

List of compatible cleaning materials

Low-level cleaning and disinfection are required for the monitor, control unit, straps and wires. These may be TGA approved Low-level Instrument Grade Disinfectants such as detergent or alcohol based disinfectant wipes or equivalent such as cloth wipes impregnated with chlorhexidine.

  • Suggested Wipes
    • Clinell Universal Wipes
    • Clinell Chlorhexidine Wash Cloths
    • Premier Disinfectant Cleaning Wipes
    • Super Sani-Cloth Germicidal Disposable Wipes
    • Or equivalent 

Moderate level cleaning and disinfection of footpads and insoles which are the most likely item to host pathogenic microorganisms as they are placed inside the shoe and are at moderate risk of contamination. This requires two-step of disinfection with pH neutral wipes and sanitising spray or equivalents.

  • Suggested Wipes
    • Clinell Universal Wipes
    • Clinell Chlorhexidine Wash Cloths
    • Premier Disinfectant Cleaning Wipes
    • Or equivalent pH neutral detergent/disinfectant wipes
  • Suggested disinfectant sprays
    • SafeGard Hospital Grade Disinfectant Spray
    • Clinell Universal Sanitising Spray
    • Scotts Sanitising Spray
    • Smart Hygiene Hospital Grade Surface Spray Disinfectant
    • Or equivalent hospital spray   

Appendix – B 

Cleaning/Disinfection Checklist Before Use

This checklist is used to evaluate and confirm if cleaning and disinfection of the nCountersonline Portable Limb Load Monitor (PLLM) device have been performed as instructed. The cleaning personnel should perform cleaning and disinfection of all items according to this checklist. 

Facility name:

Product Serial Number: 

Patient ID: 

Procedure date:

Processing/cleaning Staff Name:

Processing/cleaning Staff Signature: 

Processing/cleaning Date:

Processing/cleaning Time:    

Item Procedure Status
Preparation Put on new gloves before beginning cleaning.Completed/Not Completed
Preparation Ensure electronics are turned off allCompleted/Not Completed
FootpadsSpray with disinfecting sprayCompleted/Not Completed
Insoles Spray with disinfecting sprayCompleted/Not Completed
Finishing Allow any items that are wet to fully air dry before useCompleted/Not Completed
Disposal Dispose of wipes and gloves in the appropriate waste binCompleted/Not Completed

Note1: Ensure to spray the fabric evenly, to decontaminate. Wait to dry before use.

Note 2: In environments where sprays cannot be used, alcohol-based cleaning wipes may be used. Caution: Alcohol-based wipes may reduce the usable life of the insoles and erode the hydrophobic coating on the insoles. 

Appendix – C 

Cleaning/Disinfection Checklist After Use

Facility name:

Product Serial Number: 

Patient ID: 

Procedure date:

Processing/cleaning Staff Name:

Processing/cleaning Staff Signature: 

Processing/cleaning Date:

Processing/cleaning Time:

Item

Procedure

Status

Preparation

Put on new gloves before beginning cleaning.

Completed/Not Completed

Preparation

Turn off all electronics

Completed/Not Completed

Preparation

Disconnect all wires

Completed/Not Completed

Monitor

Wipe monitor with *Low-level Instrument Grade Disinfectant.

Completed/Not Completed

Control unit

Wipe control unit with *Low-level Instrument Grade Disinfectant.

Completed/Not Completed

Cloth Straps  

Sprayed with disinfectant spray 

Completed/Not Completed

Wires

Wipe all wires with *Low-level Instrument Grade Disinfectant.

Completed/Not Completed

Footpads

Wipe with TGA approved *Low-level Instrument Grade Disinfectant.

Completed/Not Completed

Insoles

Wipe with a TGA approved *Low-level Instrument Grade Disinfectant.

Completed/Not Completed

Finishing

Allow any items that are wet to fully air dry 

Completed/Not Completed

Disposal

Dispose of wipes and gloves in the appropriate waste bin

Completed/Not Completed

End cleaning

Store equipment in a safe place until next use

Completed/Not Completed

*Low-level Instrument Grade Disinfectant: TGA approved pH neutral detergent/disinfectant wipes Name of TGA approved pH neutral Wipes Used

Peter Barrett

Peter Barrett

Director

Peter designs and builds biofeedback products for gait and movement in the orthopaedic and stroke rehabilitation spaces. These devices are programmed for ease of use with built in help touch screens. In all cases data is transferred wirelessly to ensure patient safety.They can store and display data in real time so as to monitor the patient’s overall progress.

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