FAQ

Is the TD 100CE and Complete Care TGA or NATA approved?

Yes, the TD 100CE and Complete Care is TGA and NATA approved and is compliant with standard AS/NZS 4187.

What Australian standard does the TD 100CE and Complete Care comply to?

The TD 100CE and Complete Care is compliant with standard AS/NZS 4187.

This Standard specifies the requirements and practices necessary for the effective and safe reprocessing, storage, handling and transportation of reusable medical devices (RMDs) in human health care.

How to I handle HLD fumes?

When employing high-level disinfectants (HLDs), it is important to remember that these harsh HLDs, release harmful fumes into the air. These vapors can be quite strong and, if healthcare professionals are exposed for long, can have serious effects on the health of medical professionals who are exposed (link to Dangers of Occupational Exposure). The methods for handling HLD fumes depend on if you're manually reprocessing transesophageal echocardiogram (TOE) probes or if you're employing an automated disinfector to get the job done.

If you will be reprocessing TOE probes manually, the requirements for ventilation are pretty strict and are regulated by the American National Standards Institute (ANSI) and Association for the Advancement of Medical Instrumentation (AAMI) which provide guidelines for the selection and use of HLDs in ANSI/AAMI ST 58. According to the Joint Commission, the guidelines include the following:

Chemical sterilants should be used in an area that is properly ventilated.
When general room ventilation is not adequate, a self-contained, freestanding system or a local exhaust hood should be installed to capture chemical vapour during processing.
When an outside exhaust system is not available, a ductless fume hood can be used to deliver vapour to a filter system that chemically inactivates the vapour; then clean, filtered air is returned to the room.
Filters for these systems should be replaced in accordance with the manufacturer's recommendations.

If, however, you are using an automated system with an air filter to reprocess probes, the requirements for ventilation may vary. It is important to be sure that the filter in your automated system is designed to neutralize fumes produced by HLDs and not simply designed for vapour reduction. Units like the TD 100CE are fitted with activated bonded carbon filters which eliminate exposure to harmful vapours, essentially functioning like a ductless hood. The way activated carbon filters work is through adsorption, a process by which pollutant molecules and other impurities are chemically bound, ensuring clean air.

Ensure that your facility is doing its part to effectively remove or neutralize vapours associated with HLDs. Keeping healthcare workers protected from these fumes, especially workers who have low tolerance to such chemicals, is key to running a safe and productive facility.

How long can probes hang?

Should you hang it up, put it in a case, lay it down, or something else? And once stored, how long can probes stay high-level disinfected? Let’s go over the basics and understand what the best practices are for TOE probe storage.

First, we need to determine the best way to store your TOE probes. Unfortunately, many facilities overlook this crucial part of TOE probe care and simply store their probes in transportation cases. This is not the intended use of these cases and is, in fact, against regulations in several countries, indicating that this is an unsafe practice. There are even facilities that stuff their expensive and fragile TOE probes into pillowcases, risking damage to the probe and ensuring that the probe will not remain high-level disinfected (the inside of a pillowcase or similar item is not high-level disinfected and potentially harbours dangerous bacteria).

According to The Society of Diagnostic Medical Sonography, the best method for ultrasound probe storage will keep the probe protected from contamination and damage. While there is no hard and fast rule regarding probes storage in Australia or the U.S.A., the CDC and The Joint Commission both encourage healthcare facilities to store probes hanging vertically in a clean, dust-free environment.

To meet all these criteria effectively and for low cost, healthcare facilities should consider implementing a storage solution like the CleanShield® TOE Probe Storage Cabinet. These cabinets encase each probe, keeping them safe from physical damage. Additionally, CleanShield storage cabinets push HEPA filtered air into the chamber, minimizing the risk of airborne contaminants entering the cabinet and polluting clean probes. Storage cabinets help probes stay high-level disinfected until they are ready to be used again, safeguarding your facility’s high standards and keeping patients healthy.

Once a probe has been disinfected and properly stored in a storage cabinet, how long can it stay there before the disinfection level may become compromised? CS Medical commissioned a study to investigate and determine how long TOE ultrasound probes can be stored in the CleanShield before needing to be reprocessed.

Several probes were processed in TOEClean, dried, and stored. Half were stored in CleanShield cabinets and the other half were stored hanging in open cabinets without HEPA filtered air. The results were stunning. After seven days, those hanging within the CleanShield, “remained measurably free of contamination,” while those stored in the open cabinet had, “contracted 160 bacteria per 24 hour hang-period.”

As a result of this study, CS Medical recommends that, if all TOE probe reprocessing steps are correctly followed, a facility can store TOE probes within the CleanShield TOE Probe Storage Cabinet for up to seven days. Keeping your probes high-level disinfected and knowing how long they will stay that way is vital to the functioning of your facility. Be sure to consult your facility’s infection control practitioner and your TOE probe’s manufacturer to develop and implement a standard operating procedure at your facility regarding probe storage time.

Have I been handling my TOE probes correctly?

A thorough understanding of the TOE ultrasound probe and how it should be reprocessed is critical. This knowledge will lead to minimized TOE ultrasound probe damage, improved patient outcome and allow for proper reprocessing that reduce Healthcare-Associated Infections (HAIs). The overall length of the TOE ultrasound probe and the fragile nature of the transducer make handling of the device susceptible to damage and challenging for the healthcare professional. Care to minimize excessive handling and contact shock to the distal tip should be taken when manipulating the components during all facets of reprocessing. To properly reprocess a TOE probe, the technician should be aware of the delicate nature of the various parts. The critical difference between a colonoscopy or a gastroscope and a TOE probe is it can’t be completely submerged into the rinse and high-level disinfectant baths. The TOE probe is not water-tight, and the complete submersion of the probe could cause severe damage and result in the inoperability of the TOE probe.

The TOE Complete Care has 10 easy steps to effetely reprocess a TOE ultrasound probe:

Step # 1 - Point of Use Cleaning (TEEZyme™ Enzymatic Sponge)

Step # 2 -TOE Probe Transportation Case (TPorter™ Transportation Case - soiled probe)

Step # 3 - Enzymatic Cleaning (Medizime LF Enzymatic Cleaner)

Step # 4 - Rinse and Dry Probe (QwikDry™ TOE Probe Drying Cloth)

Step # 5 - Electrical Leak Testing (Ultrasound Leakage Tester)

Step # 6 - High-Level Disinfection (TD100 CE Automated TOE Probe Disinfector)

Step # 7 - Rinsing After High-Level Disinfection (Nephros Water Filter)

Step # 8 - Probe Drying (QwikDry™ TOE Probe Drying Cloth)

Step # 9 - HEPA Filtered Probe Storage (CleanShield™ TOE Probe Storage Cabinet)

Step # 10 - TOE Probe Transportation Case (TPorter™ Transportation Case - clean probe)

Following a successful disinfection cycle, the TD 100CE provides a printed verification record. The print out contains disinfectant contact time, average disinfectant temperature, probe and operator ID, disinfectant lot number and time and date. Proper training of reprocessing staff further ensures that the correct handling of delicate TOE probes is maintained. Complete Care offers an online training program available to all staff using the TD 100CE and allows managers to monitor this training, further ensuring compliance with healthcare facilities training compliance.

Proper storage of disinfected TOE probes is essential to maintain their level of cleanliness, before their next use, as well as to protect the probe from possible damage caused by incorrectly hanging the device. The CleanShield Probe Storage Cabinet is an integral part of the Complete Care suite of products. The cabinet is designed with hanging crescents and shelves to allow for easy and secure placement of the disinfected TOE probe. The TOE probe is allowed to hang freely inside the TOE probe storage cabinet while the probe headset and cable are held in secure positions. Once the TOE probe has been safely placed inside the storage cabinet, the door can be closed and locked for added security.

The TOE Complete Care is a start to finish the reprocessing process, equipped with all accessories needed to assure high-level disinfection with reliable print verification and training for staff. The Complete Care process improves quality, reduces variations in the disinfection process, controls costs and reduces the risk of infections associated with medical equipment, devices and suppliers.

Is there quality assurance for my TOE Probes?

Without correct compliance of transportation for TOE probes, infection outbreaks can occur. TOE probe infection can occur during transportation to and from reprocessing, from improper variations in the disinfection process and storage, furthermore can become damaged due to mishandling or transport.

These infection outbreaks can be managed by systemising reprocessing of TOE probes. TOE Complete Care is a start to finish a reprocessing system for TOE ultrasound probes, equipped with all accessories needed to assure high-level disinfection, with print verification and training for staff. The Complete Care process is designed to improve quality, reduce variations in the disinfection process, control costs and reduce the risk of infections associated with medical equipment, devices and suppliers.

The TPorter TOE Ultrasound Probe Transportation Case is a crucial part of the Complete Care System, designed to effectively and securely move high-level disinfected TOE ultrasound probes to the procedure area and then return the biologically soiled TOE ultrasound probe for reprocessing. The TPorter is a complete delivery system that allows healthcare personnel to move delicate TOE ultrasound probes throughout the healthcare facility and deliver them in a manner that creates a standardized operating procedure.

The case is designed with rugged polycarbonate construction with a clear viewing lid for easy visibility and is reclinate transportation for the fragile TOE probes. The TPorter case allows for safe and easy handing with a handle of polycarbonate construction to carry, also protecting the probe and staff from any damage or injury, complying with product transportation. With a clear lock cover to hold components into individual compartments during transport. The TPorter has multiple compartments to secure the delicate TOE Probe and accessories; TEEZyme Sponge, 2 soiled tie band tags, Bio-Barrier Sleeve, Bite Block. The TPorter uses ID Status tags for "clean" and "dirty" designation, to indicate the status of the TOE probe for processing or repossessing to the operator.

Once the TOE ultrasound probe has been enzymatically precleaned, the healthcare professional should place the PullUp™ Bio-Barrier Sleeve, located within the TPorter case, onto the TOE ultrasound probe insertion tube. When TPorter arrives at the point of reprocessing the high-level disinfection technician will physically remove the red tags and slide the lid for removal and access to the soiled TOE ultrasound probe. The ultrasound probe should be removed from the TPorter and reprocessing should begin per TOE ultrasound probe manufacturer's recommendation. Proper storage and transportation of disinfected TOE probes are important to maintain their level of cleanliness, before their next use, as well as protecting the probe from possible damage caused by incorrectly handling of the device.

The TPorter, is a dedicated transportation device, that will help minimize the risk of probe damage and reduce staff exposure to potentially hazardous biological material. TPorter is an engineered solution for the healthcare professional that cleans, high-level disinfects, stores and delivers TOE ultrasound probes for patient care.