Frequently Asked Questions

We’ve compiled answers to your most common COVID-19 and Medela Suction Pumps related questions

Reducing infection risk
What mechanisms do Medela devices have for filtering out SARS-CoV-2 particles?

Dominant Flex, Basic, and Vario 18 medical suction machines are available with a virus filter capable of reducing cross-contamination from COVID-19 with filtration efficiency of greater than 99.99987%.

When the Thopaz+ system is in use, surgical fluids, gases, bodily fluids or infectious materials are pulled through the chest tube via the suction tubing into the canister. To prevent cross-contamination the system is protected by a hydrophilic overflow and bacteria filter from POREX® located in the canister. The protection filter consists of a 3D-structure made of polyethylene which attracts aqueous solutions and swells immediately by closing the pores, when in contact with liquid. It ensures that the pump draws filtered air from the canister (Medela Validation Test Report).

Questions you may have to ask yourself before choosing the suction devices

In selecting suction systems to support care of COVID-19 patients, prioritize options that offer additional measures to avoid cross-contamination to ensure staff and patient safety.

Our portable suction machines are designed with specific features that reduce risk of cross-contamination:

  • Portable suction machines do not rely on wall/central vacuum, containing any risk of viral contamination in one pump  and as independent pumps unable to potentially spread throughout the entire system.
  • Rounded designs, soft edges, and CleanTouch buttons (built with no gaps or grooves) make disinfection of the surface quick and effective.
  • Durable case materials are able to withstand some of the most potent disinfection agents.

For more information, read our article "How to Avoid Virus Cross-Contamination of Medical Vacuum Suction Pumps with Virus and Bacteria Filters"

Are there specific medical fluid waste management practices recommended for patients with COVID-19?

Yes - for COVID-19 patients, it is especially important to follow strict hygiene procedures. For example:

  • Disposable canisters or single-use liners should be disposed of per internal policy and regional regulations.
  • Disposable liners can decrease the chance of exposure to contaminated waste associated with the manual disposal of waste and cleaning/disinfection of the reusable container. The liner and the lid are removed in a single step at the point of care, minimizing the risk of spillage and contamination.
  • Adding a solidifying agent reduces the possibility of exposure or contamination by fluid waste. Once completely solidified, the waste in the container can be disposed of as either regulated or nonregulated medical waste per the local regulation or ordinance.
  • Reusable canisters, if you have to use them, after disposing of the waste, must be cleaned and disinfected. High-level disinfection or sterilization is advised when these canisters are used for infected patients. Please be aware of any potential aerosols during disposal of the fluid waste.
  • Antiviral filters and other shut-off mechanisms are essential to help prevent contamination and overflow (or backflow) of suctioned fluids from canisters.
  • Please ensure you follow your local guidelines on managing Covid-19 patients or refer to guidelines from e.g. the WHO.

For comprehensive recommendations on fulid waste management, download the Medical Suction and Fluid Waste Management Whitepaper by Joint Commission International.

 

Meeting the demands of COVID-19
How can Medela products help hospitals respond to COVID-19-related care demands

Our produts help Covid-19 patients who receive mechanical ventilation by providing regular suction toremove secretions as the virus can cause inflammatory processes in the lung. Therefore, it is recommended:

  • To equip each critical care ventilation bed with a vacuum source.
  • To avoid use of central wall/piped vacuum in infectious disease units, per the NHS England’s recently published design notes for intubated patients in COVID-19 wards*.

*NHS England advises against use of wall suction systems in infectious disease units: Novel coronavirus (COVID-19) standard operating procedure. NHS England website.

The following Medela vacuum pumps are mobile and independent from central (piped) vacuum systems:

  • Dominant Flex, Basic: high-power suction, require a power source.
  • Vario 18: Versatile suction pumps, includes a battery-powered option.
  • Thopaz+: digital chest drainage and monitoring system.
How has Medela responded to the COVID-19 crisis?

This is an unprecedented time for all of us. As hospitals around the world are working to expand capacity and set-up temporary care facilities, the demand for airway & surgical suction pumps and digital chest drainage systems has increased significantly.

To help address this global public health crisis and ensure supply of the most urgent products, we are carefully managing our entire supply chain and have built a dedicated team who is continuously assessing the situation and works with our suppliers and partners to ensure timely delivery of our products and continued safe manufacturing.

We are working on tripling production of our Dominant Flex, Basic, and Vario 18 suction pumps, which provide  the mobility essential for care in settings in which access to central hospital vacuum is unavailable or unadvised.*

Additionally, the production of Thopaz+ digital chest drainage and monitoring systems will be increased to fill the demand for autonomous chest drainage systems.

For more information about how Medela is committing to serving all our customers, patients and employees, read this statement.

*NHS England advises against use of wall suction systems in infectious disease units: Novel coronavirus (COVID-19) standard operating procedure. Visit NHS England website here. Accessed 30 March 2020.

Safe chest drain management
Can a digital chest drain system infect other patients through aerosol particles?

Transmission of COVID-19 is primarily through droplet spread. "Aerosol" is a general term used to describe a range of particle sizes that can be propelled by coughing, talking and sneezing, as well as by certain aerosol generating procedures (see table 1 here).  It appears extremely unlikely that aerosols that could develop at pulmonary air leaks could travel over 2 meters through a chest drainage system (chest tube, chest drain tubing, and the chest drain unit) without impacting the surrounding surface at some point. In case that virus particles make it to the chest drain unit, there is a possibility that they are delivered into the environment as all chest drain systems, conventional analogue and digital ones, have some sort of venting for positive pressure compensation. There are, however, differences in how they release air into the environment. The Thopaz/Thopaz+ system has been designed with the positive pressure valve located at the side of the canister facing the pump so that air will be directed towards the pump when a patient should cough. The only other exit port to the environment on Thopaz/Thopaz+ is the exhaust at the bottom. Even in the unlikely event that a condensate was to form in this area, it would only drop to the surface below and not be aerosolized.

How to handle a Thopaz+ device after treating a COVID-19 patient
  • Follow standard hygiene guidelines.
  • After each use, the Thopaz canister and tubing must be disposed of, and the pump must be disinfected.
  • It is essential that you disinfect the bottom part of the pump and the area below the exhaust port.
  • Use disinfectant proven to be effective against viruses such as SARS-CoV-2, e.g. recommended by EPA see list of recommended disinfectants here

 

 

 

Digital chest drainage systems in ventilated patients

During ventilation, positive pressure inflates the lungs and can generate an artificial positive pressure in the pleural space. Thopaz+ quickly detects this and restores the set pressure, which is negative, and displays a flow rate triggered by the ventilator.

All chest drainage systems, including Thopaz+, react to this positive pressure. The ventilator controls airflow rather than the drainage device, i.e. tidal volumes: 500 ml per inspiration cycle or 7 ml/kg body mass.

What sets Thopaz+ apart from other drainage systems are the alarms that alert staff to a leak in the system. 

If there is a small air leak (or no air leak) in COVID-19 patients, the patient can be put on the desired pressure level – even for longer periods of time.

Does the Thopaz+ “patency check” work on ventilated patients?

Since the patient is not breathing spontaneously, or has very shallow breathing, the patency check does not work on ventilated patients. The small difference in pressure in the pleural space during inhalation and exhalation is not detected by the device.

Why should I choose a digital chest drainage system in the COVID-19 crisis?

During the coronavirus pandemic, hospitals continue to care for patients on cardiothoracic and respiratory wards, as well as in critical care units, who need chest drains for pneumothorax.

  • Thopaz+ can be used as a stand-alone unit for chest drains if no central wall vacuum is available.
  • Thopaz+ alerts staff when the tubing is kinked or disconnected, if the canister is full or if the filter is clogged. Troubleshooting is shown on the display.
  • Improved interobserver agreement due to Thopaz+’s precise air leak monitoring and trending1.
  • Thopaz+ has a silent function with no bubbling noises.
  • Thopaz+ has reduced chest tube duration for many procedures.

[1] Pompili et al. Ann Thorac Surg. 2014 Aug;98(2):490-6                                                

[2] McGuire et al. Interact Cardiovasc Thorac Surg. 2015: 1-5

 

Device handling, cleaning and disinfection
Are there any special requirements for handling devices used to treat patients with COVID-19?

The CDC recommends that all health care personnel should adhere to the Standard, Contact, and Airborne Precautions when treating known or suspected COVID 19 patients. See the CDC’s Interim Infection Prevention and Control Recommendations for Patients with Confirmed 2019 Novel Coronavirus (2019-nCoV) or Persons Under Investigation for 2019-nCoV in Healthcare Settings.

Additionally, robust hygiene procedures should be utilized, with increased attention to practices that reduce risk of cross-contamination.

 

Are there special cleaning requirements for devices used to treat COVID-19 patients?

Yes, indeed! In COVID-19 treatment settings, take care to ensure that routine cleaning and disinfection procedures are followed consistently and correctly. Use cleaners and water to pre-clean surfaces prior to wiping down with an EPA-registered, hospital-grade disinfectant.

For complete cleaning instructions, refer to the Guidelines for Cleaning, Disinfecting and Sterilizing Medela Healthcare Products.

 

 

 

Which types of disinfectants may be used on Medela devices?

The US Environmental Protection Agency recommends a wide range of disinfectants to be used against SARS-CoV-2. Of those, the following are recommended for use on the plastic surfaces of Medela Healthcare products:

  • Oxivir® TB, Oxivir® 1 from Sealed Air Diversey Care
  • Virex® II 256, from Sealed Air Diversey Care
  • Clorox Healthcare® Bleach Germicidal Cleaners and Wipes from Clorox

Additionally, non-EPA listed disinfectants recommended and tested by Medela are:

  • mikrozid® AF wipes from Schülke&Mayr AG
  • CaviWipes from Metrex
  • lncidin® Foam from Ecolab Healthcare
  • Hexaquart® plus and Meliseptol® rapid from B. Braun Melsungen AG
  • perform® from Schülke&Mayr AG
How often do I need to change the virus filter?

We recommend changing the filters:

  • Immediately in case of overflow or clogging
  • On a weekly basis with single patient use
  • On a daily with multiple patient use

Due to currently high infection risk, it might be advisable to change the filter daily.

On top, we recommend:

  • Before each patient use, please perform a filter test to detect a clogged filter
  • Comply with the recommended frequency of change with your in-house directives on hygiene
Is the bacteria filter, delivered along with the Vario pump, sufficient to filter the Corona-virus?

No, the pore size of the bacteria filters is not sufficient in this case! Please use the Medela virus filters.

How often shall I change the disposable liner?

We recommend changing the liners:

  • Immediately in case of overflow
  • Daily in the operating theatre
  • After approximately three to four days of use at the same patient postoperatively

Due to currently high infection risk, it might be advisable to change the liner daily.

Please comply with your in-house directives on hygiene.

Can I use the reusable canister with Medela pumps?

Yes, you can use the Reusable Collection System (RCS) with Vario, Basic and Dominant Flex pumps. However, for the treatment of COVID-19 patients, we recommend using the Disposable Collection System (DCS) in order to help reduce contamination of staff and patients during waste disposal.

How long can SARS-CoV-2 survive on surfaces that haven’t been disinfected?
  • So far, there is no documentation on the transfer of the virus via surfaces. However, research shows that SARS-CoV-2 can survive for up to 72 hours on plastic and steel surfaces. However, the viral load goes down significantly within hours.
  • According to co-author Dylan Morris, we still don’t know how high a concentration of viable SARS-CoV-2 is needed to infect a human being.
Devices and Accessories
Which size of canisters can I use with the Basic / Dominant Flex with the handle on top?
  • The portable Basic / Dominant Flex can be used with the Disposable Collection System in the sizes 1.5 liters and 2.5 liters.
  • For the Reusable Collection System, the sizes 1 liter and 2 liters are possible.
Which size of canisters can I use with the Vario pump?
  • For the Vario, you can use the Disposable Collection System in the 1.5-liter size. Please remember that you need an adapter (art. 077.0105) in order to attach the jar to the Vario pump.
  • For the Reusable Collection System, you can use the 1 liter and 2 liters sizes.
What is the size and weight of the Vario pump?
  • The AC version weighs 3.5 kg, the AC / DC version includes a battery and weighs 4.2 kg.
  • The measurements are as follows: 380 mm in height, 70 mm in width and 285 mm in depth.
What is the size and weight of the portable Basic or Dominant Flex pump (rack version)?
  • The weight is approximately 10 kg.
  • The measurements are as follows: 210 mm in height, 305 mm in width and 375 mm in depth.
Supply and Sales
How has Medela increased production in light of increased demand surrounding COVID-19?

As hospitals around the world are seeking to expand their capacity and set-up temporary care facilities, the demands for our mobile airway & surgical suction pumps increased significantly. We are doing everything in our power to meet these urgent demands and are working on tripling our production capacity as quickly as possible.

How can I order Medela products?

If you are interested in obtaining Medela systems in your hospital, please contact our sales teams, or find your local representative or distributor here

 

What customer support services are currently available to our facility?

We are committed to providing robust support during this time, while maintaining the safety of our employees and customers. We have compiled a library of inservice resources to help you get your new systems set-up and operational. Please refer to the page on chest drainage for more information on Thopaz+. For additional support, our service representatives are available for personalized support. To request additional support via phone and email as usual. To request aditional support, contact us.

Will Medela continue to support onsite training for new product orders?

Medela will adhere to the relevant guidelines and regulations regarding the limitation of in-person contacts in order to limit contagion risk. Additionally, we believe training should occur in a comfortable and secure environment in order to achieve the desired benefits. As such and depending on the development of the COVID-19 situation, we recommend virtual trainings.

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