In these unprecedented times, we want to reassure you that Bayer Radiology remains committed to our customers and supporting you as and when needed. To be in line with the latest Government advice on social distancing, our field force are not able to visit or meet you in person, however, they will keep in close contact with you by email and phone to respond to your needs in the day-to-day running of your departments and to offer any support or guidance you require over the coming weeks.

At Bayer we are guided by our purpose, Science for a better life. Both during and after this crisis, we will do whatever it takes to help serve the world’s health and nutritional needs.

Lynne Collins
Bayer Radiology Country Head UK/Ireland

Radiology Sales Representation update COVID-19 Bayer Injector Decontamination Procedure & Engineer Access Bayer Device Decontamination Statement Covid-19 Frequently Asked Questions (FAQ)

COVID-19 Bayer Radiology Sales Service Update for Customers

In these unprecedented times, we want to reassure you that Bayer Radiology remains committed to our customers and supporting you as and when needed. To be in line with the latest Government advice on social distancing, our sales team are not able to visit or meet you in person, however, they will keep in close contact with you by email and phone to respond to your needs in the day-to-day running of your departments and to offer any support or guidance you require over the coming weeks.

If you have an urgent request for a meeting, our sales team can facilitate virtual meetings using online video conference systems. Please call us to discuss the most appropriate time and convenient technology for you.

In the meantime, ensuring supply of Bayer Radiology products to our customers is of the highest priority for Bayer. Therefore, we have a general inventory policy which includes buffers for our sourced material. We have set up dedicated global and local teams to continuously and closely monitor the situation worldwide to ensure minimum impact on radiology medical devices and supply in the foreseeable future. If you have any queries, please do not hesitate to contact your local Bayer Radiology representative.

Many thanks for your understanding. As this is an evolving situation, we will keep you updated of any further changes in our service.

COVID-19 Bayer Injector Decontamination Procedure & Engineer Access

In light of COVID-19 developments, Bayer is providing cleaning and disinfection instructions for its medical devices. In general, Bayer recommends following instructions published recently in the Journal of the American College of Radiology, JACR. The authors recommend to either wash devices with soap and water or decontaminate using a low-level or intermediate-level disinfectant, such as iodophor germicidal detergent solution, ethyl alcohol, or isopropyl alcohol1.

1Kooraki, Soheil, et al. "Coronavirus (COVID-19) outbreak: what the department of radiology should know." Journal of the American College of Radiology (2020).

Detailed guidance on Bayer medical device decontamination can be found in the ‘Device Disinfection Statement’.

Disposables cannot be cleaned or disinfected, so must be discarded if disinfection is required:

Decontamination procedure

Injector Head/Injector Base/Display

Wipe all surfaces of the injector with soap and water or decontaminate using a low-level or intermediate-level disinfectant, such as iodophor germicidal detergent solution, ethyl alcohol, or isopropyl alcohol.

A surface being disinfected shall remain exposed to the disinfectant for no less than the minimum recommended timeframe as stated in the manufacturer’s guidelines.

If only a spray disinfectant is available, spray onto a paper towel first and then wipe the injector surface (do not spray the disinfectant directly on to any injector surfaces).

Engineers attending sites

In the event a Bayer engineer is required to attend a site, please ensure all hospital safety guidelines and precautions (including the availability of any PPE), issued to your own staff, are also provided for the engineer to produce a safe environment for any work to be carried out in.

Without suitable safety measures in place, including the satisfactory decontamination of equipment to be worked on, the engineer will not be authorised to continue until these actions have been completed.

These precautions enable our engineers to provide service continuity in the current climate.

Bayer Device Decontamination Statement

In light of COVID-19 developments, Bayer is providing cleaning and disinfection instructions for its medical devices. In general, Bayer recommends following instructions published recently in the Journal of the American College of Radiology, JACR. The authors recommend to either wash devices with soap and water or decontaminate using a low-level or intermediate-level disinfectant, such as iodophor germicidal detergent solution, ethyl alcohol, or isopropyl alcohol. Specific instructions and tested disinfectants/cleaning agents are provided on a per-product basis in the attached document. Please pay close attention to product specific operations manuals as the use of some disinfectants may cause damage to parts of the injection system and should not be used. Disposables cannot be cleaned or disinfected, so must be discarded if disinfection is required.

Kooraki, Soheil, et al. "Coronavirus (COVID-19) outbreak: what the department of radiology should know." Journal of the American College of Radiology (2020).

Click here for the detailed document

COVID-19 and Radiology – Q&A

Status April 22nd, 2020

1. What is the role of imaging in the COVID-19 pandemic?

Research continues on how COVID-19 is best diagnosed and knowledge is rapidly evolving. Viral infections like COVID-19 are primarily assessed by means of the evaluation of clinical symptoms and viral DNA tests. X-ray and CT imaging are both used to assess the extent of pulmonary manifestations and document either disease progression or treatment response, however CT is not currently deemed appropriate for the diagnosis of acute respiratory illness

The appearance of a COVID-19 pneumonia on chest radiographs and CT has been discussed in several current publications. While there are suggestive findings especially in CT, they are not pathognomonic of infection by COVID-19. Findings are typical for a variety of viral pneumonias such as those caused by the flu. More research is needed to potentially identify specific imaging hallmarks of COVID-19 pneumonias.

Chest CT and portable chest radiography can be helpful tools in assessing and documenting suspected COVID-19 infection with pulmonary manifestation but typically are not recommended for first-line diagnostic purposes.

Yee KM. Radiology has key role to play in the midst of COVID-19. AuntMinnie, accessed 26 March 2020.
ACR 2020, ACR recommendations for the use of Chest Radiography and Computed Tomography (CT) for suspected COVID-19 infection, March 26 2020.

2. Is a conventional chest X-ray (CXR) or Computed Tomography of the thorax (chest CT) the preferred imaging test in diagnosing a COVID-19 pneumonia?

CT is currently not recommended for use in screening of or as a first-line test to diagnose COVID-19. Currently, viral DNA tests remain the only specific diagnostic test for COVID-19. Chest X-rays (CXRs) represent the most commonly used diagnostic tool for pneumonia patients. However, CXRs are often performed for documentation reasons and to exclude differential diagnoses or severe complications as they are not sufficiently sensitive or specific for viral pneumonias. Most guidelines and appropriateness criteria still name CXRs as more appropriate for the work up of viral pneumonia patients which might be partially based on economic and work flow related criteria. A CT of the lung is significantly more sensitive than CXR and quite specific in its differentiation of viral vs. bacterial pneumonias and does not use significantly higher radiation levels than a 2-plane CXR. It is therefore the better tool for imaging method for COVID-19 as compared to CXR.

The British Society of Thoracic Imaging (BSTI) in collaboration with NHS England announced the COVID-19 Radiology Decision Support Tool. The decision tool can be found on the following link.

https://www.bsti.org.uk/media/resources/files/NHSE_BSTI_APPROVED_Radiology_on_CoVid19_v6_modified1__-_Read-Only.pdf

The ACR also remains clear in its recommendation: “As an interim measure, until more widespread COVID-19 testing is available, some medical practices are requesting chest CT to inform decisions on whether to test a patient for COVID-19, admit a patient or provide other treatment. The ACR strongly urges caution in taking this approach. A normal chest CT does not mean a person does not have COVID-19 infection - and an abnormal CT is not specific for COVID-19 diagnosis”

ACR 2020, ACR recommendations for the use of Chest Radiography and Computed Tomography (CT) for suspected COVID-19 infection, March 26 2020.

3. Which imaging protocol should be used for a chest CT in the diagnosis of viral pneumonia?

Should CT be clinically indicated, a high resolution (HR) CT of the chest with 1-2-millimeter reconstructions should be performed ideally in supine and prone positions. No contrast media administration is needed for the primary detection of the pneumonic infiltrates as the typical signs of a viral pneumonia (ground glass opacity or thickened interlobular or intralobular septa) are well delineated in native scans.

Gurney, Winer-Muram, Diagnostic Imaging: Chest, Textbook 1st Edition.

4. Does the use of contrast media (CM) in CT provide any incremental diagnostic benefit for COVID-19?

Not for the primary diagnosis of atypical pneumonias such as COVID-19. However, contrast media application can be valuable in case of bacterial super infection or complications and when exclusion of the main differential diagnoses of chest pain is in scope. It also plays a role in very sick or intensive care patients to ensure most comprehensive health status information.

Gurney, Winer-Muram, Diagnostic Imaging: Chest, Textbook 1st Edition.

5. Why does it appear that Radiologists perform more contrast enhanced chest CTs during the COVID-19 pandemic?

There are a few indirect drivers which could explain an increased performance of contrast enhanced CT examinations:

  • For increasingly sick patients and most pronounced for intensive care patients imaging is often performed as a more general health status check and not only to confirm a pneumonia. In these cases, contrast can be given to ensure most comprehensive information.
  • Radiologists standardly apply CM supported CT chest protocols (like oncologic chest, pulmonary embolism (PE) - and cardiac CT (cCT) –protocols) in order to rule out all potential differential diagnoses for chest pain at the same time.
  • Radiologists transfer complex examinations from interventional suites, Cath Labs and MRI into the quicker CT modality, mainly to address the more intricate disinfection and hygiene procedures associated with these examinations.

6. What are imaging features of COVID-19 in initial CT?

The known imaging features of CT in COVID-19 cases include bilateral, multi-lobar Ground Glass Opacities (GGO) and patchy consolidated opacities with a peripheral and/or posterior distribution, mainly in the lower lobes and less frequently within the right middle lobe.

Salehi S et al. Coronavirus Disease 2019 (COVID-19): A Systematic Review of Imaging Findings in 919 Patients. AJR 2020:1-7.

7. Does MRI play a role in the work up of COVID-19 patients?

MRI is usually not considered appropriate to use as the initial imaging modality of acute respiratory illness. There have been reports of cardiac complications in patients with COVID 19 infection. Like other viruses COVID-19 is able to infect the Myocardium. Contrast enhanced MRI is able to identify those patients.

Zheng et al. Covid-19 and the cardiovascular system. Nature Reviews 2020

8. Does Ultrasound (US) play a role for COVID-19?

Some use of Ultrasound as a complementary diagnostic tool or secondary modality for COVID-19 has been reported. Experienced examiners can detect the higher density (fluid filled) areas in the lung parenchyma, pleural or pericardial. The use is partly based on a lack of resources like CT but also provides benefits since point of care (POC) US can be used bedside, and avoids virus spread from patient movement to different locations.

Pablos T. Doctors in Italy, Spain using ultrasound for COVID-19. AuntMinnie, accessed 15 April, 2020.

9. Are there follow-up studies to describe the course of the disease and its CT imaging appearance over time?

Research continues to be performed and knowledge rapidly evolves. In early stages evidence suggests that the majority of patients show more Ground Glass Opacification (GGO) and lower number of involved lobes compared to follow-up scans. Intensification of a paving pattern, increase in number of involved lobes and appearance of consolidative opacities occur over time. Later disease stages report development of pleural effusions as well as progression to a mixed pattern of GGO and consolidative opacities. These findings are non-specific to COVID-19 but are consistent with the general course of viral pneumonias.

10. How many temporal stages are identified in CT findings in COVID-19?

CT findings have been characterised in five temporal stages.

  • Ultra early stage: Single or multiple focal GGO, patchy consolidative opacities, pulmonary nodules encircled by GGO
  • Early stages: Single or multiple focal GGO, or GGO combined with interlobular septal thickening.
  • Rapid Progression: Large consolidative opacities and air bronchograms.
  • Consolidation: Reduction in size and density of consolidative opacities
  • Dissipation: Dispersed patchy consolidation opacities, reticular opacities, bronchial wall thickening and interlobular septal thickening.

Pan F et al. Time course of lung changes on chest CT during recovery from 2019 novel coronavirus (COVID-19) pneumonia. Radiology 2020 February 13
Salehi S et al. Coronavirus Disease 2019 (COVID-19): A Systematic Review of Imaging Findings in 919 Patients. AJR 2020:1-7
Jin YH et al.; A rapid advice guideline for the diagnosis and treatment of 2019 novel coronavirus (2019-nCoV) infected pneumonia. Mil Med Res 2020; 7:4

11. On a timescale when are the CT findings in COVID-19 patients most prominent?

Based on current knowledge, CT seems to be able to identify pneumonic infiltrates early in the course of the COVID-19 infection, sometimes even before onset of clinical symptom. Some evidence suggests that CT findings are most prominent around day 10after onset of initial symptoms.

Pan F et al. Time course of lung changes on chest CT during recovery from 2019 novel coronavirus (COVID-19) pneumonia. Radiology 2020 February 13

12. Is there any evidence for specific imaging signs or hallmarks of COVID-19 in CT or X-ray?

Lung infections are classified as either typical or atypical pneumonias. Typical pneumonias are normally caused by bacteria and present as lobar or lobular infiltrates which are of high density, respect the lobar and lobular margins and thus are clearly delineated even in an X-ray but even clearer in CT. Atypical pneumonias on the other hand are often caused by viruses or mycoplasma. They are more diffuse and cause ground glass opacifications and thickening of certain lung membranes and structures. This is in initial stages challenging or difficult to identify on X-rays but also very clearly delineates in CT which means that CT is quite effective in demonstrating the differences between bacterial and viral pneumonias.

The characteristic pattern and distribution of viral pneumonias including COVID-19 manifestations in CT are Ground Glass Opacification (GGO), thickened inter and centrilobular nodules. While there are a few potential hallmarks discussed for COVID-19, which are e.g. early bilateral involvement, peripheral distribution and multilobar involvement these overlap heavily with the expression of other common viral disease and are not sufficient to facilitate a clear COVID-19 diagnosis.

Salehi S. et al. Coronavirus Disease 2019 (COVID-19): A Systematic Review of Imaging Findings in 919 Patients. AJR 2020:1-7
Ye et al, Chest CT manifestations of new coronavirus, Eur Radiol 2020 Hosseini et al, Radiology Perspective of Coronavirus Disease 2019 (COVID-19): AJR 2020

13. Are the pneumonic infiltrates on X-ray and or CT preceding, do they occur simultaneously, or do they follow the clinical symptomatology?

In general, the extent and severity of imaging findings correlate well with clinical symptomatology. However, there is some indication that CT is able to identify pneumonic infiltrates before patients become clinically symptomatic or even recognise they are infected.

In the so called ultra-early phase, a patient would be imaged within 1–2 weeks after being exposed to a virus contaminated environment (for instance, history of contact with a patient or patient-related family members, unit, or medical staff in a cluster environment).

In this phase no clinical symptoms have occurred but in some patients CT imaging manifestations are already described. These manifestations are general atypical pneumonia signs as e.g. single, double or scattered focal ground-glass opacities, nodules located in central lobule surrounded by patchy ground-glass opacities, patchy consolidation and sign of intra-bronchial air-bronchogram, which was dominant in the middle and lower pleura.

Jin Y et al, A rapid advice guideline for the diagnosis and treatment, MMR 2020
Wang Y et al, Temporal Changes of CT Findings in 90 Patients with COVID-19, Radiology 2020

14. What are the most common CT imaging findings in severely ill patients?

Severely ill patients with COVID-19 infection are characterised by an increasing decompensation of their pulmonary, cardiac and general health status. In CT imaging this can lead to visible bilateral and multi-lobar lung involvement and to sub segmental consolidative opacities in the lung. Also, pleural effusions have been described which are usually more typical for bacterial infections and could stem from a cardiac involvement also. Described myocarditis complications are not visible in CT until they impair the heart function significantly.

Salehi S et al, Coronavirus Disease 2019 (COVID-19): A Systematic Review of Imaging Findings in 919 Patients. AJR 2020:1-7.

15. Are there any age group variations in the CT manifestations in COVID-19 patients?

Recent preliminary research suggests that there might be a predominance of consolidation opacities in older patients and a more GGO based picture in younger patients.

Song F, Shi N, Shan F, et al. Emerging 2019 Novel Coronavirus (2019-nCoV) Pneumonia. Radiology 2020;295:210-7.
Pan F, Ye T, Sun P, et al. Time Course of Lung Changes On Chest CT During Recovery From 2019 Novel Coronavirus (COVID-19) Pneumonia. Radiology 2020:200370.

16. What needs to be considered to prevent contamination in the CT suite when performing CTs in patients with known or suspected COVID 19 infection?

In a recent expert panel publication, a group of radiologists described the policies they have developed in close collaboration with top infection control experts at their respective world-class healthcare systems. Key considerations were: coordination with infection control departments, early identification of COVID-19 patients via screening at time of scheduling, entrances, and reception desks, rapid isolation when COVID-19 is suspected, and appropriate staff training and use of personal protective equipment (PPE). Standard operating procedures for performing exams and decontaminating CT suites, especially equipment, are also required.

For a specific example of a standard operating procedure, Nakajima et al. published their infection control protocol: Ideally. two radiographers would be available for the CT scanning of patients for the assessment of COVID-19 pneumonia. Radiographer 1 uses PPE to set up the patient on the CT imaging table, while the radiographer 2 operates the CT console. The PPE includes eye protection (goggles), a filtering face piece respirator (N95), a surgical cap, gloves, a fluid-resistant gown, and shoe covers. In principle, CT examinations for patients suspected of or confirmed with COVID-19 are performed last in the daily CT schedule. The CT examination is performed as follows:

  • Radiographer 1 with PPE is on stand-by;
  • the patient and the attending medical doctor (MD) arrive inside the CT scanner room;
  • Radiographer 1 and MD set up the patient on the CT imaging table;
    Radiographer 1 and MD remove and discard their contaminated PPE (Radiographer1 and MD) inside the CT suite and perform hand hygiene;
  • Radiographer 1 and MD leave the CT scanner room;
  • Radiographer 2 performs non-contrast chest CT scanning, while Radiographer 1 and MD put on new PPE outside the CT scanner room;
  • After the CT scanning, radiographer 1 and MD transfer the patient from the CT imaging table;
  • The patient and MD leave the CT scanner room;
  • The CT scanner and console rooms are sanitised. After leaving the CT suite, the high-frequency contact surfaces (i.e., operating consoles, switches, handles, and door knobs) are wiped with a cloth soaked with alcohol-based disinfectants. The CT suite is tightly closed for 1 h to thoroughly ventilate and exchange the room air.

Additionally, the American College of Radiology maintains an updated list of references and recommendations on their COVID-19 Radiology Resources page. Consistent with the standard operating procedure described by Nakajima et al, they recommend that in addition to environmental cleaning and decontamination of rooms occupied by a patient with suspected or known COVID-19 infection by thorough cleaning of surfaces by someone wearing proper protective equipment, air-flow within fixed radiography or CT scanner rooms should be considered before imaging the next patient. Ventilation is an important consideration for the control of airborne transmission in health care facilities. Depending on the air exchange rates, rooms may need to be unavailable for approximately 1 hour after imaging infected patients; air circulation rooms can be tested.

Mossa-Basha et al. "Radiology Department Preparedness for COVID-19: Radiology Scientific Expert Panel." Radiology (2020): 200988.
Nakajima et al. COVID-19 pneumonia: infection control protocol inside computed tomography suites. Japanese Journal of Radiology (2020): 1-3.
https://www.acr.org/Clinical-Resources/COVID-19-Radiology-Resources

17. Are there any specific hygiene guidelines/ protocols recommended for contrast media injector systems?

The same hygiene guidelines that apply to the CT scanner or other relating medical equipment in the imaging suite also applies to injector systems. Bayer has provided Device Disinfection Statement for all its injectors on the recommended hygienic measures during the pandemic.

18. Are multi-patient use disposable systems of higher concern than single use systems?

In general, there is no higher concern. Cross-contamination testing has established that blood-borne pathogens do not reach multi-patient components, and designs are intended to reduce the risk of contaminating the fluid path via touch. However, if complete disinfection and decontamination of the imaging suite is required due to a suspected or confirmed COVID-19 patient, all disposables (even those labelled as “multi-patient”) would need to be discarded as part of the disinfection process. The concern with COVID-19 is surface/airborne contamination as opposed to fluid path contamination, and disposable components would be damaged by disinfectants and cannot be effectively sanitised.

19 .Does Bayer provide specific guidance on cleaning of injectors?

In light of COVID-19 developments, Bayer is providing cleaning and disinfection instructions for its medical devices. In general, Bayer recommends following instructions published recently in the Journal of the American College of Radiology, JACR. The authors recommend to either wash devices with soap and water or decontaminate using a low-level or intermediate-level disinfectant, such as iodophor germicidal detergent solution, ethyl alcohol, or isopropyl alcohol. Specific instructions and tested disinfectants/cleaning agents are provided on a per-product basis in the attached document. Please pay close attention to product specific operations manuals as the use of some disinfectants may cause damage to parts of the injection system and should not be used. Disposables cannot be cleaned or disinfected, so must be discarded if disinfection is required.

Kooraki, Soheil, et al. "Coronavirus (COVID-19) outbreak: what the department of radiology should know." Journal of the American College of Radiology (2020).

PP-CTP-GB-0034, April 2020