An independent analysis of Vitalograph’s Bacterial Viral Filters (BVF) found that the products are an efficient hygiene solution providing greater than 99.999% protection from bacterial and viral cross infection, including SARS-CoV-2, according to the company.

Cross-contamination can occur during pulmonary function testing when a patient transfers bacteria or other micro-organisms to the device. To prevent this, BVFs are used to reduce the amount of bioburden passing through the filter and then again back through a second filter to a level that is not detectable.

Based on analysis, Vitalograph’s BVFs demonstrated the following efficiencies in preventing cross-contamination in three evaluations:

  • Predicted Cross-Contamination Prevention – Technostat
    • Vitalograph’s BVFs demonstrated a 99.999999999% bacterial efficiency in preventing cross-contamination, and a 99.999999995% viral efficiency in preventing cross-contamination.
  • Theoretical Cross-Contamination Prevention – Nelson Labs Test Results (New BVF)
    • A new BVF demonstrated a 99.99998556% bacterial efficiency in preventing cross-contamination, and 99.99994375% viral efficiency of the filters in preventing cross-contamination
  • Theoretical Cross-Contamination Prevention – Nelson Labs Test Results (+7 Years)
    • A BVF that exceeded its “use by” date by at least 7 years demonstrated a 99.999999973% bacterial efficiency in preventing cross-contamination, and 99.9999% = the % viral efficiency of the filters in preventing Cross-Contamination

The Vitalograph BVF uses electrostatically charged material to trap expectorated matter plus bacteria and viruses, which provides effective protection against cross-contamination, the company says.

“In light of COVID-19 we wish to assure our customers that Vitalograph’s Bacterial Viral Filters (BVF) have
been independently tested for prevention of cross-infection. The results show that our BVFs are an efficient
hygiene solution providing greater than 99.999% protection from bacterial and viral cross infection including
SARS-Cov-2 / COVID-19,” the company said. “It is important that Vitalograph’s Bacterial Viral Filters (BVF) are used to reduce the contamination risk to spirometers, pulmonary function testing equipment and respiratory monitors, and the potential infection risk to others. When a new Vitalograph BVF is used for every patient, the interior of the device is protected which means that only exterior surfaces require cleaning.”

To gain more insight on the role of BVFs in infection control during COVID-19, RT spoke with Troy Pridgeon, executive vice president, US HC Sales and Operations, Vitalograph.

1. How is COVID-19 affecting the PFT industry, and chronic lung patients as a result? 

Pridgeon: With the onset of the COVID-19 pandemic in the United States and the subsequent stay-at-home orders, respiratory care had a seismic shift toward acute, emergent care in many places. Respiratory Therapists joined nurses, doctors and first responders on the front lines of care for those infected and symptomatic, with all of the risks and frustrations that that presented. However, many hospital PFT labs and Specialty Clinics actually closed down at the same time as a precaution to protect the chronic lung disease patients who are by definition at high risk. Thus, the short term has rendered a precipitous drop in the frequency and availability of routine testing for chronic lung patients. As the country emerges from the immediate crisis, we expect to see a backlog of patients return for testing, enhanced infection control vigilance during testing, and the potential for a new population of patients who are recovered from COVID-19 but carry the scars of the experience within them. 

2. Infection control is on everyone’s mind. What sterilization/decontamination procedures are recommended for your PFT equipment and have they changed at all in response to COVID-19? 

Pridgeon: The biggest shift has really been in prevention through effective filtering. A new bacterial viral filter (BVF) should absolutely be used for each patient being tested. The Vitalograph BVF filter is designed to fit neatly onto the flowhead and in our case have been independently verified to provide greater than 99.999% protection from bacterial and viral cross infection including SARS-Cov-2 / COVID-19. They also adhere to our Manufacturer Hygiene Policy which recommends that the flowhead be kept clear of any expectorated debris that might affect functionality if left to build up inside the device. While the use of these isn’t new, it has previously been a choice with some tests conducted utilizing one way valves or other unfiltered options at various sites. It is Vitalograph’s position that ANY device used on more than one patient should have a new BVF in place to prevent the distribution of microbes into the flowhead and out into the testing environment. Thus, the only remaining need is for exterior cleaning between patients utilizing a 70% isopropyl alcohol impregnated cloth to clean the case exterior of the flowhead and the body of the device. 

3. What role do bacterial viral filters (BVF) play in infection control and are you seeing increased use/demand for your products?  

Pridgeon: BVF filters are essential to infection control without doubt. Vitalograph have always sold and recommended their use, but since the outbreak of COVID-19 we have seen a dramatic pivot away from one-way valves and non-filtered mouthpieces except in the case of single patient use devices. We are actively encouraging our customers to convert to BVF technology if they haven’t already done so. These filters work by way of electrostatic attraction, which prevents transmission of particles as small as or even smaller than the coronavirus at 99.999% efficiency, yet also offer low resistance so as not to skew the results of the study. 

4. In addition to patient safety, how does preventing cross-contamination improve workflow for PFT technicians? 

Remember that patients aren’t the only ones at risk. Healthcare workers and office staff are just as susceptible to coronavirus, influenza, rhinovirus, tuberculosis, or any other microorganisms and as such the safety issue goes well beyond the patient. However, the routine workflow benefits of BVF filters include a significant reduction in or elimination of the time required to disassemble and clean the flowhead and a decline in the need to regularly deep clean the testing environment. 

5. Has there been any increased demand for disposable PFT devices/accessories in comparison to reusables? 

While Vitalograph BVF filters are all disposable by design, the nature of clinically valid PFT and Spirometry testing does not readily lend itself to disposable devices. The closest thing to such a device might be the Peak Flow Meter, however the results rendered are of course not nearly sufficient for diagnostic purposes. What has increased virtually overnight is the demand for a single patient use device such as the Vitalograph Lung Monitor. These reusable home monitors or screeners are affordable and can be USB or Bluetooth enabled. They also provide a wide array of result options such as FEV1, FEV6, FEV1 Ratio, FEF 25-75%, Personal Best, and so on. A patient could realistically own one of their own unit and test as frequently as needed to collect multiple data points and allow for the trending of multiple parameters. This would be very powerful tool in tracking lung function, exacerbation, and medication efficacy. This proactive approach could signal when in-lab PFT testing is indicated, if medication needs to be adjusted, or even if intervention is advisable to preempt an emergency. 

6. How is telemedicine use increasing with pulmonary function testing and how are your products integrated with telehealth and EMR systems? 

Telemedicine has seen a slow growth into healthcare for a long time now, but the COVID-19 crisis seems to be changing the game more quickly. Certainly regulatory and legal barriers to its implementation have been dramatically scaled back since the pandemic. As noted before, patients with chronic lung issues are at risk of serious complications or even death from COVID-19 or other respiratory diseases, and remote testing can be considerably safer. But moreover, in-lab testing has often been too periodic to understand how a patient fluctuates on a daily or weekly basis, or worse, simply reactionary to an exacerbation event. Telemedicine offers the promise to test patients remotely, frequently, safely and proactively while also making review and interpretation of results faster, more accessible, and easier to consult upon. In-lab PFT and Spirometry studies can likewise benefit from telemedicine and transmit results through a Vitalograph Spirotrac software integrated connection to electronic medical records systems of every type. This means that results from long ago or far away could be accessed instantly and on demand rather than being buried in a filing cabinet or warehouse. Vitalograph embraces telemedicine and EMR as important components to the future of healthcare.