Frequently Asked Questions (FAQs)
Why is the BioArmour Blood Pressure Cuff Shield needed?
Healthcare facilities present repeated opportunities for the transmission of infectious pathogens from patient-to-patient, via direct and indirect routes including: contaminated devices, equipment, supplies, environmental surfaces, as well as from the hands or gloves of medical personnel. Indeed, the ability of blood pressure cuffs to act as vehicles of Hospital Acquired Infections (HAIs) has been documented in multiple scientific studies (International Journal of Medical Sciences, 1991; 160(4):112-3) and we encourage you to review our whitepaper regarding the same. The growing concern of healthcare professionals in regard to antibiotic resistant pathogens is creating an increase in desire for disposable hygienic barriers for commonly used equipment, such as blood pressure cuffs (Dialysis & Transplantation, 2002; 31(5): 337-341).
Can’t I just clean the blood pressure cuff between uses?
Certainly, that will help reduce the spread of disease. Studies have shown, however, that a regular blood pressure cuff isn’t often cleaned properly and can be a haven for microbes and germs. Our product is intended to be an additional tool in the fight against HAIs.
Why is a copper/silver antimicrobial technology used?
Our chosen copper/silver antimicrobial technology has numerous benefits compared with various competitive antimicrobial textile treatments. The zeolite carrier, imbedded within the fabric fiber provides silver and copper ions to maintain continuous protection over a 24 hour period. It inhibits microbes with a trimodal efficacy: by starvation, sterilization and suffocation, leaving no resistant strains behind. Silver and copper have been used for centuries as an effective broad-spectrum antimicrobial.
What antimicrobial efficacy testing has been performed?
Biovation has performed pre-screening antimicrobial efficacy tests to determine the level of kill over a 24 hour period. Please see the table below for data obtained from this AATCC study.
|Test Article Identification||Log Reduction||Percent Reduction|
We are submitting the product for FDA approval. That approval includes additional testing: antimicrobial efficacy validation via a rate-of-kill study to determine how quickly microbes will be mitigated on the surface of the Shield; a broad-spectrum antimicrobial efficacy test, to determine the rate of kill of various microbes; and a minimum effective concentration study, to determine the minimum concentration necessary to obtain a 4 log reduction of the challenge organisms.
How many times can I use the BioArmour Blood Pressure Cuff Shield?
The product is intended for multi-patient use over a 24-hour period. Apply it once to a blood pressure cuff and replace it in 24 hours.
Is the BioArmour Blood Pressure Cuff Shield Disposable?
Yes, it is disposable like any other healthcare drape or shield.
What if it gets soiled by blood or body fluids?
We recommend you replace the Shield if it becomes visibly soiled during the 24 hour period.
Have you tested the level of contamination of the shield after 24 hours?
No, but we can assume that without the antimicrobial additive in the Shield the bioburden would be similar to that of a regular blood pressure cuff used on multiple patients. The efficacy tests required by the FDA do not incorporate this type of test. The tests to be performed for antimicrobial efficacy validation will provide the rate of microbial reduction for the worst case scenario contamination level.
Will the BioArmour Shield be provided in different sizes & colors?
The BioArmour Shield may be provided in various sizes to accommodate the various sizes of blood pressure cuffs on the market and we may use different colors to exhibit product sizing. At this time, we are selling & marketing only the most commonly used size.
Is this BioArmour Shield safe for skin contact?
Yes, the BioArmour Shield is safe for skin contact as proven by the Biocompatibility (ISO 10993) testing performed on the product, comprised of cytotoxicity, skin irritation, and sensitization studies.
Does the BioArmour Shield contain latex?
No, the BioArmour Shield does not contain latex.
Is there a shelf-life to the BioArmour Blood Pressure Cuff Shield?
Yes, the Shield has a shelf life of one year, based on the life of the antimicrobial active ingredients.
What is the product registration status?
The product is registered/cleared as a medical device in the following countries:
European Union, Authorized Representative is Emergo in Netherlands; registration date is 12/4/2014 and product is Class I, under Rule 1, Annex VII of MDD 93/42/EEC
Canada – product is not considered a medical device, therefore it is clear for sale
USA – FDA medical device clearance is pending
Please contact Biovation to review registration requirements for countries not listed above.
Are you looking for additional product distribution partners?
Yes, if you or your organization is interested in representing the BioArmour Blood Pressure Cuff Shield to a market outside the US, please contact Keri Seitz, VP of Sales, at firstname.lastname@example.org.