2013 BLS Systems Limited Edward J. Reesor, RRT, MBA Director of Marketing REPLACING SEVERAL SINGLE FUNCTION OXYGEN DELIVERY MASKS WITH A SINGLE MULTI- FUNCTION DEVICE This document will discuss the current healthcare culture of applying several single function oxygen delivery masks, their function and the ability to deliver superior therapy using a single multifunction device. Executive Summary The regular use of single function non-rebreather masks, simple masks and small volume nebulizer masks significantly lower the efficiency of healthcare delivery while unnecessarily inflating costs. Qualitative research suggests that common oxygen masks deliver significantly lower oxygen concentrations than assumed, providing an obstacle for quality healthcare and potentially place patients at increased risk of harm. The FLO2MAX and O-Mask High Concentration Oxygen Masks by BLS Systems Limited combine four single function oxygen delivery devices into one device, thus improving patient care while maintaining organizational efficiency. The FLO2MAX and O-Mask series of masks provide superior function than any single function mask while reducing the number of devices staff are responsible for. The FLO2MAX and O-Mask High Concentration oxygen masks simplify healthcare delivery, optimize therapeutics, reduce occupational exposure to airborne contaminants and reduce costs associated with maintaining several SKU’s. Key differences are captured in the following chart: Small Non- Medium volume rebreather concentration FLO2MAX O-Mask nebulizer mask (Simple) Mask mask Oxygen 55-60% (Garcia, 43-69% 35-50% 24-99% 24-99% concentration Earl) None. Have None. Have None. Have been been strongly Automatic Ability to Ability to been associated associated with associated with connect filter exhaled with spreading spreading with integrated standard filter particles organisms organisms spreading filter organisms Number of 1 1 1 5 4 functions Large Adult, Large Adult, Common sizes Adult, Child Adult, Child Adult, Child Small Adult, Small Adult, Child Child Ability to Yes (now None None Sole function Yes Deliver available with Medications MDI port) 2 Introduction Hospitals rely on many types of oxygen delivery devices to treat patients effectively and to the best of the abilities of the healthcare provider. Unfortunately there is an industry wide dependency on inefficient, single function devices to perform the necessary therapeutics, leading to the application of several single function devices on a patient through their care plan. The supply management, staff instruction, inventory control and waste management costs associated with several similar but separate single function products unnecessarily increase the cost of healthcare delivery. The most common types of masks used to deliver oxygen and medication are the non-rebreather mask, the medium concentration (simple) mask and the aerosol/small volume nebulizer (SVN) mask. These masks are normally available in two sizes; adult and child, and are used by all healthcare providing facilities in considerably large numbers. The average patient may use two or more of these single function masks during their admission. Investigation into the 2003 SARS outbreak identified these masks as contributing to the spread of respiratory borne particles. The FLO2MAX and O-Mask High Concentration Oxygen Therapy Masks were designed and developed to combine the above mentioned mask types into one unit while offering superior performance. This document will describe each mask type and the issues that are experienced during normal application. 3 Conventional Non-rebreather Mask The conventional non-rebreather mask is the most widely recognized oxygen mask in healthcare. It was designed to deliver maximum oxygen concentrations above the 21% found in common room air. First reported in 1919 as the Haldane Reservoir Oxygen Mask and later modified in the form of the BLB Mask, this medical device has been used largely unmodified since the 1930’s. The non-rebreather mask was designed with a series of one-way valves to direct gas from an oxygen reservoir into the mask on inhalation while minimizing room air entrainment. During exhalation, two one-way valves located on the side of the mask open to release the exhaled breath into the surrounding area. Due to a concern for patient safety in the event that the source gas was interrupted or disconnected, one of the exhalation valves is commonly removed to provide anti-suffocation protection. When one valve is removed, the resulting non-valved port acts as a continuous room air entrainment port, significantly affecting performance. Although manufactures often offer masks in both configurations, many organizations specify this safety feature during procurement processes. Mask with two exhalation valves Mask with one exhalation valve (circled in red) removed for patient safety (circled in red) Performance Many textbooks report oxygen delivery values for the non-rebreather mask at 80-95%, however these values are non-referenced assumptions based on the original design. Published research have revealed 4 that these masks deliver far lower gas concentrations than assumed, primarily due to the removal of one exhalation valve. Several studies have revealed that they significantly underperform to the extent that patients inhale as much room air as oxygen. Because room air contains 21% oxygen, a 1:1 ratio of room air and oxygen delivers a concentration of 60% to the patient. Garcia et al, CHEST 2005 (Appendix 1) revealed that a conventional non-rebreather mask operating at the prescribed oxygen flow of 8-10 Lpm resulted in 57-68% oxygen being delivered to the patient. A second study presented by John Earl, RRT at the 2003 Association of American Respiratory Care (AARC) conference (Appendix 2) stated 50- 56% oxygen being delivered under similar conditions. These findings concluded that patients actually inhale more air than oxygen during the inspiratory phase. A third abstract presented at the 2007 AARC conference (Moody et al) revealed oxygen delivery between 53-71% despite using higher gas flows of 12-15 Lpm. These lower oxygen concentrations are based on the necessary removal of one exhalation valve. The conventional non-rebreather mask therefore delivers significantly lower oxygen levels despite having the sole function of offering maximum oxygen concentrations to the patient during acute and critical episodes of distress. While not all patients require maximum oxygen delivery, the most acute crises require the ability to offer it. The result of using sub-therapeutic oxygen levels include further deterioration of the patient’s condition leading to application of more advanced therapeutic regimens by the attending healthcare professional or premature death. Subsequent treatment plans as a result of inefficient oxygen delivery devices can include the application of more expensive equipment such as non-invasive mechanical ventilation or endotracheal intubation and mechanical ventilation. These approaches carry significant risk to the patient while incurring additional and unnecessary costs as well as increased length of hospital stay. The non-rebreather mask is stocked and used by all ambulances and hospitals worldwide despite the documented performance statistics due to tradition, professional dogma and lack of affordable alternatives. This poor performance is tolerated by those who subscribe to the belief that the device delivers maximal oxygen concentration, often feeling secure that more advanced therapeutics are available as a backup safety mechanism. 5 Medium Concentration or “Simple” Mask The medium concentration or simple mask is a single function device which was designed to deliver a lower amount of oxygen when 100% oxygen is not indicated. They are applied throughout the healthcare industry to patients who are more stable and therefore less critical. These masks have a simpler design in that they do not have a gas reservoir bag nor a series of one-way valves to direct gas into and out of the mask during the respiratory cycle. The design allows more room air to entrain into each inhaled breath, diluting the 100% oxygen fed into the mask. Traditional belief reports oxygen delivery in the 40-60% range, depending on oxygen gas flow, which have been confirmed by the Garcia studies. As with all single function products, the attending healthcare professional is forced to apply additional devices offering higher concentrations if the patient’s condition deteriorates. These masks are used in considerable numbers in the prehospital and hospital setting and are commonly available in adult and child sizes. A Medium Concentration or “Simple” Mask) (Note: no exhalation valves on the side ports and no reservoir bag) 6 Aerosol or Small Volume Nebulizer Mask Aerosol or Small Volume Nebulizer Masks have the single function of aerosolizing liquid medications for direct inhalation by patients with the intent of administering them directly to the bronchial mucosa. Common medications include fast acting bronchodilators, steroids and some potent anti-biotics, which are commonly applied in cases of acute or chronic respiratory disease. These devices are assembled using three key parts; tubing to the oxygen flowmeter, a small volume nebulizer (SVN) and the mask itself. There are no valves used to direct the medication flow and the mask typically has two large holes on the sides for exhalation (see figure left, below). Aerosol Mask with Small Volume Nebulizer Attached. Aerosol Mask with large bore tubing attached