FDA EUA APPROVED COVID-19 MEDICAL DEVICE
The U.S. Food and Drug Administration has issued an Emergency Use Authorization (EUA) for the SCONE™, for use by healthcare providers (HCP) as an additional layer of barrier protection in addition to personal protective equipment (PPE) to prevent HCP exposure to pathogenic biological airborne particulates by providing isolation of hospitalized patients with suspected or confirmed diagnosis of COVID-19, at the time of definitive airway management, when performing airway-related medical procedures, or during certain transport of such patients during the COVID-19 pandemic.
Authorized non-transport use of SCONE™ is only for airway management (e.g., intubation, extubation and suctioning airways), or when performing any airway-related medical procedures (e.g., high flow nasal cannula oxygen treatments, nebulizer treatments, manipulation of oxygen mask or CPAP/BiPAP (continuous positive airway pressure/bi-level positive airway pressure) mask use, airway suctioning, percussion and postural drainage). Authorized use of the SCONE™ during patient transport is only within a hospital setting for temporary transfer with direct admission within the hospital in the presence of a registered nurse or physician. The patient should have constant monitoring of vital signs, electrocardiogram (EKG), SpO2% (oxygen saturation), End tidal carbon dioxide (EtCO2) if available throughout transport. For all authorized uses, the patient should always have supplemental oxygen during use of the SCONE™.
The SCONE™ has not been FDA-approved or cleared for this use; The SCONE™ has been authorized only for the duration of the COVID-19 public health emergency declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
HCP should follow these instructions, as well as procedures at their healthcare facility to use the SCONE™.
The instructions below are to assist in using the SCONE™. The SCONE™ is an adjunctive protective barrier designed to mitigate risk to HCP. The SCONE™ is not meant to be a stand-alone unit of PPE. The SCONE™ should always be used with appropriate PPE and pursuant to the guidance of your institution.
All connections should be tightly secured and checked frequently. Any time anyone is within the SCONE™, direct observation is required. Inspect SCONE™ prior to use. Any wear/tear of the chamber or other signs of degradation on the SCONE™ must promptly be reported to SCONE™ Medical Solutions Inc. The healthcare facility must not use on patients and must dispose of such a SCONE™. Rx Only.
- Flammability of the SCONE™ has not been tested. No interventions that could create a spark or be a flammable source should be used within the SCONE™.
- Remove the SCONE™ and use standard of care if there is difficulty visualizing or identifying anatomic landmarks or inability to intubate after the first try.
- Prolonged use of the SCONE™ may induce hypercarbia in a spontaneously breathing patient. The SCONE™ should be used with medical air flow and suction both on and working, under direct observation, and with end-tidal CO2 monitoring if available. If end-tidal CO2 monitoring is not available, then the use of the SCONE™ should be limited to no more than a short duration of time with medical air flow and suction both on and under direct observation.
- Patient transport must only occur within a hospital setting for temporary transfer with direct admission within the hospital in the presence of a registered nurse or physician. Maintenance of negative pressure with adequate air flow must be assured. All patients should be on supplemental oxygen. Patients must have continuous monitoring of pulse oxygen saturation (Sp-O2), vital signs, EKG, and End-tidal CO2 if available during transport.
- Use caution prior to use on non-sedated or lightly sedated patients with severe claustrophobia and/or confined space anxiety.
- When using the SCONE™ patients should always be receiving supplemental oxygen.
- Patients with diminished hearing may have difficulty understanding the provider while inside the SCONE™.
- SCONE™ is a single-use device and should be disposed of following the disposal instructions after use.
The SCONE™ is not authorized:
- For emergent endotracheal intubation with severe hypoxemia
- On patients with anticipated or known history of difficult airway
- On patients with other anatomical abnormalities that might interfere with clinical care including decreased neck mobility from arthritis or other causes
- On individuals with communication disorders that might interfere with clinical care
- On children under 45 lbs.
SCONE™ Instructions for Use
The SCONE™ is a single-use, clear, negative pressure chamber that attaches to a standard hospital or surgical bed and extends around the patient’s head, neck, and shoulders. Access holes, sealed by vinyl access covers, are built into the chamber to allow for isolated patient access. The negative pressure environment is generated via wall-mounted hospital vacuum lines or negative pressure pumps equipped with in-line HEPA filters. The SCONE™ unit acts as an added layer of physical barrier in addition to personal protective equipment (PPE) to prevent healthcare practitioners (HCP) exposure to pathogenic biological airborne particulates during triage, transportation, and treatment, including aerosol generating procedures (AGPs), and end-of-life care. SCONE™ will be available to healthcare providers and healthcare facilities.
Items You Will Need:
- SCONE™ Device
- 2 (or 1) Facility Wall-Mounted Pressure Regulators (capable of maintaining continuous high suction at 200mmHg to produce 30 LPM per line) OR Portable Vacuum Pump (capable of maintaining continuous high suction at 200mmHg to produce 30 LPM per line) w/ Inline HEPA Filter (single use only; recommend 0.1 μm or better filtration)
- 1 Facility Wall-Mounted Oxygen Delivery Regulator
- 2 (or 1) Healthcare Facility Standard Suction Hose Lines (minimum 1/4"ID) (Single Use Only)
- 1 Healthcare Facility Standard Oxygen Line (usually 3/16"ID) (Single Use Only)
- 1 Blanket for Patient
- PPE IS REQUIRED AT ALL TIMES WHEN OPERATING SCONE™ DEVICE.
- Remove the SCONE™ from packaging. If desired, keep the shipping box for safer disposable.
- Unfold the SCONE™ chamber by fully extending the frame and locking the hinges on each side. Verify that the 4 arm access hole covers are properly sealed.
- Place the SCONE™ at the head of the bed over the patient's upper torso (head, neck and shoulders) and tuck the slide flaps underneath the bottom front part of the frame. Drape a blanket across the patient over the front edge of the SCONE™ overlay to create a proper seal.
- Attach the SCONE™ to the bed using the Velcro straps located at the back of the device. These may be attached and reattached as needed depending whether the patient is laying supine or elevated.
- Locate the suction and oxygen port adapters sealed by caps on either side of the device. The side with 2 port adapters is for suction tubing and the side with 1 port adapter is for oxygen tubing. The port adapter caps will hang off and remain attached to the adapter when in use. If an adapter port is not in use, the cap should always be sealed.
- Connect 2 (or 1) standard healthcare facility wall suction hoses (minimum 1/4"ID) to the wall-mounted pressure gauge or portable vacuum pump(s) w/ inline HEPA filter(s) and set to continuous high suction (200mmHg) to achieve a minimum of 50-70 LPM of airflow (30 LPM per line) for a minimum clearance time of 5 minutes. When using a portable pump, each line should be connected to a single portable pump. Note, the tubing and HEPA filter(s) should be single use only. If only one line is available, set the pressure to continuous high suction (200mmHg) but allow a minimum of 10 minutes of clearance time to ensure full evacuation of airborne particulates.
- Connect 1 standard healthcare facility oxygen line to the SCONE™ port adapter, which is a single port located on the opposite side of the 2 port adapters (suction adapters) on the outside of the SCONE™ device. Connect the other end of the oxygen line to wall regulator mount and set to 10 LPM. Note, if a nasal cannula will be in use for the patient, skip this step and do not connect an oxygen line to the Scone device. Instead, run the nasal cannula through the draping to the patient. Ensure the single port adapter cap is over the port.
- Monitor patient vitals during use. (EKG, SpO2, EtCO2, etc.)
- SCONE™ is intended for use during aerosol generating procedures with continuous suction and for transport of patients in and through healthcare facilities for a maximum duration of 30 minutes. Patient vitals should be continuously monitored during use.
Performing a Procedure while using SCONE™
- PPE IS REQUIRED AT ALL TIMES WHEN OPERATING SCONE™ DEVICE.
- Instruments (e.g. EKG, SpO2, EtCO2, etc.) for monitoring may fed up under the front draping next to the patient’s torso, making sure to keep an appropriate seal around the instrumentation. Procedural instrumentation may be passed through arm access holes or also fed up under the front draping.
- Open arm access flaps as needed to access patient during procedure. Keep them sealed when not in use.
- After the procedure, wait for the SCONE™ to clear all particulates before removing.
Emergency Removal Instructions
- PPE IS REQUIRED AT ALL TIMES WHEN OPERATING SCONE™ DEVICE.
- Detach the Velcro bed straps from the bed and pull SCONE™ off the patient. Set aside.
- PPE IS REQUIRED AT ALL TIMES WHEN DISPOSING OF THE SCONE™ DEVICE.
- Once the patient has been removed from the SCONE™ device, wait for the device to clear the particulates in the environment (between 5-10 minutes depending on configuration).
- Unlock hinges and fold the SCONE™ back down into collapse position, careful to not expose the underneath part of the overlay. Place SCONE™ back into shipping box (if available).
- Follow the facility’s policy and protocol for disposal of biohazardous waste.
- The SCONE™ is a single-patient-use item and is not to be reused under any circumstances.
*** DO NOT AUTOCLAVE ***
*** DO NOT USE UV LIGHTS***
- Put on clean gloves and appropriate PPE before beginning the cleaning and disinfection procedure.
- Remove patient and O2/suction hoses from the device.
- To move device for cleaning
- Collapse SCONE by tapping on the hinges in an upward motion
- Fold the excess TPU facedown and around the sides so that you are able to pick up the device holding only the TPU that was facing outward away from the patient
- With caution careful not to drop, strike, or place heavy objects on the SCONE continue with the cleaning procedure
- Move the SCONE to a designated clean room with a flat disinfected surface
- There is no disassembly required for the cleaning
- Dispense a towelette of hospital approved EPA-registered quaternary ammonium compound/isopropyl alcohol-based hospital disinfectant wipe, and wipe clean the inner and outer surfaces of the SCONE, carful to include the oxygen and suction ports, aluminum scaffolding, and TPU material in-between the scaffolding
- If visible debris remains, repeat the procedure. Let the SCONE sit visibly wet for at least 2 minutes. Allow then to air dry.
- For disinfection, spray the inner surface of the SCONE with a hospital approved EPA-registered isopropyl alcohol-based disinfectant. Let the SCONE sit visibly wet for at least the contact time indicated in the labeling before allowing all parts to air dry. Remove and discard gloves.
- Disinfectants for Use Against SARS-CoV-2 https://cfpub.epa.gov/giwiz/disinfectants/index.cfm
- Do not use harsh chemicals, UV lights, or abrasives to clean. Do not apply heat. Do not use high concentrations of ammonium in excess of 20% as this may degrade components.
- Store the SCONE at room temperature in the original box, if possible, to avoid dust or build up on the device.
*** The SCONE is a single patient use device, and should be cleaned:
- When you have completed the continuous use period and it is going back into storage (the original box it was shipped in) AND/OR
- If there is buildup, or physical debris visibly present.
The SCONE™ is a one-time use device. The device after use is a biohazard and requires proper disposal per facility standard procedures. Please instruct all personnel involved in breakdown and disposal of the SCONE™ to be dressed in full PPE.