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Pocket BVM review by TangoMikeTM

TAC COM MED Product and Process Review
Review Date: 12/11/15
Product Name: Micro BVM
Manufactured by: Micro BVM Systems Ltd
Cost per unit RRP in USD is: $40-50 approx

Introduction:
A bag valve mask, abbreviated to BVM and sometimes known by the proprietary name Ambu bag or generically as a manual resuscitator or “self-inflating bag”, is a hand-held device commonly used to provide positive pressure ventilation to patients who are not breathing or not breathing adequately. The device is a required part of resuscitation kits for trained professionals in out-of-hospital settings (such as ambulance crews) and is also frequently used in hospitals as part of standard equipment found on a crash cart, in emergency rooms or other critical care settings. Underscoring the frequency and prominence of BVM use in the United States, the American Heart Association (AHA) Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiac Care recommend that “all healthcare providers should be familiar with the use of the bag-mask device.” Manual resuscitators are also used within the hospital for temporary ventilation of patients dependent on mechanical ventilators when the mechanical ventilator needs to be examined for possible malfunction, or when ventilator-dependent patients are transported within the hospital. Two principal types of manual resuscitator exist; one version is self-filling with air, although additional oxygen (O2) can be added but is not necessary for the device to function. The other principal type of manual resuscitator (flow-inflation) is heavily used in non-emergency applications in the operating room to ventilate patients during anaesthesia induction and recovery.

Use of manual resuscitators to ventilate a patient is frequently called “bagging” the patient and is regularly necessary in medical emergencies when the patient’s breathing is insufficient (respiratory failure) or has ceased completely (respiratory arrest). Use of the manual resuscitator force-feeds air or oxygen into the lungs in order to inflate them under pressure, thus constituting a means to manually provide positive-pressure ventilation. It is used by professional rescuers in preference to mouth-to-mouth ventilation, either directly or through an adjunct such as a pocket mask). The full-form of AMBU is Artificial Manual Breathing Unit.

Intended Use:
The Pocket BVM Resuscitator is intended for manual pulmonary resuscitation and emergency respiratory support of adult patients.
The Pocket BVM is a single-patient-use device and, as such, no service is required. It should not be re-used on other patients.
The Pocket BVM is not sterile.
The Pocket BVM is to be used by trained personnel only.

Commercial claims:
In an emergency, time is precious and having immediate access to all the right tools and equipment is absolutely essential. The Pocket BVM™ adds to its effectiveness as you have everything you need right where you need it to quickly and safely deliver emergency and clinical resuscitation or offer breathing support to respiratory distressed patients.
The Pocket BVM™ is one of the most compact, easy-to-use bag valve mask’s (BVM) available on the market today. It provides ventilation to support patients who are not breathing or who are in respiratory distress. Its unique collapsible design is quick-to-deploy and easy-to-operate. When packaged, The Pocket BVM™ is the smallest, fully functional BVM on the market. It is a solid, well-protected emergency kit device that can potentially maximize limited storage space by up to 75%.
When opened, The Pocket BVM™ is a silicon-based resuscitator designed to provide effective ventilation or breathing assistance. It’s simple and safe construction makes it desirable for use in emergency situations and can replace any standard BVM by maintaining all the standard working factors and functional operation possibilities.
Micro BVM™ silicone resuscitators use safe and user-friendly materials so the construction helps to ensure easy and fault-free assembly. All connections and materials conform to industry safety standards. The ergonomic, lightweight design of Micro BVM™ is made for optimal end-user handling. The resuscitator has a special textured surface to ensure a comfortable and firm grip, allowing for effective ventilation for extended periods all whilst reducing hand-fatigue.

Features/Benefits:
•    Includes bag, mask, patient valve, reservoir bag
•    Includes 6′ 6″ oxygen tube
•    Available with black casing or olive-green coloured casing
•    Pocket size and easy to store
•    Single use eliminates cross contamination
•    Requires minimum pressure for compression and quickly recovers shape
•    Quick to deploy
•    Textured grip to prevent slippage
•    Connections:
o     Gas inlet tube 15mm length x 6mm O.D.
o     Patient connector: outside – 22mm male, inside
o    15mm female
o    Expiratory connector (for PEEP valve attachment): 30mm male

Distribution: National and international distribution per micro bvm website
Patents: Pending worldwide
NSN: 6515-01-590-8909
Quality and Standards: FDA and CE approved
Independent data: Not reviewed
Product life: Single Use
Governance considerations: For use by trained personnel only
Training requirements: CPR/BVM training and certification

The product A was reviewed by Line9Medic Ltd trading as TangoMikeTM using the TACCOMMED methodology and reported as:

TAC:
Within licensing considerations the Micro BVM is similar in its usage as compared to other BVM options. It is highly durable and protectively packaged. BVM use is indicated in C-TECC guidelines within Warm Zone Care under respiratory considerations. The compact size and durability of the product and packaging indicates effectiveness in the tactical environment.
The formed product out of packaging was durable when tested and within product claims.

Problems existed in the removal from stowage and storage options.
1.    Being a circular storage option it was difficult to stow in existing medical packs and pouches.
2.    The twist open operation was difficult with wet gloved hands
3.    Forming of the product once removed from storage suggested parts would break during this operation as the reliance is on manual pull techniques upon working parts of the device. This was further complicated when using gloved hands and operator tendency maybe to pull on the reservoir bag thus breaking the device.
4.    Once formed the mask needs to be removed and replaced and this could cause confusion under duress or within certain environments. This is however explained on the packaging guidance infographics.
5.    Replacement of the device back into its storage option proved difficult and whilst the product is indicated for single use the literature does describe re-packaging and this would be undertaken during product familiarisation.
6.    The storage outer case is indented to suggest grip application and there are two indents at 12 and 6 o’clock suggesting the application of pull tabs. No pull tabs are supplied with the packaging however. This option would ease the removal from stowage options.
7.    These considerations could magnify with the reduction of operator fine motor skills.

COM:
Once formed the Micro BVM is intuitive in its use by persons already trained in and familiar with BVM operation.
Issues appeared with its removal from stowage options, removal from storage and formation of the working device as described under TAC. These issues suggested the intuitive nature diminished and orientation was delayed and frustrated. This implies future degradation of product faith and usage and leaves the product open to competition.

MED:
Clinically the Micro BVM is effective as suggested in the product information and licensed in its use by trained personnel. It is both FDA and CE approved.

Solutions:
TAC:
1.    External pull tabs at 12 and 6 o’clock on the outer casing to ease removal from stowage
2.    Sealed packaging with a “babybel” type configuration, or dual pull on pull tabs at 12 and 6 o’clock to open packaging.
3.    Pull tabs on the bag itself at each end to help form the product and avoid manual exertion on working parts.
4.    Small flexible hose to allow mask placement onto relevant part thus avoiding the need to remove and replace.
5.    Outer case colour to avoid black as recognition required in low light. The tactical use for this product would be away from the area of tactical considerations.

COM:
Issues addressed under TAC and would allow for more intuitive use and remote direction.

MED:
None Offered, although the TAC and COM considerations could delay medical application.

Summary:
An excellent product worthy of clinical consideration for use by any pre-hospital trained medical provider. The aspects described above reduce its tactical and operational use but could be easily addressed within existing manufacturing capabilities.
TangoMikeTM
TAC COM MED Trademarked and copyrighted all rights reserved Line9medic Ltd

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