A reference specification was developed during the course of March 2020 involving intensive work between the SARAO team, public healthcare practitioners and industry experts. A systems engineering approach was applied, identifying the real requirements of the project by understanding the clinical interventions that were needed and the hospital infrastructure into which the units would be deployed.

The reference specification based on the Continuous Positive Airway Pressure (CPAP) methodology consists of two main components:

  • A blender that controls the total respiratory gas flow and titrates a variable concentration of supplementary oxygen; and
  • A patient circuit that delivers the respiratory gas to the patient and maintains the required airway pressure. The patient circuit is considered to be a single-use, disposable item, but in an emergency it can be cleaned and decontaminated for repeated use, except for the viral filter.

In early April 2020, a call for proposals was administered by SARAO under the auspices of the DTIC. Following a thorough and open process, 95 submissions were received.

Of these submissions, six companies and consortia with the capabilities to produce the breathing apparatus at the required specifications were selected in May to continue to the prototyping phase.

Following the prototyping, manufacturing contracts for 20 000 units were then concluded during the course of July with two entities, the Council for Scientific and Industrial Research (CSIR), and the SAVE-P Consortium:

The CSIR L.I.F.E. device (4 900 units):

This blender uses a high-velocity jet of oxygen to entrain ambient air to be mixed with the oxygen in the required ratio, and requires just a compressed oxygen supply.  It can be used for both Continuous Positive Airway Pressure (CPAP) and High-Flow Nasal Oxygen (HFNO) therapy in the treatment of Covid-19 patients. It is the preferred option for hospital beds that have a wall oxygen supply, but no medical air supply.

Individual components for this device were manufactured by a range of parties across the country including the Central University of Technology and firms such as Black Capital Systems, Andani Futuretech Manufacturing, UV Tooling, Sola Medical, Gabler Medical and Pitchline Engineering. All manufacturing was done for the CSIR.

The SAVE-P CPAP 100 device (667 units)

This air/oxygen blender is based on the gas mixer that is integral to the Penlon Nuffield Series 200 anaesthesia ventilator, and requires both compressed oxygen and medical air supplies.  It can be used for both Continuous Positive Airway Pressure (CPAP) and High-Flow Nasal Oxygen (HFNO) therapy in the treatment of Covid-19 patients. It is the preferred option for hospital beds that have both a wall oxygen supply and a wall medical air supply.

The SAVE-P consortium comprises a range of companies including MCR Manufacturing, Reef Engineering, Bosch, Executive Engineering, Rhomberg Instruments, Dowclay Products, ISO Health SA, Pegasus Steel, NAACAM, AFRIT, Corruseal, New Age Medical Supplies, Aveti and Non-Ferrous Metal Works.

Clinical trials at Charlotte Maxeke Johannesburg Academic Hospital and Chris Hani Baragwanath Hospital were conducted for both devices.

Manufacture of the 2 000 SAVE-P CPAP 100 blenders was concluded in October 2020 and the 18 000 CSIR L.I.F.E blenders in November 2020. In addition to the 20 000 blenders, 63 000 patient circuits were also required. All 63 000 patient circuits were complete by February 2021, with production scheduled according to deployment of the units.

Assembly, testing and packaging for the CSIR L.I.F.E devices was conducted at Akacia Medical, and at MCR Manufacturing for the SAVE-P CPAP 100 units.

Average cost for the CSIR L.I.F.E blenders was initially in the region of R5 000 per unit. Further to achieving economies of scale in the production process, these unit costs have now been reduced to approximately R1 500.

The SAVE-P CPAP 100 blenders are entirely different units with distinct functionality and cost in the region of R17 000 per unit.

Patient circuits for both blenders are in the region of R1 500.