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COVID-19

Emergency Measures to Maintain Continuous Supply of Medical Gases

  • 1. Introduction

    SACGA member companies that are producing medical gases are deploying significant technical, human and financial resources in order to support the healthcare system to deal, in the most efficient way, with the current emergency situation due to the COVID-19 pandemic. This can only be achieved with the cooperation of the competent health authority.

    The World Health Organisation (WHO) mentions in their situation report 41: “Oxygen therapy is the major treatment intervention for patients with severe COVID-19. All countries should work to optimize the availability of pulse oximeters and medical oxygen systems…”

    Medicinal oxygen is an important drug used for patients suffering from COVID-19 symptoms and therefore the availability of supply needs to be secured to patients throughout the healthcare system. EIGA member companies in Europe have recently registered significant oxygen demand increase from hospitals from five to ten times higher than the usual consumption. Increased demand has also been reported for inhaled Nitric Oxide in hospitals treating severe COVID-19 sufferers.

  • SACGA proposes to liaise with National/Local Health Authorities to consider authorizing the following measures to alleviate the gas supply chain and better ensure the supply of all medical gases to hospitals and patients. All of the proposed measures are fully documented as per the Good Manufacturing Practice (GMP), including traceability and batch control, approved Quality Management System and entirely controlled by the Authorised Persons.

    All the changes will be implemented in close communication and collaboration with competent authorities, customers and other stakeholders.

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  • 2. Situation prior to the COVID-19 pandemic

    The medical gases manufacturers produce with a manufacturing licence under the Good Manufacturing Practice mandate. Medicinal gases are marketed with a Medicine Registration.

  • SACGA members confirm that these conditions remain in place and are adhered to. However, as result of the COVID-19 impact on the healthcare sector and the medical gases industry, primarily because of the huge need for medical oxygen for patients, SACGA proposes in section 4 some temporary measures for the duration of the COVID-19 pandemic.

     

  • 3. Current encountered emergency issues in the supply of medical gases to the market

    The following detrimental impact is occurring to the supply of medical gases to both healthcare facilities and homecare services:

    • By far the largest and immediate impact is the exponential increase in demand of liquid medical oxygen, and gaseous oxygen cylinders;
    • SACGA members have also noted increased demand for inhaled Nitric Oxide and Nitrous Oxide in certain hospitals that provide care for severe COVID-19 patients;
    • The Authorised Persons, who have the responsibility to release each batch of medical product, need to be protected from the virus. However, several local/national rules prohibit the gases industry to apply more flexible conditions for the Authorised Persons to conduct their work;
    • Operators and drivers working in medical gases manufacturing and distribution are critical to the supply of medical gases to healthcare facilities and patients. However, due to the spread of COVID-19, the medical gas industry is experiencing a severe lack of Personal Protective Equipment (PPE), e.g. respiratory masks, gloves and disinfectants;
    • The number of patients at home has increased significantly, and many of them also need medical oxygen supply or ventilator support. Due to the increased demand, initially primarily in hospitals, Home Oxygen and Home Ventilator systems are being ordered by national health authorities and hospitals to be used in healthcare facilities. This impacts homecare providers ability to ensure adequate care of existing home patients and it may severely restrict homecare for COVID-19 patients that could be discharged from hospitals.

  • 4. SACGA proposed derogations to local/national regulations as temporary solution to the COVID-19 impact on supply of medical gases to healthcare system

    SACGA members continue to comply with GMP rules and the conditions of the medicinal gases Medicine Registration. Indeed, only medical grade oxygen shall be used and supplied for patients. All batches will remain under strict control and responsibility of the Authorised Person and each batch will be released as per the Medicine Register.
    All equipment will continue to be verified to ensure safe and correct functioning for both operators and users.
    New measures will only be applied after a full risk management assessment for the safety of staff, equipment, users and patients.

    The following temporary measures are proposed by SACGA members in order to assure continuity of supply of medicinal gases and services, particularly medicinal oxygen to the healthcare system:

    1. Allow the use of industrial oxygen cylinders and cylinder bundles which are not listed in the Medicine Registration of the medicinal gas; ie
      • Identify suitable individual cylinders from the Industrial fleet (cleanliness, valve condition, technical compatibility, etc.)
      • Blowdown the cylinders to atmosphere.
      • Paint the cylinder shoulder white (not the guard) as well as a 100mm wide white ring around the cylinder body, located 150mm below the shoulder. (Colour then: Black, white, black, white, like a Zebra at the top.) This will permit the cylinder to be easily identifiable by healthcare workers, as well as filling plants.
      • Fill the cylinder as per the normal medical filling process – blowdown to atmosphere, pulse fill to 5+Bar, vent to atmosphere, fill to final terminal pressure. (or similar existing SAHPRA approved process as appropriate).
      • Normal quarantine, QC, analysis and batch release procedures as per existing SAHPRA approved systems for Medical oxygen.
      • Batching and documentary traceability as per approved SAHPRA process for Medical oxygen.
      • Returned cylinders from Healthcare facilities to be blown-down and process re-starts.
    2. Allow the use of active pharmaceutical ingredient and finished product from other manufacturing sites not listed in the Medicine Registration, but with GMP certification;
    3. Allow the installation of additional bulk & microbulk liquid oxygen storage tank installations at hospitals and medical gases manufacturing facilities, verified on product quality, though without the need for prior local permits for installation
    4. Allow the increase of filling capacity of medical cylinders by installing or using additional filling equipment in medical gases manufacturing facilities, hence also increase the number of cylinders filled, without the need for prior local permits for installation and inspection or regulatory authorizations;
    5. Allow the use of technical grade pressure, flow regulators and other gas administration accessories at healthcare facilities, which after risk assessment, are also verified on correct operation, because there is not enough of such medical grade equipment to provide to healthcare staff;
    6. Allow a temporary one-year extension of service life of medical Valve Integrated Pressure Regulators (VIPR) (installed on a cylinder), to allow that more VIPR’s can remain in the supply chain;
    7. Allow a temporary one-year extension of service life of other CE-marked valves and regulators necessary in the administration of medicinal gases;
    8. Allow a temporary one-year extension of pressure equipment statutory test periods to enable resources to be focused onto Covid-19 infrastructure development
    9. Allow 24/7 transport without restrictions of medical gases within the country and across borders, which is needed for optimal sourcing between production plants, in order to assure continuity of supply;
    10. Allow the Authorised Person to release remotely and for multiple production sites listed in the Medicines Registration, in order to provide flexibility and protection in working conditions to assure continuity of supply;
    11. Allow the possibility to have only electronic delivery documents and avoid paper, hence protect the drivers.

  • SACGA is proposing to work with the national transport ministry on the temporary derogations to dangerous goods transport regulations. There are already derogations for inspection of tankers and the possible proposed extension of driver licences. A further derogation is being proposed to relax the test interval for gas cylinders.

    SACGA proposes to allow these capacity upgrades by means of official derogation and limited in time to the duration of the crisis as assessed by the authorities, provided that all activities are all documented as per the Good Manufacturing Practice, (including traceability and batch control), approved Quality Management System, entirely controlled by the Authorised Persons and according to good practices and safety standards.

    At the end of the COVID-19 pandemic or upon request of the national/local competent authorities, SACGA members will stop the proposed temporary measures and re-instate the original requirements as per the GMP and Medicine Registration requirements. Full communication with all stakeholders will be assured at all times.