Medical Gase Council Activity Report

During the first part of 2020, all the efforts of the MGC were made to help our Industry to deal with the Coronavirus pandemic, which in some cases saw oxygen demand increase up to 10 times.

Different issues have been addressed:

- Industry regulatory relaxation measures

- Disinfection of the container returning from hospitals

- Use of industrial pressure regulators

- Counteracting the publishing of O2 98% monograph as proposed by EDQM

- Preparation of the weekly communication on shortages published in the EMA weekly report

- Response to EMA on Direct Healthcare Professional Communication (DHPC) of Nitrous oxide & Nitrous oxide mixtures on the risk of infection of the professional workers who administer the Nitrous oxide mixture to COVID-19 patients

Several task forces have been set up in a timely manner and with very short deadline for deliverables:

- Task force for COVID-19 - Emergency Measures to Maintain Continuous Supply of Medical Gases

- Task force with IGC COVID-19 - Measures to Disinfect Externally Contaminated Gas Packages

- Task force for COVID-19 Temporary Use of Equipment Not CE Marked as Devices in Medical Gas Service

- Task force with QPPV of the company to prepare official response to EMA DHPC

Weekly conference calls have been organized.

COVID-19 Publications & documents

- BN 25 COVID-19 - Emergency Measures to Maintain Continuous Supply of Medical Gases

- BN 27 COVID-19 Temporary Use of Equipment Not CE Marked as Devices in Medical Gas Service

- Official answer to EDQM public consultation and guide document for National Associations

- Official Response to EMA about DHPC of N2O and N2O mixtures

IMPACT:

The relaxation measures required in BN 25 have had a direct impact for all companies. Several authorities fully accepted the measures document (like French authorities) other granted partially them (as Italy, Spain, Portugal, Germany etc).

The introduction of the new European pharmacopoeia monograph O2 98%, as proposed by EDQM, would allow the hospital use of dual-stage concentrators as an alternative to the supply of liquid oxygen.

This, de facto, without reliable data on safety, quality and efficacy on O2 98% produced according to the proposed monograph and without a regular and rigorous approval process by the expert of the 9G Pharmacopoeia group.

The diffusion of DHPC provides that, in theory, each MAHs reaches each professional user with its own communication, this entails a considerable use of resources and the possible involvement of specialized companies. EIGA response was that this topic should be mainly addressed by the manufacturer of the equipment used to administer the drug and it was not related to the drug itself.

Nitrosamine Impurities

EMA has issued documents concerning the risk of the presence of nitrosamine impurities in human medicinal products containing chemically synthesized active pharmaceutical ingredients.

EIGA WG7 has set a path forward how to deal with the subject, as not all of the medicinal gas products need to be evaluated but only human medicinal products containing chemically synthesized active pharmaceutical ingredients. That means that oxygen, nitrogen, air (compressed and synthetic) as well as helium and carbon dioxide (if coming from a natural source) do not fall under this new regulation.

EIGA issued a letter to N.A. to explain how to deal with the subject, the letter was well received.

IMPACT: This should be the basis for the product risk assessment for all the EIGA member companies and their current medicinal authorised products and therefore a very useful tool for all EIGA member companies to be used for the evaluation of risks of nitrosamine impurities.

Use of Quality Risk Management for Preparation of Validation Protocols for Medicinal Gas Cylinder Filling

WG7 has published Doc 228/20 in the intention to provide guidance on preparing the protocols for performing validation of systems used for filling medicinal gas cylinders, in compliance with Good Manufacturing Practices. It provides an overall risk assessment to identify and evaluate potential critical steps in the manufacturing processes for filling medicinal gas cylinders.

IMPACT: This publication provides guidance to EIGA members on how to perform the risk assessment of their medicinal gases manufacturing operations at container filling facilities, and therefore a useful tool for all EIGA member companies.

PROGRAM FOR 2020

- Lobbying for a review of EMA Guideline on Medicinal Gases and Annex 6

- Preparation of GDP (Good Distribution Practice) Guideline

- Preparation of Guideline on Pharmaceutical Data Integrity

Revision of Good Homecare Practice -TP24: final editorial revision. A cartoonist is working on the drawings.

PROGRAM FOR 2020

- Oxygen Fire Safety Devices, AHG M11

- Review TP24 – Good Homecare Practice

- Revision Doc.128 (Design and operation of vehicles used in medical oxygen homecare deliveries) + SA 29 (Homecare Vehicle Fires)

- Working with FH on outreach programme

Publication of a technical bulletin entitled MDR Implementation – Consequences for Notified Bodies and Impact on Medical Device Industry that raises concerns about the consequences of the new Medical Devices Regulation (MDR) on Notified Bodies (NB), the potential need for changing of NB and the possible shortage of NBs.

IMPACT: giving the keys for gas manufacturers to anticipate and to ensure that they will be able to put medical devices (gas or pipeline systems) on the market without disruption.

Revision of a technical bulletin entitled Use of Copper Beryllium Alloy for Medical VIPRs, as beryllium is one of these “substances of concern” for which the level of requirements has raised, especially in the new Medical Device Regulation (MDR). A 2%-beryllium copper alloy is used for springs in oxygen regulators, as it is safer than stainless steel.

IMPACT: giving evidence that Copper Beryllium alloys can continue to be uses in medical regulators in conformity with the most recent and stringent regulation.

Publication of a document entitled Unique Device Identifier (UDI) for Medical Devices Used in the Gas Industry. UDI is a new requirement from the new medical device regulation (MDR) which encompasses end-to-end traceability and registration of medical devices on a new European regulatory database called EUDAMED.

IMPACT: providing gas manufacturers with a guideline where the specificities of the application of UDI to gas medical devices and medical gas pipelines are detailed.

PROGRAM FOR 2020

- Issuing a TB to clarify the responsibilities of VIPRs manufacturers and the gas manufacturers regarding the maintenance, the withdrawal of service and the usability of medical gas package.

- Publishing a short educational cartoon/video be to be watched before any specific training on a gas cylinder fitted with VIPRs.

- The work on the impacts of the new Medical Device Regulation (MDR) will continue with:

o Commenting on public enquiries of MDCG (Medical Device Coordination Group) draft guidelines.

o Collecting the potential issues and concerns regarding the new role of Person in Charge of Regulatory Compliance created by the MDR (ART. 15).

o Obtaining that CO2 for endoscopy and colonoscopy is classified in class IIb not class III (the higher class of risk)

- Establishing common answers to the General Safety and Performance Requirements (GSPR) for carbon dioxide medical device technical file and converting in a harmonised standard.

Draft version of existing TB, with new set of data and documentation plus a Scientific Report to support the Bulletin. Next step is to present the new draft version in about a month.

The ADG-M.14 started its activities in October 2019.

New monograph Oxygen (98 per cent):

- Evaluation of the available data. Data appears to be neither suitable, nor complete.

Monograph Air, medicinal:

- General evaluation of the PID (Photo Ionization Detector) method for the measurement of oil in gases as alternative to the unreliable detector tubes (e.g. Draeger tubes), potentially used also for in-line process analysis.

Corrections for existing inconsistencies or proposal for changes of:

- Nitric Oxide,

- Nitrous oxide,

- Nitrogen,

- and Argon Monographs.

AHG.M-5 N2O Clinical Best Practices (previously named Countering Negative articles on N2O) was activated. Not a brand new AHG, but new representatives, new Chair and a new scope. The purpose of this ad-hoc Group is to promote the safe clinical usage of medicinal N2O and N2O mixtures and raise awareness of the misuse/abuse of these medicines.

AHG M13 revision on EIGA doc 195 was closed. Revision of the EIGA document regarding on site manufacturing of medical oxygen in healthcare facilities

MGC

- Continue actively to act as EMA stakeholder for any impact matters for industry

- Position EIGA as a recognized stakeholder by relevant Authorities, such as the work done with European Medicine Agency (EMA)

- Anticipate and integrate changes in regulations that could impact or modify significantly the medical gases sector.

- Continue the publication of documents related to the safe design, manufacturing, operation and use of the products.

- Ensure a regular communication and an active collaboration between medical working groups and ad-hoc groups.

- Promote synergies with the WGs and AHGs under the other Councils.

- Pursue the development of the relationship and synergies with National Associations and sharing EIGA/MGC views on the current topics.

Working Group 7, Medical Gases

Harmonization & alignment with other associations and authorities:

- Pharmacopeia Comparison Document Review

- BCGA Document on Good Distribution Practices

- BCGA Document on Guideline on data integrity

- BCGA Document on RPV

Working Group 10, Homecare

Define Standards & Best Practices

- Revision Doc 141 (2013) Planning Oxygen Supplies for Respiratory Patients when Travelling

- New Document – Reprocessing of Medical Devices Used for Oxygen Therapy and include in this document the Technical Bulletin (Handling and Cleaning Externally Soiled Medicinal Gas Containers)

- Revision Doc 193 (2014) Guidance for Safety and Reliability of Oxygen Self-Fill Systems

- Revision of doc 198 (2015) Security and Safety for Homecare Field Personnel

Working Group 15, Medical Devices

Define Standards & Best Practices

- BP: Preparation of technical files (MDR)

- BP: Guideline for vigilance / post-market / PSUR

Regulatory Affairs, promoting our industry and influencing

- Common approach / mutualised data for class MD gases (letter to EC + follow-up)

Developing new standards

- Medical device gas standard and specification (one by gas)

- VIPR handling device / protector (EIGA then ISO)

- Electronic content gauge / display used with medical VIPRs

Communication with "todays" means

- Informative / Educative videos

- EIGA youtube channel

- Wikipedia (identification of the subject that we should follw/create)

• Possible a new AHG will be created, composed of representatives of WG2, WG7 and WG8 on the Quality of medical and food packages

• It is anticipated that these two AHG will close in 2020 :

- AHG M11 - Oxygen Fire Safety Devices – Firebreaks

- AHG M12 Microbiological contamination