1. Key topics from the last report.
The latter part of the previous year and this year we have seen that WHO has focused a lot on medical oxygen with publication of some documents. While this is a very good thing on the one hand, on the other hand we have had cope sometimes inaccurate information on these documents.
In this regard, in the first part of 2021 MGC, WG7 and AHG M.14 were involved in the preparation of the reply to:
EIGA remarked to WHO the need to have two different monograph since the product have a different quality and impurity profile.
Also other organizations (CGA, AIGA, ISO TC 121 etc) sent their comment and proposals in line with EIGA position.
Although WHO GMP are not mandatory in Europe (we stick to EU-GMPs), EIGA saw a great chance to introduce some amendments and points there, to be used later (if approved from WHO) as reference on the much more important ongoing work on that WG7 is carrying out, that is the revision of EU-GMP Annex 6.
In relation to the potential publication of the monograph of Oxygen 98% from PSA (currently under evaluation), for which it is believed that there may be potential risks for patient safety, P. Cornille, J. Strybol, MGC, with the collaboration of Fleishman Hillards have prepared a document with the aim of clarifying that our Industry:
despite the period has put us under pressure, do not compromise on the quality and pharmaceutical safety of medical gases (especially oxygen) supplied to hospitals
has proven that there is no shortage of the medical oxygen molecule thanks to the continuous production of large quantities of cyrogenic 99,5% oxygen.
that we are willing to collaborate, as experts, with regulatory authorities and other industries in the interest of patient health.
The document was sent to the European Commission and well received.
During the COVID-19 pandemic, patients receive High-Flow Nasal Oxygen (HFNO) as an effective means of treatment, capable of delivering an oxygen flow rate of up to 60 litres per minute. As more wards are equipped for oxygen treatment and HFNO treatment, it is possible the ventilation systems will not be able to maintain atmospheres that are not oxygen enriched.
Therefore during the COVID-19 pandemic the risk of oxygen-enriched atmospheres in healthcare facilities is higher than usual. Although well known, EIGA wants to make all healthcare facilities aware of oxygen hazards and propose precaution measures.
In this respect, WG7 prepared the Safety Alert SA 45/21 “Hazard of Oxygen-Enriched Atmospheres in Healthcare Facilities”
The new Medical Device Regulation (MDR) will apply from May 26th.
A lot of effort of our WGs & AHGs have been put in place and is still on going to identify, evaluate, communicate requirements and possible changes, as well as an important work is being carried out to be able to have an interpretation that is closer to the specificities of our medical devices in the official guidelines.
In the light of the above,
WG15 with good chance has managed to avoid the classification in class III for CO2 for endoscopy applications. The official publication of an MDCG (Medical Device Coordination Group) document is awaited. Class III represents the highest class for a medical device and would have imposed a lot of effort for the industry equating it, in terms of requirements, to an implant or a surgical prosthesis (for instance performing clinical studies on CO2)
WG 15 completed the list of “Safety and performance requirements” for CO2 MD
AGH M.15 with the contribution of WG10 issued the TB-38 “Home Care Service Providers’ Obligations under the Medical Devices Regulation” with the aim of giving guidance on the interpretation of this regulation for Home Care Service Providers (HSP) and to provide recommendations on how to implement the requirements of this regulation.
Cylinder Internal Quality
The topic is addressed by AHG-M.16.
It has been confirmed that no regulation or standards to follow. So we will define an EIGA standard. To do this, EIGA members are collecting in-house data (how much particles are usually in cylinders).
The outlook is finishing between end of year (best case) and end of next year (worst case).
2. Working Groups and Ad Hoc Groups created
AHG-M.17 Unclassified gases used for medical purposes
There are technical industrial grade gases used for medical purposes for which in (some or all) EU member states there is no clear medical intended use to us as suppliers and therefore no clear regulatory status, though the authorities know in most cases that these gases are used for medical purposes. Moreover, some gases have a different status in the member states. Therefore, the applicable rules for such gas can vary in the different member states
Purpose of this task is to define and propose:
1. Responsibility and liability of the gas industry
2. Common rules for manufacture to be applied for such gases without clear medical intended use to the suppliers
The main purpose and objectives of this new AHG will be:
To investigate in case of need expressed by MGC and/or WG7 and/or WG10 and/or WG15, reported adverse events related to medical gas and advise on appropriate recommendations and actions to be taken by EIGA and/or EIGA members.
To act as a focal point within EIGA for matters concerning pharmacovigilance
This will be a permanent group to be activated on specific demand of EIGA concerned Councils/Groups
3. Working Groups and Ad Hoc Groups closed
AHG M15 Impact of MDR on HSP
Publication of TB-38 “Home Care Service Providers’ Obligations under the Medical Devices Regulation”
IMPACT: providing guidance on the interpretation of this regulation for Home Care Service Providers (HSP) and to provide recommendations on how to implement the requirements of this regulation.
4. Key objectives and initiatives the coming two years
The leading theme of MGC is become an agent of change. To achieve this important goal, we will work to:
Place EIGA as a recognized stakeholder by relevant Authorities
Continue actively to act as EMA stakeholder for any impact on our industry
Promote changes in Regulation and standards through public consultation, lobbying activities, participating to specific ad hoc groups etc.
Anticipate and integrate changes in regulations that could impact or modify significantly the medical gases sector.
Publish white papers on specific themes to spread out our view and best practices in a proactive way
Continue the publication of documents related to the safe design, manufacturing, operation and use of the products
Ensure a regular communication and synergies between medical and non-medical working groups, ad-hoc groups and also with National Associations
4.2 Working Group 7, Medical Gases
Lobbying for GMP Annex 6 and the EMA Guidelines on medicinal gases (CPMP/QWP/1719/00) review: Ideal time as the EU Commission strategy involves a revision of the basic pharmaceutical legislation (target date for a proposal: 2022).
External Temperature/Humidity monitoring for compressed & liquefied gases
4.3 Working Group 10, Homecare
Start work on replacement document for Hygienic reprocessing (revised Doc 157)
Review of Doc 193 (2014) – Guidance on safety and reliability of Oxygen Self fill systems
Start review of Doc 198 (2015) – Security and Safety for Home Care Personnel
4.4 Working Group 15, Medical Devices
Document on new Nitric Oxide generating devices
Uniform application of classification according to new MDR of Gases and mixtures for In vitro applications
Obtain that medical devices gases may be delivered with electronic IFU (Instruction For Use)
VIDEO on VIPRs Use (content and wording agreed, sketches ready): soon the best supplier will be selected and the budget required for approval
4.5 AHG M.5 - N2O clinical best practice
AHG with the aim to produce communication material (Brochure, press release, publication) on the clinical best practices of use to mitigate the potential safety risks related to the human exposure to N2O and N2O mixtures
4.6 AHG M.8 - ISO TC 121 Mirror Group
High contribution on the new standards on proportioning units, air compressors and PSA for medical gas supply systems.
Close monitoring of the relationships between ISO 10297 (cylinder valves), used for PI marking, and ISO 10524-3 (VIPRs), used for CE marking
4.7 AHG-M.14 “Pharmacopoeia 9G group Mirror”
New Oxygen 98 monograph: data evaluation and refining of the proposed monograph;
PID analysis of medical gases on oil, starting with Medicinal Air or Oxygen 98 (refer to the above for explanations);
Stability of gases at molecular level;
Proposal to include the capacitive hygrometer as European Pharmacopeia method for determining water in gases (starting proposal was to apply it to Nitric Oxide).
5. Working Groups and Ad Hoc Groups to be created in 2021
6. Working Groups and Ad Hoc Groups to be closed in 2021