04

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

This Briefing Note is intended to support EIGA Members applying to the relevant regulatory or national health authority to allow the use of equipment not CE marked as medical equipment (to Medical Devices Directive 93/42/EEC) during the coronavirus (COVID-19) pandemic for use in medical or breathing gas service.

This publication can be viewed or downloaded on the EIGA Website (restricted to EIGA Members only, please login first) by clicking here.

05

TB 35 - COVID-19 - Multilateral Agreement M326 - Periodic Inspection and Test of Pressure Receptacles for the Carriage of Gases of Class 2

As a direct result of the Coronavirus (COVID-19) pandemic EIGA requested an exceptional temporary derogation to ADR be issued to assist in the availability of pressure receptacles for primarily medical oxygen, but also to other gases related to the medical supply chain.

The derogation is granted via a Multilateral Agreement M326, which permits Countries that have enacted ADR into their national transport legislation to agree to a variation to ADR. It does not require that every country has to sign an MLA for it to be adopted in an individual country.

This Technical Bulletin TB 35 provides explanation to EIGA members and others who fill the listed products in M326, what they should do and not do.

Doc 195/20 Safe Design and Operation of On Site Generation of Oxygen 93% for Medical Use

The design requirements for the supply source used to supply medical oxygen to the pipeline system are detailed in the standard, EN ISO 7396-1 Medical gas pipeline systems; Pipeline systems for compressed medical gases and vacuum. Two different products are included in the standard:

• Medicinal oxygen supplied from liquid oxygen vessels and/or gaseous oxygen cylinders; and

• Oxygen 93 manufactured on-site within the healthcare facility, using an oxygen concentrator unit.

This publication provides guidance for the safe design, installation, operations, maintenance and quality management of oxygen 93 concentrators systems used in healthcare facilities.

It is intended for use by EIGA Members, healthcare facility managers and responsible pharmacists, oxygen concentrators’ manufacturers; and national regulatory authorities involved in the regulation and inspection of the manufacturing and administration of gases for medicinal use.

This revision of the document includes general changes and the impact of the Medical Device Regulation.

This publication can be viewed or downloaded on the EIGA Website by clicking here.

07

EUROPEAN COMMISSION PROPOSES TO DELAY MDR BY A YEAR DUE TO COVID-19

On Friday 3 April 2020, the European Commission adopted a proposal to postpone the date of the application of the medical devices regulation (MDR) by one year to 26 May 2021. The proposal has now been sent to the Council of the EU and the European Parliament for approval. The purpose of the delay is to allow member countries, health institutions and the medical technology industry to prioritize the fight against the coronavirus pandemic. The decision also takes into account the need of increased availability of medical devices across the EU, while continuing to ensure patient health and safety until the new legislation becomes applicable. The delay will not alter the substance of the MDR. MEP Peter Liese, EPP spokesperson for health expects a broad majority in favour of the proposal within an urgency procedure in the European Parliament. Read more, or link to proposal.

08

EU ETS - EU CARBON MARKET COLLAPSES AS COVID-19 CAUSES ‘PERFECT STORM‘

Coronavirus pandemic has pushed down EU ETS prices from an average of 24 EUR per ton to a range between 16-18 EUR, challenging the decarbonization of the EU’s energy sector as price for emitting falls. The Market Stability Mechanism could solve the problem in 2021. Link to RECHARGE article

09

CLIMATE POLICY - EU COST-BENEFIT STUDY SEEN BACKING 55% EMISSIONS CUT BY 2030

The Commission recently published the launch of a public consultation on increasing the 2030 emission targets to achieve the 2050 carbon neutrality goal. The roadmap signals that the 2030 reduction targets must be raised from 40% to a range between 50% and 55%. The roadmap is another step towards the publication of an impact assessment in September. Link to Euractiv article

10

CLIMATE POLICY - GLOBAL HOPES FOR HYDROGEN ECONOMY REVIVED AMID EU PUSH

Bloomberg released a global industry outlook where it argues that 34% of GHG emissions could be cut by hydrogen produced from renewable electricity at reasonable costs. Link to the Euractiv article

11

STATE AID - COMMISSION RESISTS COMPETITION REFORM PLANS UNTIL 2021

The European Commission will not start looking in EU competition rules until at least 2021, despite pressure from some Member States including France and Germany, which aim for a modification of the State Aid framework to encourage the creation of European champions. Link to Euractiv article

12

CLIMATE POLICY - GASIFICATION WITH CO2 STORAGE REDUCES THE COSTS OF THE EU’S ZERO CARBON STRATEGY BY 40%

VOX advocates for the production of hydrogen from coal and gas coupled with carbon storage techniques as one of the ways to reduce the cost of achieving Europe’s 95% emissions-reduction goal by 40%. The report uses a global climate-energy economic model to compare three energy production scenarios. Link to VOX CEPR Policy Portal article

13

TAXONOMY - COMMISSION PUBLISHED INCEPTION IMPACT ASSESSMENT

The European Commission has published its roadmap and inception impact assessment (IIA) for the delegated act (DA) on the technical screening criteria for the climate change mitigation and adaptation objectives, and is welcoming feedback until 20 April 2020. The Commission should adopt this delegated act by 30 December 2020, and will use the final report of the Technical Expert Group on Sustainable Finance (TEG) as a basis when drafting this delegated act that will incorporate the TEG recommendations into law. Link to Roadmap and Inception Impact Assessment

14

Doc 903 - EIGA Safety and Environmental Award Schemes

The EIGA Safety Advisory Council has proposed a number of changes to ensure that the Awards continue to support EIGA’s safety mission. These changes have been approved by the EIGA Board of Directors and will be implemented for the 2019 Awards, presented at the next Annual General Meeting of Members.

The changes and revised definitions are detailed in the revised version of Doc 903 Safety and Environmental Award Schemes. The principle changes are as follows:

Zero Accident Award – Location

The qualification for the award has been changed from “no lost time injury” to “no recordable injury”. To qualify for an award the location shall have achieved the number of working hours, or consecutive years, without a recordable work injury to any of its Employees or Contractors, starting in calendar year 2019. Recordable work incidents before 1st January 2019 shall not be included in determining the classification of the award. Examples to clarify are given in annex A.

An application for a Zero Accident Award shall be deferred for one year if an incident with a potential for severe injury or fatality (PSIF) has occurred during that calendar year. The application form has been updated accordingly.

Safety Innovation Award

The EIGA Safety Innovation Award criteria have been slightly modified and the application form has been updated accordingly.

This publication can be viewed or downloaded on the EIGA Website (restricted to EIGA Members only, please login first) by clicking here.

15

Doc 229 - Guidance for Manual Handling Activities of Cylinders

Manual handling is an important issue for the industrial gases sector (including all areas such as medical, food etc.). Many activities of the industrial gases industry involve manual effort which have the potential to cause harm if not properly managed. Manual handling related injuries are a major cause of lost workdays.

This publication covers the ergonomics and occupational health of manual handling activities in the industrial and medical gas sector. Included specifically are ergonomic principles that can be adopted to reduce likelihood of musculoskeletal issues.

16

SA 43 - Accidental Removal of Valve Stem

A recent incident reported to EIGA highlighted the risk of accidental removal of a cryogenic valve stem when attempting to open the valve during normal operation of filling a cryogenic tank. The particular design of valve used a ’threaded bonnet’ where the stem of the valve is attached to the main body of the valve via a screw thread. The design is not used on most cryogenic valves available on the market today, which more commonly use a bolted bonnet. This Safety Alert can be used to highlight the risks of threaded bonnet type valves.

This publication can be viewed or downloaded on the EIGA Website (restricted to EIGA Members only, please login first) by clicking here.