On the 5th of April 2017, the European Parliament adopted stricter rules that are expected to overhaul the regulatory regime that applies medical devices placed on the EU market. The initial European Commission proposal for a Medical Devices Regulation was published half a decade ago, in July 2012. The legislative process to come to this point straddled two Commissions and took in its stride a recent EU constitutional change.
The main objectives of the revision were to ensure:
A consistently high level of health and safety protection for EU citizens using these products
Free and fair trade of the products throughout the EU
That EU legislation is adapted to the significant technological and scientific progress occurring in this sector over the last 20 years.
As described by an informed commentator, this regulation is a supernova of a regulation in the medical device landscape, with an initial text of 60 pages that exploded to six times that size. This ambitious piece of legislation will extend the scope of prior legislation, ensure a better supervision of independent assessment bodies, clear rights for economic operators, and introduce stronger requirements for clinical evidence.
HCWH Europe’s main objective in engaging in the policy process was to help phase out carcinogenic, mutagenic, and reprotoxic (CMR) substances, endocrine disrupting chemicals (EDCs), and particularly phthalates in medical devices if safer alternatives are available and technically feasible. Annex I.2.7.4, of the medical devices Regulation includes a 0.1% concentration limit for category 1A and 1B CMRs and EDCs in invasive devices and those that come into direct contact with the body. Devices would only be permitted to contain such substances at a level above this limit if a justification is provided (note that the latest version of the text includes derogations).
Importantly, within a year of the Regulation’s entry into force, the Commission will provide a mandate for the relevant scientific committee to prepare guidelines on phthalates. This would include a benefit-risk assessment of their presence, as they are CMRs or EDCs, and such assessments would have to be updated within five years. The Commission would also issue similar mandates for the preparation of guidelines on other CMRs.
The Regulation also includes labelling provisions: a label on the device and packaging would have to say if the device(s), their parts, or materials contain CMRs or EDCs above the concentration limit. A list of such substances must be included.
Publication in the Official Journal is expected in May or June 2017. The new rules will apply three years after publication as regards medical devices.
On the 14th of March, the European Parliament formally adopted the Mercury Regulation thus restricting the use of mercury, a persistent pollutant that has adverse effects on the environment and human health.
For HCWH Europe, the main area of focus was on dental amalgam - Article 10 of the regulation. In its original proposal, the Commission was far from ambitious: of the nine measures listed in the Minamata Convention, they had selected two to phase down the use of dental amalgam:
Extend the use of dental amalgam in its encapsulated form
Mandating that dental facilities be equipped with amalgam separators to retain and collect amalgam residues.
The final agreement, however, is more robust: it includes a ban of dental amalgam fillings for children under 15 and for pregnant and breastfeeding women as of 1st July 2018. The text also requires each Member State to set a national plan by 1st July 2019 on how it will reduce amalgam use. The Commission will report by mid-2020 on the feasibility of phasing out dental amalgam (preferably by 2030), to be accompanied by a legislative proposal, if appropriate. In addition, dental practitioners will be responsible for the conditioning and disposal of their waste and they are expected to make sure that these stages are carried out in an environmentally sound manner.
The text agreed with Council of ministers was approved with 663 votes to 8 (and 28 abstentions).
On Friday 14th of April, HCWH Europe's Climate & Resources Policy Officer Ana-Christina Gaeta gave a presentation in a session entitled Environmentally friendly healthcare, she presented hospitals in the HCWH Europe network that are actively working to reduce their institution’s environmental footprint.
To illustrate the relationship between climate change, health, and the healthcare sector, Ana-Christina explained the different ways that climate change is having an impact on the health of the European population, the strain that climate change can pose on health system’s ability to provide care, and the different ways that hospital’s carbon intensive activities are contributing to climate change, and in turn contributing to making people sick.
Ana-Christina’s presentation Reducing healthcare’s climate footprint: Lessons from European hospitals, showcased case studies of European hospitals with impressive climate change mitigation policies.
Region Skåne in Sweden has done impressive work by implementing ambitious regional renewable energy targets. To reach their goals, the region has built a wind turbine plant that provides 40% of the energy used in healthcare, and in 2016 it finalised the construction of the Forensic Psychiatric Centre, which is the largest passive house in Sweden (running on 100% renewable energy). The healthcare sector of Region Skåne is also reducing their climate footprint through green procurement of products and green innovation.
Klinikum Neukölln in Berlin (part of the Vivantes Hospital Network of Germany) is known as Vivantes' “Energy Saving Hospital” for its combination of energy saving measures, such as the implementation of a rooftop-photovoltaic system and low investment measures such as behaviour change programs e.g. replacing old lighting with high efficiency bulbs, and strict monitoring of air conditioning in low-transit areas. Since 2003, the hospital has avoided over 100,000 tonnes of CO2, saved 400,000 MWh of energy, and approximately €23 million in energy costs.
With the aim of inspiring other hospitals to follow the footsteps of the hospital’s being presented, the presentation closed with an invitation to hospitals to reduce their own emissions, and to join the Global Green and Healthy Hospitals (GGHH) network.
The (un)recognised pathways of AMR: Air pollution and food
Webinar recording and presentations available
On Tuesday, the 28th of March, HCWH Europe and HCWH US & Canada hosted a joint webinar: "The (un)recognised pathways of AMR: Air pollution and food". A recording of the session and the featured presentations are now available on the HCWH Europe website.
The aim of this webinar is to address and examine two important means of transmitting drug-resistant bacteria - food and air. It is well known that the health sector contributes to pharmaceutical pollution of the environment (which leads to AMR) through inappropriate prescription practices, poor waste management, and unhealthy food choices in hospitals.
Speakers and presentations
Melanie Giangreco, National Program Assistant for the Healthy Food in Health Care Program - Health Care Without Harm U.S. & Canada
Melanie provides organisational support to the national program and Clinician Champions in Comprehensive Antibiotic Stewardship (CCCAS) Collaborative. Ms. Giangreco earned a Bachelor of Science degree in Environmental Studies with concentrations in policy and design. She has more than ten years of experience working on both conventional and organic farms, including small scale meat processing operations.
Johan Bengtsson-Palme,Researcher - University of Gothenburg, Sweden
Dr. Bengtsson-Palme holds a PhD on the effects of antibiotics in the environment, his research covers impacts of antibiotics from different sources: aquatic environments, sewage, sewage treatment plants, and pharmaceutical production. In 2014, he and his colleagues presented an unprecedented diversity of antibiotic resistance factors in an Indian lake subject to waste from pharmaceutical pollution. Many of which seem to be easily transferrable to human pathogens.
HCWH Europe respond to consultation on European Commission's action plan on AMR
On the 30th of March, Health Care Without Harm Europe submitted a response to the European Commission's Public Consultation: Commission Communication on a One Health Action Plan to support Member States in the fight against Antimicrobial Resistance (AMR) finishing 28th of April 2017. HCWH Europe emphasised that the new action plan against the rising threats from antimicrobial resistance (AMR) must include actions to tackle AMR in the environment.
HCWH Europe’s response to the consultation included several recommendations, stressing the need to develop minimum manufacturing standards to prevent pharmaceutical waste that leads to AMR – giving greater attention to environmental safety throughout the regulatory framework for the authorisation procedures of medicinal products. Manufacturing standards need to be developed amongst all Member States to address this issue.
To establish and maintain good manufacturing practices, environmental criteria should also be included in the market authorisation procedure for medicinal products sold in the EU. The European Commission should work with international governments and regulators to establish evidence-based targets for maximum levels of antimicrobial active pharmaceutical ingredient (API) discharge associated with pharmaceutical manufacturing. This should be enforced at international level, regardless of the origin of the products.
It is important to develop a strategic approach on pharmaceuticals in the environment (which will also address antimicrobials) at the EU level in the framework of Directive 2013/39/EU. Inaction at this level could hamper the implementation of the new Action Plan on AMR.
The expected release date of the new action plan is June 2017.
HCWH Europe presents food report at Health Promoting Hospitals & Health Services (HPH) conference.
Food is a central and essential component of our lives. Not only does it provide nourishment, it is a hugely important part of every economy and has deep links with people’s cultural identity. However, the food that we produce, consume and waste has a major impact on the environment and on people’s health.
Given the threats that our food system poses to the environment, the economy, and society as a whole, it is imperative that all economic sectors move towards healthier and more sustainable food production, procurement, preparation, consumption, and disposal practices.
The report takes a look at the work carried out in healthcare facilities across Europe on providing healthy, local, seasonal, and organic food and in preventing and reducing food waste. The main aim is to highlight the common challenges in implementing healthy and sustainable food policies in some European hospitals, and to provide some examples of leading institutions that could inspire and encourage others to follow suit. At the heart of the report are a number of case studies, which demonstrate the awareness and progressive practices at 22 healthcare facilities within the EU. The report also provides an introduction to the European policy context that is supposed to favour sustainable food practices.
A further aim of the work is to alert policy makers to the fact that conscious efforts to provide healthy and sustainable food are growing because it can also be economically feasible, particularly if the wider benefits to society are taken into account. European legislators should therefore work towards a legislative framework that will ensure a common understanding of healthy and sustainable food in order to facilitate the implementation of harmonised sustainable food strategies across sectors and across the EU.
Some final recommendations are presented, reflecting the learning of leaders in this field and the views of some hospitals and health systems that are already engaged in promoting sustainable and healthy food policies at their institutions.
As co-organisers of the HPH conference, HCWH Europe organised a Healthy food and well-being in healthcare workshop, moderated by Deputy Director, Grazia Cioci. Experiences and best practices of linking healthy food and well-being to the healthcare sector in Austria, United Kingdom, and Taiwan were presented.
Katharina Roth, Research assistant at the Bio Forschung Austria and member of EcoBuy Programm Working Group Food of the City of Vienna, introduced the importance of enjoying your food and the Austrian culture behind it through its music and art.
She also gave insights into the results of the Green Public Food Procurement in European Cities questionnaire. Vienna is included as one of the best examples for introducing some obligatory and optional criteria in creating “a naturally good dish” - one that uses organic, seasonal, and regional produce, using only small portions of meat, and putting attention on its aesthetic.
Dr Susannah McWilliam, Manager of the Food for Life Hospital Leaders Programme of the Soil Association in United Kingdom, presented the framework they use for enhancing care, supporting rehabilitation, and improving health by focusing in five main areas:
Patient food experience
Staff health and well-being
Food retail and vending
Community and partnership
Approximately 1.5 million people work in the UK National Health System (NHS), representing the 5th largest workforce in the world. The majority of the hospitals and healthcare facilities send mixed messages about consuming more healthy food, whilst junk food is promoted for staff working night shifts. In recent years however, policy has experienced a shift and now all NHS hospitals must develop and maintain a food and drink strategy that includes:
The nutrition and hydration needs of patients
Healthier eating for the whole hospital community, especially staff
Sustainable procurement of food and catering services
It was recently reported however, that some still do not apply these standards, and improvements need to be made to food quality, sustainability, customer feedback, tender contracts, and economic resources. You can read Dr. McWilliam's thoughts on the workshop in her blog post.
Dr Tina Chiu, Researcher at the Tzu Chi Medical Foundation in Taiwan, explained the impact of what we eat from an environmental and health point of view. One of the products with the greatest impact on our health and environment is meat, especially red meat. Reducing or substituting animal protein for plant protein is associated with lower mortality rates and greenhouse gas emissions from livestock.
Tzu Chi Hospitals provide an example of how encouraging hospitals to offer menus with less animal-based products can impact on patients’ recovery. They have also organised education programs intended for both patients and staff, educating the whole community on the benefits and misconceptions around vegetarianism...
Transitioning to a circular economy is all about changing the linear way the European supply chain currently operates: take – make – dispose. A circular economy represents an economic model where resources are ultimately never wasted; the healthcare sector has a major role to play in improving resource efficiency and minimising waste.
The healthcare sector is a major public purchaser of goods and services – requiring a vast diversity of medical equipment, high-tech facilities, experts, and personnel in order to provide efficient medical care to their community. Considering how resource intensive healthcare facilities, such as hospitals, are, there is immense potential to improve resource efficiency through asset sharing.
In this webinar, you will learn about ways that your hospital can reduce its environmental footprint, and save costs through simply sharing the resources you already have! Lieke will introduce the concept of sharing assets and the opportunities this presents for sustainable healthcare organisations. FLOOW2healthcare.com is a unique online platform that brings healthcare organisations or departments and entities within organisations together to share equipment, facilities, excess stock, and staff knowledge leading to financial savings, an enriched network, and a sustainable healthcare system.
Lieke van Kerkhoven-Introducing FLOOW2
FLOOW2 Healthcare, Co-founder
Lieke van Kerkhoven is one of the co-founders of FLOOW2 Healthcare and responsible for business development, Lieke has a background in healthcare. She studied medicine and has been working in several managerial and organisational positions in healthcare organisations in The Netherlands and abroad for the past 10 years.
Wouter van Wijhe-Paving the way for asset sharing at Radboud University Medical Centre
Radboud University Medical Centre (UMC), Nijmegen
Wouter van Wijhe is a Policy advisor for sustainability at Radboud UMC, one of the major university medical centres in The Netherlands. Radboud UMC will launch their own sharing marketplace coming May. Wouter will share their reasons to start sharing assets, their expectations, and the preparatory process needed to pave the way for launching a sharing marketplace in a complex organisation like a university medical centre.
Ted Antrag-One year after implementing an internal sharing marketplace.
WECF | Recycling contaminates plastic children’s toys with toxic chemicals from electronic waste
A new global survey finds that recycling plastics containing toxic flame retardant chemicals found in electronic waste results in contamination of the world’s best-selling toy: The Rubik’s Cube.
The study was performed by IPEN (a global civil society network) and Arnika (an environmental organization in the Czech Republic), and the toxic chemicals are OctaBDE, DecaBDE, and HBCD and are used in the plastic casings of electronic products. The survey of products from 26 countries, including Netherlands, found that 90% of the samples contained OctaBDE or DecaBDE.
In the Netherlands, Arnika purchased several rubik’s toy samples and brought them for analysis in the Czech Republic. Two car toys were chosen for laboratory tests. The analysis found that both samples contained OctaBDE and DecaBDE at elevated concentrations. “Toxic chemicals in electronic waste should not be present in children’s toys,” according to IPEN-member WECF International. “This problem needs to be addressed globally and nationally.”
The study emerges days before the global Conference of the Parties to the Stockholm Convention will decide whether to continue allowing the recycling of materials containing OctaBDE and possibly make a new recycling exemption for DecaBDE. Another critical decision of the Stockholm Convention Conference will be to establish hazardous waste limits...
My first stop at the airport was a quick snack en-route to the conference. The airport Spar offered an abundance of fresh fruit and veg, including organic options, and an inviting array of fresh salads just inside the doors – our high street convenience stores could learn a lot about product placement and display to tempt customers with inviting and nutritious ranges.
Speaking first at the workshop was Katarina Roth, from Austria’s Bio Forschung team. Katarina shared her work on mapping green public procurement across Europe. Inspiring case studies include Munich, where local businesses use a sponsorship model, supporting local day-care centres to upgrade their ingredient quality for the children’s meals. These centres are now using organic ingredients as most of the additional costs are sponsored.
There was great interest in my presentation on the Food for Life Hospital Leaders Programme, the Food for Life Catering Mark, and the changing policy landscape in England around staff health and wellbeing. I spoke about the changes that have been happening in English hospitals under the CQUIN, such as the removal of chocolate from till points, and the consistency now expected across all NHS retail outlets. There were lots of questions from other delegates e.g. on the challenges of existing contracts and the importance of support through national policy, so hopefully useful learning for others to take away.
The last speaker was Tina Chiu, a Taiwanese Dietitian at the Buddhist Tzu Chi Medical Foundation. She shared the innovative model in place in the Foundation’s hospitals that I don’t think is replicated anywhere in the UK. All food served in their hospitals is vegetarian, and the team actively use and develop the academic evidence base on the impact of a vegetarian diet on recovery and improvement on longer term health. It isn’t all theory though as the dietetic team run events, such as targeted workshops for patients with cardiovascular conditions teaching cooking skills, shopping tips, exercise tips, and including sessions with the cardiac specialists. For them, educating clinical staff on the benefits of vegetarian diets on health is also key, and look out for new studies due to be published soon...
BUND networking conference “Climate Protection in Hospitals” in Berlin
BUND, the German branch of Friends of the Earth, runs projects such as the BUND Label “Energy Saving Hospital” and has built a network with over 1,500 members. Equipped with comprehensive high-end technology to provide medical care, hospitals are facilities with enormous resource consumption. These buildings and services, however, hold an enormous potential for saving energy and money. In Germany up to €600 million could be saved if hospitals invest in buildings and energy supply and six million tons of harmful CO2 could be avoided, without any restrictions to the clinic’s services – often even increasing comfort.
This year, BUND is organising a network conference: “Climate Protection in Hospitals”