The Safer Medical Devices Database

Health Care Without Harm Europe has been involved for many years in promoting PVC-free and/or phthalate-free medical devices as part of the solution to a non-toxic healthcare sector. We published several fact sheets (see below) to help hospitals understand the basic steps they need to go through, and demonstrate that they are not the first (and will not be the last) to do so.

In recent years, several alternative medical devices have appeared in the market where phthalates and PVC were successfully substituted by less harmful chemicals, but this information is not consistently available for all stakeholders. HCWH Europe identified the need to develop a broadly accepted tool for the healthcare sector to identify alternatives to medical devices containing phthalates or PVC. The Safer Alternatives Database is an open-access web-service maintained and administered by HCWH Europe.

Products included in the database are PVC-free products or products where phthlates have not been intentionally added.

The Safer Medical Devices Database is intended for health procurers, to help staff responsible for procuring medical devices to carry out informed decisions and purchase phthalate and PVC free medical devices, for regulatory bodies, to assist in dealing with the pre-market authorisation process of medical devices and for manufacturers and other interested parties to promote their products in the European market.

The information contained in the database is solely based on data provided by the manufacturers and publicly available data. HCWH-Europe personnel and manufacturers can enter information in the database, but only HCWH-Europe can validate data.

Number of products currently in the database: 242332

Number of registered users: 3267

What is the issue?

The physical properties and low production costs of PVC have made it the material of choice for medical devices.

From an environment and health perspective, however, PVC is far from ideal, posing problems throughout its life-cycle. PVC is carbon-intensive to manufacture, exposes patients to harmful substances during use, and creates hazardous pollutants during disposal.

Over the last 30 years, concern has grown about the safety of phthalates used to soften PVC medical devices, because they are not bound to the PVC matrix and can leach out from medical devices into the solutions the devices are transporting into the patient.

There are many non-PVC materials available, suitable for a wide variety of medical applications, which do not require phthalates or other softeners. The potential hazards posed by phthalates leaching from equipment and being carried into the patient can therefore be avoided. Many European hospitals are seeking alternative materials for medical devices and phasing out PVC or phthalates in their medical devices.

Contrary to what many people might think, in Europe many medical device manufacturers offer PVC-free versions of medical devices.The price premium is not always as drastic as is often assumed. The price difference, if any, depends greatly on national markets and the individual contracts between hospitals and suppliers. Hospitals can lower per-unit costs by purchasing in large volumes: here price differences can be negotiated down to a minimum. Ultimately, the benefits to health can outweigh higher costs, especially when considering the long-term benefits for society at large.

Hazardous Chemicals in Medical Devices: Phthalates

How to survey PVC use in your hospital and begin a successful PVC phase-out programme

PVC/DEHP phase-out is possible anywhere in Europe: Model hospitals show how to succeed

Health Care Without Harm (HCWH) Europe

Health Care Without Harm Europe is a non-profit European coalition of hospitals, healthcare systems, healthcare professionals, local authorities, research/academic institutions and environmental and health organisations. It currently has 73 members in 23 countries of the WHO European Region. HCWH Europe brings the voice of healthcare professionals to the European policy debate about key issues - chemicals, climate change and health, green building, green procurement, pharmaceuticals, sustainable food and waste management.

HCWH Europe educates the healthcare sector to understand the importance of the environment and presses healthcare leaders and professionals to advocate for broader societal policies and changes. HCWH Europe leverages the enormous purchasing power of the healthcare sector to drive markets and stimulate innovation for safer products.

Funding

Health Care Without Harm (HCWH) Europe gratefully acknowledges the financial support of the European Commission. HCWH Europe is solely responsible for the content of this database and the views expressed do not reflect the official views of the European Commission.