REACH and RoHS implications for the healthcare industry

16/06/2015 08:58:27

The medical industry is governed by strict standards to ensure that all medical devices used by patients are safe. 
This is a run-down of two important pieces of legislation and why they are important for the medical industry.

Ultimately, these regulations are there to protect human health and the environment from the use of harmful chemicals, and to make the people who place chemicals on the market responsible for understanding and managing the risks associated with their use. 

What is REACH?
REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals.  It entered into force on 1 June 2007, and is ‘a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals’ ( 2015).
Almost every business is affected by REACH. Any company that manufactures or imports goods into the EU has to ensure that any REACH classified material contained in their products does not exceed restrictions defined by the guidelines. For example, if a company imports foam for use in mattresses, the manufacturing company is responsible for ensuring all ingredients contained within the foam are registered with REACH.
At Dartex®, we ensure that all of the chemicals used to create our polyurethane coated fabrics are REACH compliant. 
Did you know – REACH regulations are reviewed every six months?
Make sure that when you’re picking your suppliers, you ask how often they are reviewing their products. Dartex® has an in-house technical team dedicated to ensuring its products are compliant and all of the chemicals used in its products comply fully with the current standards.
What is RoHS?
RoHS stands for Restriction of the Use of Certain Hazardous Substances (RoHS), and restricts the use of six dangerous substances in Electrical and Electronic Equipment. It’s closely linked with the Waste Electrical and Electronic Equipment Directive (WEEE) which sets collection, recycling and recovery targets for electrical goods to tackle the huge amounts of toxic e-waste generated from electronic equipment.
As a supplier of medical fabric for use in electronic medical equipment, such as beds and wheelchairs, Dartex® ensures that all products that it manufactures meet these guidelines.
The directive was updated in 2011 and RoHS2 became law in the UK in 2013. While some US states have introduced limited RoHS-like laws, there is currently no federal US equivalent to EU RoHS.
What do manufacturers need to know?
For healthcare equipment manufacturers who buy polyurethane-coated products for their medical devices, it’s important to ask if your suppliers are REACH and RoHS compliant. All components that make up your medical device have to be traceable; right down to the ‘nuts and bolts’ of your component parts.
Your suppliers have a duty to follow the guidelines, even though they are not making the end product. Make sure you ask to see their certificate of compliance for the product they are supplying to you.
What do clinicians need to know?
A key purpose of the REACH and RoHS standards is to make sure that all products have traceability. However small the chance, if something goes wrong you need to have the knowledge and security that you can go right back to the source of all the parts that go into the end product for your patient to find out what went wrong.
Don’t be afraid to ask for evidence of compliance.
Every roll of Dartex® we produce is issued with a certificate of compliance to give you peace of mind.
If in doubt – give us a shout! Our technical team is happy to answer any questions you have on REACH and RoHS. 


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