5 Questions You Need to Ask about EPA and REACH

As the medical device industry continues to expand globally, it is increasingly important for device designers and manufacturers to ensure that their products and processes are compliant with both U.S. Environmental Protection Agency (EPA) standards and REACH regulations in Europe (ECHA). Design engineers and manufacturers can help ward off unnecessary compliance headaches later in the process by consulting with qualified expert suppliers early in the design stage.

Keeping up with evolving environmental and chemical safety regulations in a global market can be overwhelming. Medical device manufacturers and designers need to comply with numerous FDA regulations and obtain 510(k) approval; it’s not unusual for users who are well into their new product commercialization process before realizing that they have a problem. Often they discover that their chemistries aren’t EPA compliant or that their equipment isn’t the most efficient or simply inappropriate. In most cases, if their chemistry is not EPA or REACH compliant, it’s because they are using a process that was once compliant, but due to evolving regulations, is no longer.In a multinational manufacturing company, conflicts in local regulations make such situations understandable and familiar—yet avoidable. By being proactive, engineers can bring cleaning and lubricant suppliers on board who are thought-leaders and have expertise in environmental regulations. It is an essential practice in order to specify a manufacturing process that will be compliant for years to come. This gives the end-user long-term assurance their process is both viable and can save them significant time and money.
 

Changing Regulations—An Overview

The REACH regulations currently being implemented into law in the European Union will be in full effect by 2018. The United States is currently in the process of putting harmonized regulations similar to REACH into effect, so the methodology of evaluating and maintaining chemical compliance will soon be done in a similar fashion in both the U.S. and the E.U. In addition, the state of California, a leader in clean air regulations, is implementing stricter clean air standards by requiring chemistries to meet ever more restrictive volatile organic compound (VOC) attainment levels. This rapidly changing landscape means that many manufacturers will be required to find alternatives for many chemistries that can have a significant impact on their manufacturing process.

However, some changes, such as those eliminating the production of HCFC-225 solvent, have been a long time coming. Beginning January 1, 2015, HCFC-225 solvent will no longer be produced due to its status as a Class 2 ozone depleting substance. Suppliers that are up-to-date on EPA regulations will be ready by 2015 with alternative products that do not contain HCFC-225 solvent. Some suppliers already offer alternative products and can provide consulting with engineering expertise to implement those alternatives immediately.

Suppliers that are knowledgeable and current on rapidly changing global regulations and deadlines are in a better position to provide their customers with sound recommendations of suitable products and process equipment to use. If regulatory changes are anticipated, decisions can be made early-on that will insure investment decisions make the most sense up front and for the long term.

Asking the Right Questions

Suppliers should be knowledgeable about the globally changing regulatory landscape. Your supplier should also be able to provide long term EPA/REACH compliant products. You should ask a few essential simple questions initially to help determine if a supplier understands the requirements, such as: 

It makes sense to partner with that offer EPA and REACH compliant products. They should also be able to assist customers in making certain their engineering processes are both compliant with global regulations and also efficient in meeting manufacturing standards. This value-added partnership, formed right away during the design stage, rather than after investment is made in the manufacturing processes, is instrumental in saving time and money for long-term efficiency and profitability.

Jay Tourigny is vice president of Operations at MicroCare Medical. He has been in the industry more than 25 years, and holds a Bachelor of Science degree from Massachusetts College of Liberal Arts. Tourigny holds numerous US patents for cleaning related products that are used on a daily basis in medical, fiber optic, and precision cleaning applications.