By Jay Tourigny, MicroCare Medical
The medical device industry is going global–are you ready for it? While it can be overwhelming to keep up with regulations in a global market, it has never been more important for device designers and manufacturers to ensure that their products and processes are compliant. But don't be afraid. Suppliers, such as MicroCare Medical, can help you navigate the evolving regulatory landscape.
So, what are you facing? Here are the top five industry-wide regulations that could affect the way you do business.
1. Clean air standards
The EPA has set protective health-based standards for ozone layer protection, which may result in restrictions or outright bans on chemicals and materials you work with on a daily basis. The state of California, a leader in clean air regulations, is implementing stricter clean air standards by requiring function specific chemistries to meet ever-more restrictive volatile organic compound (VOC) attainment levels. Furthermore, beginning January 1, 2015, HCFC-225 solvent will no longer be produced due to its status as a Class II ozone depleting substance.
Manufacturers and suppliers are required to find cost-effective alternatives that perform as well as their predecessors. Some suppliers already offer alternative products that do not contain HCFC-225 solvent, are VOC-free and comply with EPA standards. Be proactive, and consult with qualified expert suppliers early in the design stage to eliminate unnecessary compliance headaches later in the process.
2. Globally Harmonized System of Classification and Labeling of Chemicals (GHS)
GHS is intended to align the major hazard communication standards in use around the world – including labels and material Safety Data Sheets (SDS) – and will be in effect throughout the EU early this year. The new system provides a basis for harmonization of rules and regulations on chemicals at a regional, national and international level, and is relevant to any organization supplying products or working in chemical manufacturing and distribution, which includes the healthcare community. The biggest changes for most organizations will be hazard classifications, safety labels, and material safety data sheets.
3. The International Medical Device Regulators' Forum (IMDRF)
The IMDRF has been officially announced, which is the successor organization of the Global Harmonization Task Force (GHTF). Built on the strong foundational work of the GHTF, the Forum will discuss future directions in global medical device regulations and will accelerate international medical device regulatory convergence by developing guidance on strategy, policy, directions, membership and activities. Stay up-to-date with evolving global medical device regulations to make sure your process continues to be compliant.
4. REACH regulations in Europe
The REACH regulations currently being implemented into law in the European Union will be in full effect by 2018. REACH is intended to regulate chemicals and their safe use to improve the protection of human health and the environment. Manufacturers are required to gather information on the properties of their chemical substances, and register the information with the European Chemicals Agency (EHCA). The United States is currently in the process of putting harmonized regulations similar to REACH in 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.
5. Unique Device Identification (UDI) System for Medical Devices
At the end of 2011, the GHTF published the final version of guidelines to its “Unique Device Identification (UDI) System for Medical Devices.” While this system is in its first stages of developments and still needs several rounds of guidance and approvals, it seeks to provide a single, globally-accepted system for positive identification of medical devices. This UDI system is expected to increase patient safety, as the device will be traceable with adequate information from the manufacturer through to the healthcare provider. Should this system come to fruition, manufacturers will need to create and maintain globally unique UDIs on their medical devices or its packaging.
Don't get left behind with the changing global regulations. Bring a well-chosen supplier on board to assist you early in the design stage to make sure your products and processes are current and compliant.
Jay Tourigny is Vice President of Operations at MicroCare Medical and can be reached at JayTourigny@microcare.com. He has been in the industry for 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.
MicroCare Medical is a supplier of advanced cleaners, carrier additives, coatings and lubricants to medical device designers and manufacturers throughout North America and Western Europe. Learn more about the MicroCare Medical “Expertise in Action” and 48-hour turn-around policy at www.microcaremedical.com. You can also see MicroCare Medical at Booth #2267 at MD&M West.