Gary Morgan is on The BRIDGE!
The BRIDGE is an online network from LMT dedicated exclusively for members of the Dental Laboratory community. Join free to connect with Gary.
"Our business will continue to change to meet new demands. It's less about the ability to manage change and more about the strength to lead change," said Ivoclar Vivadent's CEO Bob Ganley during his State...See more of the Industry address to the more than 700 attendees at the 87th Annual Cal-Lab Meeting held at the Westin Michigan Avenue. One development Ganley discussed is the growing irrelevance of geographical barriers due to new technology and the increasing competition between labs because of it. "You must understand who you are and have some kind of identifiable message on how you differentiate yourself. Now that's more important than ever," said Ganley. In keeping with the meeting's "Winds of Change" theme, many of the other presentations focused on new technologies and adapting to an evolving landscape. Lee Culp, CDT, explained the cultural challenge of going digital in his lecture, Digital Workflow, from Production to Esthetics with Full Contour. The meeting also featured a three-part presentation on shading zirconia with Peter Pizzi, MDT, Bob Posey and Robin Carden; Dr. David Little on Implants, Technology and the Team Approach; an update on market trends from Bennett Napier, CAE; internet marketing advice from Robert Gitman; and author Robert Stevenson's keynote address, If You Don't Like Change, You Will Hate Extinction. In addition, Safelink Consulting's Gary Morgan, CDT, gave a regulatory standards update. Next year's Cal-Lab meeting is February 20-21;for more information, visit www.cal-lab.org.
At the Cal-Lab Meeting in Chicago, Safelink's Gary Morgan, CDT, offered an update on various regulatory issues, including OSHA, the FDA and the Medical Device Tax. Here's an overview: OSHA has revised...See more its Hazard Communication Standard. "This is a major change you need to be aware of and address right now," said Morgan, noting that OSHA is making enforcement a priority and laboratory inspections and penalties are on the rise. As part of the new standard: Laboratories must update their hazard communication plan which details how staff should safely work with chemicals. "You need to figure out what you have: conduct an assessment, determine safe practices, create a written program and label all chemicals with their contents," said Morgan. OSHA has also adopted a Global Harmonization System (GHS) that requires images or pictograms on dangerous, corrosive or toxic substances. Manufacturers and distributors are required to label original containers and the lab should either provide the same labeling information on secondary containers; use an alternate labeling system, such as the HMIS or NFPA labels; or post the labeling information in the area where chemicals are used. Safelink has a GHS toolkit with more information and pictogram labels; call 800-330-6003 or visit www.safelinkconsulting.com . OSHA is instituting new Safety Data Sheets (SDS) for materials; these were formerly called Materials Safety Data Sheets but OSHA has dropped "Materials" from the name. "As you receive the new SDSs, don't throw the old ones away," said Morgan. "Archive them; your lab needs them for historical reference." Laboratories must train staff on the new labeling requirement and SDSs by December 1, 2013 and manufacturers must be completely transitioned to the new SDSs by June 1, 2015. One new toxic substance that OSHA is testing for—but most labs don't know about—is hexavalent chromium, which results from melting, soldering or welding chrome cobalt. "At an OSHA inspection, one lab didn't know what this was and hadn't tested for it. Although it then tested and found no exposure, the lab still had to pay the penalty." Labs can hire an industrial hygienists to do the testing or contact the OSHA consultation service in their state who conducts the testing at no charge. Morgan also offered this information on the FDA and Medical Device Tax: In addition to paying a higher registration fee, labs required to register with the FDA must now also provide more information, including their website address. "Be careful what you put on your website," warned Morgan. "If the FDA sees you marketing something you don't have a 510k for, it will hold you accountable. Labs have already seen this happening and have been served with cease and desist letters." Will custom implant abutments be considered a Class 2 medical device? "Stock implant abutments are considered Class 2 medical devices—requiring manufacturers who make them to register with the FDA—but we're still waiting to hear how the FDA will address custom implant abutments," said Morgan. "This is a gorilla we're going to have to face; we should hear from the FDA soon, stay tuned." Medical Device Tax implications: The cost of doing business just went up. "Although most labs don't have to deal with paying the tax, the materials used will be taxed. Who are the manufacturers going to recover that tax from? You guys, unless they decide to eat it," said Morgan. "If the tax isn't showing up on your invoices you need to ask if it's included." Morgan also offered these tips for a safer workplace: Distracted driving and texting. "Be proactive, have a policy on safe driving practices." Have a contingency plan for natural disasters such as Storm Sandy. "You need to keep your business going in the event of an emergency," said Morgan. Workplace violence. "It's the thing no one wants to talk about, but you should at least have a 'no weapons' policy." for more on the Cal-Lab Meeting, click here.