REGULATORY UPDATE: What You Need to Know About OSHA, FDA and the Medical Device Tax
Posted Apr 16, 2013, Published 2013-04-01
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 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 "Archive them; your lab needs them for historical reference."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.
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