Archive for the ‘Regulatory Compliance’

Filed under: Regulatory Compliance — Michael Prather @ 9:09 am

This training video, produced by the US Occupational Safety and Health Administration, shows proper procedures for donning (putting on) and doffing (taking off) all types of respirators.

Filed under: Regulatory Compliance — Michael Prather @ 9:59 am

Published by the US Occupational Safety and Health Administration in December, this new training video clarifies the differences between facemasks and respriators.

Filed under: Pandemic Flu, Regulatory Compliance — Lindsay Nemastil @ 10:05 am

President Obama has approved legislation to increase the budgets to two of the key government agencies responsible for ensuring occupational safety.  The appropriations bill, signed into law in December, will increase 2010 OSHA and NIOSH budgets by 8% and 5%, respectively.  According to Safety + Health magazine, the agencies expect to use the additional funds to hire compliance officers and expand pandemic flu preparedness.

Filed under: Pricing Trends, Regulatory Compliance — Lindsay Nemastil @ 3:08 pm

Months after first beginning their climb, natural rubber latex prices continue to hover near record levels set earlier this month closing at 742 sen/kg Thursday (Source:  Malaysian Rubber Board).  Despite improved production, supplies have been slow to reach the market in recent weeks as dealers hold stock in anticipation of higher prices.

Driving the higher prices:

- Weakened supplies due to lower winter season production
- Stronger than anticipated global economic recovery
- Increased demand from the Chinese automotive industry
- Rising crude oil prices

Filed under: Regulatory Compliance — Michael Prather @ 3:14 pm

The Center for Devices and Radiological Health (CDRH), a part of of the Food and Drug Administration, issued an import alert January 4 following determination that the many foreign glove manufacturers have “failed to consistently provide medical gloves of adequate quality”.  According to the alert, more than 200 glove manufacturers are currently in detention; of those, 16 are in Level 2 and 12 are in Level 3 detention.

When inspected medical gloves fail to meet Good Manufacturing Practices (GMP) upon FDA inspection, the manufacturer is placed in one of three levels of detention whereby any shipment may be detained by the FDA without physical examination.  Repeat offenders face escalating levels of detention, with each level requiring additional evidence of compliance in order to be removed from the list.  In Levels 1 and 2, manufacturers must provide consecutive independent lab test results confirming that their medical gloves are not adulterated for removal consideration.  Removal from Level 3 detention also requires independent audits or FDA inspection.

We applaud the FDA for its continued efforts to ensure the safety of those whom rely on medical gloves for protection.