Cambridge company still waiting to sell millions of masks in storage
CAMBRIDGE -- Millions of masks are still sitting in a Cambridge warehouse waiting to be sold.
The company is waiting for certification from an American regulatory body for its N95 masks. Health Canada has signed off on the masks, but there are still roadblocks to selling in Ontario.
Steve Mai, CEO of Eclipse Innovations, said his company wants to help during the pandemic.
"Get our products into the hands of health-care workers so we don't have a shortage and then to make that sustainable to the country long term," Mai said.
But, Mai said he's been waiting in the queue for certification for his respirators by an American regulatory body, called the National Institute for Occupational Safety and Health (NIOSH).
"They said there's about 15 to 20 applicants being processed as we speak in the prioritized state of where we are," Mai said.
“Due to the unprecedented number of new applicants, currently priority is being given to new approvals and extension of approvals submitted by existing approval holders and new domestic respirator manufacturers/applicants," a statement from NIOSH said in part. "With the current COVID-19 situation and domestic priorities, it is difficult to project a timeline for new international manufacturers to receive a NIOSH approval."
Health Canada said the company's device is authorized for import or sale in this country through an interim order after completing a scientific assessment to ensure the device meets requirements for safety and effectiveness.
Health Canada said it plans to extend the order to this fall to introduce regulatory changes.
But Maid said there are roadblocks without the NIOSH stamp of approval.
"Companies have to meet the NIOSH standard," said Michael Hurley, president of the Ontario Council of Hospital Unions of CUPE. "Meeting the standard is not something that another body can actually do for you."
"We need to get to a point where our products are accepted into the supply chain that currently we don't have an avenue to get into," Mai said.
Mai added his company got into the market because of a lack of domestic PPE. But, now they are caught up in red tape and expect more hurdles in the future, like border closures affecting NIOSH inspections.