INDIANAPOLIS (WTHR) — As hospitals desperately search for safety equipment to help protect their medical staff from coronavirus, 13 Investigates has learned multiple shipments of personal protective equipment (PPE) have been sitting in shipping warehouses around the country, waiting for federal regulators to inspect and release them.

“We ordered a bunch of N95 masks last month, and we have hospital clients here looking to us saying ‘Where’s our product?’ We tell them it’s here, but it’s not being delivered yet,” said Victoria Fine, who owns a small company in Indianapolis that is helping secure medical supplies. “We’re ordering and others are ordering, but they’re not getting to the front lines.”

In March, Fine and her husband quickly converted their Indianapolis promotional products company to focus on PPE, responding to the need of medical centers treating patients stricken by COVID-19. Fine Promotions had existing relationships with companies in China, where the majority of face masks, gloves, face shields and other medical safety equipment is produced.

“When the factories there contacted us to say they were open and asked if we needed supplies, we jumped at that opportunity because so many clients here in the United States were looking for it,” Fine told 13News. Then the small business got an endorsement from the American Hospital Association as a preferred supplier of PPE, and orders for safety equipment flooded in.

Ordering the supplies and getting them shipped from China has been the easy part. Once the orders arrive in the United States, Fine says that is when the real challenge begins.

Tracking a shipment of face masks

Friday morning, Fine told 13News about a shipment of more than 100,000 N95 face masks that her company ordered for four hospitals in central Indiana. And she provided 13 Investigates with the tracking log for those medical supplies.

The UPS tracking information shows the masks left Hong Kong on March 28. That same night, after a brief stop in Taiwan, they arrived in Anchorage, Alaska. By 9:58 a.m. the next day, the N95 masks had nearly finished their journey across the globe and were at the UPS shipping hub in Louisville — about 100 miles from the Indianapolis-area hospitals that had ordered them. Then they sat. And sat. And sat some more.

According to the tracking log, it took nine-and-a-half days for the U.S. Food and Drug Administration to begin inspecting and processing the shipment. It then took another two days for the shipment to be cleared for delivery. The clearance came April 9, the same day 13News contacted the FDA to inquire about delays involving PPE ordered for Indianapolis hospitals. The face masks were delivered this morning, April 10, at 10:12 a.m. — nearly two weeks after they first arrived at the Louisville UPS distribution hub.

“They’re stuck in Louisville, and that’s really frustrating for us and for our clients who really need those supplies,” Fine said Friday morning, about an hour before the masks were delivered. “This is a shipment that’s been on hold a full seven days or more, so we’ve lost a week of getting these out to hospitals.”

Another shipment of N95 masks headed for Indianapolis hospitals arrived at the FedEx Indianapolis distribution hub earlier this week. That shipment from Shenzhen, China, has been awaiting FDA approval and is currently marked as “pending” with a “clearance delay.”

FDA “doing everything we can”

The FDA declined to comment on the specific details of the delayed PPE shipments to Indianapolis, but an agency spokesman sent 13News a statement.

“The FDA is doing everything we can to support patients, health care professionals, hospitals, medical product manufacturers and the public during this pandemic. To do that, we are working to provide maximum regulatory flexibility to facilitate the availability of needed products, including PPE, during the COVID-19 pandemic, while still providing crucial FDA oversight. We understand the importance of bringing needed supplies into the country and the agency is fully open to helping to facilitate the entry of such products into the U.S.

The FDA is working to help ensure imported PPE either have been granted an Emergency Use Authorization or fall under FDA’s immediately in effect guidance documents. An imported product that does not appear to belong to either of these groups or is not properly documented when shipped may cause a delay while FDA reconciles the status.

In efforts to avoid delays of legitimate shipments, we urge importers to review the FDA Import Program webpage and FDA’s instructions to importers for important information surrounding importing products, including PPE, to ensure that the proper documentation is submitted at the time of entry.

The FDA has adjusted our import screening to further expedite imports of legitimate products and are continually monitoring our import systems to prevent and mitigate potential issues. The FDA has been ready and available to engage with importers to minimize disruptions during the importing process and we have established a special email inbox, COVID19FDAIMPORTINQUIRIES@fda.hhs.gov, for industry to quickly communicate with the agency and address questions or concerns.”

Tracking logs associated with the shipment of protective masks imported to Indianapolis indicate the FDA did not have sufficient information to approve the shipments without additional details.

UPS told 13 Investigates that federal inspectors are closely scrutinizing shipments of foreign medical supplies that do not have proper paperwork.

“With international brokerage and [U.S.] Customs, it has to be done a certain way,” explained UPS spokesman Matthew O’Conner. “All the paperwork has to be perfect or it cannot be released.”

Fine Promotions said it provided all additional information requested by federal inspectors, but the shipments were still not approved for release for several more days.

“It seems there are not enough boots on the ground to process all of the incoming inventory, and I think they need more help,” Fine said. “They didn’t grasp the amount of orders coming in from other countries.”

Delays cause concern

Many more orders of PPE are now on the way. In just the past ten days, Fine Promotions has placed orders for more than 1.25 million pieces of PPE requested by 20 hospitals across the country. It is a tiny portion of the total PPE shipments now being imported into the United States to help medical centers and first responders battle COVID-19, and Fine fears continued delays could further compromise the safety of health care workers who need them.

“We’re hearing they really need these items now. It’s not just me I’m advocating for. It’s every supplier whose bringing in PPE that’s kind of hit this obstacle as we are trying to get this equipment to the front lines,” she said.

Nurses worry about the delays, too.

“Time is critical. It makes a huge difference,” said Jean Ross, a registered nurse and co-president of National Nurses United, the country’s largest union and professional association of RNs. Ross says the shipping delays involving protective medical equipment is a nationwide problem.

“We’ve heard of FDA holding up [shipments]. We’ve heard of FEMA holding things up. There’s really no good distribution plan. There’s no plan. It makes me wish that nurses were at the top of the chain because we would have a plan,” she told 13News.

FEMA insists it does have a plan and is trying to loosen regulations to get PPE to nurses and doctors more quickly. In the meantime, critical safety supplies are being delayed – sometimes for days, sometimes for weeks – as health care workers and hospitals continue to wait.

“I just don’t see why it needs to take this long,” Fine said. “Let’s get this stuff where it needs to go.”

A FedEx spokeswoman sent 13 Investigates the following statement about imported PPE shipments that travel through FedEx facilities:

FedEx is using its global network to transport critical aid and medical supplies for our customers and charitable organizations to regions around the world that have been impacted by COVID-19. We have a long history of close cooperation with government agencies and work to minimize any delays for our customers’ shipments. FedEx is committed to compliance with all rules and regulations in the markets where we operate.