These Bay Area residents need medical equipment, yet they wait amid supply-chain woes

Called its own public health crisis on top of the pandemic, supply-chain issues are blamed for the Bay Area’s lack of items such as wheelchairs and medical equipment|

FDA device shortage list

The 2020 CARES Act amended the Federal Food, Drug, and Cosmetic Act to include requirements for manufacturers of certain devices to notify the FDA of a permanent discontinuance or interruption in the manufacture of the device during a declared public health emergency.

The shortage list as of the end of January included:

• Dialysis-related products

• Personal protective equipment

• Testing supplies and equipment

• Ventilation-related products

Source: FDA

The ramifications of the global supply chain disruption for local medical supply companies are on stark display right now at a Petaluma industrial park.

That’s where Labcon makes pipette tips, which are the pointed and slender devices used in medical research and lab facilities. Business has boomed since the pandemic, so much so that the U.S. Defense Department awarded it a $60 million contract last October to increase production.

But the business has been stymied as it awaits boxes and labels to be packaged with Labcon products and then shipped across the world, said Jim Happ, president of Labcon North America.

“Sometimes we go a week without boxes or a week without labels because there is no label stock or raw materials,” Happ said. “But we don’t shut down. We keep manufacturing and just accumulate stuff everywhere while waiting for packages to come in.”

Labcon is just one example of the hiccups, pivots and challenges that North Bay medical device providers face regarding backups with the global supply chain, which also affects local consumers waiting on such necessary products. That’s especially the case for local companies that rely on imports or have to export products to foreign countries.

Home medical supply is a diverse industry encompassing breathing apparatuses, which may include oxygen; tubing that needs to be changed regularly; mobility devices; incontinence aids; bathroom safety equipment; wound care; as well as masks and so much more.

One pressing issue: waiting for containers to arrive so they can be restocked and then sent back out to cargo ships at the Port of Oakland.

That’s the case over at Mac Thin Films, a Santa Rosa optical coating company whose products are used for medical purposes such as diagnostic imaging, and in making cars and office-equipment. The company is mainly an exporter, said Mark Madigan, chief executive officer.

The timeline on cargo shipments has increased from six weeks to 16 weeks since mid-2021, he said. The result: Mac Thin Films has been forced to order more of its specialty glass from Europe that is uses in production.

“We have to have more in the pipeline because of that lead time,” Madigan said.

“Not only it impacts production schedules; meeting customer demand; there’s a much higher carrying cost,” he said of the amount of time that his business has to hold inventory. In fact, one of its major production lines is not operating this week because of a lack of material.“

About 60% of exports from Mac Thin Films are shipped out, Madigan said. The company recently shipped containers out of the Port of Oakland to Asia for an order that it had been trying to fill since late September.

“We haven’t seen any improvement yet,” he said of the backlog.

In Petaluma, Labcon benefits by using raw materials that are sourced domestically. But it has been hampered by the wait for containers as it exports about 35% of its products, Happ said. “We have accumulated millions of dollars of inventory that can’t leave because we can’t get containers fast enough,” Happ said.

“We need like two to three containers a week and we often get zero to one container a week,” he said. “Just like the whole supply chain is messed up with stuff coming in, it’s equally messed up with stuff going out.”

The issue is also playing out for consumers. For example, Peter Basco is practically confined to his apartment in Vacaville.

While he is disabled, he’s homebound in part because the supply chain issue has made it impossible for him to get the wheelchair he needs to be more mobile.

Basco is among millions of people in the U.S. struggling to obtain in-home medical equipment. For some, it is matter of life and death. For others, it affects their lifestyle, while for others, it is more of a nuisance or inconvenience.

“I made an order in June for some walkers and still haven’t gotten them. It is pretty incredible,” Carlene Chavez of Piner’s Medical Supply in Napa said in January. She handles all the ordering for the company, which has been in business since 1946.

Basco ordered his chair there in December. Even Chavez doesn’t know when it will arrive.

The delivery delays are being blamed on manufacturers’ inability to get the parts they need to build the products and the disruption in the supply chain.

“Supply chain shortages and disruptions have evolved over the course of this pandemic. At the onset of the pandemic we were dealing strictly with global demand for PPE products and an equally significant reduction in the manufacturing output for those very same products,” explained Mike Schiller with the Association for Health Care Resource and Materials Management, a leading membership group for health care suppliers.

The industry has been plagued with such shortages as semiconductors, aluminum, resins, silicone and energy. Labor shortages are impacting shipping ports and transportation sectors, and closer to home, clinical and supply chain staffing challenges, Schiller said.

“In my 35-year career as a supply chain professional, I have never seen anything, or worked in an environment, quite like this one.”

Personal implications

“Basically I rely on a wheelchair to do everything, even going to doctor’s appointments,” Basco said. “Without a wheelchair, I’m pretty much bed bound. I do have a walker, but I’m limited how long I can stand and how long I can walk.”

Last spring, he was a given a power wheelchair. The problem is its size.

The 51-year-old has been disabled since 2014 as a result of complications from lymphedema in his legs.

Fortunately, he is able to get most of what he needs delivered to his front door or family members bring him supplies. As for doctors, tele-medicine is the answer.

When Piner’s told him his chair was back ordered, he called around to see what another store would say. Same answer.

Because Basco has his hospital bed through the Napa company, which boasts of being Napa County’s No. 1 medical supplier, he stuck with them. The other bonus, he said, is Piner’s will assemble and deliver the wheelchair whenever it does arrive.

Stocking the shelves

Chavez said most customers at Piner’s are understanding of the delays. Still, the wait is unprecedented.

Specialty chairs used to take 14 days to build, now it’s closer to three months for her to see one delivered. A regular wheelchair would arrive in seven days; it’s also now taking three months. If scooters were in stock, it would be a three- to seven-day turnaround; now it’s 15 weeks.

Chavez is being told parts from China are the problem.

Jack’s Medical Supplies in San Anselmo is also having trouble stocking mobility devices — walkers, transport chairs, wheelchairs.

“We sell lift chairs. Those are almost a year out now. Usually they had the parts there to build and would send it in a couple months,” said James Clendening, an employee at the Marin County store.

That store is having a problem with anything that is made overseas or has components that are not from the United States.

“A lot of our inventory, though it says made in the USA, a lot is assembled in the USA and they get their parts from overseas and such,” Clendening said.

Most medical supply stores said they are coping by reaching out to more vendors and making bigger orders in the hopes something arrives. Customers may not be able to get the brand they want, but alternatives are usually an option.

These stores said supply shortages started at the onset of the pandemic two years ago, but the problems have gotten worse in the last six months.

“I think everyone that we deal with has also had a problem trying to find the exact product they are seeking. I was just on the phone with one of my customers who likes a particular glove that has been available for 30 plus years and it is not available,” said Lyn Sweet, who, with husband Steven, owns Sonoma Surgical Supply in Santa Rosa.

“The manufacturer is aware it is a problem and that the substitution is not working,” Sweet said.

Manufacturing woes

Another issue vexing retailers is computer chips, which are used in almost every device built today, whether medical related or not.

“We are competing with cellphone manufacturers, huge ones, car manufacturers, huge ones with high volumes, consumer appliances that are all cloud-connected these days,” said ResMed CEO Mick Farrell. “And we’re competing for those same parts and pieces that we can put into medical devices to give people the gift of breath.”

ResMed is the leading global manufacturer in sleep apnea therapy. According to the American Sleep Apnea Association, 22 million people in the United States suffer from sleep apnea. This sleeping disorder can be serious because breathing starts and stops.

The other top manufacturer of continuous positive airway pressure, or CPAP, devices, is Philips Respironics. That company last summer issued a recall for devices manufactured between 2009 and April 26, 2021.

“There needs to be better parity and distribution of microchips,” said Tom Ryan, CEO of the American Association for Homecare. “Right now it’s capitalism.”

And that means the highest bidder gets the chips, and that’s not a medical device manufacturer.

This trade group for the home medical equipment industry represents 380 companies.

Ryan said until medical devices are given a priority allocation for chips, shortages will continue. He called it a “public health emergency.”

FDA device shortage list

The 2020 CARES Act amended the Federal Food, Drug, and Cosmetic Act to include requirements for manufacturers of certain devices to notify the FDA of a permanent discontinuance or interruption in the manufacture of the device during a declared public health emergency.

The shortage list as of the end of January included:

• Dialysis-related products

• Personal protective equipment

• Testing supplies and equipment

• Ventilation-related products

Source: FDA

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