This is an excerpt from Medically Necessary, a health care supply chain newsletter. Subscribe here.
The story: A perfect storm of supply chain issues recently led to disruptions for two skin disinfectant products.
Group purchasing organizations are tracking shortages of BD’s ChloraPrep skin disinfectant product and PDI’s iodine prep pads.
The story behind those issues offers a useful glimpse of how the COVID-19 pandemic has changed the health care supply chain and how the industry is responding.
The problems: BD’s ChloraPrep products, pen-like applicators used to disinfect skin before surgery, are running into several different problems simultaneously.
“The COVID-19 pandemic has put enormous stress on BD production capacity. In addition, we have recently experienced unexpected issues unrelated to COVID-19, including recalls and third-party supplier constraints,” a BD spokesperson told FreightWaves via email.
A BD page dedicated to the supply problems notes that the company is working to increase manufacturing capacity to resolve the disruption.
The company has issued three voluntary recalls for ChloraPrep products over the last 12 months.
“That put them a little behind the eight ball,” Kim Anders, who leads strategic supplier engagement for Premier, told FreightWaves.
Now BD is having trouble sourcing the resin needed to make the plastic applicators, Anders said. A third-party manufacturer that makes the product has also slowed down production, but BD didn’t specify why that’s happening.
The price of some resins has more than doubled over the last year, according to data from the online marketplace The Plastics Exchange.
BD has told customers that a replacement product will be available in July, but it hasn’t shared details about pricing, Anders said.
PDI has shared far less information about its shortage. The company didn’t respond to questions about the problem. Anders said the only information PDI has offered Premier is that there’s a supply chain disruption. That shortage is relatively recent and Premier is working with PDI to get more information.
A look ahead: BD’s shortage reads like a supply chain parable about the difficulty of recovering from the COVID-19 pandemic.
The lack of information on PDI’s supply issues highlights a different problem: the need for more supply chain visibility. FDA hasn’t received any reports about shortages of these products, which are regulated as drugs.
PDI is communicating with customers and other stakeholders about the disruption, but Anders said they still lack critical information.
“How long is this going to last? Is this a temporary glitch and we’ll be back on once a container arrives?” Anders said. “That’s really what our members want to know. … Do we mitigate through the shortage or do we have to make a full transition?”
Anders said Premier is working to identify where raw materials for medical products come from so the company can respond to these kinds of disruptions faster.
In Congress, some legislators have proposed giving FDA the power to collect more information about the volume of drugs produced in other countries to help avoid shortages.
During the pandemic, the agency has also started monitoring shortages of some medical devices. Now FDA wants to build a full-fledged program to monitor shortages of medical devices.
“Through this program, CDRH will better be able to predict, prevent, alert and mitigate interruptions in the medical device supply chain,” an FDA spokesperson told FreightWaves.
The final word: For Anders, the recent issues with BD’s and PDI’s skin disinfectant products are essentially the result of the COVID-19 pandemic’s global and long-lasting effect on health care supply chains.
“This is a global issue. This isn’t one, two suppliers. This is across the board that we’re seeing impact,” Anders said. “It’s finished goods. It’s shortages. It’s price increases. It’s inflation. It’s all compounding into the perfect storm.”