Safety first: 3 points on safety, standards from Healthcare Elastomers

FAIRLAWN—Operating in the health care space comes with great responsibility.

And that responsibility means holding yourself to higher standards. It means thinking outside the box and finding the right solutions to ensure the safety of patients and first responders.

Throughout the Healthcare Elastomer Conference hosted May 8-9 by Rubber News, experts from around the industry discussed what it takes to ensure that medical devices and personal protective equipment performs exactly as it's supposed to—at the highest possible levels.

Here's a look at three points about safety and standards shared by speakers during the two-day event.

There are certain standards medical gloves must meet.

But what good are those standards past the packaging of this critical PPE? And can we guarantee these standards are even met in the first place?

Katrina Cornish, research director at the Ohio State University, and Alison Bagwell, CEO of Shield Manufacturing L.L.C., both discussed key flaws in the standardization of medical gloves.

In her presentation, "Durability Variation amongst Medical Gloves Made from Different Elastomers," Cornish noted that while medical gloves must meet certain standards for mechanical performances and perforations at the time of packaging, there are no standards currently in place for durability once those gloves are removed from their packaging.

"People expect a glove to be what they expect a glove to be," she said. "… They don't expect (the gloves) to break, they expect to have protection."

And unreliable gloves in the medical field, Cornish said, mean higher rates of health care-associated infections.

"The bottom line is flimsy gloves cost lives," she said.

Bagwell reinforced this concern in her presentation, "Medical Protective Devices and New Manufacturing Paradigms," stating that gloves are not tested with ergonomics in mind.

"(Surgeons are) screwing, they're tightening, they're hammering, they're sawing, which is making the gloves stretched, twisted (and) pinched."

And gloves are just not tested against these conditions, she said.

Durability aside, if the glove doesn't break, is it still even protecting you?

Bagwell thinks probably not, noting that industry standards for medical gloves are long overdue for an update.

As requirements for gloves change and expand, the standards regulating these gloves have not, especially with the development of new drugs, chemicals and even medical procedures, she said.

Some of these new procedures or substances have not been tested with the gloves we use today, Bagwell said, so there is no assurance that the wearer is protected from the risks associated with exposure to these substances.

Then there's the risk of endotoxins, Bagwell added, noting these can be present on surgical gloves, among other medical devices.

Endotoxins, also referred to as LPS (lipopolysaccharides), can cause inflammation and fevers in patients, and in some cases anaphylactic shock or death, according to the National Institute of Health.

While there is work being done in some countries to develop standards for endotoxins on gloves, there currently are none, Bagwell said.

But even if we have the standards in place, that doesn't necessarily mean they're always going to be met, according to Cornish.

Cornish said rates of inspection are so low that some manufacturers are willing to risk paying fines for putting substandard gloves to market.

"They prefer to risk paying the fine because the chances of getting caught with a substandard glove were so low that it's a better business proposition for them to make an inferior glove," she said of some manufacturers she heard from based in Southeast Asia. "They can make it cheaper."

Cornish and Bagwell both are calling for higher and more comprehensive standards for the gloves industry.

And more accountability.

"Our health care workers were put in really bad spot three years ago (due to COVID), and they still are today," Bagwell said. "And that's not going to change because it never has."

Kraton Corp.'s Nexar-brand anti-fog technology truly came from circumstances that became typical during the COVID-19 pandemic.

What Kraton found was that the percentage of health care workers wearing protective eyewear was shockingly low, Jim Smith, Kraton director of strategic initiatives, told the Healthcare Elastomer Conference audience.

During 2020 and 2021—when hospitals were inundated by COVID cases—more than 80 percent of health care workers reported having exposure to bodily fluids in their face or head; more than 70 percent had eye mucosal exposure; and more than 73 percent had such exposure while working in patient rooms, the emergency room or surgery.

But during those two critical years, only 10.8 percent of the health care workers reported wearing face protection when such exposure occurred in 2020, and an even lower 8.5 percent in 2021.

And Smith said that top reason the first line responders didn't take advantage of the masks, goggles or face shields was fogging. When fogging occurs, it prevents proper PPE use, causes repeated face touching and increases job difficulty.

"Health care workers chose proper vision over protection," Smith said.

But it's a choice Kraton determined they shouldn't have to make, prompting development of the Nexar technology.

What the materials firm found was that most health care fogging solutions were inadequate, failing even the "8 seconds to fog test" set by the American National Standards Institute, let alone the 30 seconds specified by ASTM International.

Many of the current products available also contain PFAS, which is coming under growing regulatory scrutiny in Europe, the U.S. and elsewhere around the globe.

But in testing thus far, he said Kraton's Nexar anti-fog polymer coating takes more than 10 times longer to fog than current technology, remaining fog free even after 60 seconds, according to independent testing.

It also excelled in hospital testing in the ER at Massachusetts General Hospital, receiving positive reviews across the board.

"We're trying to roll this out quickly," Smith said, adding that Kraton is looking for a commercial partner such as a goggle or face shield manufacturer.

Kraton also is working on a second-generation version that will be aimed at industrial applications, which he said is potentially a much bigger market for Nexar than health care.

Henri Asselin, vice president of engineering and technology for Beacon MedTech Solutions, told the Healthcare Elastomer Conference what it's like for the molders who live in the contract manufacturing part of the medical goods industry.

Those are the custom molders who generally do work according to the specifications of their customers, and the amount of input they have can range widely from being a trusted partner whose opinion is valued, to the other end of the spectrum, where they perform the job just as the customer has requested.

The key to success in this arena is developing successful, partnerships, the VP for Leominster, Mass.-based Beacon MedTech said. That communicating clearly about:

• Product scope;
• Product development status;
• Part design inputs;
• Metrology expectations; and
• Functional requirements.

There can be potential challenges between the OEM customers and the contract manufacturer, so it is vital that the two organizations are in close alignment to ensure the success of a new product innovation from launch to full commercial production volume, Asselin said.

To keep both sides on the same page as a project moves along, he outlined nine "Pillars of New Production Introduction." That is the basic blueprint that starts with product design and ends with sustaining production, and has each needed benchmark along the journey. Communication between the contract molder and OEM also is critical when moving from one pillar to the next, to ensure both sides agree it is time to move to the next step.

Asselin said to go from the start of a project to launch typically takes from 12 to 18 months, but he has known some more complex product developments that took between three and four years to completion.

Erin Pustay Beaven contributed to this report.