When Regulation Goes Right—And Wrong

By April 27, 2020Medical Design, Process

The point of regulation is to keep people safe.

All the nuance and complexity distills down that essential goal. From the EPA to the FAA to the FDA, the organizations that regulate industry do so as representatives of the people affected by what they put out.

Annoying as they can be, regulatory bodies are a necessary part of the process. They set third-party standards based on scientific evidence, and provide incentives (or disincentives) for adhering to those standards. Certification, clearance, and/or acceptance by regulatory bodies are some of those incentives. Liability is the opposite.

For example, the healthcare industry has a complex and evidence-based pathway for products and treatments to enter the system, and even more scrutiny is given before they become widely used. There are significant checks and balances put in place before anything is ever used on a patient. Even once. Even in an emergency.

The goal behind this rigorous process is always to make one decision: “Do the risks outweigh the benefits?” To answer this, there are a myriad of considerations to weigh. Not just about the disease or injury being treated, but also about the highly variable humans by or on which a product would be used. By the time things are made available to healthcare practitioners, it is assumed that enough evidence has been gathered and made available that proper clinical judgments can be applied at the point of care by those who are qualified to make those critical life-and-death decisions. Things are expected to work as they are presented, with explicit exceptions that need to be clearly conveyed (i.e., contraindications). This is done for good reason: So medical practitioners can focus on effectively managing patients.

Viewed correctly, regulation is a guiding force for innovation—adding fuel to the fire for developers to “get it right” and consider all of the known variables. Like being guided by an expert physical trainer at the gym, the result is a stronger, more effective product. And you, or the patients in this case, are less likely to get hurt in the end.

Regulation is a balance of nuance

Regulation can be frustrating for any business. It causes delays, it costs money, it feels oppressive and clunky—and sometimes it is. Sometimes it’s even mishandled—but we’ll get to that.

However, in the long run, apart from saving lives, effective regulation saves time and money—in litigation, in recalls, in PR. Think about it this way: most regulations were put in place after something went horribly wrong. Building codes and room capacity limits are both perfect and tragic examples.

Thoughtful and strategic regulation keeps people and businesses safe by attempting to prevent problems before they happen, which is much more efficient long-term. We never see the problems and tragedy that doesn’t happen, and as such, have little appreciation for the regulation that prevented it.

At SPARK we’re no stranger to regulation. Sean Higgins, our Manager of Medical Devices, was part of the FDA’s 2014 CDRH Public Workshop on Additive Manufacturing for Medical Devices. His role was cautionary.

Part of their intent was determining how best to apply regulation for 3D printing to preemptively avoid mishaps—which if done in a reactionary manner, could lead to more strangling constraints. Sean is especially worried about that now, with people of varying degrees of experience (or complete inexperience), 3D printing impromptu devices in an attempt to help hospitals treating COVID-19 patients. In a recent post, Sean explains the dangers of 3D printing and reiterates that most medical devices must still meet specific criterion, if not be reviewed by the FDA before being put into use, even during this crisis. So don’t expect to solve any ventilator problems with your spool of ABS resin and parts from Home Depot.

If you’re curious about open-source ventilator design, these folks have completed some fairly in-depth research and rankings. However, they explicitly point out that such devices are unlikely to be used in the US without extensive testing.

On a positive note, there are some ways home 3D printers can help front-line workers without directly endangering anyone with untested medical device components. Take a look at this 3D-printed ear saver for the elastic bands on medical masks. Or this hands-free doorknob attachment.

For even further thought on Good Samaritan product development efforts, you can read our industrial designer Chris Murray’s take here.

When nuance is neglected and regulations clash

One example of poorly thought out regulation is the case of ethylene oxide (EtO), a gas used to sterilize medical equipment—including some types of sterile single-use PPE.

The ban started with a good-faith argument by the EPA: Cancer-causing ethylene oxide was found in too-high levels in residential areas near sterilization facilities.

Great, let’s fix it.

According to the FDA, at the time EtO was responsible for over 50% of medical device sterilization—but this made up less than 1% of total EtO use. The bulk of the chemical is used as an industrial agent for making plastics. But because sterilization facilities use the gas in relatively small quantities, they were overlooked, even with such a critical application.

In a misguided attempt to quickly solve the problem, some states enacted total bans of EtO sterilization—ordering closure of several plants toward the end of 2019. Elsewhere, state regulators were more thoughtful; rolling out temporary closures to allow for emissions upgrades. They shared the FDA’s concern about the diminished capacity for sterilizing medical devices made from fabrics, electronics, parts with convoluted or closed-off geometry, and other delicate instruments that can’t stand up to heat, steam, or gamma radiation methods.

A few months later, when COVID-19 hit and PPE and sterilization was suddenly in high demand—some facilities remain permanently closed. Regulation of the chemical was deemed necessary to protect people—but myopic, heavy-handed execution led to increased risk and danger in the current medical crisis.

For such an important resource, the EPA and FDA should have coordinated strategically to schedule emissions upgrades that wouldn’t risk crippling our national ability to safely and effectively produce sterilized medical equipment in a time of need.

Hindsight is 20/20

Nobody likes a Monday morning quarterback. We are, no doubt, making plenty of mistakes right now, and while some of that should be expected given the situation, it should be minimized as much as possible. The key is that we get enough things right to come out in the best condition possible as a people.

We can’t change what has already happened or what could have been. Let’s leave the finger pointing to politicians, lawyers, and media outlets, as there will be plenty of that to come. The focus needs to be on what meaningful things we do moving forward. That is all that will make a difference for the better.

The people courageous enough to make decisions in real time are doing so for the benefit of us all, and they are all doing the best they can with what they have. That includes medical professionals on the front lines, medical device developers and manufacturers, pharma big and small, and regulators alike. They all need our support right now more than ever.


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