By G. Wayne Moore, B.Sc., MBA, FASE
The floor of Congress is often fertile ground for well-intentioned but misguided legislation to be planted. The oft-repeated story of the nervous leader of a firing squad shouting out: “ready, fire, aim,” is a prime example of a sequence error that, unfortunately, is often repeated when bills are being written. In a moment of self-confession, House Speaker Nancy Pelosi once quipped: “We have to pass the bill so that you can find out what is in it.”
Well, I read the Critical Medical Infrastructure Right-to-Repair Act of 2020 and found that it falls into the legislative trap mentioned above. The bill was clearly written in a vacuum with no visible input from the medical equipment industry, or from other critical federal agencies such as the U.S. FDA and the U.S. Patent and Trademark Office (responsible for patent, trademark, copyright, trade secret, and enforcement policies). This bill should be called the “Don Quixote-Effect Act of 2020” as it is truly a “knight-errant” bit of legislation that mistakes windmills for dragons.
As pointed out in 24×7 editor Keri Forsythe-Stephens’ September Up Front column, this law would:
- Protect equipment owners, lessees, and servicers from liability under federal copyright law for creating an incidental copy of service materials or for breaking a digital lock during the course of equipment repair in response to COVID-19
- Allow equipment owners or lessees to fabricate patented parts on a non-commercial basis and as needed for repair or maintenance in response to COVID-19
- Invalidate provisions in equipment contracts to the extent that they prohibit or restrict the repair or maintenance of critical medical infrastructure in response to COVID-19
- Require manufacturers to provide, on fair and reasonable terms, access to information and tools used to diagnose problems and service, maintain, or repair equipment
Put another way, this law would:
- Destroy various general copyright laws.
- Destroy provisions of contract laws.
- Destroy patent laws.
- Destroy the Digital Millennium Copyright Act.
- Invalidate FDA regulations.
- Introduce adulterated products into interstate commerce.
- Throw the door on cybersecurity wide open to hackers.
- Invalidate certain equipment certifications, such as UL listing.
- Put patients at additional and unnecessary risk.
While we can all agree that a better relationship between medical device manufacturers and third-party service providers would benefit healthcare providers and patients—especially during these extraordinary times—having Congress trample on multiple laws of the land seems to me as a very poor way to get there.
With no regulatory or quality management restrictions on who can make demands from original equipment manufacturers (OEMs) and forcing OEMs, through this legislation, to provide service manuals, intellectual property, tools, proprietary test equipment, etc., the law may turn out to be a giant step backward for patient safety, facilitating less expensive and timely repairs, and fostering a better working relationship between OEMs and third-party service providers.
As a third-party service provider, I want to work together with OEMs to bring about a more mutually beneficial and healthy working environment—not try to use government force to compel them in a unilateral manner. I also strongly believe that third-party service providers must do their part as well by employing a well-vetted quality management system, specifically ISO 13485:2016 into their business.
We should also encourage the FDA to allow third parties to register as service providers, following all relevant provisions of the FDA quality systems requirements, such as filing Medical Device Reports when a patient injury or death is related to a service event. As responsible third-party service providers, this is our part in fostering better OEM relations and protecting patient safety.
Although the Critical Medical Infrastructure Right-to-Repair Act of 2020 is ostensibly only intended to be in effect during the pandemic, there is no reason to believe that it would not become a permanent law—and that is a scary proposition for any of us who have created and want to protect intellectual property; without that protection, medical device innovation will cease to exist.
Fortunately, this legislation, as it is currently written, is going nowhere—and that is its justly deserved fate. As a good friend of mine, who is the CEO of a large third-party service provider, put it: “Just forcing the release of manuals, software, and removing liability on everything via regulation is dangerous in this complicated industry.”
So, let us do the right thing and get back to the table of honest collaboration between the concerned parties and leave the heavy hand of government out of it.
Editor’s note: Do you agree or disagree with this assessment? Share your thoughts below.
G. Wayne Moore, B.Sc., MBA, FASE, is CEO of Acertara Acoustic Laboratories and 2020 Chair, Ultrasound Section—MITA/NEMA. Questions and comments can be directed to 24×7 Magazine chief editor Keri Forsythe-Stephens at email@example.com.