Why The Right to Repair is Essential | Mark Newell, Dir. Operations Support, Advocate Aurora Health

Feb 28, 2022


Tue, 2/22 9:27AM • 25:08


manufacturers, hospitals, patient, repair, equipment, service, provide, opponents, maintain, support, cost, timely, care, hear, state, owners, htm, staff, federal regulations, service provider


Chyrill Sandrini, Mark Newell


Chyrill Sandrini  00:15

Welcome to htm Insider. Again. My name is Chyrill with MultiMedical Systems. I’m your host, and today we have Mark Newell, which I’m excited to have you as a guest mark of Welcome to HTM Insider. Take a moment introduce yourself to everyone!


Mark Newell  00:33

Hi, everybody. My name is Mark Newell, I’m the Director of Operations Support for Advocate Aurora Health’s Healthcare Technology Management Program. I’m about a 30 year veteran of healthcare technology management. I spent my first about eight years as a technician directly. And indirectly, my leadership roles as I support my staff, I’ve done repairs and training on Equipment service up until probably the last two or three years.


Chyrill Sandrini  01:01

Oh, wow, quite a history, quite the long term experience that you have there, so it’s great to have you on and share your thoughts on right to repair and what’s going on in Illinois. So what is right to repair mean to you Mark and, and what’s going on in your neck of the woods? Well,


Mark Newell  01:19

for right to repair, to me, it means the ability to fix what we own. For hospitals, it means when we buy something, we can purchase any service manual software keys, or especially tools and technical training. So we can self maintain. It lets us provide redundancy and support options. You know, it’s us, the original equipment manufacturer, or both in tandem. It lets us be in control of our equipment replacement cycles. So we can continue to fix stuff and maintain it after the OEM discontinues their support and allows us more options for providing timely, affordable, safe patient care.


Chyrill Sandrini  02:00

Yeah, you know, I agree. And I, I want to ask you now about some struggles. So you know, I, I see it right, I see it from even the rural hospital aspect, even into a division that’s near and dear to my heart surgical services endoscope repair on the pressure from the OEMs to the independent service organizations. So can you share with us some of your struggles that are occurring in your facilities and in your in your area?


Mark Newell  02:30

Sure. I mean, from a high level, we’ve seen an increase in OEMs, not offering service manuals and technical training for new product with no options to purchase at any price. We’ve also seen it when manufacturers buy other manufacturers through Mergers Acquisitions, and they discontinue training for an existing product. Overall, this erodes our ability to be timely and cost effective and supportive our equipment, we steward the resources to ensure saving some services, say here to offset those other services there we offer as charity to those patients we serve. As of 2019, I think we did around 2 billion. And under uninsured charity type work for the community, we serve as a whole.


Chyrill Sandrini  03:18

Wow. Wow. And you find prices are just going up. And they’re attainable, especially in your situation from the OEM service contracts and


Mark Newell  03:36

the prices are going up when there are no when the manufacturer knows there are no options. And they will price things such that as an example. They’ll say it’s X amount per PM, you need four PMS a year. You do the math, those four PMS cost more than the whole full service agreement does. They do it to force you so it’s a guaranteed revenue stream


Chyrill Sandrini  04:04

Right it must be kind of frustrating, you know, and your position is trying to manage that budget and provide patient care.


Mark Newell  04:12

Yes, it is. When we looked at with patient care during COVID When it was really going course now it’s going again it was very pronounced initially mainly due to manufacturer staff being out sick, in some cases delays due to access to the equipment to the infection control processes put in place by manufacturers in the sites, you know there was parts availability, you know, and supply chain issues is a secondary problem you know, mainly due to warehouse staff, you know, for the order and shipping side and the factory people being sick. Nothing was being made, you know, outside of COVID. It’s generally been delays in service staff being available, I suspect to manufacturers tightening up their financial bottom line limiting staff in the region to provide service. And also very likely, with the typical challenges, same typical challenges hospitals face, you know, dealing with staff turnover, retirement and time off for family or illness.


Chyrill Sandrini  05:14

Right. We all understand, especially in this industry, there’s a shortage of qualified, experienced biomed techs, especially when you get to the higher imaging equipment, you know, ventilators, ultrasounds, I’m sure you guys are experiencing that same struggle as well. And how’s it affecting patient care?


Mark Newell  05:33

It affects it in that if there’s something we can’t get trained on, and we’re reliant upon only the OEM, it’s a delay. And some manufacturers, even with the full service contract can be 24 hours on site response. Some can be longer, we’ve seen 48 hour, we’ve seen manufacturer solutions, where they’ll come back and say, well, here’s what we can do, say if your demand customer, and it’s X amount of 1000s of dollars for an expedite fee, if you want to move to the front of the list to have somebody come out. That’s what it is. And if there’s no third party solution, and you can’t get trained, you are stuck in that situation of waiting for an OEM to show up when they have someone available. And it could be days. So you’re on bypass of the state, you’re not treating patients. You know, you’re deferring care,


Chyrill Sandrini  06:32

deferring care and lots of revenue, right?


Mark Newell  06:37

It’s loss of revenue. But first and foremost, it’s the patients that suffer, you know, somebody may have had a stroke, somebody had a heart attack, somebody needs to get something done before they can be, you know, be screened and pre approved to go in for another surgery to help them with a health condition. They can’t get it done. Because you’re waiting for service, or you have equipment down. Now you’re ORs are backed up. Because you’re waiting on the vendor to come out to service something which creates a whole other problem. Yes, yes. It’s not to be over the top, but it is it comes down to patient safety. Ultimately.


Chyrill Sandrini  07:18

No, no, I hear what you’re saying. Um, do you see or I can think of maybe if you had anything in the world to be what would be the solution that you would offer Mark to, to work in conjunction with the OEM, right? Pay patient care and patient safety? First and foremost, what would be a solution? Well,


Mark Newell  07:45

I think first off, I think the solution right now, it because of all the right repair legislation that’s out there being considered state and federal level, I think it’s important for legislatures to be shown the entire picture. So they’ll come to the realization that besides to federal regulations on the books for manufacturers and equipment for what they do, there are also state and federal regulations in place pertaining to the patient care providers, owners of the equipment. These regulations tie to CMS Conditions of Participation related to accreditation requirements, meeting licensing, to provide care and if applicable standards and codes around how things are maintained. That said, I believe there shouldn’t be a requirement for manufacturers to provide that technical literature training, especially software, etc, to the owners and service equipment. For a fair and reasonable cost. It can be as simple as using existing master service agreement master purchasing agreements in place in the industry, to help define fair and reasonable costs for equipment owners, it could be as a compromise to the manufacturers, it can be like a different approach with the independence, one price for the owner, one price for the input service provider, but to provide it. At the end of the day, I think, you know, something like this can allow the care providers who own the equipment to provide the timely care, you know, create more brand loyalty, because if something’s easier to fix, and less costly maintain, it tends to get purchased again, and allow the care providers to extend the life of their capital expenses by allowing them to maintain and operate electrically more effectively, and in turn, have more equipment available to provide quality, safe, timely care to the patients served.


Chyrill Sandrini  09:25

Yeah, no, I agree. I agree with you. Like if you can get it done, how do we sit down with those OEMs? How do we get how do we need an arbitrator do we need is this kind of like, you know, divorce court, we need somebody to arbitrate what’s going on here? How’s that gonna work? Well, there



have been some things set up nationally regarding between manufacturer and service providers, and that’s going slow my understanding some of the lobby groups did peel off from that, and hence why there’s it’s a two pronged at the state and federal level, you know, again for I would ask, you know, for like Congress, you know, take a look at the regs currently in place, you know, for the health care providers, because I think more rules on the device owners isn’t needed, I really think is against the awareness of what is already in place. What is needed to better serve the patient community overall as affordable, timely access to care by requiring manufacturers to provide support literature Training etc. at a fair and reasonable cost, that would help ensure that need to the patient community is being served as met and follows it again, it’s like a broken record is we just need to have access. I think I think there’s been several false flags raised, you know, around this stuff by the opponents to right to repair. You know, one is cybersecurity. And what’s interesting is, it’s the manufacturers that make the patches for cybersecurity, for their product to make them available. So if a hospital has internal service staff, to hospitals, not going to go forego installing a patch, you know, to protect its patients and its own operations. So there’s cybersecurity to me is a moot point, as long as the manufacturers are making it, that customers and owners are going to have it installed. It’d be foolish otherwise, you know, for fear of modifications, I’ve heard that from some of the opponents. You know, there’s federal regulations in place around medical equipment modifications, you know, now, if a hospital or service provider modified something to be out of compliance with the FDA regulations that stipulate all devices must be underneath FDA 510 K. There would be many legal problems, to say the least.


Chyrill Sandrini  11:43

For sure, I just don’t foresee that happening. I would have to say never is never. But I know this industry pretty well. And patient care, patient safety is top priority. And I never seen anyone try to shortcut any repair any PM process that could harm a patient. Right?


Mark Newell  12:07

Right. Right. Usually when something goes sideways, it’s a bad actor, not a bad company philosophy, per se. It’s that individual that they made a poor choice at that point in time.


Chyrill Sandrini  12:23

So in Illinois, are you guys looking at a vote currently? What does that look like? As far as like, hold on a ballot? Can you update us there?


Mark Newell  12:34

long story short, they’re making sure it’s a mutually agreeable bill that addresses the concerns of the customers, hospital owners, and the concerns of the manufacturers. Because I think really, a lot of this is compromise. You know, we don’t want it for free, to be fair, reasonable cost. But at the same time, we need to have access to a service manual or a schematic. You know, if there’s concerns around liabilities and intellectual property that can be addressed in a bill,


Chyrill Sandrini  13:11

right? I really believe it’s something that everybody’s learned to work together play better than the sandbox right together. Right? You know, and it’s unfortunate because it is affecting patients. And it’s putting strain on people like yourself, your staff, and, and your clients, which is your hospitals, your caregivers, your end users, or doctors or nurses. Unfortunately, this is a nationwide issue. And we keep hitting it state by state. I really wish there was a larger federal platform that would really grab all the states and work on it together as one initiative, instead of each state having a different plan. We’ve had a lot of we’ve had a lot of guests on from Binseng Wang, Perry Kerwin, Ben Scoggins, and everyone that I’ve heard from says patient care, patient cares first, right? I wish we can get the entire nation on the same platform. Let’s talk about patient care. Let’s not talk about all this other things that that will come in an agreement for Right.


Mark Newell  14:23

Right. Right. And that’s where the opponents hospitals are concerned with patient care because that’s what we do we take care of patients. Opponents will at times it feels like they’re trying to introduce fear into something and they will cite a number of X number of deaths and no number of deaths is acceptable of course. But what they sometimes omit to mention is that X number of occurrences occurred out of in the in the data time period. They say the FDA study somewhere over For a, I believe it was a billion clinical procedures nationally, between surgeries and X ray CTS, MRIs, injections, cancer treatments, l things that involve a piece of equipment. So, as a whole, the process has been working, which corresponds with when the FDA did their report. They didn’t see a smoking gun here, they didn’t see an issue on the side of the manufacturers or the maintainers. For them to jump in, right.


Chyrill Sandrini  15:36

So let’s just say the opponents so to speak, win this battle, right, everything’s in favor of what they’re proposing. What do you think that outcome? How would that look for your facilities,



I would predict we continue to see operating costs of equipment continue to rise, mainly due to being no options for the customers, no safety, no self maintaining no competition from independent service providers, etc. You know, this lack of competition, means the manufacturers essentially become a monopoly. And it also mean a have higher capital costs, do the manufacturers be able to dictate to us, you know, our replacement cycles, you know, to all the care providers and hospitals, you know, and this ultimately, the impact is on the consumers, both private and government. So, and this may be one of the takeaways here, I think, for legislators that if this doesn’t come to pass, is that, that for the government, Medicare, Medicaid, health care facilities operated county governments, military, hospitals, etc, they’re in the struggle to, you know, the government does have more options in the public does, you know, they can either cut services somewhere else offered by the government, or it can raise taxes, you know, on their constituents to cover the increased costs. Or it can just take off fixing the original source of the problem by supporting right to repair legislation.


Chyrill Sandrini  17:08

Right. Yeah, I hear exactly what you’re saying. This is a very important issue. You know, our listeners out there, our viewers, if you guys want to weigh in, you know, I think the more that we become aware as a clinical engineering community, and you know, speak up, voices do matter, votes do count, and especially in something that is critical as this. So if you could talk to the beam that’s out there in your neck of the woods, what would you want them to do? What do you want them to call their legislator? Like? How could they get involved because this directly affects them.



So my words to the field are for all the HTMs  out there working for hospitals and clinics is the the work of their government liaison departments within their facilities. Because those people know the right people to get in front of the right to reach out to regarding helping raising awareness. They can use the social media through LinkedIn, they can look at the alliance that was set up with TRYMEDX, Crothall, Sodexo, ABM, etc. and point to all these other supporting documents, etc. To help show if you don’t have the right to repair hospital, your costs are going to go up this and what they come to the table, you have their administrators locally, your costs are going to go up, you’re going to have to wait for equipment to be fixed, which means the patients suffer for having access to affordable care. Yeah,


Chyrill Sandrini  18:41

I agree. You know, I think if we had more patients aware of what’s going on. Right. And the lawmakers, people that make these decisions can be patients themselves, right?


Mark Newell  18:56

Yes, yes. And they’re also ultimately, besides medical, I mean, this, of course, automotive industry went down this path. They’re doing it right now, you know, for cell phones and appliances and everything else. But the concept of right to repair it affects where you take your car to get your oil change where you buy your tires. You know, if you have to get your refrigerator fixed, you know, what are you paying for it to get that repair all of this ties together with competition. And that ties into what the FTC did as well for their paper they put out about helping support competition.


Chyrill Sandrini  19:32

Right and it is it’s the dollar right? It’s dollar people’s pocket because when the hospital’s paying more the dealership is paying more John Deere tractors paying more, whatever it is, from that that cost perspective. It’s if the price goes up to the consumer, the customer.


Mark Newell  19:53

Yeah, it’s a food chain. It’s a food chain. Because they say a hospital cost goes up. You know, first and foremost always be emphasizing on the safety and access to timely access to care costs go up? Yes, I suppose you have to make decisions internally, they’re a business, they have to make decisions. You know, are we doing raises this year? Are we doing hiring, you know, refilling positions? are we offering this to these underserved communities, you know, uninsured communities to provide care? It costs money to do it.


Chyrill Sandrini  20:26

Yep. I mean, if you own something, you should have the right to repair it, have the manuals, the service, you should have that available to you. You bought it? You buy?


Mark Newell  20:38

Right. That’s where I have seen some products in industries, where they’ve they’ve shifted to a s APS or software as a service model. You don’t truly own things. And it’s kind of like our phones used to be, you know, you just sign a phone plan to give you a phone. You’re always paying you’re 3040 50 100 bucks a month. Yeah, you know, indefinitely. And that’s where I think I’ve seen some manufacturers do that, too, for the equipment where you, if you don’t take a contract, they’re not going to come out. I’ve had one one manufacturer make a statement to that effect.


Chyrill Sandrini  21:24

Yeah. And I really feel for the smaller hospitals have smaller health care systems throughout the United States, because they don’t have the buying power or the negotiation power that you do.


Mark Newell  21:33

Correct. And that’s, yeah, and there’s many small hospitals serving millions of patients, you know, can this rural hospital, operate one CT scanner? Well, if they can use get trained, absorb some of the risk or use a third party, alternate provider, now they can maybe cut some of their costs in half. Now, they can technically afford to maybe run two machines, without having to severely compromise on something else in the services they offer to their patient community.


Chyrill Sandrini  22:03

I agree, I really believe two misses this something that I believe even to a cell phone is sustainability. And you should have the right to maintain that sustainable equipment, if it’s working to provide that care, well, you don’t have the funds to purchase brand new,


Mark Newell  22:23

right? If the device is still deemed clinically viable for providing safe quality patient care, if the device can be put back into operate, you know, original manufacturer’s specifications, you should be able to maintain it, you know, buy what you need to buy.


Chyrill Sandrini  22:43

So we’re coming to the end of our podcast today, Mark, and something we’d like to close with is your Wow word, your Word of Wisdom, around right to repair give me a few words, I know it’s a lot to put you on the spot. But maybe you can give something that, you know, is something that people can think about when they think about right to repair,


Mark Newell  23:04

ultimately exempted from my my perspective, it’s about safety, because I mentioned earlier, and I’ve been doing this for roughly 30 years. And besides that, I’m a father of five, one of my kids was born 11 weeks early. And so I look at all their life support equipment, my child was on. Same equipment when I was a tech, I used to fix myself. So I you know, I know that focus, these people are working on it. I’m comfortable. It’s safety, but for the legislature’s and hospital administration, administrators, it’s awareness that, you know, you can request this is something you don’t just settle for the status quo. You have the wallet, you can ask


Chyrill Sandrini  23:54

I like that. I like that. I mean, as we all know, we always ask the worst thing they could say is no. Right?


Mark Newell  24:03

And if another manufacturer comes out with a competing product, he says, Oh, I’ll do that. Guess where the business goes?


Chyrill Sandrini  24:10

Yeah. I really appreciate your view on patient safety, the right to repair, you know, calling to action, the awareness. And I think that’s really important. We’re really appreciate your time. You know, I’d like to follow up with you in a few months and see how things are going and see how things worked out there and you’re in your home state. I wish you the best of luck. And again, thank you for joining us on htm Insider. Thank you. htm insider listeners. Follow us on your favorite podcast locations including iTunes Spotify, and we look forward to hearing your comments and your input. Thank you again and have a great day.