AEMT pdf - NREMT Advanced Emergency Medical Technician Updated: 2023

EMTs (Emergency Medical Technicians) and paramedics are the real-life superheroes who rush to our aid in times of medical emergencies. They are highly trained professionals dedicated to saving lives. In this article, we'll share valuable insights from our team about common misconceptions and questions they often encounter.

1. Lights and sirens on an ambulance means pull over and STOP!

When you see an ambulance approaching with lights and sirens, remain calm and pull over to the right side of the road as soon as it is safe to do so. Clearing the way allows EMTs and Paramedics to reach their destination quickly and provide critical care to those in need. Keep in mind, occasionally an ambulance and a smaller paramedic vehicle may travel together, so be sure to yield to both.

2. Understanding the difference between EMTs and Paramedics

EMTs and paramedics both provide emergency medical care, but they differ in terms of training and scope of practice.

EMT:

Basic level of training in emergency medical care.

Can assess patients, provide basic life support, and administer some medications.

Typically provide immediate medical assistance, stabilize patients, and transport them to a hospital for further treatment.

Paramedic:

Advanced level of training in emergency medical care.

Can perform more advanced medical procedures such as administering medications, interpreting electrocardiograms (ECGs), and providing advanced life support.

Work with ER doctors to perform advanced medical procedures outside of the hospital and bring the ER to you.

3. Ambulances are not taxis

Using ambulances solely for medical emergencies is crucial to ensure that those in life-threatening situations receive prompt and specialized care. By reserving ambulances for genuine emergencies, we prevent unnecessary strain on emergency medical services, allowing them to efficiently respond to critical situations where every second counts.

4. Several factors are considered when deciding which hospital you go to!

Including:

Do you have a preferred hospital?

Do you need a trauma center?

Do you need a stroke center?

Do you need a cath lab?

Do you need a pediatric specialty doctor?

Do you need special mental health services?

5. What is the difference between the two EMS vehicles you see on the road?

911 Ambulance:

This unit is operated by 2 EMTs and has all of the equipment needed to transport you to the hospital. 

Paramedic Unit:

This unit is operated by 2 Paramedics. These units carry advanced life support equipment and medicines that bring the emergency room to you.  

6. How do I know if I need a paramedic or EMT?

When you call 9-1-1, our dispatchers are expertly trained to ask the right questions, provide instructions and make sure the right resources arrive quickly.

To wrap it up, let's take a moment to appreciate the incredible work of EMTs and paramedics and gain some valuable insights into their world. These real-life heroes go above and beyond to provide emergency medical care when we need it most. By understanding the challenges they face and recognizing the life-saving impact of their work, we can show our support and gratitude for these amazing individuals who stand ready to make a difference in our lives every single day.

Next Steps & Resources:

Learn more about our Emergency Care services.

To make an appointment with a physician near you, call 800-822-8905 or visit our website.

The material provided through HealthU is intended to be used as general information only and should not replace the advice of your physician. Always consult your physician for individual care.

© Provided by TAPinto

After graduating from the Rochester Institute of Technology in 2020, Cassy Smithies took a job at Epic Systems, joining thousands of other young brainiacs who work for the hugely successful medical software company in Verona. Her job, in a nutshell, was to make Epic software more intuitive and less head-scratching for patients and medical staff alike.

“The job had its good parts,” she says, including the interplay with her team colleagues. But Smithies found the long hours grueling, work expectations unrealistic, and there was a continuing sexism issue she saw with some male leaders. (Epic declined to be interviewed for this article and offered written comment on only select questions, as noted.) 

Smithies quit Epic after a two-year tour as a “user experience designer.”

“It became pretty obvious that another opportunity would be a better fit for me,” she says, acknowledging Epic tried to convince her to stay. Today, Smithies remains in Madison and is a senior product designer for Fetch, a rising consumer rewards company.

“I would have absolutely loved to stay in healthcare,” Smithies says, sounding a note of regret. “That was important to me. When I graduated college that was my goal.”

But Smithies couldn’t continue in her chosen field. When she joined Epic, she, like all employees, was required to sign a noncompete agreement. It effectively blocked her from working in healthcare for one year upon leaving the company. 

Critics say these stipulations needlessly constrain Epic expats from earning a living and seriously retard what should be the centerpiece of the Madison area economic strategy: the growth of health-information technology firms spurred by Epic’s extraordinary success.

Indeed, Epic’s restraints are so expansive they could be swept away by a controversial Federal Trade Commission proposal to outright abolish noncompete and similar restrictive employment clauses.

Describing them as “a widespread and often exploitative practice that suppresses wages, hampers innovation, and blocks entrepreneurs from starting new businesses,” the FTC asserts that ending noncompetes could increase wages by nearly $300 billion a year and boost career opportunities for around 30 million Americans.

In Epic’s case, Isthmus reviewed company documents from 2021 that showed former employees in their noncompete periods are barred from taking jobs at roughly 4,500 firms that have business ties to Epic, its customers, its partners or its competitors. 

The verboten list includes giant health systems and physician groups, major health insurers, a plethora of billing services, health consultants of all sorts, not to mention seeming oddities like Little Rock Ambulance, the YWCA of Southeastern Massachusetts and the Buffalo Urban League (click here to get a PDF of the list). 

All were off-limits for former Epic employees after their departure from the Epic mothership. When asked about this, the company was non-responsive in a written reply: “Our agreements say that after employees leave Epic, they can work anywhere they wish as long as, for a certain period of time, the work they’re doing doesn’t involve Epic software.”

While the 4,500 number was higher than what a half-dozen Madison-area tech executives and Epic veterans guessed, nobody was surprised at the existence of what several called “the blacklist” of companies where former Epic employees are barred from working in their noncompete period.

Surviving the noncompete restrictions has long been a rite of passage for Epic expats. They joke about taking their “gap year” as if they were delaying college for 12 months to work in a bike shop or to bum around Europe. But that’s no longer a good comparison. Some former employees, including Epic stock owners, can now be blocked for as long as two years from working in healthcare.

Aris Blevins, who worked almost seven years at Epic, points to not just the noncompete clause but also what he calls the “all efforts’’ pledge Epic requires of new hires: “that you will devote your full business and professional time and energies to Epic and will neither accept nor conduct any other business or professional activities.…” In other words, no part-time or outside work, including no teaching. (The clause goes on to say no overtime will be paid either because the company says salaries are designed to compensate for overtime.)

“Between the noncompete and all-efforts clauses, Epic makes it basically impossible for people to launch a healthcare startup,” Blevins says. “I’m sure Madison would prefer it if Epic were more like Microsoft in Seattle.” He explains that “literally hundreds of startups have been founded by former Microsoft employees who know how to integrate with Microsoft and build businesses on top of its technology.

“You don’t see that around here, and there’s a reason: Epic,” Blevins says.

As for Epic’s take on things, it firmly lays out its position in its employment agreements with new hires. Because the company is engaged in a “highly competitive business,” Epic says it needs to take steps to protect its intellectual property and trade secrets. And because it “expends substantial time, money and effort” in schooling new employees who develop “relationships” with Epic customers and consultants, the company says it needs to protect its interests by enforcing a noncompete policy when staffers depart.

Epic founder Judy Faulkner, who launched the company in 1979 with 1.5 employees, built her software company slowly, deliberately and by accretion. And conspicuously without meddlesome outside investors providing capital.

Epic’s revenue hit $1 million in 1985, $50 million 15 years later, and jumped to $502 million in 2007. All along Epic’s highly rated medical software program systematically built out to include patient scheduling, billing, clinical notes, the MyChart patient portal, the Hyperspace login for users, and much more in an integrated package that customers increasingly demanded. 

The Epic workforce — a mere 29 in 1990, 400 10 years later — soared to 3,000 in 2008. Total employment now numbers around 12,500, with 11,000 at the sprawling campus in Verona. A recently announced expansion will add 1,700 jobs in 2023 and a new round of office construction.

What fuels Epic’s growth? Clearly the superiority of the Epic software package is a huge advantage. But the company was also in the right place at the right time with the right product.  In 2009, when the Obama administration opened the spigots of federal funding for electronic health records, Epic already had 30 years of EHR experience under its belt.

An eventual $35 billion flowed to hospitals and clinics to subsidize their transition from paper to electronic health records. This supercharged EHR installation as promised, says one Epic watcher, but Epic’s lockdown of former employees simultaneously created a shortage of skilled workers to run the systems once they’re installed.

 “Epic cannot do it on its own,” he says. Nor can the hospitals and clinics. Even Epic has grudgingly accepted this state of affairs by allowing hospitals and physician practices to contract with outside consultancies (albeit Epic-certified) like Nordic, HCI Group, Tegria (Bluetree) and others that specialize in optimizing Epic software once it’s installed. Epic also has an in-house consultancy called Boost.

The irony is that the non-Epic consultancies actually strengthen Epic’s hand in controlling wayward staffers. That’s because Epic requires the consulting group to sign an operating agreement that incorporates Epic’s noncompete requirements. In short, former Epic employees can’t begin their consulting career until their noncompetes expire.

The same dynamic plays out if Epic’s medical and clinic customers want to hire former Epic employees to pilot their health record systems once they’re up and running. Ain’t happening. Their contract with Epic bars them from doing that until the expats’ noncompete periods have passed.

If you’re keeping score, that’s three different ways that former employees are handcuffed in legal zip ties. Even Epic’s modest app marketplace has become a tool to control their job prospects. According to a former Epic employee, third-party medical app developers can’t sell through Epic unless they, too, agree to not hire anyone from Epic still in their noncompete periods.

Clearly, Epic has constructed a mighty legal edifice to protect its interests. Blevins can testify to its power. He took a job with Gundersen Health System in western Wisconsin last summer. He says both he and Gundersen felt his role was so different from his Epic work that it wouldn’t run afoul of the noncompete issue. But five weeks on the job he says Gundersen cut him loose when Epic objected.

Gundersen, which merged with Bellin Health Systems in December, did not respond to interview requests. Epic says while it would notify a customer of a contract violation it would not instruct the customer to fire the offender.

Blevins, who wanted to stay in healthcare, now finds himself working for a video-technology company, Sonic Foundry, in Madison. He and his former Epic colleague Cassy Smithies are the rare Madison techies who will speak on the record about flaws they see in Epic’s operation.

That anonymous techy quoted on federal funding would only talk about Epic if he was not named. It’s a familiar story. Industry people who follow Faulkner’s work are almost always effusive in their praise of Epic’s success, but they also fear reprisal should the company conclude they’re not playing by the Epic rulebook.

“We know Epic has the money, the time and the power to make our lives miserable if they want,” says another tech industry insider.

 That’s “miserable” as in being on the wrong end of bullying phone calls and “cease and desist” letters from Epic. The sort of things that can ruin an entrepreneur’s day, as he or she ponders the hard reality of what it would mean to be kicked out of the Epic ecosystem. 

It’s not just that former employees are expected to honor their noncompete promises, everybody who contracts with Epic or its customers is expected to steer clear of noncompliant expats. Those 4,500 or so companies make up the so-called blacklist.

The consultancies, for example, are especially vulnerable to Epic pressure. If they hire a noncompliant expat, they risk being barred from the Epic user network. And if they are barred from the user network, they can’t tweak software they can’t access.

The power dynamic with the 250-plus health systems that contract for Epic software is a bit different. They pay a ton of money for software licensing and ongoing maintenance upgrades. They would love to hire bright young Epic technicians to run their software once it’s installed…but not at the expense of angering Epic.

“These clients will adhere to Epic’s restrictions on who they can hire and when,” says another industry observer: “Why would they want to get in a pissing match with their software vendor after they just invested a $100 million or more with them?”

Leaving the mothership and dealing with the noncompete can prompt an outright existential crisis for departing Epic employees. What will I do with my life?

“You’re either forced out of the EHR industry and have to start over in a new field or you’re punished if you want to continue in it” (by having to sit out the one or two year noncompete), says Epic expat Tim Lopez, who left the company because he felt he and Epic no longer shared the same values.

Lopez eventually found a good job in Milwaukee healthcare, but it took him 33 months to get there. “This is one reason why the electronic medical record industry sucks,” he says.

Other Epic expats are irked at the lost money and lost freedom they say they suffered by the limits placed on their job mobility. The consultancy jobs are highly attractive for exactly those reasons. They pay substantially more than Epic. They’re usually premised on a normal 40-hour work week, while Epic software installers might rack up 60 hours a week during a high-pressure installation. Consultants can also pick their own projects. And they can work remotely, which Epic does not allow except for Boost staff. (Faulkner believes Epic’s distinct culture is reinforced by having the team working together in Verona.)

The remote-work prohibition can seem particularly onerous at a time when working at home is so pervasive in the workforce. As one Epic veteran recounts, it was the sole reason he quit. He and his wife have several children and wanted to raise them closer to their faraway grandparents.

He thought he found an acceptable job with a major health system, but he says the Epic human resources department felt some of his job responsibilities would overlap with what he was doing at Epic. “It was really just up to them alone to decide,” he recalls. In the end, he just quit, found another healthcare job close to the grandparents — and did what other former employees do in that situation: Go silent on social media in hope that Epic doesn’t track his whereabouts until his noncompete period passes.

Another Epic veteran, who had soured on the company when it tried to force employees back to the campus during the early days of the pandemic, found a legal loophole to remain in health tech while working in Madison. He recalls the first time he created an external account on the Epic user network: There was an immediate hit on his LinkedIn account from Epic. “My name was flagged instantly for a manual review of my Epic status.”

The fact he wiggled through a crack in the noncompete edifice doesn’t change his opinion of how dysfunctional it is for so many of his colleagues. They can’t easily find a new job where their expertise is relevant: namely as an Epic software consultant or a direct hire by a health system using Epic software.

“Epic seems really focused on the idea of ‘the golden handcuffs,’” he says. “That it’s going to be really expensive for you to leave Epic. That you will have to find a job for a year or two that may not play to your workplace strengths. That you will probably make less money than if you had stayed.”

He pauses for a moment then makes a point that all thoughtful critics of noncompetes make: “If they only work at Epic because they’re scared of leaving, that’s not good for anyone.”

Despite all the hoopla, there is no telling when the Federal Trade Commission will finish its review. Roughly 20,000 comments were submitted for consideration in the proposed rule-making (see page 22). 

Years may pass before the FTC takes a final vote. Steph Tai, a University of Wisconsin Law School professor, predicts if a new rule is finally adopted, “there’s almost a 100% chance it will be challenged in court.”

It’s no surprise that a noncompete ban would touch off a lengthy political donnybrook. FTC chair Lina Khan, who is young, progressive and strongly committed to antitrust enforcement, infuriates many Republicans for just those reasons. 

Her announcement that the FTC would target noncompetes quickly drew opposition from business interests, including the U.S. Chamber of Commerce and its affiliate, Wisconsin Manufacturers & Commerce. Opponents make both a jurisdictional argument (noncompetes are a state and not federal matter) and a practical one.

This is the belief that noncompetes are needed to protect trade secrets and client lists, which is very much Epic’s thinking. Another problem to be addressed, as WMC President Kurt Bauer put it in a letter to the FTC: Why would an employer pay for skills-based training and reimburse workers for tuition if “the employer could no longer expect the employee to stay with the company for any duration?” Workers and bosses, in other words, would both be losers if noncompete stipulations were cast out, according to Bauer.

The history of Silicon Valley teaches a very different lesson. 

Begin with the fact that California outright bans enforcement of noncompete clauses of the sort that Epic believes is integral to its economic success. Then consider the rich legacy of one of the most celebrated breakout moments in American technology. This was the 1957 walkout of the “traitorous eight” engineers — as their fuming boss at Shockley Semiconductor Laboratory described them. They launched Fairchild Semiconductor Corp. as a direct challenge to the mercurial Nobel Prize winner William Shockley’s semiconductor company.

The number of startups traced to Fairchild’s eight founders is simply staggering. Upwards of 2,000 companies are identified, many of them (one assumes) disappearing beneath the waves. The same research published by Tech Crunch in 2014 found that 92 of 130-plus large publicly traded companies in the San Francisco Bay area had Fairchild roots. Their aggregate value? More than $2 trillion. Total employment? More than 800,000 people.

“Every time we came up with a new idea, we spawned two or three companies trying to exploit it,” legendary Fairchild cofounder Gordon Moore told the researchers.

This is very much not the Epic style, and it’s why some Madison notables think it’s in Epic’s own best interests — as well as the community’s best interests — to rethink its strategy. 

Joseph Dahari, who runs the coworking space 100state, whose members include many former Epic employees waiting out their noncompetes, says their timeout “prevents them from exercising their intellectual capital and their industry-specific knowledge.”

While Dahari feels it’s wrong to villainize Epic for doing what is common in the business world, he is puzzled why Epic doesn’t craft its story to include the great companies — Redox, Nordic and Carex, among others — that grew up around Epic.

Faulkner doesn’t seem to recognize that “a rising tide lifts all ships,” says Dahari.

Tom Erickson, director of UW-Madison’s School of Computer, Data and Information Sciences (and a veteran of the Boston tech scene), says Epic can protect its intellectual property without tying the staff up in suffocating legal restraints. Tailored nondisclosure agreements are one alternative. Both he and Tai cite other legal tools to protect proprietary information, while allowing bright young staffers to move on to new jobs or start their own enterprises.

“Innovation is stymied by noncompetes,” says Erickson. They block people with bright ideas from pursuing them “even if it’s not clear if the new company would be competitive or complementary to the older one.”

Tai suggests a ban on noncompetes might even benefit Epic, because it would open the door to places where Epic employees want to work — usually health tech, service, and care organizations. “Having the ability to hire Epic-trained employees in those positions might actually make those various organization more likely to adopt Epic software,” says Tai.

Mark Bakken, a serial entrepreneur (he co-founded Nordic) turned venture capital investor in health startups, sees room for compromise on noncompetes. “I’ve been on both sides,” he says. “It sucks when you invest a ton of money in employees, train them, pay them well — and somebody else waltzes in and says: ‘Now that you’re experienced, I can pay you slightly more than the company that got you here.”

Bakken pauses and switches gears: “At the same time, it’s like, ‘Hey, it’s a free country. This is what America is built on, right?’ Personal initiative.”

Bakken’s conclusion? “I think a six-month noncompete seems appropriate.”

Erickson is more unequivocal about freeing employees from the restraints of noncompete contracts. “Individuals need to be able to choose where they want to work,” he says. This includes tapping their own hard-earned knowledge to start their own business.

Noncompetes supply corporations “massive leverage” to block such enterprising individuals, Erickson argues. The new business never launches because the creators fear getting sued into submission.

Erickson, who ran a large cloud platform service in Boston, says the city’s software industry boomed in part because Lotus, the big dog on the software scene in the 1980s, never tried to choke off the startups that sprouted around it.

In 2014, Erickson took to the pages of The Boston Globe to support a plan to make noncompetes unenforceable in Massachusetts. He argued they made it harder “to spin off great ideas into new companies” and functioned as cooling-off periods “where great ideas slowly burn out.” This was preventing the Massachusetts tech scene from reaching its full potential as a tech center, he warned. 

The same warning, it seems, may well apply to Madison and Epic.

[See “Broad overreach” for excerpts of comments on Epic’s noncompete agreements submitted to the Federal Trade Commission by former and current employees.]

A hundred Baltimore City Fire Department employees are called back to work overtime each day because of the agency’s staffing crisis, fire officials said at a Board of Fire Commissioners meeting this month.

Those employees are often firefighters asked to man shifts as paramedics or emergency medical technicians, positions that have been beset by vacancies for years. More than 60 of the department’s 380 emergency medical service jobs are unfilled, leaving nearly a 16% vacancy rate in one of the country’s busiest fire agencies per capita, department leaders said Tuesday during the first day of city budget hearings.

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That vacancy rates increases to 32% when factoring out administrative positions, fire union officials said. The 61 vacancies are mostly paramedic positions that require extra schooling to provide advanced life support.

“It’s no secret we have a huge workload. One of the highest, one of the biggest on the East Coast, and our neighbors are starting to face the same shortage as far as paramedics leaving for other jurisdictions for more money and less work,” Acting Fire Chief Dante Stewart told City Council members in a 2 1/2-hour hearing.

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On one Saturday in May, eight fire engines had to close because of staffing issues caused by people taking vacation time, officials said at the exact Board of Fire Commissioners meeting.

Mayor Brandon Scott’s $4.4 billion budget proposal includes a $15.4 million increase in fire department spending to $332.9 million for the fiscal year starting July 1, in part to create more positions that will need to be filled.

The City Council, which for the first time in over a century has the power to reallocate funds, will consider the spending plans over the next month.

The fire department’s proposal adds about two dozen emergency medical service positions to the agency’s staff of 1,760, which has an overall 12% vacancy rate. Stewart said the department is working on attracting new hires, in part by incentivizing EMTs to further their education to become paramedics. And multiple recruiting classes are being trained through the fire academy.

Four of the new positions are “community paramedics” who would help reduce the city’s demanding call volume by reaching out to residents and connecting them with resources instead of making repeated trips to the hospital, said James Matz, assistant chief of the department’s emergency medical services. That outreach effort could include helping a resident with an opiate issue or linking someone without transportation to medical care.

Ambulances respond to over 525 incidents each day in the city and about half of them result in a hospital trip, Matz said in a previous City Council hearing this month. About 33,000 calls per year are low acuity, meaning that they need minimal care. The toll strains both personnel and the department’s aging fleet of firetrucks and engines, which can cost more than $1 million each.

“We’ve got to stop taking people to the hospital, into the emergency room every day,” Matz said.

Community paramedics would attend to residents who habitually call for an ambulance.

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“From Jan. 1 to March 31, six people accounted for 170 responses. Just six people alone,” he said.

During the first three months of the year, COVID-19 expenditures and the fire department’s dependence on overtime created a $32.2 million deficit. The department spent $17.4 million on overtime to cover vacant positions, a 70% increase over the same period last year.

Each emergency response costs roughly $1,500 to $1,800, which is billed to the patient’s insurance, Matz said. The department has generated significant revenue through federal reimbursements for transporting patients who are eligible for Medicaid. An anticipated $40 million is expected from the program during the next fiscal year.

The mayor’s spending plan for the department also sets aside funds to create four safety officer positions recommended in an investigatory report that revealed operational and accountability issues in the agency after three firefighters died in a vacant rowhouse fire in January 2022.

Safety officers have administrative duties and are in charge of safety tactics at fire scenes, such as when to pull out of a burning house. Now two officers on each shift will respond to a scene, rather than one.

The investigative report also recommended the department create aides for battalion chiefs to help the commanders make decisions during hectic fires. Battalion technicians and safety officers are both roles recommended by the National Fire Protection Association but have not been implemented in Baltimore.

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Permanent battalion technicians were not included in the Scott’s budget proposal. A pilot program will continue to run in the meantime, staffed by officers working overtime.

The council’s budget hearings will continue through June 6. A final budget must be approved by June 26.

SOFTWARE

Medical devices have to be designed so that people can use them easily and reliably. Human factors considerations have gained increased attention since the release of FDA's guidance document, Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management, in July 2000. This document, and a 1996 FDA document, Do It by Design—An Introduction to Human Factors in Medical Devices, both supply useful guidance-level information but are not recipes for successful engineering of human factors considerations. The documents also supply many examples of the things that can go wrong with human factors in medical devices.

Human factors engineering must be considered in the industrial, mechanical, electrical, electronic, and software design of a medical device. This article only examines how human factors considerations should be handled during the gathering, maintenance, and validation of requirements for medical device user interfaces that are implemented in software. It won't provide tips on how to make devices easier to use, but it will lay out a methodology for incorporating, tracking, and documenting human factors throughout the development process.

For medical device software professionals, including developers and software validation engineers, it should be evident that there is a relationship between validation and human factors engineering (HFE). FDA defines validation in the General Principles of Software Validation (2002) as “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.” Clearly, the human factors studies, tests, and design recommendations are focused on only one thing: user needs and intended uses. How those needs and intended uses are gathered, documented, and communicated are the focus of this article. Verification that those requirements can be “consistently fulfilled” also relies on having adequate requirements that are effectively communicated to the verification team. This too is addressed in this article.

A Brief Primer on Human Factors

Step one in human factors engineering is determining the humans for whom the device is designed. Who are the people who will actually interact with the device? The list might include patients, patient family members (home treatment), doctors, technicians, nurses, and service personnel. It may even include production personnel who might deal with human factors issues associated with the assembly, packaging, and transport of the device.

From a regulatory point of view, it might first appear that FDA is only concerned with human factors designs that promote safety and efficacy for the patient. However, care providers may be just as confused by a poorly conceived human factors design, which could lead to errors and unintentional actions and compromise safety and efficacy. The same logic applies to other potential device users.

Human Factors and Software

Human factors engineering as a discipline concerns itself with the study of how users employ and respond to a device. HFE leverages this information to optimize the user experience. HFE in medical devices is somewhat different from that in other industries in one important way: The optimum and preferred designs for a device are not necessarily the safest designs. HFE for medical devices needs to balance the need for safe and accurate use with the desire for efficiency, attractiveness, size, cost, and other user preferences.

Software designers need to understand human factors engineering considerations when planning the software for a medical device. Unfortunately, software engineers are not always the best at human factors engineering. To deal with this, device firms can develop specific user interface requirements.

Developing User Interface Requirements—If They Are Required

It is evident from the few competing considerations mentioned above that many stakeholders, including users, should have an input into the development of requirements for a device's user interface. But the right user interface design is not often obvious at the beginning of a project. Besides human factors, many needs must be considered. Lawyers may have opinions about intellectual property territories or protected trade names that must be avoided. Marketing personnel may have an opinion about what sells. Clinical certified can provide opinions on terminologies and workflows that are common and well understood in the care environment. Users may be concerned about confusion if other devices have radically different interfaces. Human factors engineers can capture some, but not all, of this information.

For example, HFE professionals understand the users of a device well enough to optimally design the arrangement of information on a display so that it is intuitive to use. These engineers also have the expertise to design user navigation through the interface so that it seems natural and requires only minimal training and documentation.

However, these experts may not be aware of whether a competitor owns patents on certain aspects of a user interface design. They may not have insight into how prior generations of a device may affect next-generation designs. For these reasons, user interface design requires a delicate balance of legacy and improved elements. Too much change will confuse legacy customers who buy new devices. Too little change will create a perception of design stagnancy and can create market problems. No single person, whether a human factors engineer, software engineer, or product manager, is likely to have insight into all disciplines that will have influence on the new product's human factors design.

Many companies take on the human factors design with available resources; others contract with HFE experts to guide them through the process. It is also common for software developers to take on the task of user interface design and development alone. They often argue that the user interface is part of software design and should not be considered a set of requirements. The rationale most often given is that the developers do not want to be prevented from making needed late life cycle changes to the user interface. Embedding the user interface in requirements constrains the developers' ability to make changes quickly and often.

For example, developers often want control over the real wording of the text that is static on a display. Or they may want control over the wording in alarms, alerts, or error messages. Oftentimes the reason for this is that developers want or need to adjust the text strings to fit available space. In addition, they want the freedom to define the text for error codes because these codes are needed during the design and development phases of the code. Anyone who has encountered an error message similar to “Error 0A2E–Page zero violation at x002567a8H” has experienced a portion of the user interface that was controlled by the software developer. It is loaded with information that is of value to a software developer, but it means little to the device user. It conveys no information on the situation's level of danger or what steps to take for correction.

A major reason for having design controls is to limit late life cycle changes made without the knowledge of the development process stakeholders. If one accepts the view of FDA that human factors, which include user interface design, are important to the safe operation of a medical device, then it is difficult to defend software developers' argument that user interface details should not be considered requirements.

Even from a business perspective, it makes good sense to treat the software user interface as a set of well-controlled requirements. User interface design is part science, part art, and part emotion. Getting consensus on a design is time-consuming and therefore expensive, regardless of whether the requirements are defined by outside consultants or in-house teams. Preserving the investment in the collection of those inputs and controlling changes that deviate from those opinions are necessary steps to protect the investment and to reduce the likelihood of having to rework a design that doesn't meet stakeholder expectations.

Communicating and Documenting User Interface Requirements

Regardless of how the requirements are gathered, the team members must communicate with each other to understand user interface design proposals and inputs from the stakeholders in the process. The medium and language used to communicate these requirements can be problematic.

Development and verification test engineers want to see detailed requirements. Developers want the details so they don't need to fill in requirements as part of the design and implementation process, guessing what the various stakeholders want. Verification testers want the details that will help them design test protocols without guessing about how the features of the user interface will be implemented.

The question of how much detail to put in requirements is a source of much debate. However, the following items, as a minimum, should be considered for specifying a user interface:

• Size, placement, and color scheme of the display or subdisplay area.
• Font, font size, and font color.
• Exact text to be displayed and any formatting that is critical.
• Navigation to and from the display element.
• Details of any user inputs that are activated or deactivated in that display mode.
• Details of any animations or live (updated in real time) data values on the display (e.g., “The heart rate display shall be updated once per second to show the instantaneous heart rate as of the most exact interpulse interval” or “The pump shall indicate that the timed delivery is active by displaying a stopwatch icon whose hand rotates 90 degrees every second”).
• Any underlying functionality that may cause changes to the display mode.

In contrast to the needs of the technical stakeholders, nontechnical users of the requirements need fewer details. They prefer high-level views of the display designs and navigation through the user interface to see how it is affected by alarms, alerts, notifications, and help screens. They need to visualize the look and feel of the interface, and that is hard for anyone, technical or nontechnical, to do from hundreds of pages of text descriptions.

Consequences of Miscommunication

The inability to agree on communication and documentation levels for user interface requirements is often what tempts developers to simply implement the interface as a means of communicating the interface proposal. As undesirable as this is, it is very common. And there are significant consequences of such actions.

Using operational software to communicate with other stakeholders is probably the least efficient means of doing so. Implementing the interface software is time-consuming and ties up the software developers.

Software prototypes of user interfaces are likely to have flaws. Reviewers may concentrate on the imperfections of the prototype implementation rather than focus on the overall design.

Pushing forward with interface implementation forces the implementer to make decisions too quickly or to skip over areas that are not defined. On-the-fly decisions may not be properly documented and the design may be incomplete. Once the entire stakeholder team is exposed to the prototype design, the design may require changes that are expensive and difficult to implement. There might also be resistance from the software engineers because the code is already written.

Latent defects can be introduced in the code if changes are made too frequently and too quickly. Rapid prototyping software is rarely intended to be used in the final product, but all too often that intent is not honored. Complex software can be designed with many dependencies and interdependencies. Oftentimes these complexities are not well documented. This is especially true when software is designed quickly for prototyping purposes. As the prototypes are evaluated, there may be a tendency to react to criticisms without thinking through the effect of each change, and this can lead to unintentional defects in other areas.

Inadequately documented prototype code does not supply the verification test team needed inputs for its test designs. The team is left only with the software itself as a self-documenting requirements specification. Any test activity under these conditions is of little value. The tests will only verify that the software does what it does, not that the software does what was specified or desired by the team.

The software may be written to test user interface preferences rather than for the underlying functionality of the device. This can cause unanticipated rework later in the implementation phase because the functionality is shoehorned in to fit the user interface design.

And it should not be overlooked that this method does not satisfy the regulatory guidelines of the sequence of activities that includes specify, design, implement, and test.

Developing User Interface Requirements That Work

Systematic design and development of software-implemented user interfaces for medical devices is difficult. There is no single medium for adequately communicating the requirements or the design to the broad spectrum of device user stakeholders.

One approach that can be successful is to use different tools and media for different stages of the interface definition. Very-early-stage work in which product-level requirements are verbalized by the team can simply be captured in text documents or requirements management tools. Later, some sort of visual medium or technique is needed to communicate look and feel. Storyboarding on paper, whiteboards, or slide presentations can work for early concepts and may be adequate for simpler interfaces. Later-stage, more-ambitious interfaces might require more-sophisticated tools or media. Professional graphics software like Adobe Illustrator can be used to show both high-quality mockups of screen designs and navigation pathways through the interface. These storyboards or flowcharts can become very large for more-complex user interfaces. However, they are quite effective as a communications tool that almost everyone can understand.

Rapid prototyping tools are also effective for communicating look and feel. Such tools are quite effective in quickly creating on-screen representations of concepts that are interactive with the reviewers. Unfortunately, these tools often lack a complete documentation trail. Storyboards and flowcharts are much easier to work with in later phases of this process.

Note that rapid prototyping software tools do not suffer from some of the problems related to rapidly developing prototype code that would be used in the device itself. For example, most rapid prototyping tools use proprietary languages, tables, or scripts to create the interactive user interface software. The so-called software is not encumbered with much of the underlying functionality, so changes made to the user interface are less likely to have unexpected consequences elsewhere in the system. Furthermore, even if frequent changes do introduce latent defects, they are less likely to be transferred to the final device because the language used to develop the rapid prototype generally is not used for the real device.

Regardless of which tool or medium is chosen for the graphic description, the method should be

• Understandable by the lowest technical common denominator on the team.
• Flexible for quick changes based on review comments.
• Representative of what the users will actually see on the hardware display. (Don't ask the team to use their imaginations any more than necessary.)

Reviews at this phase should be centered on the graphic tool or medium chosen for the graphic description. Criticisms and comments can be documented in text, but discussions about the operation of the user interface should always be visual and in the context of the graphic tool.

The next stage of the user interface development is to detail all the requirements for the interface and its underlying functionality in a text document or requirements management tool. This step involves refining the look-and-feel concept that the stakeholder team agreed on.

The text description needs a high level of detail for input to the code implementation activity and the test design activity. No detail should be left undocumented. If a detail is not documented, the team has to assume it will not be implemented or tested. The software developers and test developers should be able to design in parallel based on the details provided at this stage.

As an example, consider a screen-based user interface design for a medical instrument. For every screen that was defined in the storyboard or flowchart, the requirements document should specify the following:

• The contents of the display (as taken from the graphic medium).
• The events that would result in the screen being displayed (represented in the graphic medium).
• The events that would result in leaving the display (represented in the graphic medium).
• The user inputs that are armed and disarmed while in the display. (These should be cross-checked against the graphic description for thoroughness. For example, is every armed input represented by an action if the input is activated? Is every input possibility that is not represented in the graphic model disarmed?)
• The underlying functionality while the screen is displayed.

Figure 1 shows an example of a graphic description for a simple stopwatch function that is implemented in software with a graphical user interface. Each screen is represented on the chart to match as closely as possible the display as it will be seen on the device being designed. Each screen is named or labeled to help create a language that can be used to discuss the design. The black arrows represent navigation from display to display. The action that initiates the transition to or from a display is annotated on the display itself. Functional requirements associated with a display are annotated in the margins.

Figure 1 is a very simple example. Real-world designs are obviously much larger and more complex. Large application presentations require significant organization to facilitate understanding and to avoid a rat's nest of interconnecting lines. Large applications also need large-format printing to create charts that can be reviewed in a group setting. It is not unusual for these displays to run in multiple panels of 3- to 4-ft lengths.

The important point to note in Figure 1 is that the language used to describe the proposed user interface is universally visual. Anyone can look at the pictures, follow the lines, and understand the designer's intent. The large-format panels make it easy to jot notes, make changes, or list questions in real time during reviews. The universality of the visual medium makes it easy for all stakeholders to understand and participate in the design process.

The text document can be organized using an outline template to ensure consistency of detail from screen to screen. This document is neither entertaining practicing nor is it a good way to get the big picture of how the interface will react to the user (that is the job of the graphic description of the prior stage). However, the format is invaluable for forcing engineers to think through every aspect of the interface operation before code or tests are written. Such critical thinking usually leads to additional questions and often brings to light missing or flawed information from the previous steps.

The Iterative Process

For iterative refinement of requirements, engineers must go back to the stakeholder team for additional information or to present proposed solutions to problems discovered in detailing the text description. As the refinements are made to the text description, it is important to make the corresponding changes to the graphic description. As long as the two descriptions are kept synchronized, it may not be necessary for the nontechnical team members to review the detailed text description. Removing those extra steps helps streamline the review and approval process. It should be a goal to communicate with the nontechnical team members using the graphic description.

It is also valuable to note that the graphic description is important beyond the initial design phases of the device. The graphic description is useful for training purposes for non-development-team personnel and is the best high-level view of the device operation for future development teams that may be called on to maintain the device.

Traceability

To recap, the requirements phase described here for user interface requirements has gone through three stages: the system-level interface requirements, the graphic description, and the text description.

It is important not to lose information from a prior stage as details are further refined. This means that some level of traceability should be in place to manage the requirements. There are challenges in tracing requirements from text to graphics and back to text as the requirements evolve through the three stages. Careful planning and thought about how traceability is to be implemented will affect the organization of the documents themselves.

Implementing a standard for uniquely labeling each screen, navigation path, or event can facilitate traceability to and from the graphic description. Hierarchical organization of the graphic description and the corresponding text descriptions will make the traceability more understandable, thereby making it a useful management tool, not just a regulatory nuisance.

Figure 2 shows an example of how this might work. Again, a sample of a simplified stopwatch implemented in a graphical user interface software system is used for illustration. The top band is the graphic medium description. This is similar to the example used in Figure 1, but this time the navigation arrows are labeled (e.g., 01, 02, etc.). The labels for what action initiates the navigation used in Figure 1 have been removed to simplify the information. Each display or screen is uniquely labeled in the tab for that screen. The annotations above some of the screens often become functional requirements related to that screen. They, too, are given numbered labels. This provides the ingredients for uniquely identifying required elements of the graphic description.

The Software Requirements box in Figure 2 represents the software requirements that could be derived from the graphic description. For each uniquely labeled screen (e.g., Zeroed Screen), there should be some itemization of the contents of the display that ultimately should be verified. Such contents might include any buttons or other user controls, static displays, dynamic displays, banners, positions, colors, or fonts. Navigation to and from the display is detailed using the unique labels described above. It should be noted that detailing “to and from” results in redundant requirements. However, it makes the requirements easier to use and provides a cross-check in the requirements development and review processes.

User inputs that are disabled are just as important to detail as those that are enabled. In this example, they are identified with an X prefix. The lines that drop down in the figure from the graphic description to the software requirements represent the logical linking between graphic description and requirement. Note that the unique labeling implicitly creates the linkage without the use of any tool that provides links between the graphics tool and the text tool.

The Verification Tests box of Figure 2 shows in a sparse form how the verification tests for the user interface might be organized. In this example, the navigational requirements are Tested for a screen in one test procedure, the contents are Tested in a second procedure, and any functionality associated with the screen is Tested in a third procedure. Again, the unique labeling provides implicit traceability. Alternatively, requirements management software tools such as Telelogic's Doors or Rational's Requisite Pro can be used to manage traceability.

Verification Testing

The methodical nature of the detailed requirements of the text description leads to methodical development of verification tests. The process promotes consistency of detail in requirements, design, implementation, and tests. This type of process also lends itself to using templates for each section of the text description, design, or test, thus making the development, review, and approval processes that much more efficient. In reviewing the text description, attention can be focused on the details, because the look and feel were reviewed in the graphic description.

Validation

Validation comprises many activities, including the verification testing just described. According to FDA's General Principles of Software Validation, verification testing provides objective evidence that the “requirements implemented through software can be consistently fulfilled.” However, it is quite possible to perfectly implement requirements in software but have a product that fails to meet user needs. For this reason, manufacturers often design a separate protocol of validation tests to provide “objective evidence that software specifications conform to user needs and intended uses.”

Validation testing, or usability testing, for user interfaces is a subject complex enough for a number of articles. Suffice it to say that this type of testing should definitely include real intended users using the device for all known intended uses, in all known intended use environments. For simple user interfaces or for devices used in noncritical applications, validation testing can be designed by a collaboration of those who understand the technical details of the device and those who best understand the intended uses, users, and use environments. Complex or highly critical applications would benefit from testing by organizations of professionals who specialize in user and usability testing.

Conclusion

Development of safe software user interface requirements depends on many human factors considerations that cannot be adequately addressed by software engineers alone. A team of stakeholders of varied interests is necessary to get a balanced input. Communicating with such a broad spectrum of technical capabilities is challenging. A method has been proposed here for facilitating that communication, preserving the agreements that result, and tracing them to the final product.

Because developing cutting-edge medical devices is so complex, it can be easy to overlook the fact that the devices are being designed for users. Those users' understanding of devices will come from very limited or nonexistent training. They will often be using similar devices with dissimilar user interfaces. Poorly designed user interfaces can confuse nurses and medical technicians who use the devices to provide care.

Besides decreasing productivity, bad design has the potential to harm patients by producing anything from poor diagnoses to injury due to unintentional misuse of a device. Addressing human factors throughout the entire development process ensures that the user interface is as simple and foolproof as possible.

Acknowledgement

The author recognizes and appreciates the efforts of Patrick Wu in helping with the graphics for this article.

David Vogel is president of Intertech Engineering Associates Inc. (Norwood , MA). He can be reached at [email protected].

Copyright ©2007 Medical Device & Diagnostic Industry

PERINTON. N.Y. – EMTs and paramedics provide critical services.

As part of National EMS Week, students at Eastern Monroe Career Center spent part of last Friday getting hands-on experience as emergency medical service workers.

EMCC offers a two-year course for high school students who want to become certified first responders. The goal is to create a direct class-to-career pipeline.

“I’ve really enjoyed it – getting to actually see what goes on in the medical field and be able to learn and do hands-on stuff,” Spirit Hoffere said.

“Their goals are to be EMTs, firefighters, allied health professions like nursing, respiratory therapy, they want to be a [physician’s assistant], or a physician. We really want to raise awareness this week and say we’re here, we do an important job in our communities,” instructor Sean O’Donnell said.

Students get their NYS Department of Health Certified First Responder certification, their NYS DOH Emergency Medical Technician-Basic Certification, and American Heart Association CPR/AED certification and take a state exam, which is one of the first steps to becoming a certified EMT.

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A hundred Baltimore City Fire Department employees are called back to work overtime each day because of the agency’s staffing crisis, fire officials said at a Board of Fire Commissioners meeting this month.

Those employees are often firefighters asked to man shifts as paramedics or emergency medical technicians, positions that have been beset by vacancies for years. More than 60 of the department’s 380 emergency medical service jobs are unfilled, leaving nearly a 16% vacancy rate in one of the country’s busiest fire agencies per capita, department leaders said Tuesday during the first day of city budget hearings.

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That vacancy rates increases to 32% when factoring out administrative positions, fire union officials said. The 61 vacancies are mostly paramedic positions that require extra schooling to provide advanced life support.

“It’s no secret we have a huge workload. One of the highest, one of the biggest on the East Coast, and our neighbors are starting to face the same shortage as far as paramedics leaving for other jurisdictions for more money and less work,” Acting Fire Chief Dante Stewart told City Council members in a 2 1/2-hour hearing.

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On one Saturday in May, eight fire engines had to close because of staffing issues caused by people taking vacation time, officials said at the exact Board of Fire Commissioners meeting.

Mayor Brandon Scott’s $4.4 billion budget proposal includes a $15.4 million increase in fire department spending to $332.9 million for the fiscal year starting July 1, in part to create more positions that will need to be filled.

The City Council, which for the first time in over a century has the power to reallocate funds, will consider the spending plans over the next month.

The fire department’s proposal adds about two dozen emergency medical service positions to the agency’s staff of 1,760, which has an overall 12% vacancy rate. Stewart said the department is working on attracting new hires, in part by incentivizing EMTs to further their education to become paramedics. And multiple recruiting classes are being trained through the fire academy.

Four of the new positions are “community paramedics” who would help reduce the city’s demanding call volume by reaching out to residents and connecting them with resources instead of making repeated trips to the hospital, said James Matz, assistant chief of the department’s emergency medical services. That outreach effort could include helping a resident with an opiate issue or linking someone without transportation to medical care.

Ambulances respond to over 525 incidents each day in the city and about half of them result in a hospital trip, Matz said in a previous City Council hearing this month. About 33,000 calls per year are low acuity, meaning that they need minimal care. The toll strains both personnel and the department’s aging fleet of firetrucks and engines, which can cost more than $1 million each.

“We’ve got to stop taking people to the hospital, into the emergency room every day,” Matz said.

Community paramedics would attend to residents who habitually call for an ambulance.

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“From Jan. 1 to March 31, six people accounted for 170 responses. Just six people alone,” he said.

During the first three months of the year, COVID-19 expenditures and the fire department’s dependence on overtime created a $32.2 million deficit. The department spent $17.4 million on overtime to cover vacant positions, a 70% increase over the same period last year.

Each emergency response costs roughly $1,500 to $1,800, which is billed to the patient’s insurance, Matz said. The department has generated significant revenue through federal reimbursements for transporting patients who are eligible for Medicaid. An anticipated $40 million is expected from the program during the next fiscal year.

The mayor’s spending plan for the department also sets aside funds to create four safety officer positions recommended in an investigatory report that revealed operational and accountability issues in the agency after three firefighters died in a vacant rowhouse fire in January 2022.

Safety officers have administrative duties and are in charge of safety tactics at fire scenes, such as when to pull out of a burning house. Now two officers on each shift will respond to a scene, rather than one.

The investigative report also recommended the department create aides for battalion chiefs to help the commanders make decisions during hectic fires. Battalion technicians and safety officers are both roles recommended by the National Fire Protection Association but have not been implemented in Baltimore.

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Permanent battalion technicians were not included in the Scott’s budget proposal. A pilot program will continue to run in the meantime, staffed by officers working overtime.

The council’s budget hearings will continue through June 6. A final budget must be approved by June 26.