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This report originally appeared in the October 2009 issue of DOTmed Business News

The discovery and development of anesthesia is one of the most important medical breakthroughs of the 19th century, as it allowed for complicated and life-saving surgeries to be done while a patient was asleep, increasing the likelihood of survival in many cases.

While nitrous oxide was used on dental patients as early as 1844, it wasn't until 1890 that Dr. Frederick Hewitt introduced an anesthesia machine, considered to be the first piece of anesthesiology equipment. This machine was designed to administer variable doses of nitrous oxide and oxygen gas via a large rubber reservoir bag and a three-way valve to the patient.

Englishman John Snow is often credited as being the first anesthesiologist. Although he died years before Hewitt's invention, Snow still made significant strides forward for anesthesiology. Snow's contributions include a public relations victory of sorts - he personally administered anesthesia to Queen Victoria to help her during labor for two of her children.

Anesthesia equipment and anesthesiologists have come a long way since Snow and Hewitt. Today's anesthesia systems and workstations consist of functional sections for ventilation, including source of gases, flowmeters/mixers for gas dosage, vaporizers for storage and dosage of inhalation agents, patient breathing systems, ventilators, monitoring equipment, and other helpful accessories.

OEMs such as Penlon, Datex-Ohmeda (GE), Datascope and Draeger Medical are the leaders in the field today, and each has continued to develop safer and more advanced anesthesia equipment, improving comfort for patients and ease-of-use for practitioners.

Business Developments

According to Medtech Insight LLC, a medical technology marketer, the total U.S. anesthesia and ventilation products market is expected to reach $3.6 billion in 2012, up from $1.9 billion in 2002. Those figures include sales of all anesthesia delivery products, such as integrated anesthesia systems, anesthesia and respiratory accessories, blood gas monitoring products, pulmonary function testing products, and ventilators.

But business is also booming for refurbishers, service contractors and many dealing with the safety of the equipment itself.

Clinical Engineering Consultants repairs and manages anesthesia equipment for hospitals and other customers, and also sells refurbished units. They have seen business rise as hospital administrators become more judicious with their budgets.




"We have been in an up market. The main reason is that most hospital administrators are really savvy right now as to on-going service costs and they are looking for companies that have the expertise to come in and save them some money," says Randall Smedley, president of the Kentucky-based company. "A lot of hospitals are also looking right now to use some good used parts. They no longer feel they always have to go with new parts because of the quality of the used parts that can be offered."

Refurbishments

For facilities with limited budgets that need to replace their outdated anesthesia systems, quality used systems and refurbished models are a practical alternative.

"Refubished units are a viable option. We all should be concerned with how to reduce costs without reducing quality and there are some very good alternatives out there now," says Brad Rumph, president of Heartland Medical, an anesthesia systems support company. "Also, so-called older vintage equipment that manufacturers have dropped support for, actually can still be maintained by third-party providers as the parts are out there."

Many of those in the refurbished field have been happy with what they have seen in recent months as business has increased.

"The market was stable in 2007, 2008, and in the first six months of 2009. Since June of 2009, sales have increased dramatically," says Aaron Frye, owner Doctors Depot, Inc. "We believe many centers that had capital freezes have removed these holds and started making purchases."

Anaserv Medical Inc., based in Dawsonville, Georgia, does a number of refurbishments on anesthesia systems.

"You strip it down totally, take it all apart and then you clean it, sand it, prime it, paint it and you replace rubber goods," says Anaserv CEO Ken Kirby. "They have annual kits for the equipment, which are like service kits and they include all the parts inside the absorber. That's where the breath comes through to the bag. You want to clean inside of there totally. Check all the primary and secondary regulators, rebuild those as necessary and calibrate the flow meters."

Frye describes the refurbishment process as follows: "For an anesthesia machine, we completely disassemble the machine and repaint it. Anything that isn't perfect is replaced, whether it's a decal, pieces of plexi glass... so that everything looks and functions like new," he says. "Refurbished units can save a buyer at least 50%."

Since new units can run anywhere from $30,000 to $70,000, substantial savings can be realized.

Taking a close look

Improperly checking anesthesia equipment prior to use can lead to patient injury and has also been associated with an increased risk of severe postoperative morbidity and mortality.

In 1993, a pre-anesthesia checkout (PAC) recommendation was developed by the FDA and widely accepted to be an important component of safe anesthesia practice, but since that time, because new anesthesia delivery systems have been developed and equipment designs vary greatly, no single checkout procedure can be mandated. Still, last year, the FDA developed new guidelines and issued a report of its findings.

The report reads: "A new approach to the pre-anesthesia checkout has been developed. The goal was to provide guidelines applicable to all anesthesia delivery systems so that individual departments can develop a PAC that can be performed consistently and expeditiously."

Jose Morillo, owner of J Morillo Sistemas Biomedicos in Venezuela, has observed that operators who check their machines each time before using them have had no problems.

"Operators can identify a malfunction before a procedure starts," he says. "They need to check the connection, hoses, pressure of lines and cylinders, oxyflush valve, flowmeter valves and linearity, O2 protection valve, N2O /O2 inverse relation protector, CO2 absorber status, bag, ventilator, accessory monitors and anesthetic agent level."

When David Jesse, president of M-TEC, starts any preventative maintenance program, he understands that leaks are the most important thing to look for.

"For the most part I always start off with a leak check on the machine and go through the manufacturer's testing procedures that are written," he says. "Machines should be checked at least daily for leaks but its best to do this before each use. The most important thing customers need to do is to maintain a clean machine. Machines should be checked by a qualified biomedical equipment technician on a semi-annual basis. On a monthly basis, a machine should have its absorber broken down and cleaned."

There are plenty of other things that need to be looked at as well.

"Periodic replacement of batteries and assessment of tubing/connections is important for routine management," says David Ogren, president of OMED of Nevada. "Pressure and vaporizer testing is vital for safe operation. Vaporizers need to be refurbished on a 24 to 36 month schedule, based on hours of operation. I do not think this is being done in most facilities."

Time for Service

While the most common service problems deal with malfunctioning O2 sensors, bellows and ventilators, the cause of those malfunctions is often found within the failure of a smaller part of the machine.

"Service issues are mostly related to tubing, valves and battery problems," says Ogren. "When selling a refurbished machine or just servicing a machine for one of our customers, all aspects of the operation are tested and certified for use."

Anaserv's Kirby says there is a strict procedure that is followed when they go in for a service call.

"We perform leak-checks on the absorber. We leak-check for low pressure and high pressure systems. Run the ventilator with full function, check all the alarms and calibrate as necessary," Kirby says. "If we find a leak we just have to chase it down and usually troubleshoot by going backward... Sometimes we have to pressurize and then get the snoop (dishwashing liquid that makes bubbles when a leak appears) and a lot of times it will just be a loose connection or something that needs to be tightened. Here, we're dealing with pressures usually less than 1 psi. We create a vacuum with that and it has to stay deflated for 30 seconds and if it doesn't you have a leak."

Advancements

Industry experts point to some significant improvements in anesthesia technology in recent years, including the evolution of equipment with integrated functionalities and enhanced ventilation capabilities.

According to Rumph, there is a lot that is new that needs to be considered when someone is purchasing this equipment.

"There are more advanced ventilator modes utilizing the traditional bellows providing users a better feel and indication visually of what is happening with their patient," he says. "Also electronic flow capturing of gases in tandem with visual flow tubes, advanced functions such as fresh gas compensations and compliance compensations and reduced volume absorber systems with heaters."

Pressure support ventilation, in which the ventilator automatically completes the breath in a spontaneously breathing patient, is a particularly noteworthy advancement in some modern-day anesthesia systems.

"We're seeing modular absorbers or absorbers crafted is such a way that a non-technical user can break them down for cleaning," Jesse says. "We're seeing ventilators that use exhaled volume sensors to adjust the flow rate and tidal volume to accurately deliver what the user has dialed in."

New, advanced anesthesia systems with integrated patient monitoring are more complex and that can create a safety issue if they are not used properly, so training is essential.

Insurance Issues

While companies may be able to add on different brackets or provide a shelf coming off of the side of the machines, they generally shy away from doing any major work on the anesthesia machines themselves.

"There isn't a whole lot we can do because it's a life support piece of equipment," says Frye. "If anything is structurally changed and anything happens to a patient, immediately a lawsuit would be on us."

For that reason, insurance plays a big role when it comes to this equipment. Service and refurbish providers need to be sure they have the proper coverage.

"It is critical in doing business since anesthesia equipment is so high on the risk management continuum," says Smedley. "We carry an adequate amount of product and service liability insurance. In our experience, most clients require $1 million to $2 million of this type of insurance for maintenance and service of the equipment."

Before buying any anesthesia equipment, the following questions should be answered to make sure you are getting what you need: What type of anesthesia is expected to be used? Does CO2 monitoring need to be done for your patients? Does the anesthesia provider have any influence on whether the machine has manufactured parts still being produced? Is this machine going to be used internationally?

"It's important to understand what you are getting and be smart with your buying solutions," Morillo says. "This equipment is as important as anything to do with surgeries and it needs to be treated with special care."

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DOTmed Registered Anesthesia Equipment Sales & Service Companies
Names in boldface are Premium Listings.

Domestic
Troy Lair, The Compliance Doctor, LLC, CA
DOTmed Certified
Aaron Frye, Doctors Depot, Inc., FL
DOTmed 100
Rodrigo Henao, Medilab International Corp., FL
Ken Kirby, Aneserv Medical, Inc., GA
Dave Wayne, SE Medical Systems, GA
Travis Nipper, Clinical Engineering Consultants, Inc., KY
Jerry Riley, DRE, Inc., KY
Brad Rumph, Heartland Medical, KY
Ana Ortega, General Biomedical Service, Inc., LA
Kevin Blaser, Coast To Coast Medical, MA
Jeff Rhinehart, Metropolitan Medical Services, NC
David Ogren, OMED of Nevada, NV
Philip Mothena, Simple Solutions, Inc., VA
David Jesse, M-TEC, WA

International
David Lapenat, Anda Medical, Canada
DOTmed Certified/100
Jose Morillo, J Morillo Sistemas Biomedicos, Venezuela

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