7 Factors to Consider When Buying Used Medical Equipment

Are you thinking about buying used medical equipment but feeling unsure about the process, safety, or warranties involved in such a purchase? Read on to learn 7 things you should consider before buying used medical equipment.

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6 Tips on Selecting Prime Patient Monitoring Equipment

Advances in medical technology have allowed for smaller, more effective, and less invasive patient monitoring capabilities. Certified pre-owned medical monitoring equipment offers a cost-effective way to provide high-quality equipment for medical facilities or home care. Reputable companies also offer a warranty and a money-back guarantee.

6 Tips on Selecting Prime Patient Monitoring Equipment

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Welcome to WordPress. This is your first post. Edit or delete it, then start writing!

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Hello world!

Welcome to WordPress. This is your first post. Edit or delete it, then start writing!

1 Comment

Stirring Up the “Winds of Change”

Well, here it is 2017.  A brand new year, full of new surprises and prospects ahead and already the gloomy clouds are beginning to gather on the eastern shores.  I think the time has come to “batten down the hatches” and prepare for bad weather.  This storm is nothing new.  It seems to visit every twenty years or so.  Well that’s the last time it came around.  In March of 2016, with little fanfare or notice, the FDA submitted for comment Docket Number: FDA-2016-N-0436 which deals with those organizations that service, sell, repair and refurbish medical equipment.  As we all know there are three basic entities that deal with this process.  These, of course, are the OEM, HTM and the ISO. Submission of comments was to end in May, however, due to “over whelming response” the end date was extended to June. Well the request for submissions got around seventeen comments, not a large response. Throughout the year other meetings were held and in most cases were attended by a large contingent on representatives from various OEM’s.  All of us should be aware of their position on the subject of service and that is that they should be the only entity to service their equipment.

As with any gathering of this type there always seems to be one individual or organization that really gets wound up and excited and wants to push the agenda.  In this case it is an organization called MITA (Medical Imaging and Technology Alliance).  MITA decided to take it upon themselves to do a “Survey”. Before we get to the results of said “Survey” we should look who makes up this organization.  No surprises here. This organization is made up of fifty-seven major players in the medical technology business. Names like GE Healthcare, Siemens, Philips and Medtronic are just a few of the members. Yes, I understand that this organizations primary area of representation is in Radiology, but many of them have their feet in both Medical Technologies.

Now back to the survey results. According to the MITA survey “85 percent of Americans agree that the government should take action to resolve concerns around third party service of medical devices”. Also, “74 percent of Americans think that, like OEMs, third party servicers should be strictly regulated under FDA guidelines”. Now here is the real kicker. “82 percent of Americans would think twice before seeking treatment at a facility that allows device maintenance by unregulated services.”  Are you kidding me?  How are hospitals going to pull this off? I think these folks are forgetting something.  Almost all hospitals, large or small, have some form of an Engineering Department.  Most have a Biomedical Technician that supports their needs, either full time or part time.  I believe it is the responsibility of this technician to verify any and all repairs, maintenance, purchases and rentals that are delivered to his or her site.  As far as repairs, I believe that these technicians should verify completeness and accuracy of equipment repaired by ISO’s and OEM’s prior to putting said device into service.

So, I ask what’s behind this recent foray into the concerns of the OEM. Now that you have asked, I think the issue is money, money and more money.  If they cannot drive out the ISO by withholding information, manuals, software upgrades and by charging expensive fees for parts, then the next best way is to have the ISO overregulated. They say that their concerns are for “Patient Safety” yet they offer no numbers to back-up their statement. No proof, no facts, just unsubstantiated shock therapy. Anybody remember Ralph Nader and his Ladies Home Journal article about hospitals “Electrocuting 1200 people a year and killing many more.”? Same unproven garbage.

Those of you that are ISO’s, it’s time to listen up. If this attempt does not fail, your future livelihood and bottom line will be affected. More importantly, hospital, clinics and other facilities that utilize third party service providers will lose a respected alternative source caring for patients and ultimately drive up the cost of healthcare even further.

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Winds of Change

We, the residents of Southern California have two basic wind patterns to be concerned about. There is the On-Shore flow, which brings in the cool ocean breezes of the Pacific.  The other pattern is the Off Shore flow, which are referred to as the Santa Ana Winds.  When the Santa Ana winds blow, things usually get dry, hot and uncomfortable.  Personally, I prefer the On Shore Flow.  For those of us in the Biomedical Industry, there is another wind we need to be aware of.  It has started only as a breeze, but as it builds, we are going to see some changes come into our lives.  One of the first blogs I wrote for this site had to do with the relationship between those that service and repair our medical equipment.  A brief reminder about OEM, In-House and ISO technicians would be in order, however, by now we should all know where we fit into the scheme of things.

Hidden in the dark recesses of a most recent publication was an article regarding the “FDA’s new docket seeks input on the refurbishing, servicing of medical equipment, devices.” I know what your next question is. “What does this have to do with me?” Well I am just about ready to let you know.  The use of this method by the FDA allows all interested “stakeholders” to input their comments into the docket for examination by the FDA.  As of the closing day (May 2016) there were 84 comments submitted along with support documentation. To para-phrase a movie title, if I may. “Some were Good, Some Bad and Some Ugly”.  Do you feel the breeze picking up?  Let me remind you that a change in the wind does not always mean trouble. It all depends on what the wind picks up, how hard it blows and to which direction it originates.

When everything settles down, I expect to see some changes in the ways that all three of the servicers interact. I would like to see a better balance struck between us all. The most improved product of these winds would be a better dialog between the OEM, In-House and the ISO service technicians.  Remember, all of us are aiming for the same bullseye, that being safe and affordable patient care. As for the In-House Biomeds, I believe things are going better, as most OEM’s prefer to deal directly with a healthcare center. As for the ISO, I perceive some changes that will help cull out those organizations that fail to all into line.  What I see is a little more regulation, more documentation, more quality control and more education.  Many of the firms (ISO’s) I know are already doing these things and more. There are some that don’t.  Just like separating the wheat from the chaff the winds of change will blow them away.  What are you going to be?

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The Keeper of the Keys to the Kingdom

By this time in the Biomedical Circle of Life most of us have had a fair share of Equipment Control Programs which help us keep track of what we have and where its located. By now most of us are tired of the whole process of incoming inspections, tagging, cataloging the various devices, setting up maintenance programs and all the fun jobs that come with new equipment.  Next of concern to us is maintaining a certain level of replacement parts for repairs and preventative inspections for these new devices. The final point of interest is service training.   Whom do we send?  What is the cost? Where do we send? How do we spread this new information around to others on staff?  These are all excellent steps, maybe not in the right order, but good starting places.

With todays advanced technology, I believe we are lacking one very critical bit of information. The control of equipment data and information should be an area of extreme concern.  Most new monitoring systems whether they are bedside monitoring, telemetry devices or defibrillators, they are driven as much by software as they are by technology.  The time has come that we start putting time and concern into maintaining better control of these parameters and how they are going to fit into our daily routines.  Maintaining an accurate and up-to-date database of all software and equipment configurations should be the minimal starting point for our endeavor.  We need to keep records as to what revisions are being used and the various locations within the institution.  In many of today’s healthcare facilities we can have a large variety of different configurations and software versions.  From the outside, all of the equipment can look the same, however what is stored inside, what makes it work, can be very different.  Machines like people can all look alike but can speak different languages.  Sometimes we can speak the same language with different dialects.

In the past it was a simple task that if you needed a module for yourself you could go to another department and “borrow it”. Today with our new technology that can present a problem.  One that we as Biomedical Technicians need to be prepared to address.  We need to invest the same amount of time and due diligence into this portion of our task as we do with the incoming portion.  Keeping these records accurate and up-to-date will prevent a calamity in the future, should the devices under our control need to be serviced or reassigned.  Software and programming disks should be kept in safe places and in proper order for future needs.  Compatibility concerns need to be identified and addressed.  Documents covering configurations of bedsides and central stations need to be kept safe and up-to-date.  Encourage a hard copy and digital copy of such information.  Remember that this information is as important as the service manual. So if you have not started collecting this information, consider doing so.  Failure to do so can come back and bite you later.

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Equipment: Buy, Rent or Lease

Historically,  the main option that was available to healthcare facilities both large and small was to purchase the equipment they need for the day to day operations within their facility.  Buying equipment requires a large investment in time and money.  Typically a number of the leading vendors were approached and asked to display their products.  With each display, evaluations were done to verify that the equipment being presented fit the needs of the facility and the population of patients that they care for.  Once the decision was made purchase orders needed to be cut, funds set aside to pay for the new equipment were needed.  In most cases, in-service training was needed to prepare the staff to properly operate the equipment.  Once the equipment was delivered, it required installation and set-up, further in-service, cataloging and rigorous mandatory incoming inspections.  Training programs for the staff, that was designated to maintain, incurred further expense on behalf of the hospital.  Maintenance requirements were established, and preventive maintenance programs were put in place to verify continued proper performance and safety.  Parts inventories needed to be established, test equipment needed to be acquired and repair skills and procedures needed to be passed along from those who were trained to those who were not formally trained.  All of the mentioned needs do not make buying new equipment bad, just expensive and time consuming.

 

As concerns about the cost and investment needed to support a hospital have grown and concerns about the rising cost of healthcare have grown, hospitals have needed to find a way modify and improve services without making larger financial investments in staff, facilities and equipment.

With the rapid changes and improvements in medical technology many smaller hospitals found themselves in a quandary.  The newer technology was beyond the financial reach for them to purchase or the long term investment was not there.  The need was there.  The answer to their problem was met with the ability to lease equipment that they needed without the long term investment.  Equipment like CAT Scanners, MRI Scanners, PET Scanners vastly improved patient diagnosis and care, but were beyond the financial ability to make the necessary investment.  Now these devices can be leased for a period of time, without the heavy investment and could be replaced as technology changes and patient needs changed. Maintenance costs were greatly reduced because the leasing company took care of these, training cost were reduced and viable income could be produced with little or no investment buy the hospital.  Facility costs were reduced because most of these units were transportable and arrived within their own facilities only requiring connection to the hospital services.  The lease option to lease equipment provided the ability for a number of smaller facilities, clinics and physician offices to have access to the newer technology without the investment, further improving income for the leasing facility.

 

The leasing option works very well for high dollar and slightly longer needs, but there needed to be a method or program by which hospitals and clinics could acquire equipment, staff and services for the short term.  Short term needs can be vary.  Peak flu seasons, an influx of visitors during a certain season, vacations of staff, even short term disasters require a short term answer.  The best method to address is the rental of equipment and staff from companies that specialize in providing this type of support.  Equipment can be rented for the day, week, month or year with little or no notice needed. Require no capital investment.  In most cases rentals come fully supplied with everything you need, require little setup time and little in service.  Rentals are available day or night, delivered within hours and require no long term investment for maintenance, if it breaks or fails, the rental company replaces it.  When the emergency or need diminishes, rental equipment can be returned with little more than a telephone call.  So the next time a need arises, think rental, a quick and easy answer to your immediate needs.

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NON-INVASIVE BLOOD PRESSURE MEASUREMENT A HISTORICAL PERSPECTIVE ON THIS TECHNOLOGY

In 1896, the Italian Scipione Riva-Rocci introduced the first mercury sphygmomanometer on the upper arm. It enabled the measurement of absolute systolic blood pressure, finding of the characteristic sounds by the Russian Nikolai Sergejev Korotkoff in 1905, the upper arm method also allows the registration of absolute diastolic blood pressure.

One year after Riva-Rocci’s findings, Leonard Erskine Hill and Harold Barnard reported blood pressure monitoring during anesthesia for the first time. Their almost concurrently invented devices consisted of a narrow armlet to occlude the brachial artery, a small bicycle-type metal pump and a metal manometer graduated in mmHg.

As all of us are aware, that blood pressure measurement is the most fundamental sign of cardiac health. Accurate blood pressure measurement is one of the essential needs in the treatment and diagnosis of hypertension. In today’s healthcare setting there are basically two methods to determine the accurate measurement of blood pressure. Each method has certain concerns that come with the method of choice. The two basic methods for determining accurate readings of this vital parameter are: invasive and non-invasive.

With the invasive method of measurement we are required to “invade” the patient and use a unique setup of a transducer, tubing, fluid and a patient monitor to read and display the information. This method is more frequently found in Surgery and Intensive Care where the patient requires constant monitoring. The invasive method does bring possible inherent issues when used. Some concerns are cost, contamination, lack of mobility and infection. All of these concerns limit the use of this method from the general population of patients and in settings not conducive to the required “invasion” of the patient.

The more preferred method for determining blood pressure within the general population of patients is the non-invasive method of commonly referred to as NIBP. It is this method that we will refer to for the remaining article. During each cardiac cycle, blood is pumped from the heart to the arteries and the rest of the circulatory system. Blood pressure (BP) is the force that is exerted on the walls of the artery and is most commonly referred to as arterial blood pressure (ABP). During each contraction the BP varies between systolic (SP) and diastolic (DP). Systolic is the highest reading during contraction and systolic is the lowest reading. The average of arterial blood pressure during a cardiac cycle is defined as the mean arterial pressure (MAP). The difference between systolic (SP) and the diastolic (DP) determines the pulse pressure (PP). Blood Pressure (BP) does not remain constant in the body and varies at different locations. In clinical practice refers to the arterial pressure measured at the upper arm.

During a 24 hour period the BP value can vary due to stress, drugs, disease and nutritional factors. The typical values referred to are the SP and the DP and are measured in millimeters of mercury (mmHG).

The two main methods on determining NIBP, in use today, are the Auscultatory Technique and the Oscillometric Technique. The Auscultatory Technique requires the use of a mercury column or aneroid sphygmomanometer, an occluding cuff and a stethoscope and listening to the sounds made during the blood flow in the brachial artery. These sounds are called the Korotkoff sounds. This method requires selecting the proper size cuff, placing it on the upper arm at the same height as the heart, inflating the cuff to about 30mmHG above the anticipated SP, deflating it slowly (2-3mmHG) per second and recording the sounds and finish when the sound disappears. This method requires the observer to determine the patient’s pressure by following the five (5) phases of the auscultatory sounds. This method can be complicated and requires a professionally trained observer. Additionally, this method is difficult to use in noisy locations.

The oscillatory technique is currently used in most automatic devices developed today. This method requires the use of an occluding cuff placed on the brachial artery and inflating it to above the SP. Sensors within the cuff or the machine detect the pressure oscillations of the arterial wall during deflation of the cuff. The main difficulty of this method is to determining the SP, MAP and DP from the oscillatory pulse. In most cases the SP and DP values are determined using algorithms, however, most manufactures of BP monitoring devices develop there own algorithms for determining the SP and DP values.

Modern systems are oscillometers utilizing one cuff that fulfils both occluding and sensing functions. The cuff inflates above systolic pressure and deflates either continuously or in a step-wise manner. An electronic transducer detects the pulse pressure wave, as well as the gauge pressure, in the cuff. Systolic pressure is recognized as the point where the rate of increase in the size of oscillation is maximal; diastolic pressure being that of maximal rate of decrease in size of oscillation. The readings are compared with an internal equation. Errors of automated non-invasive systems include those of all systems using an inflatable cuff.

Algorithms for present day systems are closely guarded secrets which are developed by manufacturers NIBP systems and are not made know to the outside world. However there are ways of monitoring your MAP through the use of a simple formula:

MAP= [2DP+SP]
3

The range for MAP is between 60 and 110. This provides a single number for the monitoring of blood pressure that determines organ perfusion. As can be seen, modifications to both systolic and diastolic can lower your MAP to within a respectable range.

Regular monitoring of your blood pressure should be a routine aspect of your life. Recent changes in the ranges of Normal Blood Pressure should be used to determine your individual risks.

Hopefully this blog gives you a better understanding about the significance and use of the modern day NIBP monitor and it’s function.

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Biomedical Departments versus Third Party Service Organization and the OEM

From a historical perspective the field of Biomedical Technology is relatively young. Over the past fifty years we have seen the field grow from it’s infancy into the technology giant of today. With each new growth spurt we have seen the scene change. First there was the OEM (Original Equipment Manufacturer), then the In-House Biomedical Department and closely followed by the Third Party Service Organization. During this period of growth, the question has always remained the same: “Who can do it better?” The truth of the matter be said, is that it is all a matter of your perspective.
My perspective has been built on forty plus years of working with all three of these organizations. My thoughts and feelings are that all three of these businesses have a place within the cycle of life for our technology. Let us take a look at some of our options and see how they stack up.

The OEM is the starting point for most discussions on medical technology. These large, expansive organizations are on the front lines of researching, developing, manufacturing and servicing the equipment we use today. This is what they do best. Once a product or product line has been developed, tested and sold on the market place, their job has been done. They monitor its progress and use; service it when it needs to be serviced and after of period of time they begin the process all over again. Eventually they mark the old line as EOL (End of Life). After a period of time any further support begins to drift away. Parts are harder to find and service is out of support. This is how the technology keeps pace with the ever changing needs of the market. If that was not the case we would all be driving Models A’s. Change from this perspective is good. That which remains is not bad, just older.

From the perspective of the in-house Biomedical Technician all equipment is good. It is their job to keep what they have working and see to it the interface between the technology and user remains intact. They are also on the front lines. Different lines, however. Their job is to assist in keeping beds full, medical staff happy, maintain a continuity of flow within their respective settings and to respond promptly when any of these concerns begin to fail. In many cases Biomeds have little if any choice as to what comes their way in regards to equipment. However, the more enlightened healthcare managers are now seeking out their opinions and are enjoying the rewards of involving them in the decision making process for future purchases. Everyday the Technicians sit in their trenches working away and doing everything within their abilities to maintain the status quo. Let’s make it work like it should, as long as it should which keeps the house humming along, regardless. In most cases, when EOL comes along he is hardly concerned. It is normally not within his job description to worry about it until it happens. This is where our last provider comes in.

The Third Party Service Organization provides a vital function to assist in-house staff by offering a variety of service and support options that can and do help keep the proper flow of support and service. Now, here is where the rub comes in. Many OEM’s and In-house departments look down their collective noses at these organizations. Why? Simply because some feel that they are trying to take MY job, put ME out of business or otherwise influence MY responsibility to make decisions on MY equipment. Really? Nothing could be further from the truth. Change your perspective and look again and see that together there is plenty of room on the team for each. Third Party Organizations should be looked at as to their ability to support the In-House function. Long after parts and service are discontinued by the OEM, they stand ready to help extend the life of the equipment found in-house. Many of them stand ready when an urgent need for extra equipment is called for. Long after the EOL bug invades your systems, they are there to assist with your designated responsibility of: “Keeping everything working and by doing so at an economical cost to your organization.” Even in some cases, before the EOL, we find that these types of support organizations can provide us with an economical and cost effective way of servicing our equipment. In these days of hard economic decisions and climbing healthcare costs, the third party service organizations can allow us to actually lower costs in servicing equipment in our care. Every institution in the business of healthcare wants to reduce expenses and cut costs all the while maintaining a high quality of patient care and safety. The Biomedical Technicians have a vested interest in doing what is needed to reach these goals, whether working as a member of the In-House Biomedical Department or a Third Party Service Organization; it is OUR job to maintain.

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