What You Should Know About Medical Equipment Repair & Inspections

Click to enlarge images

PREVENTIVE MAINTENANCE INSPECTIONS OF MEDICAL EQUIPMENT

Preventive maintenance equipment inspections help maintain the functionality and longevity of your equipment and reduce your exposure to liability. These annual inspections may also be referred to as Annual Inspections or Performance Verifications.

Where applicable, equipment inspections are required to maintain regulatory and accreditation compliance.

In most cases, equipment inspections are recommended by equipment manufacturers.

In some cases, equipment inspections are required by liability insurance carriers, some offer discounts with documented verification of annual inspections.

Failure to have equipment properly inspected could potentially lead to:

Misdiagnosis of patients if equipment is not performing to required manufacturer standards.

Increased liability risk due to potential for patient or staff injury due to electric shock.

QUALIFY YOUR SERVICE VENDOR

Even if a service company is performing inspections and placing inspection stickers on your equipment doesn’t ensure they are meeting the manufacturer’s recommendations for your equipment. Not all service vendors are equal, it is a good idea to verify that you are paying for and receiving the exact services you require.

For the protection of your practice, your medical equipment must be inspected to the level recommended by the equipment manufacturer. This means your service vendor must have the most up to date inspection procedures, utilize the appropriate diagnostic equipment recommended by the manufacturer and have their diagnostic equipment calibrated annually as recommended by the manufacturer. Additionally, service vendors should provide you with written or electronic documentation for any service or inspections performed at your practice.

To verify your vendor is meeting the manufacturer recommended requirements ask the following:

Your vendor should be able to confirm they have the most current service manuals or procedures from the manufacturers of your equipment? A properly qualified vendor should have a current electronic library of manufacturers service manuals available to their technicians while on site for service.

Your vendor should be able to confirm they have the proper diagnostic equipment recommended by the manufactures of your medical equipment.

Your vendor should be able to provide you with calibration certificates for all diagnostic equipment utilized at your practice (this is a requirement of some regulatory and all accreditation bodies).

It may not always be easy to verify if a vendor is utilizing proper diagnostic equipment, different manufacturers have varying requirements. Some less reputable service companies may avoid purchasing required diagnostic equipment due to added costs. This can increase your practices liability exposure.

Proper inspection procedures cannot be executed on certain types of medical equipment without specific diagnostic equipment.

Examples of diagnostic equipment and costs:

Welch Allyn Patient Monitors – Many models require multiple specific pieces of equipment for proper inspections. The prices listed are an average purchase price of different models.

The required diagnostic equipment includes a NIBP Simulator $1,500, a SpO2 analyzer including both Pulse and Saturation rates $1,500, Welch Allyn calibration manifold - $900, temperature well for calibration - $900, with ECT a patient simulator is required - $1,000 and an electrical safety analyzer - $1,000. All together, this is roughly $6,800.00 to inspect one type of equipment.

Electro Surgical Units – Proper electro surgical unit analyzers cost $6,000- $10,000, an electrical safety analyzer is also required - $1,000, totaling to approximately $7,000 - $11,000.

This example shows why a lesser service company might not incur the expense to purchase required equipment, at your risk. Certain types of medical equipment, as shown above, without specific diagnostic equipment cannot be properly verified.

ACCURACY OF DIAGNOSTIC EQUIPMENT

Advancements in technologies within the past 10-15 years have led to more accurate diagnostic equipment. Some service companies perform inspections with older equipment. This is simply due to their lack of investment or resources in newer more accurate equipment. Older equipment can often lead to false positives and false negatives in testing of equipment. A false positive means that older diagnostic equipment could miss a failure of your equipment, potentially exposing you to liability concerns. A false negative could suggest a failure of facilities equipment that doesn’t exist, potentially exposing a facility to additional repair costs.

FREQUENCY OF INSPECTIONS

The majority of medical equipment manufacturers only require annual inspections of their equipment. Certain medical devices, for example: some AED’s & Electro Surgical Units require semiannual inspections. Manufacturer’s inspection recommendations should be noted in the equipment service manual. A knowledgeable service vendor should be able to provide you with the manufacturers recommendations. If a service vendor recommends you have semiannual inspections, ask them to show you this recommendation in the equipment manufacturers service manual.

REPAIRS OF MEDICAL EQUIPMENT

Medical equipment may require service or parts replacement. In many cases, manufacturers recommend a preventive maintenance inspection be performed following any repair service being performed on the equipment to ensure it is functioning accurately. This requirement is usually found in the manufacturer’s service manual.

VENDOR CONTRACTS

It is recommended that your medical equipment preventive maintenance contracts include verbiage stating “equipment will be inspected to manufacturers recommendations utilizing the required diagnostic equipment recommended by the manufacturer when available or applicable”. There are occasions where older medical equipment may be utilized in a practice. There are cases where service manuals may not be available for this equipment for reasons such as the manufacturer is no longer in business or no longer provides product support. For this reason the recommendation for the above statement, “when available or applicable” is necessary. In these cases, your vendor should inspect your equipment to “Industry Standard’s”. This means the inspection of the equipment is to the recommended specifications of similar equipment for which inspection recommendations are available. This also includes the utilization of proper diagnostic equipment and the performance of electrical safety testing where applicable.

IN CONCLUSION

Unqualified equipment service providers may leave you with an increased risk of liability by not meeting the recommendations of the manufacturers. Verify your service company is providing you with the services necessary to meet all of your practice needs and are not over charging you for services not rendered or needed.

By Mark Tyler, President of Tyler Bio-Engineering L.L.C.

For any questions related to medical equipment inspections, requirements, to receive a free equipment consultation or to obtain a quote call us at (810)208-0848.

The Alienation Of America’s Best Doctors

The best and the brightest simply don’t want to become doctors anymore. Physicians are burning out. They are leaving the profession. They are going bankrupt. They are selling their private practices to big hospitals. They are retiring early. We are facing a growing doctor shortage.

Michigan Physicians Society Announces Exclusive Insurance Program

Michigan Physicians Society (MPS) partners with Professional Casualty Association and Doeren Mayhew Insurance Group to Offer Express Medical Malpractice Insurance Checkup and Exclusive Insurance Discounts to MPS Members

Better to Live and Die in the U.S.A.

The United States healthcare system is often berated for how it treats patients near the end of life. They are purportedly attached to tubes and machines and subjected to unnecessary invasive procedures that cause inordinate pain with no potential benefit, there is underutilization of more compassionate hospice services. This “travesty” is expensive, as the care of dying seniors consumes over 25% of Medicare expenditures. We hear this story so often; it is almost taken as gospel-- but is it actually true? Is it more expensive and invasive to die in America than in other developed countries?

Gun Ownership and Doctors?

According to the Pew Research Center, there are approximately 32,000 gun-related deaths annually in the United States; 19,000 are suicide, 11,000 are homicide, and the rest are accidents, police shootings or of unknown causation. Moreover, there are more than 78,000 nonfatal gun wounds each year. Given the disproportionate number of victims that are less than 40 years of age, the morbidity and mortality of gun violence is significant. Physicians are involved with many types of public health issues, but few are as controversial or divisive as gun safety. Is it really an issue that falls within the medical domain?

O Tempora, O Mores: Affordable Care Act - Big Dream or Big Let Down?

I confess I was a strong proponent of the Affordable Care Act. My reasoning was subtler than the hallowed pantheons of its staunch supporters and the apocalyptic predictions of its detractors. Forty years after graduating medical school I concluded, after many stutter steps, the American healthcare delivery system was economically unsustainable and the citizenry was neither living longer, nor better, despite medical expenditures that dwarf any other developed nation. My career also allowed me to personally interact with cardiac surgeons from all continents and see that their clinical results and research efforts were laudatory by any standards.

High Depression Rates in Resident Physicians — Fact or Fiction?

The December 8, 2015 issue of JAMA had a startling key clinical point; the prevalence of depression or depressive symptoms among resident physicians in training was 28.8%. The data was generated by meta-analysis of 31 cross-sectional and 23 longitudinal studies published in peer-reviewed journals involving 17,560 trainees. Two-thirds of the trainees were in North America, but the others were from Asia, Europe, South America, and one from Africa. Sensitivity-analysis confirmed that no individual study affected overall prevalence by more than 1% and that the incidence of depression was not influenced by study design, continent of origin, surgical vs nonsurgical program nor level of residency year.

Can a Robot Outperform Your Surgeon?

In the current competitive environment, healthcare providers often attempt to separate themselves from their competition by marketing themselves as using the newest technologies for their procedures. This is an age defined by finding the next best thing and the American public responds to this strategy. My personal experience has been in cardiac surgery, but the principles are equally applicable to other specialties, particularly tertiary referral practices.

Hospital Administration Attempts to Cut Costs and Increase Quality at Expense of Physicians

A nonprofit hospital care system in Oregon with 450 beds has been in an acrimonious negotiation with its staff hospitalists for the past 2 years. The mounting economic pressures on this small, community oriented institution have had the expected consequences of hiring new administrators to implement the latest trends to rein in the budget and effect efficiencies of healthcare delivery-- as if that has been so successful in the rest of the country. The battle has really centered over the physicians losing control of their work time allocation, individual decision-making for diagnostic and treatment plans, as well as bristling at bonuses based on the administration’s definition of quality.

Vox Clamantis in Deserto - New 5-Star Review Process to Advise Public Worries Physicians

I did my undergraduate studies at Dartmouth College in Hanover, NH. The school’s Latin motto is “Vox Clamantis in Deserto”, which translates to “A voice shouting in the wilderness”. Its founding mission in 1769 was to “civilize” the Native American youth and, perhaps in a deconstructionist era, this sounds paternalist and demeaning.

Michigan Physicians Society Supports Inner-City Education

Yesterday afternoon I had the privilege of helping to honor the graduating class of 2016 at Experiencia Preparatory Academy. They have 3 graduates this year that have overcome a special set of challenges, including moving from Mexico to the United States and having English as a second language.

Michigan Physicians Society Celebrity Golf Clinic

We are excited to announce our next MPS Event! We are hosting an exciting evening of learning, networking, and fun at 4-Seasons Golf, a private indoor golf club in the heart of Downtown Birmingham on Wednesday, Apr 27, 2016, 6:00 PM - 9:00 PM.

Affordable Care Act: Affordable for whom?

Entering its third annual open enrollment period, Obamacare is the subject of cacophonous political acrimony, again, championed by its supporters and vilified by its opponents. Each side presents its own “metrics” of success or failure

Death Panel Myth Debunked - Prioritizing Patient Education

American healthcare’s mostly fee-for-service reimbursement model encourages doctors to order tests and procedures so as to make a reasonable living from practicing medicine. There is no incentive to have conversations with patients.

Big Pharma Using Mail-Order Pharmacies to Maintain High Prices

The United States has the dubious honor of paying the highest prescription drug costs in the world. Many healthcare economists attribute this to relatively lax cost regulation compared to other wealthy countries; however, a decade of insurers paying only for generic drugs when available and limiting drug choice in specific formularies has had little modulating effect.

Merit-Based Incentive Payment Structure: The Solution to Medicare Sustainable Growth?

The Medicare Sustainable Growth Rate (SGR) was initiated as part of the 1997 Balanced Budget Act with the goal of controlling Medicare Part B spending for physician services. When Medicare spending under a year’s physician fee schedule exceeded the rate of growth of the covered Medicare population and the rise of GDP,

Mental Health Spending: A Story of Failed Supply and Demand

Several weeks ago I was in Palo Alto, California walking along Camino Real abutting the Stanford University campus. I noticed a newly-constructed high-link fence isolating the commuter train tracks from the pedestrian walkways. Another “shovel-ready” infrastructure project to nurture the economy?

Photos - MPS Auto Show Event - Lingenfelter Collection!

Our auto show event at the Lingenfelter Collection was a huge success! Approximately 100 attendees enjoyed an evening of learning, networking, and fun at the Lingenfelter Collection, one of the most notable car collections in the world! A special thanks to M1 Concourse and the Lingenfelter Collection for sponsoring this event.

Michigan Physicians Society Auto Show Event - Lingenfelter Collection!

We are excited to announce our next MPS event! MPS members will enjoy an exciting evening of learning, networking, and fun at the Lingenfelter Collection, one of the most notable car collections in the world! Learn about car collecting as an alternative investment strategy while enjoying a private tour of the Lingenfelter Collection.

Physicians Role in Drug Pricing

Two new drugs, Repatha and Praluent, were approved by the Food and Drug Administration several months ago amid much ballyhoo. Both are antibodies that specifically target PCSK9, a protein which reduces the number of receptors on the liver that remove LDL cholesterol from the blood. By blocking PCSK9’s ability to work, more receptors are available to clear LDL. This novel mechanism was proven safe and effective in clinical trials, lowering LDL cholesterol levels by 40% or more in patients already taking statin drugs. However, powerful treatment comes with a powerful cost-- over $14,000 per year for each patient.

Physician or Salesperson? - The Ethics Behind Patient Donors

Maybe it’s because we have entered the silly season with a full cast of presidential aspirants, but I have recently mulling over the perception of behavioral impropriety. To translate from spin doctor to medical doctor, I mean professional behavior that may not be overtly unethical, but exudes self-interest over patient well-being. In the academic world, full disclosure includes financial interest with potential conflict, disclaimer of previous publications, responsibility for informed consent and approval by the appropriate research committee. In our practices, particularly in the clinic or hospital setting, much focus is on constructing a firewall between the pharmaceutical and the medical-device sales force and medical providers.

Page: 123 4 - All