What You Should Know About Medical Equipment Repair & Inspections

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.

 

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