Biomedical Equipment Management includes all aspects in the life cycle of equipment. The pertinent activities include User Requirement Specifications for purchase, negotiations, pre-purchase verifications, purchasing, meeting pre-installation requirements in terms of accommodation and environment, installing, acceptance testing and verifying the performance characteristics, training operators, preventive maintenance through scheduled maintenance both by the operator and technical support teams, optimum use of the equipment for patient reporting, availing maintenance contracts, calibrations, managing breakdowns, change management, decontamination and cleaning, ensuring safety and finally, decommissioning.
Equipment Maintenance forms just one component of equipment management.

The brand name and 3 numbers are generally employed in identifying an equipment. Equipment Model Number, Serial Number and Lab unique equipment ID

The model number is typically located on the front/behind of the equipment or on the cover of the service manual and is provided by the Manufacturer. It is mainly related with equipment’s design. This is important while ordering spare parts.

This is usually found on the data plate as well, is a serialized number (could contain alpha characters) provided by the manufacturer. This number is crucial to device alerts and recalls. Each equipment has its own unique serial number. The AMC/CMC status of your equipment is traced by the manufacturer using this number. Since these numbers are generally located at the back of the equipment, it is recommended that the number is included in the equipment label which is pasted on a prominent part of the equipment. This will enable easy access for placing breakdown/service calls.

Every institution has several equipment which are inventoried and given an asset code number. The administration will track the equipment through this.

URS means User Requirement Specifications. It is important that the user of an equipment -in this case laboratory staff- are included in the decision making process while ordering an equipment. Among the points to be considered while making decisions are: robustness, accommodation and environment requirements (temperature, water, and power supply), design (floor vs bench-top), throughput, user-friendliness, safety, availability of technical support and service contracts, availability of consumables, reagents and spare parts and most of all, cost and the performance specifications.
It is also vital to understand the duration, parts and services included in the Warranty and those excluded. It is ideal to have an URS checklist in every lab which will include at least the above mentioned points. It is the responsibility of the technical team to make the management aware of the specific needs of the lab. The URS will enable this. A good URS checklist can enable a robust system of purchase.

Even before the equipment arrives in the lab, lab should ensure the accommodation and environment needs for the equipment. This is especially important with reference to power supply, climate control, water supply and drainage requirements. Before the installation of an equipment, the lab should verify that the equipment has arrives without any visible damage, all the parts listed in the checklist are available and that the spare parts are supplied as per catalogue.

Every equipment/ testing method will come with performance specifications. The lab has to evaluate if these are acceptable for the use of the lab before a purchase is approved. These are generally the following

  • CV% for precision
  • Accuracy (measured bias) or comparability as r value (measured differences) as slope and intercept
  • Linearity over the measuring interval or analytical measurement range (AMR)
  • Limit of detection (LoD) and limit of quantitation (LoQ or analytical sensitivity)
  • Specificity or interference
  • Reagent or sample (analyte) carryover limits, if applicable
  • Reference interval or decision value (interpretive information)
  • As explained above, the manufacturer makes certain claims with regard to performance specifications; precision and accuracy among others. However, it does not guarantee that it can meet the Quality Specifications set by the lab for each analyte. A test attains fitness of purpose when it meets the Laboratories quality requirements. If the Performance specifications are verified only post purchase, as generally done, it could prove detrimental. Therefore it will be in the lab’s interest to pre-verify suitability of the method, before purchase, as part of the URS. An FDA approved method just means that the claimed performance specification has been verified. It does not necessarily mean that the method performance will be acceptable. The onus is on the lab to understand this and pre-verify the suitability and fitness of purpose of the method.

    Installation qualification (IQ) verifies that the equipment and its subsystems have been installed in accordance to manufacturer’s specifications. It is usually performed by the company’s field representative. The IQ process should be verified by the lab for completion in as much that all the claimed parts and spare parts have been installed or supplied respectively, the requirement of power, water and other requirements are met, all parts are intact and undamaged. It is ideal to make a checklist of the installation criteria upfront and fill it. Generally the equipment manufacturer provides such a list. It should be signed and countersigned by the vendor and the lab.
    OQ (Operational Qualification) is the validation that provides evidence that the instrument operates as expected and confirms that installation was successful. Done by the field representative and lab technicians with training of instrument operations and testing of controls, calibrators and a few patient samples

    Validation - confirmation through the provision of objective evidence that requirements for a specific intended use or application have been fulfilled (ISO 9000). This is the responsibility of the manufacturer. If an in-house test is developed, the onus is on the laboratory to validate the method.
    Verification - confirmation through the provision of objective evidence that specified requirements have been fulfilled (ISO 9000). This is the responsibility of the laboratory.

    Verification is also called Performance Qualification (PQ). Methods/ equipment are generally validated by the manufacturer. However, the claims need to be verified before patient reporting is done by the method. This is because during transportation and handling, testing systems can change significantly.
    ISO 15189, in Clause 5.5 mandates the need for evaluation or verification of methods both before it is used for patient reporting as well as periodically, at defined intervals. At the time of installation, this process is called Acceptance testing. Periodic verifications must be done at defined intervals and as part of Change Control; i.e., if the equipment is moved.

    The claims for precision, accuracy, linearity, reagent or sample (analyte) carryover limits and Reference interval require verification. The details of these are explained in Labs for Life Quality Control Module (Volume 1)

    Equipment training is very important for optimum functioning, avoidance of breakdown, personnel safety. If the operator maintains the equipment well, all of the above become easy. Moreover, in remote areas where technical support is hard to avail, a well-trained operator can use his/her skills to resolve minor breakdowns with or even without remote support and make authorized part changes if adequate spare parts are stored as per the equipment management policy of the lab. New hands should be given induction training before they are authorized to handle costly equipment. Ongoing training and evaluation for staff operating equipment regularly is also mandatory. A training calendar with aspects of training required and hours per topic should be developed at the beginning of the year and diligently followed through. Equipment Maintenance and management should become part of the competency evaluation records of those technicians using different equipment.

    A substance, preparation, or material used to calibrate or adjust a measurement is called a calibrator. A calibrator has a known value which traceable to the SI unit.
    Calibration is the process of verification by comparing the accuracy of a measuring (test) instrument against a reference standard, within defined limits of accuracy and uncertainties, in order to detect, correlate and eliminate, by adjustment of any discrepancy, the test equipment being calibrated.

    Any analytical system, be it an equipment or a reagent, will undergo wear and tear/ deterioration over time. These require readjustment to eliminate the inaccuracy created by the deterioration.
    For calibrating tests calibrators are required. These calibrators should have good traceability for the tests to be readjusted using these. Analyte calibration is generally done by the operator as per the lab protocols.
    For equipment calibration, the readjustments are done using calibrated equipment whose accuracy is traceable through an unbroken chain of comparisons to the SI unit. Equipment calibration is usually done by the equipment manufacturer or authorized agencies. In-house calibrations can be done if trained personnel and accurate instruments are available for the same. In India, the calibration agency has to be certified by NABL which accredits the agency to the ISO standard, 17025. NABL 500, Directory of accredited Calibration Laboratories (free download), gives the names of authorized calibration agencies.

    Every analyte calibration should be followed by Quality Controls. After analytical equipment are calibrated also, verification should be done with quality controls. This is called calibration verification. For non-anytical equipment calibration, a certificate showing the calibrating equipment‘s traceability is required. The calibration certificate also should disclose and uncertainty at different operating levels. For more about this read, the equipment management module of Labs for Life

    Troubleshooting is a form of problem solving, often applied to repair failed products or processes. It is a logical, systematic search for the source of a problem in order to solve it, and make the product or process operational again. Troubleshooting tables for several equipment are available in the WHO equipment Maintenance Manual for Lab Equipment (Free download). Most equipment come with flags to point to the possible cause of error to enable easy trouble shooting. These flags need to be understood and remedial mechanisms followed diligently. It must be clarified by the manufacturer/supplier during training as to what instrument flags and alerts should the lab personnel watch out for. Also, it should be clearly known to what extent/step the equipment troubleshooting can be done by the lab personnel and which snags are to be addressed by the manufacturer only. It is a good practice to put up the error flags as Job Aids beside the equipment

    All equipment with an in-built in software generate data. This data is raw data, when it is an outcome of a measurement. The data can also be for equipment usage (user log), error flags, calibration, QC, results of measurements, etc. The format of files cloud be varied- Excel spreadsheet, ASCII, SAS dataset, text file, etc. For more on this, see the Equipment Management Module of Labs for Life

    Audit trail is a record showing who has accessed a computer system and what operations s/he has performed during a particular period. It is useful for maintaining integrity of data, system security and encouragement of personal accountability.

    SOPs for the equipment operation including policies and procedures for maintenance should be defined in appropriate documents. Keeping good equipment records will allow for thorough evaluation of any problems that arise. Each major piece of equipment will have its own equipment maintenance document. Smaller, commonly used equipment such as centrifuges and pipettes may be managed with an equipment maintenance document.
    Specific processes, flags, key operation guidelines should be displayed as bench aids. It is recommended that there be an overall maintenance and calibration chart for all the equipment in the lab showing the last maintenance and calibration dates and the next due be made. Over and above this, a label should be attached to each instrument indicating as a ready reckoner when the last maintenance and calibration was done and when the next maintenance or service should be performed. For more on this, see the Equipment Management Module of Labs for Life

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