Medical equipment manufacturers aim to manufacture the quality and performance of their equipment. To protect human life and ensure efficiency, they must meet stringent specifications. While many factors go into manufacturing a medical device, calibration is integral to any manufacturing process. Even the tiniest discrepancies in raw materials, work processes, or test methods can result in faulty products and some with dangerous side effects.
That’s why equipment calibration is crucial. Manufacturers often perform validation tests on their equipment to maintain quality. These tests measure how well each component in the medication delivery system functions alongside others and if they produce the intended results.
With that in mind, here are five equipment calibrations essential to medical manufacturers:
Table of Contents
Procedures and Instructions:
Equipment manufacturers’ crucial step toward equipment calibration is establishing proper procedures for initial setup, including temperature control and agitation. While manufacturers may provide specific guidelines for each operation, certain basics are required for all equipment regardless of who uses it.
To establish a procedure, manufacturers should record equipment data using standardised formats.
This data should include:
- The type of equipment and its maintenance record
- The calibration of the system
- The equipment’s maximum and minimum operating temperatures
- Its operational speeds and time
After recording data, manufacturers should perform formal sanity checks on the system’s operation to ensure that all inputs are valid. These may include visually inspecting devices such as glass containers, spouts, and needles to ensure they are fully immersed in a fluid and not solid objects such as gravel or another type of solid impurity.
Many industry organisations have established international regulatory standards for medical equipment calibration. These standards ensure consistent results across different countries. While most equipment manufacturers have developed their calibration procedures, it is also important to reference internationally recognized standards.
These standards may be specific to the device type, device model, or region of use. For example, National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body in India that offers accreditation to calibrate and test clinical laboratories.
Records and Documentation:
After performing all the necessary regulatory standards and dynamic testing, there is a need to record the results. Here, during the machine calibration services, keep track of each step of the equipment calibration process. This is important not only for regulatory compliance but also to document the test outcomes and procedures to record what was done.
The step includes documentation of each test run, including the results, equipment serial number, and test date. Individual records may be kept in written reports, digital photos, or other easily accessible forms.
Long-term equipment storage is not good practice and can negatively affect the equipment and its user. For instance, out-of-use equipment will require frequent maintenance and may need replacement parts. The most important thing is keeping records of the regulatory standard test and the results.
After documentation and records, manufacturers should implement the calibration strategy. This step may include training personnel on the technique and providing assistance where necessary. The most significant factor for successful medical equipment calibration is a consistent understanding of the equipment’s operating conditions among staff.
This may require convenient access to equipment via an interoperable network. Technicians and other personnel should be taught how to perform the test procedures safely and accurately. This may require simple training on how to perform the critical steps of equipment setup, testing, and reporting.
After detailed documentation of the calibration process and equipment operation, you’ll need to analyse the results to determine if your equipment performs as expected. Consecutively, technicians and other employees should be analysed to determine where improvements are required.
It may include hiring outside experts to perform Validation Testing or another type of on-site analysis, conducting surveys of employees to identify areas of concern, and conducting equipment inspections to determine the best course of action for needed improvements. Vendors can also be looked at to see if they have any potential conflicts of interest or if their equipment is suitable.
Additionally, conducting a functional test is an essential step during analysis. This is done to assure that the equipment performs as expected when a patient is present. It could consist of adjusting dials, switches, and bottles to ensure patient comfort and safety.
Medical equipment calibration is an essential step in ensuring the safety and reliability of medical devices. This process helps ensure that equipment works as intended by measuring its performance against regulatory standards and other standards-based products.
While manufacturers may provide specific guidelines for each operation, certain basics are required for all equipment regardless of who is using it. To establish a procedure, manufacturers should record equipment data using standardised formats and make an analysis of the work that has been done.