Repair and Maintenance in Medical Devices

Repair and maintenance are two very important terms in the asset management field. The terms we mentioned are valid not only for medical devices (Orthopedic Drill Power Tools Repair, Saw Power Tools Repair, etc.), but also for all devices and equipment that have a lifetime in our lives.

In fact, the ultimate goal of repair and maintenance is the same:

To achieve the most useful life for the device and equipment we use.

What Is The Difference Between Repair and Maintenance?

Repair is an action we take to return a device to proper operating condition. In other words, it is making the device work again after a malfunction. Maintenance, on the other hand, is the preventive activities applied to both prolong the life of a device and minimize the failure situation.

The Role of Biomedical Units in Hospitals in Repair and Maintenance of Medical Devices

With the development of technologies in medical devices, the number of electronic devices in hospitals has increased. The existence of products that need technical service, in other words, living products, has increased the importance of biomedical units in hospitals today.

The duties of biomedical departments in hospitals can be misunderstood. Some hospitals consider that the biomedical department has the authority and acquisition to repair all medical devices. Sometimes, biomedical units may be exposed to hospital pressure to repair the device with the available facilities due to the high costs that may occur when it is sent to the manufacturer.

What are the Duties of Biomedical Units in Hospitals?

  1. To give an opinion in the preparation of the technical specifications of the medical devices that are considered to be taken into the institution and in the acceptance of the examination of the purchased medical devices. To provide process follow-up of guaranteed devices.
  2. Periodic calibration of the medical devices in use and preventive maintenance and repair of these devices.
  3. Keeping records by accompanying the demo, installation, maintenance and calibration stages of medical devices.
  4. To ensure that the spare parts stock, inventory of medical devices and all information about the devices are kept up-to-date.
  5. To record the use of medical devices by training the relevant personnel.
  6. To take the necessary measures to protect patients and employees from the harmful effects of medical devices, to monitor whether the devices are working efficiently and in accordance with their purpose. To ensure the follow-up of medical device accidents and the implementation of research / development programs on medical devices.
  7. To carry out the necessary studies to ensure that the relevant devices are used by the user in accordance with the standards and in a way that does not pose a threat to the health of the employee and the patient, and that the appropriate materials are used in the appropriate place.
  8. Following the defective devices, ensuring the follow-up of the exit-return processes out of the institution.

Biomedical units in hospitals can only perform maintenance and mini-repairs of the device in accordance with the manufacturer’s instructions.

Why Biomedical Units Cannot Repair Devices in Hospitals?

After production, electrical medical devices must be subjected to EMC and LVD electrical safety tests in accordance with ISO 13485 and CE regulations. In these tests, the manufacturer guarantees that all parts of the device will not change during the life of the device.

In other words, it is very dangerous for patient and user safety to change a circuit or part in the device, considering the cost of part replacement from the manufacturer as high. At the same time, when a spare part is changed that is not suitable for the operating conditions of the device, greater damage may be caused to the device than usual.

For example, orthopedic surgical power tool systems are put into a 134°C steam autoclave to be sterile before each operation.  In other words, all parts of the electrical device must be resistant to this temperature.  If the biomedical units skip this detail and replace a lower quality spare part for less cost, the device may receive greater damage.

In addition, according to the IEC 62353 standard, electrical medical devices must be subjected to leakage current and insulation tests after each repair.

Persons or institutions that will provide technical service according to ISO 13485 should document the following procedures for the validation of technical service processes.

  1. Defined criteria for review and approval of the processes;
  2. Equipment qualification and qualification of personnel;
  3. Use of specific methods, procedures and acceptance criteria;
  4. As appropriate, statistical techniques with rationale for sample sizes;
  5. Requirements for records (see 13485 – 4.2.5);
  6. Revalidation, including criteria for revalidation;
  7. Approval of changes to the processes.

Evaluation of Repair and Maintenance in Medical Devices Blog

Biomedical engineers play a major role in the development of medical devices. However, in order for a biomedical engineer to repair an electrical device, it is necessary to receive training from the production center of the relevant device and to provide mandatory electrical safety tests within the hospital.

Considering that there are hundreds of different medical devices in hospitals, it is not possible for biomedical units to have knowledge of the production processes of all devices. Even if the whole process is mastered, skipping the safety tests that should be done after the repair can cause very serious risks.

The main job of biomedical units is to ensure that a device is operated in a healthy and safe manner from the purchase to the end of the device’s life cycle.

Products such as orthopedic surgical power tool systems with high investment costs; It must be repaired in authorized services for the health of the patient / user and for the hospital not to face unexpected costs.

Repair and Maintenance in Medical Devices

Please check also "Orthopedic Surgical Power Tools - Purchasing Tips"

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References

  • Limble CMMS, 19 April 2021, Know The Difference Between Repair And Maintenance, Link.

  • T.C. SAĞLIK BAKANLIĞI, GİRESUN İL SAĞLIK MÜDÜRLÜĞÜ, DR. ALİ MENEKŞE GÖĞÜS HASTALIKLARI HASTANESİ, 10 Mayıs 2019, Link.

  • IEC 62353 – Tests After Repair of Electrical Medical Devices

  • EN 60601 – Medical electrical equipment and systems

  • ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes

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