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An Overview of Reprocessing of Reusable Medical Devices

calendar02 Dec, 2022
timeReading Time: 4 Minutes
An Overview of Reprocessing of Reusable Medical Devices

Reusable Medical Devices are devices that healthcare facilities or others can reuse to diagnose and treat multiple patients. The devices include endoscopes, surgical forceps, laryngoscopes etc. The Reprocessing of Reusable Medical Devices must be done before using or reusing them to avoid any infection or bacterial spread.

Medical device market and reprocessing in India

The Medical Device Industry in India has increased over time, particularly in surgeries and diagnosis of various health issues. The rapid growth in the same has been made possible due to the advancement of technology and medical science. The idea of reprocessing reusable medical devices has also been an outstanding achievement in providing cost-effective and sustainable health care. The challenge lies in safely and successfully conducting the reprocessing, preventing infection and controlling it, ensuring the safety of the patients and using the resources effectively while keeping the environment in priority.

To reprocess medical devices, the current requirements are based on the devices’ intended use. Critical medical devices are supposed to be sterilized, and semi-critical instruments must be disinfected at a high level. However, fixing a device whenever possible is always preferred to make it safe to use. The devices must be made with such materials and designs that it gets easier to reprocess them.

Reprocessing of Reusable Medical Devices

The Reusable Medical Devices may get contaminated and soiled with bacteria and microorganisms when used on patients. These devices are required to get reprocessed before reusing to avoid any infection. The Reprocessing of Reusable Medical Devices is a detailed and multistep procedure to clean, disinfect and sterilize the Medical Devices. The labelling instructions for Reprocessing of Medical Devices must be appropriately followed after each use and before the reuse by a single or different patient, depending on the labelling instructions and devices. Proper Reprocessing of Medical Devices is extremely important for protecting patient safety. There are three different levels of decontamination for reusable medical devices-

  • General Cleaning
  • Disinfection
  • Sterilization[1]

This kind of medical device may be labelled as single-use, single-patient use or reusable multi-patient use.

Improper Reprocessing of Reusable Medical Devices can lead to problems such as blood retention, tissue retention and debris or soiling some reusable medical devices. The debris may cause the microbes to survive subsequent procedures of sterilization or disinfection, which may lead to healthcare-associated infections, also known as HAIs. The Improper reprocessing of medical devices may also cause severe patient problems, such as tissue irritation. The regulators are taking steps to reduce the risk of infection from reprocessed reusable medical devices.

Places where Reprocessing of Reusable Medical Devices is done

Reprocessing Medical Devices is an essential procedure in providing safety to the patient. Medical device reprocessing is done to remove tissues, blood and other biological elements, kill certain infectious microbes, and make the device safe and sound for the next patient. Reprocessing Medical Devices is time and labour-intensive, and each medical device requires a particular reprocessing system. A group of trained staff performs the reprocessing in various places, which include-

  • Health care facilities
  • Inpatient and Outpatient facilities
  • Medical office suites
  • Standalone provider facilities like ambulatory surgery centres
  • Standalone reprocessing service facilities

Procedure for Reprocessing of Reusable Medical Devices

The Reprocessing of Reusable Medical Devices involved the following steps-

  1. The devices are initially cleaned and decontaminated immediately at the point of use, such as in the operation room, to prevent the contamination of devices such as drying of blood, tissue and other biological debris, germs etc.
  2. After the initial and on-the-spot cleaning, the Medical Device is sent to reprocessing area, where it is cleaned thoroughly.
  3. At last, the Medical Device is either sterilized or disinfected, depending upon the use of the device and the manufacturing material of the same. The device is then stored back or made to use again.

Types of Reprocessing Of Medical Devices

The Reprocessing of Reusable Medical Devices can be done for the following types of Medical Devices-

  1. Reusable medical devices are first supplied as sterile devices to the user and are required to be reprocessed after the first use and before the subsequent use.
  2. Reusable medical devices are first supplied as non-sterile devices to the user and are required to be reprocessed after each use.
  3. Reusable medical devices are meant only to be reused by a single patient and are required to be reprocessed between each use.
  4. Single-use medical devices that are first supplied as non-sterile medical devices to the user must be reprocessed before use.

FDA’s criteria for Reprocessing of Reusable Medical Devices

The medical devices must contain the following criteria while labelling the instructions for Reprocessing Reusable Medical Devices-

  1. Labelling must mention the intended use of the medical device.
  2. The instructions for Reprocessing Medical Devices must advise the users to clean the device thoroughly.
  3. Instructions for Reprocessing Medical Devices must indicate the appropriate microbicidal process for the device.
  4.  The Reprocessing instructions must be technically feasible and must include only the devices and tools that are legally valid.
  5. Reprocessing instructions for medical devices must be comprehensive.
  6. Reprocessing instructions for medical devices must be understandable.  

Conclusion

Earlier, medical devices were made primarily to make the device functional and focus mainly on the clinical user. In contrast, the current market redefines the customers’ requirements and makes medical devices reusable, including all the associated devices available for reprocessing. Additionally, regulations are made where the manufacturers must give detailed prescriptions to follow the reprocessing instructions. Reprocessing reusable medical devices are the most efficient, sustainable and cost-efficient way to treat and diagnose patients.

Read Our Article: When is Import of Medical Devices for Personal Use Allowed?

Snehita Shukla

Snehita has her qualifications in B.Com LLB and LLM, and holds a specialization in Corporate & Financial Laws and Policy. She is hardworking, dedicated and sincere. She has a great command in english and has great problem solving, critical thinking and writing skills which makes her stand out of the crowd. She has a keen interest in legal research work and content writing, she also has a hold in legal research methodology. She loves to take challenges and to explore new topics to research on. She aims to improve her knowledge and skills through her experience.

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