May 25, 2022 admin
Safety of medical devices:
A medical device is defined as “an instrument apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related object, including a component part or accessory, designed for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals, or intended to influence the structure or function of man or other animals” under the US Food Drug and Cosmetics Act (FD&C Act). Sterilization of medical equipment is the chemical or physical process of removing all forms of microbial life and related spores using a variety of procedures, including autoclaving, hydrogen peroxide vapour, radiation, ethylene oxide (EtO) gas, and other processes. Controlling the risk of any procedure utilising semi-critical or critical medical devices that could be harmful to the patient’s health is vital. Due to the high financial expenses of single-use vital medical devices, it is attractive to repurpose single-use items as single-patient: rather than utilising a device only once, practitioners may use it numerous times on the same patient over the course of hours or days. This method also avoids several time-consuming high-level disinfection criteria. To keep the status quo of duodenoscopy treatments in a hospital, potentially infected medical instruments were utilised on a variety of patients in one recorded example. Failure to adequately sterilise important medical devices used in endoscopic procedures such as bronchoscopy, cystoscopy, and duodenoscopy has resulted in multiple MDR pathogen outbreaks, with devastating repercussions for patients.
Reprocessing of medical devices:
Medical devices that can be used to diagnose and treat several patients are known as reusable medical devices. Surgical forceps, endoscopes, and laryngoscopes are examples of reusable medical devices. Reusable devices become soiled and infected with bacteria when used on patients. Reusable devices are cleaned, disinfected, and sterilised to eliminate the risk of infection from a contaminated device. Reprocessing produces a medical device that can be safely used more than time in the same patient, or in more than one patient when the labelling requirements for reprocessing are completely and accurately followed after each use of the device. Reusable medical devices must be properly reprocessed to ensure patient safety. Given the enormous number of such devices in use, the chance of contracting an infection from an improperly reprocessed medical device is minimal, but the potential for infection outbreaks linked to their use remains a major public health concern. Furthermore, infections caused by improperly reprocessed devices are frequently overlooked and not reported to the FDA.
Because poor device reprocessing is rarely explored as a cause of HAI, the number of HAIs linked to it is unknown. Blood, tissue, and other biological material (soil) can be retained in certain types of reusable medical devices if they are not properly cleaned between patient visits. This debris may allow microorganisms to survive disinfection or sterilisation, resulting in Health Care-Associated Infections (HAIs). Inadequate reprocessing can potentially cause tissue irritation from remaining reprocessing ingredients, such as chemical disinfectants. The FDA is working to lower the risk of infection from reprocessed reusable medical devices. FDA, as a public health agency, supports collaboration among all stakeholders, including manufacturers, health-care institutions and personnel, accrediting organisations, professional organisations, standards-setting organisations, and government agencies.
Disinfection or sterilization of medical devices:
Different levels of invasive procedures are involved in operations that breach sterile tissue or regions or mucous membranes in patients. The device’s invasion potential determines the danger of infection and the microbicidal processes that should be performed. Medical equipment is categorised as critical or semi-critical depending on the level of invasion. The US Food and Drug Administration (FDA) has amended the Spaulding categorization to critical, semi-critical, and non-critical depending on the anticipated application of the device. Critical devices, such as sterile tissues, are those that are injected directly into the bloodstream or come into contact with body areas. Most surgical instruments, irrigation systems for sterile instruments in sterile tissues, endoscopes used in sterile body cavities such as laparoscopes, arthroscopes, and intravascular endoscopes, and all endoscope biopsy accessories are among these. Any surgical procedure requires strict adherence to sterile protocols. Dry heat, EtO, formaldehyde, gas plasma, peracetic acid, electron beams, and gamma rays are all common sterilising methods. In the United States, the FDA emphasises that sterilising methods used in device manufacturing settings are governed by 21 CFR Part 820 Quality System (QS) rules. For medical device sterilisation in manufacturing environments, the FDA examines two primary categories of sterilisation technologies: established methods and new approaches.
Instrument disinfection solutions offered by IMAEC Ltd:
IMAEC MEDNTEK Ltd. offers the best chemical disinfectants for medical instrument disinfection. For disinfection of surgical instruments, we offer a triamine based disinfectant Cidaltek ID50 that cleans the organic material, and soil, and disinfects the equipment. It is compatible with metal equipment and prevents rusting. It also has applications in the disinfection of RO membrane. Another disinfectant used for reprocessing scopes or heat-sensitive medical devices is the Cidaltek OPA which contains Ortho-pthaldehyde. It is recommended for endoscope reprocessing by the WHO and CDC. We also provide indicator strips that are used to check the active component of the disinfectant present in the container when using it multiple times.
1.Health, C. for D. and R. (2022, April 4). Reprocessing of Reusable Medical Devices. FDA; FDA. https://www.fda.gov/medical-devices/products-and-medical-procedures/reprocessing-reusable-medical-devices
2.Josephs-Spaulding, J., and Singh, O. V. (2021). Medical Device Sterilization and Reprocessing in the Era of Multidrug-Resistant (MDR) Bacteria: Issues and Regulatory Concepts. Frontiers in Medical Technology, 2. https://www.frontiersin.org/article/10.3389/fmedt.2020.587352
3. Merritt, K., Hitchins, V. M., and Brown, S. A. (2000). Safety and cleaning of medical materials and devices. Journal of Biomedical Materials Research, 53(2), 131–136. https://doi.org/10.1002/(sici)1097-4636(2000)53:2<131::aid-jbm1>3.0.co;2-i