Posted by Reprocessing is a term used to describe a procedure performed on a used device to enable its secure reuse. It also includes testing and reestablishing the functional and technical safety of the employed device, as well as its sterilization, cleaning, disinfection, and associated operations. Medical equipment used repeatedly for patient diagnosis and treatment is known as reusable medical devices. Medical instruments that can be reused include laryngoscopes, endoscopes, and surgical forceps, to name a few. Unlike reusable devices, which can be used again after following the proper cleaning, disinfection, and sterilization protocols, single-use devices are designed by the vendor to be used once.
As a result, MDR defines several obligations and specifications for reprocessing reusable and single-use devices. Reusable medical equipment gets dirty and contaminated with bacteria when used on patients. Reusable devices go through “reprocessing,” a thorough, multi-step process to disinfect and then sterilize them to eliminate any danger of infection from a contaminated device. A medical device can be safely used multiple times in the same patient or several patients if the reprocessing labeling instructions are carefully and correctly followed after every device use. To preserve patient safety, reusable medical equipment must be properly reprocessed.
The Causes
Reprocessing medical devices seem quite simple, but sadly many things can go wrong and leave you with a device that hasn’t been cleaned thoroughly and can’t be sanitized or disinfected. There are reported instances where the IFU for cleaning was not observed, resulting in a device that was not sanitized and an infection linked to healthcare (HAI).
Certain forms of reusable medical equipment may retain blood, tissue, and other biological waste (dirt) if not properly cleaned in between patient uses. Health care-Associated Infections may result from bacteria surviving the subsequent cleaning or sterilizing procedure due to this debris (HAIs). Other negative patient consequences from insufficient reprocessing include tissue irritation from leftover reprocessing components, such as chemical disinfectants.
Who’s Responsible For Repurposed Medical Devices?
The duty of ensuring that reprocessing methods are effective and adhered to falls on the numerous stakeholders involved in this issue. The maker of the medical equipment begins this process. Before a medical device can be lawfully commercialized in the USA, the firm that developed it must submit it for FDA clearance. A reusable device’s creator must demonstrate that it can be properly cleaned and, if necessary, disinfected or sterilized.
How Medical Devices Be Reprocessed?
Medical instruments that can be reused include stethoscopes, forceps, and endoscopes. Reprocessing may involve point-of-use treatment, cleaning, repackaging, top-level disinfection, and sterilization, among other procedures, depending on the categorization of the device. Per the Centers for Disease Control, sterilization and disinfection are crucial for preventing the transmission of infectious germs to patients through medical devices and instruments. The risk of infection decreases, and patient outcomes are enhanced in a healthcare facility by adhering to industry best practices and guidelines for medical device reprocessing.
Semi-Critical Medical Device Reprocessing
During a process, semi-critical equipment may contact mucous membranes or skin that isn’t intact. Laryngoscopes, certain endoscopes, anesthetic equipment, and cystoscopes are a few forms of semi-critical medical equipment. Although semi-critical devices should be clear of germs, a few bacterial spores may still be present. 3 Sterilization is advised for semi-critical devices, and cleaning is required. When sterilization is not an option, high-level disinfection is permissible.
Non-Critical Medical Device Reprocessing
Devices that only make contact with intact skin and not mucous membranes are considered non-critical. Stretchers, blood pressure monitors, and stethoscopes are a few examples of non-critical medical devices. This group of devices needs to be cleaned and, if used by multiple patients, low- or intermediate-level sanitized.
Critical Medical Device Reprocessing
Important equipment directly interacts with the vascular system and other sterile body parts. Necessary medical equipment includes surgical forceps, implants, scalpels, biopsy tools, and urine catheters. Sterilization must come first, then cleaning for crucial equipment. Steam sterilization, sterilization with evaporated hydrogen peroxide, and liquid chemical sanitation are all typical sterilization techniques.
Efficacy of MDRs
The effectiveness of device cleaning and processing in healthcare settings has come under more and more scrutiny. Most of the time, cleaning a gadget begins immediately after usage, removing any obvious contamination close to the point of use. This initial cleaning step greatly influences the succeeding cleaning steps. Cleaning steps must be carefully examined based on information about the device’s clinical use, the likely soil it will face, cleaning procedures, and the diversity of cleaning chemistries used in healthcare settings. Different acid, neutral, and alkaline-based formulations are employed as cleaning agents, but it’s also important to consider the water quality and follow any recommended cleaning techniques. At this step, it’s crucial to consider device compatibility and safety because cleaning is a typical cause of gadget damage.
The general use of these techniques is frequently specified in a device’s design specification but can be constrained by the tolerances needed for heat and even pressure on the materials utilized. Except for the use of UV-based disinfection systems, radiation techniques are not frequently used. For thermosensitive devices, many approved chemicals or chemical-based procedures can be utilized as replacements. In these situations, disinfection and sterilization are accomplished using several chemical procedures, particularly those centered on oxidizing agents. These processes frequently offer advantages over steam sterilization in terms of material suitability, reprocessing cycle time, and cost.
The Bottom Line
Overall, it is urged that producers of reusable devices pay more attention to processing capacity earlier in the manufacturing process and give healthcare institutions clear, written, and verified instructions for usage and reuse. The importance of this component in the regular, safe, and efficient usage of such equipment at these institutions is highlighted by the increased regulatory focus on it, both domestically and internationally. Processing instructions are necessary for device manufacturers’ reputation and financial gain, as well as to meet standard standards. They are also a crucial component of client requirements. The development, testing, and commercialization of sterilization and disinfection procedures follow worldwide and national regulatory regulations. Both these procedures and the usage customs in various nations can differ greatly. To ensure the device is used safely and effectively worldwide, an awareness of these processes will shape the design, risk analysis, and creation of the instructions for usage in the future.