It’s no secret that technology is useless without a real-world application for it.
Laparoscopic surgery can speed patient recovery times, lower complications, and allow doctors an unprecedented view inside body cavities. As minimally-invasive techniques have evolved, so has the complexity of the corresponding medical devices used in surgical procedures. Laparoscopic instruments are intricate, produced by craftspeople using computer-aided design, analysis tools, and specialized testing laboratories. And from a quality perspective, they must stand up to both demanding surgical techniques and standards of practice for cleaning and sterilization.
In recent years, healthcare facilities have had to answer to public concern over those standards of practice. A number of high-profile audits of traditional medical equipment following hospital-acquired infection cases revealed significant bio-burden in medical devices.
Without question, among the primary factors in improving patient outcomes is establishing and enforcing rigorous cleaning protocols for reusable medical devices. One of the advances that not only safeguards patients but also promotes improved working conditions for surgical staff and healthcare technicians is the growth in use of laparoscopic instruments that can be taken apart, cleaned, and visually inspected prior to sterilization.
Examples of instruments that are available in the market in take-apart form are scissors, graspers, dissectors, and clamps. These devices generally consist of three components: a shaft, an insert, and a handle. Assuming the insert can be removed from the shaft, visual inspections down the lumen are possible.
What To Look For
In facilities where as many as tens of thousands of instruments per day are in circulation for back-to-back procedures, and turnover in technicians can be high, the competent staging and efficiency of the cleaning operation is crucial, and successful outcomes are key to patient safety. Here are some things to keep in mind when considering working with take-apart instruments:
Take-apart instruments should promote ease of staff training and successful reuse. Some lines come with intuitive and easy-to-grip dual release buttons that aid assembly and disassembly while preventing the instrument from inadvertently disengaging. In some lines, secure reassembly after cleaning can be assured with the addition of visual markings and audible clicks to minimize the possibility of human error.
Take-apart instruments should be designed with reprocessing in mind. Prior to the advent of take-apart instruments, the interior of an instrument shaft would typically be inspected using a digital scope. Following protocols, discovery of any bio-burden would have triggered a repeat of the series of earlier cleaning steps recommended by the instrument manufacturer. The best quality outcomes for Central Sterile Technicians in reprocessing the equipment properly the first time will come with clearly stated validated reprocessing instructions for use (IFU). Proper understanding of the IFU can be gained through partnering with the company’s product consultants and securing all the necessary training.
Take-apart instruments should provide flexibility for Central Sterile Processing to process assembled or unassembled. This versatility of sterilization validation has multiple advantages in preparing sterile containers for the OR. When assembled, the equipment trays can be arranged with instrumentation according to surgeon preference in advance, saving valuable time in the OR and ensuring surgeon and nursing focus on the patient, versus assembling instruments. However, some hospital protocols stipulate using one handle for multiple instruments, so sterilization in a disassembled configuration is sometimes preferred. Having the flexibility to sterilize in assembled or disassembled configurations is ultimately the most valuable, as most hospitals or surgical centers will need to use both approaches in a typical day.
Take-apart instruments should be ergonomically sound. Cleaning attributes are paramount, but take-apart instruments should not sacrifice ergonomic comfort and functional versatility. Properly designed ergonomic instruments can reduce instances of intra-operative hand fatigue and temporary digital nerve compression by cushioning and evenly distributing thumb pressure in the contour of the ring handle. They may also be insulated to reduce direct exposure to conductive metal surfaces. Furthermore, they should be versatile in providing connectors for clamps, dissectors, and graspers, allowing for adjustments in the OR.
What Does The Future Hold?
The industry is working hard to address patient safety and improve patient outcomes. The Food and Drug Administration, which oversees medical devices, and organizations like the Association for the Advancement of Medical Instrumentation (AAMI) are working diligently to issue and promote guidance on visual inspection, which may ultimately lead to regulatory action.
For now, healthcare facilities need to build in all of the safeguards they can and work with device manufacturers to ensure that validated reprocessing IFU are clarified and well understood. The best way to stay on track is to select instruments that are easy and intuitive to use and assemble from a partner who will provide all of the service you require in working effectively with the latest advances in instrument design and functionality.