Master's Thesis: Quality and Lifetime test methods

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Method for evaluation of accelerated cleaning of medical devices

1. Introduction

Elekta manufactures products for stereotactic neurosurgery that is a specialty often used for DBS implantations, brain biopsies, drug deliveries to delicate brain targets, as well as cranial radiosurgery. Leksell Vantage Stereotactic System was introduced for clinical use during 2017.

Medical devices are used in sterile environments and require cleaning before sterilization. For materials such as polymers and anodized aluminum, repeated cleaning can cause wear or deterioration over time. Different cleaning agents impact products in various ways, so Elekta aims to recommend cleaning methods that are suitable for use throughout the entire product lifecycle.

2. Background

Currently, Elekta exposes the product to cleaning and sterilization cycles throughout its intended lifespan, replicating actual use. This process requires significant time and effort due to the time for exposure as well as the variety of cleaning agents and combinations used for medical devices. Consequently, there is a need for an accelerated method for cleaning agent exposure, which could be integrated with subsequent evaluation processes.

3. Problem Statement

• What are current methods available for accelerated cleaning? To be done as literature search, contact disinfector manufacturers, contact different hospital reprocessing sites, cleaning agent manufacturers etc.

• What are some state-of-the-art techniques used for exposing materials for chemicals in order to evaluate compatibility. Typical materials are anodized aluminum, titanium, stainless steel and various polymers. This could be to elevate concentration, temperature, exposure time etc.

• Are there evaluation approaches that can be used on these products to predict deterioration after only a few cleaning cycles? Parameters for evaluation could be anodization thickness, friction, SEM analysis, visual appearance etc.

4. Output

• A standardized method suitable for Elekta sterilizable products to facilitate accelerated cleaning evaluation. This procedure should be compatible with various types of cleaning agents.

5 Who are we looking for?

• Has a preference for Masters-level education, with interests in materials, medical devices, and surface treatment. Responsibilities include laboratory work involving cleaning agents and methods for surface analysis.

6 Practicalities

Location: Stockholm

Start date: Upon agreement