Reusable Medical Devices
This article was originally published in RAJ Devices
Executive Summary
Australian TGA recommendations on the safety of reusable devices
Australian TGA recommendations on the safety of reusable devices
The Australian health minister's Advisory Council subcommittee on therapeutic goods has published a document entitled Reducing the Public Health Risks Associated with Reusable Medical Devices, which provides recommendations on strategies to be adopted by healthcare facilities and health authorities to improve the cleanability of reusable medical devices1. It includes:
- a review of the literature about contaminated reusable medical devices;
- a discussion on design characteristics that create difficulties for cleaning and sterilising;
- a discussion about the important role of central sterilising personnel and the need for education and training;
- guidance on issues to consider when purchasing instruments; and
- information and suggestions about medical device incident reporting and investigation of potential breaches of infection control.
Posted on the Therapeutic Goods Administration's (TGA) website in July 2004, the National Coordinating Committee on Therapeutic Goods’ (NCCTG) document describes factors such as matted surfaces and rough edges on devices as being likely to trap bioburden and debris, and complicate the cleaning process. Amongst the recommendations are some directed at the devices industry, including those on:
- instrument design:
- reusable medical devices need to be designed to enable adequate reprocessing;
- instrument containers need to be designed from robust materials to withstand sterilisation and to protect instruments in transit and storage;
- healthcare facilities and instrument providers need to collectively develop standardised procedures for managing loan sets and privately owned instruments including allowing sufficient time for cleaning and sterilisation; and
- healthcare facilities need to consider implementing programmes to review and decommission superseded medical devices; and
- manufacturers’ instructions for use:
- manufacturers should consider, as part of the design, the ability to disassemble and reprocess the device;
- manufacturers should provide accessory aids to facilitate cleaning, particularly for devices with complex designs;
- manufacturers should ensure the instructions for use are appropriate for Australian context and accompany all devices supplied in Australia;
- suppliers/manufacturers, healthcare facilities and healthcare professionals should ensure personnel receive adequate training on the correct handling of medical devices;
- healthcare professionals using the device should ensure instructions provided with the packaging are not discarded at the point of use and reach the Theatre Sterilisation Services Units (TSSU) and Central Sterilizing Supply Departments (CSSD);
- TSSU and CSSD personnel should incorporate the manufacturer's instructions in the Quality System Controlled Document process for maintenance, as a quality record; and
- perioperative, CSSD and TSSU personnel should report cases of inadequate or inappropriate instructions to the manufacturer or supplier and the TGA.
The document also contains further recommendations for healthcare facilities, healthcare personnel and purchasing departments.
References
1. Reducing the public health risks associated with reusable medical devices, dated May 2004, posted 28 July 2004, www.tga.gov.au