WHY SINGLE-USE INSTRUMENTS?
A single-use medical device is intended for use on a single patient during a single medical procedure and must then be discarded.
With the emergence of new diseases such as Bovine Spongiform Encephalopathy (BSE) and Creutzfeldt-Jakob Disease (CJD), as well as the rise in hepatitis cases over the last decade, decontamination of medical devices has become a major concern. By 1997, 23 deaths from CJD had been recorded in Britain, increasing to 143 by 2004. The number of individuals potentially incubating the disease remains unknown.
A study published in September 2004 by the U.S. FDA confirmed that infectious agents (prions) responsible for these diseases are highly resistant to conventional sterilization methods, even at elevated temperatures. This study highlighted that chemical decontamination procedures could:
Cause darkening of some instruments
Damage carbon content in metals
Corrode gold plating, welded, and soldered joints
Research published in New Science revealed that even routine sterilization above 138°C does not inactivate CJD. Consequently, surgical instruments, endoscopes, and laryngoscopes previously used on infected patients may contribute to the spread of infection. Additionally, a report by the Decontamination Working Group (DWG) identified significant deficiencies in sterilization sites within British hospitals.
Hospital-acquired infections (HAIs) are a critical issue. The Public Accounts Committee estimated over 100,000 cases of HAIs annually in England, costing the NHS £1 billion and causing 5,000 deaths. Inadequate reprocessing of reusable medical devices is one of the contributing factors.
The NHS is investing significantly in improving hospital cleanliness due to rising litigation costs. Public awareness and media influence have also led to increased demand for single-use medical devices.
A 1996 French public study revealed that:
92% preferred single-use products for themselves or their relatives.
60% feared contracting diseases from reusable instruments.
62% were willing to pay for single-use products.
Hospital infections are now the fourth leading cause of death in the United States, following heart disease, cancer, and strokes (Reference: The Hospital-Acquired Bloodstream Infections, Vol. 7 No.2). Given these statistics, single-use medical devices are considered a more effective measure to minimize risks.
Single-use instruments eliminate cross-infection risks as they have never been used on another patient. However, they become contaminated hazardous waste post-use and must be promptly disposed of and incinerated. Guidelines for disposal are available in Safe Disposal of Clinical Waste (Health Advisory Committee, HSC ISBN 07176 26927) and are endorsed by the World Health Organization (WHO).
The environmental impact of single-use versus reusable instruments remains debated. A 1998 report by Bell emphasized that the environmental burden of cleaning and sterilizing reusable instruments should be considered alongside the disposal impact of single-use products.
Concerns exist regarding the quality of reusable instruments after prolonged use. Monitoring and tracking the frequency of reprocessing is complex and costly, requiring significant capital investment, personnel, and overhead expenses. Contracting out reprocessing adds further challenges such as accountability, accessibility, repair/replacement costs, transportation, and audit trails.
While converting to a single-use system may initially increase budgets due to bulk purchases, storage needs, and incineration costs, the long-term savings and reduced risks make it a viable option. Eliminating the risk of fatal diseases justifies the investment in single-use devices. Though not feasible for all surgical procedures, single-use should be adopted where effective alternatives exist.
Single-use devices are not designed for cleaning. Reprocessing them contradicts manufacturer guidelines and poses sterility risks (as stated in the MRHA document DB 2000 (04)).
Reprocessing may cause breakage or impair performance, affecting patient outcomes.
Residues from prior procedures or sterilization agents can cause toxic reactions in patients.
Even if bacteria are eliminated, bacterial endotoxins may persist, posing a serious risk.
Reprocessing can alter the chemical and physical properties of a single-use device, potentially harming patients.
Original packaging ensures sterility. Reprocessing may compromise this protection.
Reusing single-use devices transfers liability from the manufacturer to the reprocessor.
HAIs lead to increased healthcare costs, including compensation claims. Avoiding these risks justifies the use of single-use devices.
Single-use medical devices offer numerous advantages, including convenience, reliability, time and cost savings, and complete sterility. Since they are new for each use, they eliminate the risk of infection. Although challenges exist, the benefits far outweigh the risks, making single-use instruments the preferred choice for ensuring patient safety and healthcare efficiency.