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Weighing the Pros and Cons

This article aims to open up discussion on the topic of disposable and reusable medical devices and address some of the implications in using either of these options.

Questions are very often asked within the world of decontamination such as, “Should we be using disposable medical devices instead of reusable?”, “What are the advantages and disadvantages of either type?”, “What are the cost and infection implications?” and “Is it acceptable to re-use disposable devices?”

History

Many years ago everything used on patients would have been reusable, even down to the medical instruments, linen, swabs and dishes. Very little would have been disposed of and we know now that decontamination would have been carried out insufficiently, if at all. This caused the spread of infection and in many instances, death.

Late in the Nineteenth Century hospitals started to reprocess, pack and sterilise most of their surgical items. A ‘cottage industry’ was formed, in which water boilers were commonly used and generally referred to as sterilisers, although they were in fact pasteurisers. These heated water to boiling point for the processing of utensils, instruments, syringes and needles. There were only a limited number of disposable devices available and these were very expensive.

As time progressed and improvements were made in manufacturing, most notably in the plastics revolution, reusable devices started to be replaced with disposables. Opinion on whether this is cost effective, however, is still a topic of conversation today. Some hospitals will risk assess the cost of using disposables instead of reusables as a way of saving money, which has led to some organisations actually reusing disposable items several times. This is not good practise and will be addressed in more detail later in this article.

Many improvements have been made in the decontamination of reusable medical devices and organisations now work to recognised standards, such as ISO 13485. In the UK these standards are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA is a competent authority that employs a notified body to audit departments that reprocess medical devices.

In some instances, however, the risk of infection can mean that it is favourable to use a disposable device. As part of the quality management system departments will monitor and measure the cleanliness of the devices being reprocessed.

Case study

Bioburden and endotoxin testing is carried out on a regular basis and by monitoring the results this will highlight any problems with the cleanliness of the device.

Endotoxin is a toxin lipopolysaccharide, formed by the breakdown of the cell wall of gram-negative bacteria. Bacterial endotoxins can be active even if the bacteria from which they are released are killed.

My personal experience of this happened while I was decontamination lead for a Trust in West Wales, when we were reprocessing speculums for family practice clinics. Results of the bioburden testing, which were carried out over a period of time, showed that speculums were not being cleaned effectively. This resulted in the Trust moving over to using disposable speculums.

Differentiating devices

There really is little difference in appearance between a disposable and a reusable vaginal speculum, except that the disposable speculum is clearly marked for single use.

There is a danger in some organisations of newly qualified doctors using single use devices, especially items such as scissors, and mistaking them for reprocessable devices instead of disposable items. Procedures are set in place within the decontamination unit where, on return by the users, these should be identified and disposed of. There are, however, occasions when this doesn’t happen.

Although progress is being made by manufacturers of medical devices, there are some medical instruments that cannot be produced as disposable. Many orthopaedic sets, for example, are complicated and very expensive to manufacture - disposal after a single use would not be viable.

The everyday ‘knives and forks’ of surgical instruments are more likely to be disposable. These include items such as:
– Burrs
– Diathermies
– Disectors and elevators
– Forceps
– Hooks and probes
– Needle holders
– Retractors
– Scalpels
– Scissors
– Speculums
– Sponge holders
– Suction tubes

Disposable devices will be bulk sterilised a single time as part of their manufacturing process. Ethylene oxide (ETO) and gamma radiation (GR) sterilisation are traditional methods used by manufacturers. Manufacture will take place in a cleanroom, with standards used by a reprocessing department that are in line with ISO 14661 for cleanrooms and associated controlled environments, and the classification of air cleanliness. Disposable devices are marked with a symbol identifying single use.

Reusable devices endure multiple trips through washer disinfectors and autoclaves, and are treated with chemical sterilising agents. The manufacturer of the medical device, in accordance with legislation, must provide adequate reprocessing instruction.

Single use, disposable supplementaries, such as gallipots, kidney dishes and various types of packaging are now widely used in the UK. This enables the decontamination department to concentrate on instrument reprocessing and to provide a faster turnaround.

Questions can be asked as to the impact on the environment when disposing of, rather than reusing, these items. Risk assessments will have been carried out, taking into account not only the cost to the organisation and the effect on the environment, but that also considering the risk of infection present when reprocessing items that are designed for single use.

Reusable versus disposable

In the case of reusable versus disposable plastics the differences are easily identified; it is not always so easy when it comes to medical instrumentation. Disposable scissors, for example, will have a single use symbol etched onto them, thus informing the user that the scissors have been manufactured for one use only.

In the UK, organisations are guided by the MHRA and follow Single-use Medical Devices: Implications and Consequences of Reuse - DB 2006(04) v2.0.

The following is an extract from the foreword of the aforementioned document.

To reuse a single use device without considering the consequences identified in this document could expose the patient and staff to risks that outweigh the perceived benefits of using the devices.

Key points to consider are:

– A device designated as single use must not be reused. It should only be used on an individual patient during a single procedure and then be discarded. It is not intended to be reprocessed and used again, even on the same patient

– The re-use of single use devices can affect their safety, performance and effectiveness, exposing patients and staff to unnecessary risk

– The re-use of single use devices has legal implications

Reprocessing single use devices

The reprocessing and re-use of single use medical devices does happen - even though the MHRA advises against it. Organisations often justify reprocessing by saying it is more economical and has environmental benefits.

Many organisations do not have the budget available to buy disposable devices. In the majority of instances, however, as they are not charged for the reprocessing of the device they will choose to carry on using a reprocessable item. If it can be proved that the device cannot be cleaned effectively and poses a risk of infection, then a decision has to be made by senior management to change to disposable.

There is also the cost of disposing the single use medical device and the impact this has on the environment.

Questions are being raised as to whether the reprocessor of the single use medical device can ensure that the device is safe to use, as in many instances single use devices are reused without adequate evaluation of the increased risks to patients. 

Associated hazards

MHRA’s publication draws attention to the hazards and risks associated with reprocessing and reusing single use medical devices. It covers the legal issues and regulatory requirements of such actions. It also considers the implications of damage to the materials or construction of the device and inadequate decontamination procedures.

Reprocessing single use devices may compromise their intended function. They may not be designed to allow thorough decontamination and re-sterilisation. Reprocessing a single use device may alter its characteristics so that it no longer complies with the original manufacturer’s specification. Any reprocessing may damage or alter it to the extent of making it unsafe to reuse.

If the device no longer complies with the original manufacturer’s specification, then the performance of the medical device may be compromised. Single use devices will not have gone through extensive testing, validation and documentation to ensure that they are safe to reuse; they are manufactured as a single use device and are not intended for re-use.

A medical device made for re-use must work as well as it did on its first use every time it is reprocessed. The manufacturer will validate the device for re-use and provide adequate reprocessing instructions when the device is placed on the market.

Changing to disposables

The following sections detail rationales for swapping from reusable to disposable medical devices, including the potential for cross infection, the inability to clean and decontaminate, residues from chemical decontamination agents, material alteration, mechanical failure, and its intended purpose.

Potential for cross infection

Infection is one of the greatest patient safety concerns associated with re-use. The risk of cross infection may increase due to the inability of the reprocessing system to completely remove viable microorganisms. 

This may be due to design features such as narrow lumens, or the type of material used; for example, whether it is heat sensitive. Removal of viable microorganisms may be incomplete, transferring them to the next patient.

Inability to clean and decontaminate

A satisfactory cleaning process for devices must be able to access all parts of the device to allow complete decontamination. At the end of that process the cleaning agents must also be able to be completely removed. This process should be validated to establish that it will consistently provide results that comply with its predetermined specifications. Examples of device features that make cleaning difficult are acute angles, coils, long or narrow lumens, and specialist surface coatings.

Inadequate cleaning can lead to:

– Prions - These are infectious agents, smaller than viruses. Unlike other pathogens, prions contain no deoxyribonucleic acid (DNA) or ribonucleic acid (RNA). Their only known component is a protein with an abnormal configuration

– Prion diseases - These are fatal and infectious neurodegenerative disorders, with no known immunisation or treatment
Chemical decontamination residue

Some materials used in device manufacture can absorb or adsorb certain chemicals, which can then gradually leach out from the material over time. Disinfectants may be absorbed by plastics and leach out during use, resulting in chemical burns or a risk of sensitisation of the patient or user.

Material alteration

Exposure to chemicals such as cleaning agents and chemical sterilants may cause corrosion and/or changes in the materials of the device. Exposure to elevated temperature or pressure during the sterilisation process may also alter the properties of the device material or cause degradation. Plastics, for example, may soften, crack or become brittle.

Mechanical failure

Some devices may experience stress during each cycle of re-use, leading to fatigue induced failure and fracturing, such as in single use drills, burrs, saw blades and craniotomy blades.

Intended purpose

The intended purpose is the use for which the device is designed, according to the information supplied by the manufacturer on the labelling, in the instructions and/or in the promotional materials. If the device has been manufactured as single use then it is not intended to be reused.

The United States Food and Drug Administration’s (FDA) definition of the re-use of single use medical devices is as follows:

1. Original device - A new, unused single use device.

2. Single use device (SUD) - A SUD is a device that is intended for one use or use on a single patient during a single procedure.

3. Reprocessed SUD - This is an original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient.

4. Supplemental validation submission (SVS) - The Medical Device User Fee Modernization Act (MDUFMA) requires that, in order to remain on the market, certain devices which have already been cleared through the 510(k) process are required to submit validation data regarding cleaning, sterilisation and functional performance. This additional data is referred to as a supplemental validation submission.

5. Validation - Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled. Validation can be divided into process and design validation. Process validation means establishing, through objective evidence, that a process consistently produces a result or that a product is meeting its predetermined specifications. Design validation means establishing through objective evidence that device specifications conform to users’ needs and its intended use.

6. Validation data - Validation data includes cleaning and sterilisation data, as well as functional performance data to demonstrate that a single use device will remain substantially equivalent to its predicate device after the maximum number of times the device is reprocessed, as intended by the person submitting the premarket notification, or 510(k).

Summary

Reprocessable devices - These should be used where instruments are complicated, expensive, difficult to clean and have been manufactured purposely for reprocessing.

Disposable devices - These should be used where the devices are manufactured purposely for single use.

Reprocessable devices of the same type are difficult to clean and therefore likely to spread infection. Using disposable devices aids in the reprocessing time of other hospital instruments and therefore allows decontamination departments to process and return medical instruments to theatres more efficiently.

Reusing single use devices - Single use devices are not manufactured, tested or validated to withstand reprocessing. They should not be used unless a risk assessment has been carried and it can be proved that using the single use device would not have a detrimental effect on the patient.

Author


Georgina Curtis


Georgina Curtis has more than 15 years’ management experience working within the NHS and private healthcare sector decontamination units in the UK. She has worked as a Quality Manager responsible for implementing and maintaining QMS in line with the appropriate standards, and as General Manager taking full responsibility for the running of such departments.

She has considerable experience in the development and implementation of operational standards and guidelines, policies and procedures, and in project managing the installation and commissioning of new CSSDs (Central Sterile Stores Department).

Over a period of time Georgina worked in a hospital in Riyadh, Saudi Arabia, updating internal policies and procedures for a CSSD department. This involved becoming familiar with the AAMI (Association for the Advancement of Medical Instrumentation) standards and other regulatory requirements associated within the workings of Arab healthcare.

After gaining experience in training and assessing in decontamination facilities (this includes dental) GMC Consultancy was formed and provides decontamination management cover, review and implementation of QMS, internal audit quality training and training in decontamination processes.

GMC Consultancy offers CSSD departments in the UK and the Middle East the expertise required to implement a quality management system – in line with ISO 13485 – which involves training staff on how to perform internal audits. Advice and guidance on the setting up of a CSSD is also offered.


Georgina Curtis

Website:
http://www.gmc-consultancy.com

Email:
info@gmc-consultancy.com

Phone:
+44 (0) 7854 368266

info@gmc-consultancy.com
http://www.gmc-consultancy.com
+44 (0) 7854 368266

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