Can disposable devices be used more than once?

Disposable products in dentistry: can they be used more than once?

Can disposable devices be used more than once?

Paradoxical though it seems, the temptation to reuse disposable products – perhaps after trying to sterilize them – is more frequent than you might think. 

The answer is obviously NO. But do we know why? 

There are many reasons, but in short, we should remember that: 

  • this is a choice that impacts infection control prevention measures in a dental practice, and puts staff at risk
  • it is a breach of EU Regulation MDR 2017/745 currently in force
  • it does not follow the manufacturer’s instructions for use

 

As their name indicates, disposable products and devices are designed and manufactured to be disposed of after a single use by a single user, after which they cannot guarantee the same performance and level of protection and may even increase the risk of cross-contamination. 

Furthermore, single-use devices are NOT designed to be cleaned or sterilized, so reusing them to reduce waste or costs should not even be considered, because reprocessing affects their barrier capacity. These items must be disposed of after each use in accordance with current regulations, which often identify these products as disposable.

Why is infection prevention so important?

Today, particularly after the COVID pandemic, dental professionals should be aware of the risk of infection that even the simplest procedures may entail. This is why prevention and safety protocols must be followed and implemented scrupulously. 

Knowledge of the cross-transmission of infections and the implementation of preventive protocols are key elements to help protect dentists, operators and patients from risks and complications that may be extremely serious. This is therefore a priority that must be acknowledged and put into practice by the staff of all dental practices. 

Adoption of guidelines: the new MDR

Given the importance of this issue, specific regulations and guidelines have been issued over the years for the prevention of infections and thus also for the correct use of disposable devices.   

For the European Union, the new Medical Devices Regulation (EU) 2017/745 or MDR has been in force since 25 May 2017 (with full implementation on 26 May 2021).   

The new Regulation, which is valid in all European Union countries, defines more stringent rules and restrictions that all manufacturers, distributors and dental practices must comply with, with stricter measures for transgressors. This is to offer greater protection for patients and users of the medical devices, guaranteeing greater transparency and information on the devices. 

For dentists and dental clinics, this offers the advantage of an informed choice to ensure safe, tracked and controlled solutions at all times, but it also establishes the obligation to use devices (including disposable devices) in accordance with the guidelines, thanks to more comprehensive information and instructions for use provided by the manufacturer.

Disposable devices: why the information and instructions for use must be understood

The instructions for the safe use of single-use items are not just suggestions. They are important safety indications that manufacturers are obliged to provide.   

They are there because infection control must be a top priority when it comes to medicine and therefore also to dentistry.   

The principle of prevention requires the use of disposable PPE and its disposal after each use. Although this system may initially seem wrong, also in terms of environmental sustainability, its purpose is to ensure maximum safety for operators and patients.   

    

Therefore, also thanks to the new MDR, manufacturers must provide clear and comprehensive information and instructions on the correct use of instruments, in accordance with best practices for infection control and operator and patient safety.   

For their part, dentists are expected to be able to interpret this information and must follow the instructions on all devices used.  

Manufacturers must provide clear information on the use and characteristics of the devices, including through a system of immediately comprehensible pictograms.

do not re-use icon

One example is disposable devices which, in addition to clearly stating all the indications for use in the instructions, must have this pictogram on the packaging to make it immediately clear that the product is strictly disposable and must therefore be used only once and never reused. 

 

Interested in the new MDR? Like to know more?   

Euronda is one of the first Italian companies to obtain MDR certification for all its Medical Devices (class I, IIa and IIb). Read our article on the subject.

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