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Features / October 4, 2023

Amalgam separators

by Jane Renehan

Jane Renehan on amalgam seperators

Jane Renehan provides the answer to another reader’s question regarding dental amalgam separators.

The question – Dear Jane…

This query is in relation to dental amalgam separators and the regulations. My local authority contacted me recently requiring that I complete a self-declaration questionnaire and return it along with specific documentation. Can you clarify what steps I should take to be compliant? 

The answer

The EU Mercury Regulations (SI No 533 of 2018) are based on environmental rather than healthcare regulations. This is why the local authorities are the competent authority appointed for monitoring compliance requirements of dentists and dental premises in their area. 

Each practice must complete and return a self-declaration questionnaire to their local authority. If you are the owner of a number of premises, you may have to deal with more than one local authority. 

Dentists and dental practice owners are legally obliged to prevent release of dental amalgam waste into the environment. Failure to comply with the regulations may result in a criminal prosecution.

The Dental Council published Code of Practice regarding: Dental Amalgam (July 2018). This is essential reading for practice owners, dentists and responsible persons. 

A copy of this booklet should be maintained in the practice compliance waste management folder. 

From 1 January 2019, operators of dental premises in which dental amalgam is used or dental amalgam fillings or teeth containing fillings are removed must ensure that their facilities are equipped with amalgam separators for the retention and collection of amalgam particles.

Regulatory oversight

As is always the case with compliance, written proof of your adherence to the regulations is essential. Relevant documentation should be held centrally in your waste management folder. These records must be accessible when required by an inspector. 

Your local authority may ask you to provide the following:

  • Hazardous waste collection receipts for the past few years
  • Maintenance records for the last few years covering each amalgam separator installed
  • Records of retention levels for each amalgam separator for the past few years.

Retention levels

Since 1 January 2021, all amalgam separators in use must provide a minimum retention level of at least 95% of amalgam particles. The regulations require that amalgam separators must not drop below this retention level. 

The manufacturer’s operator manual for your suction motor will detail the precise visual checks and functional servicing that should be carried out.

Manufacturers usually recommend that your suction unit is serviced annually by a suitably qualified dental engineer. Check your user manual; identify what is recommended for your particular suction unit. 

Written proof of the tasks carried out at the time of the annual service should be sought from the dental engineer. You will need this document to demonstrate compliance with the regulations.

The manufacturer’s user manual routinely advises that regular in-practice checks are carried out on the levels in the waste amalgam collector vessel. Any routine testing of the audio and visual alarm systems on the suction unit should be documented. Carrying out the manufacturer’s recommended actions should maintain the unit in compliance with the EU standard.

Your manufacturer may advise that an amalgam collector vessel will need changing at least once per year. The levels of waste found in the collector vessel may vary from surgery to surgery. Particular attention is required when the suction unit motor is shared between a number of surgeries. 

I advise that the collector vessel on a suction unit should be visually checked by the operator two or three times per year. 

Be aware that treatments provided by dental hygienists can generate amalgam particles. So do not assume that a dental hygienist’s suction unit will not require a maintenance schedule.

Some practices have a sedimentation separation amalgam separator retrofitted to existing suction pumps. The fitting of this type of single-use cartridge must be done by a suitably qualified individual. In this situation, you should have a written service arrangement with an authorised collection and disposal service. The waste collector cartridge must be replaced at least every year or sooner, if required. 

Careful monitoring of the retention levels in this type of unit is critical to maintaining it within the EU standard.

Compliance folder

It is good practice to have a written waste management policy that is specific to your premises. This document will give an overview of practice procedures on managing the risk and non-risk healthcare waste generated at your facility. 

It is good practice to have a centralised practice waste management folder to keep your waste records to hand. Maintaining practice waste amalgam compliance records in the same location as the other waste documentation is recommended. 

For each suction unit, it is advisable to hold the following in the waste management folder:

  • The manufacturer’s operator manual
  • Local operating procedures setting out when and how the suction unit should be routinely checked
  • Instructions on how to change the waste amalgam collector vessel. Include guidance on how to securely store the removed collector vessel prior to collection
  • Correspondence relating to your agreement for ongoing service provision by your nominated authorised waste collection company
  • A log-sheet of the in-surgery visual checks on each suction unit. Record the date and name of individual who checked the suction motor and amalgam separator
  • Installation report for amalgam separator units put into service from 1 January 2018
  • Service and maintenance reports for amalgam separator units from 1 January 2019
  • Where relevant, written proof of a dental engineer’s removal and safe disposal of an old suction unit.

In circumstances where practices produce no waste amalgam particles (such as an orthodontic practice), it is advisable to undertake a written risk assessment setting out the justification for not installing an amalgam separator. File this document with your waste management policy or safety statement.

Be inspection ready!

Dentists and practice owners should be aware of their legal obligations under the EU mercury regulations. 

Maintain all suction units in compliance with the EU standard by following the manufacturer’s instructions. 

Keep all records, correspondence and other relevant documentation relating to waste dental amalgam in one location. 

The local authority for your area is the oversight body and is authorised to monitor your compliance either by requesting sight of your documentation or by carrying out an announced or unannounced practice inspection.

Dentists and dental practice owners are legally obliged to prevent direct and in-direct release of dental amalgam waste into the environment. Failure to comply with the EU mercury regulations may result in a criminal prosecution. 

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