Cleaning and sterilising waste medical instruments containing metal for recovery: RPS 160
Updated 30 October 2023
Applies to England
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This publication is available at https://www.gov.uk/government/publications/cleaning-and-sterilising-waste-medical-instruments-containing-metal-for-recovery-rps-160/cleaning-and-sterilising-waste-medical-instruments-containing-metal-for-recovery-rps-160
This regulatory position statement (RPS) does not change your legal requirement to have an environmental permit for a waste operation to clean and sterilise waste medical instruments containing metal. This applies to both single use and end-of-life multiuse instruments.
However, the Environment Agency will not normally take enforcement action against you if you do not comply with this legal requirement provided that:
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your activity meets the description set out in this RPS
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you comply with the conditions set out in this RPS
In addition your activity must not cause (or be likely to cause) pollution of the environment or harm to human health, and must not:
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cause a risk to water, air, soil, plants or animals
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cause a nuisance through noise or odours
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adversely affect the countryside or places of special interest
1. Activity this RPS applies to
This RPS applies to the cleaning and sterilising of waste medical instruments containing metal coded 18 01 03* (infectious waste). This will allow the waste metal to be sent for metal recovery rather than sent for treatment or incineration. The waste codes after treatment will be 18 01 01 (if sharps) or 18 01 04 (non-sharps).
2. Conditions you must comply with
You must:
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clean and sterilise the waste at the site where it was produced (this includes a site that provides equipment to staff who may then use it off site and return it for sterilisation)
- use a sterilisation plant that has been designed, installed, and serviced following environmental standard ISO 13485:2016 for medical devices - quality management systems - requirements for regulatory purposes
- carry out the sterilisation process following health technical manual HTM 01-01 parts A to E - management and decontamination of surgical instruments (medical devices) used in acute care
- send the sterilised waste to a recovery process at a suitably permitted site that renders it both unrecognisable and beyond use to prevent the waste instruments being illegally reused
- keep records for 2 years to show that you have complied with this RPS and make these records available to the Environment Agency on request
You must not treat more than 1 tonne per day.
3. When you must check back
The Environment Agency intends to review this RPS by 1 August 2026.
The Environment Agency can withdraw or amend this regulatory position before the review date if they consider it necessary. This includes where the activity that this RPS relates to has not changed.
You will need to check back from time to time, including at and before the review date, to see if this RPS still applies.
This RPS remains in force until it is removed from GOV.UK or is otherwise identified as having been withdrawn.
4. If you cannot comply with this RPS
If you operate under this RPS but can no longer comply with it, you must stop the activity to which this RPS relates and must tell the Environment Agency immediately. Email wastetreatment@environment-agency.gov.uk and put ‘Cleaning and sterilising waste medical instruments containing metal for recovery: RPS 160’ in the subject.
5. Contact the Environment Agency
If you have any questions about this RPS email wastetreatment@environment-agency.gov.uk.