Source: MHRA / Govb.uk 24.11.21
Residue particles can end up in the patient’s eye. For the attention of decontamination specialists, theatre practitioners and anyone involved with the cleaning and decontamination of medical devices.
Cataract surgery is one of the highest volume types of planned surgery in the UK and the use of phacoemulsification is the method used in most cases. Hospital Episode Statistics (HES) data show that there were over 10,000 phacoemulsification extractions of lenses from 2017 to 2020.
The MHRA has ongoing concerns regarding particulates found in the eye during or following surgery, with the potential to lead to post-operative infection such as endophthalmitis or toxic anterior segment syndrome (TASS). Particles could be caused by several factors including cleaning and environmental issues, for example water quality and/or air filtration in theatre.
This guidance aims to minimise the risks associated with inadequate or improper cleaning and decontamination of phacoemulsification (phaco) handpieces.
In the period from 2017 to 2020 the MHRA received 38 reports of particles found in the eye either during or after surgery. Investigation found that these particles were of various substances such as organic matter, crystalline material, fibres, or pieces of plastic. In most cases it is difficult to determine the source of the particle. However, there is some evidence from manufacturer investigation and published literature to suggest that:
- particles can become trapped as residue in the handpiece throughout the cycle of clinical use and decontamination
- processes such as pre-cleaning flushing, and appropriate cleaning chemistries can reduce the risk of material becoming lodged within the handpiece
- extended time taken to process and transport the handpieces for in-depth cleaning may contribute to organic and crystal particles being trapped and then dislodged into the eye of a patient during subsequent use.
During 2020 the MHRA worked with leading manufacturers of phacoemulsification handpieces to ensure that the cleaning and decontamination instructions supplied with the devices were amended and updated to meet the latest regulatory requirements for safety and performance for CE marked devices.
- Review cleaning instructions before purchase. Ensure that the pre-purchase process involves commercial, clinical (operator and other theatre staff) and cleaning/decontamination experts as set out in HTM 01-01: Management and decontamination of surgical instruments: Part B – Common elements, section 3 Design and pre-purchase considerations.
- Ensure all consumables, including processing chemicals, are compatible with your phacoemulsification system.
Procedures and staff training
- Organisations should have standard operating procedures (SOPs) for reprocessing that include documented approval for products to be used and an escalation process.
- Ensure that staff responsible for pre-cleaning and decontamination and handling these devices have received appropriate training in accordance with the manufacturer’s instructions through a local training plan. Keep an up-to-date log with initial and refresher training intervals.
With close attention to the manufacturer’s most up-to-date cleaning instructions:
- immediately flush phaco handpieces after the end of each use
- transfer them to the decontamination facilities as soon as practically possible
- position the handpiece within the washer and autoclave, using appropriate caskets as necessary
- ensure devices that require special cleaning are identified as such and cleaned appropriately.
Report any suspected or actual adverse incidents involving these devices through your healthcare institution’s local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales.
Managing Medical Devices – see sections 3, 5, 6, 7 and 9.
Additional guidance applicable in England:
- Health Technical Memorandum (HTM) 01-01 – Decontamination of surgical instruments
- Health Technical Memorandum (HTM) 04-01 – Safe water in healthcare premises
- Health Technical Memorandum (HTM) 03-01 – Specialised ventilation for healthcare buildings
- Health Building Note (HBN 13) – Planning and design of sterile services departments
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