Ophthalmological surgeries Handpieces: special points of attention

1. The MHRA concerns

Between 2017 and 2020, the UK Medicines & Healthcare products Regulatory Agency (MHRA) received several reports concerning external substances found inside the eyes of ophthalmic surgeries patients. All the subjects had been treated with a phacoemulsification procedure.

Different particles were detected either during or after the surgery. The investigation conducted by the UK competent authorities connected these particles to various sources such as:

• Crystalline material;
• Organic matter;
• Fibers;

Further investigation from Manufacturers provided evidence that the source could be the surgical handpieces utilized during phacoemulsification extractions.

Throughout the cycle of clinical use and decontamination, several substances can be captured by the medical devices, consequently entering in contact with the patients ‘eyes.

Adding to this, the handpieces’ processing and transport phases may also contribute to the particles (especially from an organic and crystal origin) being trapped into the mentioned devices.

Contact with the human eye may lead to several post-operative infections, including Toxic anterior segment syndrome (TASS) and Endophthalmitis.

2. The MHRA response

Considering the concerns raised by the upper mentioned reports, during 2020, the MHRA worked side by side with several high-volume handpieces manufacturers, focusing on the products intended for phacoemulsification (also known as phaco handpieces). The main objective of this joint work was to minimize the risks associated with improper cleaning procedures and decontamination processes of these medical devices.

To ensure phaco handpieces undergo proper cleaning and decontamination processes, the MHRA is working side by side with the relevant manufacturers, updating the devices’ Instructions for use (IFU) and amending them under the latest safety and performance regulatory requirements for CE marked devices.

In addition, further investigations clarified that the utilization of proper cleaning chemistries and techniques of pre-cleaning (flushing) could actively reduce the risk of particles being lodged within the devices.

3. The MHRA Actions

To ensure safety in ophthalmological surgeries, the MHRA took extensive action regarding the acquisition, utilization, and incident reporting procedures for phaco handpieces.

Referencing the Health Technical Memorandum 01-01: Management and decontamination of surgical instruments (medical devices) used in acute care Part B: Common elements, the MHRA provided extensive advice on the relevant devices.

A renewed attention has been put on:

• The involvement of commercial, cleaning, and clinical experts in the pre-purchase process;
• A proper review process of the devices ‘cleaning instructions before the purchase phase;
• The importance of ensuring that all the consumables, including processing chemicals, are compatible with the relevant phaco systems.

Regarding Manufacturers ‘responsibility, the MHRA encourages the production organizations to:

• Focus on proper standard operating procedures (SOPs) for reprocessing, stating documented approval for products and an escalation process;
• Provide local training plans to appropriately instruct the staff responsible for pre-cleaning, decontamination, and handling procedures.

In addition, consistent attention has been put on correcting the After-use behaviours. After the utilization of phaco handpieces, the user should:

• Immediately flush the device;
• Bring it to decontamination facilities in the shorter time possible;
• Identify devices that require special cleaning and address their decontamination process accordingly.

Thus, all of these indications are advised to be included in the IFUs for manufacturers selling aforementioned devices on the UK market.

Finally, to prevent the risk of infections on surgery patients, the users have been exhorted to report suspected or actual incidents involving phaco handpieces immediately.

Surveillance will be performed either by:

• The local healthcare institution incident reporting system;
• The national incident reporting authority of England, Scotland, Northern Ireland, or Wales.

Hopefully, the extensive action taken by the MHRA will allow phaco handpieces to be properly decontaminated, avoiding further damages to the UK citizens undergoing cataract-removal surgery.

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Davide Flore 

UK Regulatory Affairs Department

09.12.2021

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References:

• UK. (2014). Managing Medical Devices. Retrieved on 02/12/2021 from https://www.gov.uk/government/publications/managing-medical-devices

• UK. (2021). Handpieces used in the phacoemulsification technique of cataract removal: need for careful cleaning (DSI/2021/009). Retrieved on 02/12/2021 from https://www.gov.uk/drug-device-alerts/handpieces-used-in-the-phacoemulsification-technique-of-cataract-removal-need-for-careful-cleaning-dsi-slash-2021-slash-009

• UK Department of Health. (2016). Health Technical Memorandum 01-01: Management and decontamination of surgical instruments (medical devices) used in acute care Part B: Common elements. Retrieved on 02/12/2021 from https://www.england.nhs.uk/wp-content/uploads/2021/05/HTM0101PartB.pdf