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RCOphth Safety Announcement: BSS and Open Systems for Injectable Medicines

13 December 2017

Following reported errors of drug misidentification  in other specialties causing serious harm, when an injectable medication was decanted into an ‘open system’, eg a gallipot, before administration, NHS Improvement has expressed concerns to RCOphth about the widespread practice during cataract surgery of decanting BSS (balanced salt solution) from the infusion bag into a gallipot at the start of the procedure which may then be drawn up and used to re-inflate the eye later in the operation. In addition, concern was raised that BSS kept in a gallipot might pose a risk of potential bacterial contamination.

In response, the College has replied that given the short duration that BSS typically remains in a sterile gallipot during cataract surgery, it does not consider that this practice poses a sterility issue. However there is a potential risk for drug misidentification although no other drug would commonly be placed into a gallipot during cataract surgery. RCOphth has pointed out that BSS is not currently available as a pre-filled syringe and that preparing and labelling of several syringes of BSS at the beginning of each case would be both impractical and potentially wasteful.

It is acknowledged that other injectable re-constituted drugs prepared in advance for intracameral administration, e.g. cefuroxime, acetylcholine, should be drawn up into labelled syringes. With regard to BSS, the College takes the view that, rather than mandating a particular approach, eye units should individually consider and risk–assess the use of gallipots in intraocular surgery, taking into account the risk of misidentification and the need for actions which reduce risk, such as labelling the gallipot, not storing BSS in the gallipot and only using BSS that has immediately prior to use been run into the pot, in the light of their case-mix and local policy.

RCOphth Quality and Safety Group