Possible lapse in cleaning and disinfection procedures at Regional Fertility and Women's Endocrine Clinic

EDMONTON – Alberta Health Services (AHS) has today started to notify 141 patients of the Fertility Clinic (the ‘Clinic’) at the Royal Alexandra Hospital (RAH) that patients who underwent an endovaginal ultrasound in this Clinic between Nov. 14 and Nov. 20, 2017, may be at exceedingly low risk of exposure to blood-borne and sexually transmitted infections.

AHS first became aware of this issue on Nov. 20, 2017, and a subsequent review and investigation was conducted.

AHS confirmed that the root cause was human error related to adhering to AHS’ standards of excellence in Medical Device Reprocessing (MDR).

This includes inconsistent tracking and documentation of the number of reprocessed probes available for endovaginal ultrasounds scheduled from Nov. 14 to 20, 2017, and, overscheduling of procedures.                    

MDR is an essential service within a healthcare setting that includes the provision of safe surgical and diagnostic equipment. This includes procedures for consistent tracking and documentation, and scheduling of procedures – which in this case were not followed properly.

The reason for providing notification of this MDR error to patients and the public is because after a thorough investigation, AHS cannot be certain that all MDR practices within the Clinic during this timeframe were conducted according to our usual high standards, including the way staff tracked and recorded the number of reprocessed probes available for endovaginal ultrasounds scheduled from Nov. 14 to 20, 2017; and the proper cleaning and disinfection of the ultrasound probes used during this timeframe.

AHS concluded that the risk of transmission of any significant infectious agent is near zero.

While it is likely that most patients involved would have had procedures with cleaned and disinfected ultrasound probes, we cannot be absolutely confident about this. As such, and in keeping with AHS values, disclosure of this MDR issue was provided to all impacted patients.

AHS understands this information is concerning to patients and families, and we share those concerns. All Albertans expect to receive safe and quality care in all our facilities and this is an expectation we also share with our patients.

While risk of infection is considered exceedingly low, those who do wish to be tested will be provided with instructions for simple blood and/or urine testing that can rule out infection.

Our immediate focus right now is to provide support to our patients through sharing information, addressing questions and providing reassurance that this MDR error has been fully addressed and solutions implemented straightaway, and poses no ongoing risk to patients.

AHS has reviewed the circumstances and all reprocessing logging requirements and procedures with all Clinic staff, and have put into place a strengthened logging and monitoring process.

In order to prevent this type of error from happening in the future, AHS has:

• ensured that the maximum capacity for ultrasounds is not exceeded by having ultrasound bookings monitored daily by the unit manager;
• placed qualified and certified MDR technicians in the Clinic to perform all reprocessing;
• increased staff education on medical device reprocessing; and
• implemented a new practice that an educator from RAH’s Medical Device Reprocessing Department (MDRD) review the Clinic’s reprocessing standards, confirming staff competency and daily monitoring.

To protect patient privacy and confidentiality, AHS will not be providing any further detail relating to the patients impacted.

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