“Look Alike Medical Devices” Presenter: Megan Adey, CRM Hospital: Apollo

“Look Alike Medical Devices”Presenter: Megan Adey, CRMHospital: Apollo 30-31 August Brisbane

Clinical Governance Process Overview • Incident reported through the AIMS system • Potential SAC score 1 actual 3 • Identified by the Patient Safety Coordinator (responsible for AIMS) • Referred to the Incident Review Panel (IRP) who triaged the investigation to the Medication Safety Sub-Committee (MSSC) • Tabled at the Medication Safety Sub Committee • TGA and Department of Health notified • Investigated • Findings and recommendations reported to the IRP and the Drug & Theraputics Committee (MSSC reports to the DTC) • Incident Review Panel chaired by the General Manager • General Manager issued an alert and withdrawal of the device

The Incident • Patient was on a planned progressive regimen of drug therapy using a pump • The patient received a dose of medication in two (2) hours • Dose written up as over forty-eight (48) hours • Family and patient worried about the effects this would have on current treatment and further treatment • Medical Officer caring for the patient reviewed patient and discussed the out come with the patient and the family • No harm incurred or disruption the drug regimen

Reporting of the incident formally • Obstacles and barriers • The incident was reported on the AIMS system in November 2005 • The incident was referred to the appropriate committeess for management progression and resolution • The TGA did not make a recommendation to the manufacturer that the product should be redesigned despite the warning that came with the alert that this device could cause serious harm and or death if the users were not aware of the product information • TGA sent an alert about this device in September 2005 following a different report to them containing instructions regarding the differences • This alert was not distributed to the appropriate persons at the hospital

Incident Review Process and key findings • An RCA was not undertaken but a formal investigation was conducted by the Chair of the MSSC and the PSC • Pump X was only used in a particular specialty ward for a particular medication and particular patients • These patients could ambulate freely with the pump in situ • The ward required new pumps and filled out an order for 2 pumps • The order was written by the CNM who ordered the previous pump • The order was sent by the Business Manager throught the shared stores pathway (the hospital shares a stores process with another hospital-capella) • The pumps arrived and were delivered to the ward • The receiving clinician noted they were different and pushed them to the back of the cupboard and educated the staff accordingly • November 2004 a different clinician needed a pump all otheres were in use and took the pump from the back of the cupboard and the medication was delivered

Key findings and recommendations • On investigation it was discovered that the pumps were named both Lplus and not the same or similar to the pump used before. • Lplus delievered medication in mls per hour • L1 delivered medicatiojn in mls per 24 hours • Lplus has a blue background • L1 has a dark purple background • The rate is in LCD and not very distinctive • Neither pump had been used since they were ordered

L1 and LP

Old and new pumps

OUTCOME and Recommendations Once the investigation was completed a formal report was sent to the General Manager (and Chair of the IRP) Recommendations 1. Remove the pumps out of circulation and replace with syringe driver pumps that have good clear labelling 2. Request to the TGA for a new alert and torRecommend to the manufacturers to change the labelling and design 3. A pathway is set up to ensure any TGA alerts are disseminated to all clinical areas 4. Review the current ordering system for medical devices-clinicians to order and Directors to sign off • Recommendations completed {No 1 immediate} • Reccomendation 2 was not taken up by the company or the TGA

Shared learnings Look alike devices are not uncommon and present a real risk • Often little visible differences • Difficult to read labelling • Instructions hanging from pumps are an infection control risk • SUGGEST • Strong labelling • Store away from similar devices • Brief instructions on the outside of the storage facility • Ordering medical devices • Make sure the process is clear • Ensure that the users fill out the purchase requisition and that they check the brochures and information about new models

Shared learnings • Review your equipment ordering process, who does it , who checks • What happens when a device is delivered • Is it matched to the product description ? Who does this the orderer ofr the receiving clinician • Who is responsible, who signs off? • Is there a dedicated person that receives equipment • What happens to that equipment • Are education sessions conducted -? Do staff have time to ‘fiddle’ and play with it • Does it need louder brighter labelling ? • What process is in place to rectify incorrect delivery? • How many people are in that pathway? • Can that pathway be streamlined?

What were the key events • New device ordered some time after the old one • New product on the market • Orderer queried about the model • Not a clinician and ordered the incorrect device • The receiving clinician recognised the mistake but did not know what pathway to follow to rectify the mistake • Pumps stored in ward area new staff unaware of problem and failed to identify the potential for error • IMPORTANT • Conduct a risk assessment on all new products and if you cannot reduce the risk of error with labels or other means send it back and order another safer product

“Look Alike Medical Devices” Presenter: Megan Adey, CRM Hospital: Apollo