Preventing Adverse Effects from Medical Devices

1. Preventing Adverse Effects from Medical Devices A Saudi Food & Drug Administration Program January 2008 Tim Ritter, Senior Project Engineer

3. “Intensive Care” • Credit to the artist – Yan Nascimbene • Illustration for an Annals of Medicine article in New Yorker magazine (10.12.07) newyorker.com/reporting/2007/12/10/071210fa_fact_gawande/ • The Checklist by Atul Gawande

4. Intensive Care is Extremely Complicated • Dr. Gawande concludes: Delivery of intensive care has become so complicated that checklists should be developed and followed for each procedure or “action” • He presents a study that determined the average number of actions ICU patients require per 24 hr

5. Actions include • Suctioning a patient • Responding to fibrillation • Programming an infusion pump • How many actions per day??? • . . . . .178

6. How many errors occurred? • Remarkably, nurses and doctors were observed to make an error in just 1% of 178 actions • However . . . that is still 2 errors/day with every patient! • Unknown ─ the percentage of errors that produced an adverse effect

7. Preventing Adverse Effects from Medical Devices • Today, in this workshop, we will look at several technologies and case studies to learn how some of those errors and adverse effects might be prevented • We want to look at failures and errors to identify • equipment that needs repair or modification • supplies and accessories that are defective • the need for user training • problems that should be reported to SFDA

8. Preventing Adverse Effects from Medical Devices Session 1 (45 min) Introduction Tubing and cable misconnections Surgical fires / oxygen-enriched environments* Session 2 (60 min) Reducing infusion pump errors – “smart pumps”** Defibrillators Hospital beds *Printed with Laser Safety handouts **On SFDA MDS Web site

9. Preventing Adverse Effects from Medical Devices Session 3 (60 min) Electrosurgical/surgical diathermy units Imaging equipment Laser safety Questions and discussion

10. Any questions or concerns about: • Aspirators or suction regulators? [2 points] • Hospital electrical or medical gas/vacuum systems? • A technology that is not listed on the program? • How many nurses work in: • Intensive care? Emergency care? • Operating theater? Med/surg? • Emergency care? Pediatrics? • What technology is associated with the most problems/hazards???

11. Top 10 Health Technology HazardsListed alphabetically • Alarm hazards • Burns during electrosurgery/surgical diathermy • Burns during magnetic resonance imaging • Caster failures • Infusion pump programming errors [Number 1] Health Devices – November 2007

12. Top 10 Health Technology Hazardscontinued • Misconnections of blood pressure monitors to intravenous lines • Needlesticks and other sharps injuries • Radiation dose in computed tomography • Radiation therapy errors • Surgical fires

13. Preventing Misconnections of Lines and Cables A Saudi Food & Drug Administration Program January 2008 Tim Ritter Senior Project Engineer

14. Misconnections – Why do they occur? • Patients are connected to an increasing number of medical devices – with so many lines and cables, it’s not obvious which components should be connected • If it can happen it will – many medical devices which should not be connected share a common type of connector (e.g. Luer) or can be connected by using an adapter

15. Misconnection Awareness is Needed • Misconnections are preventable errors – when misconnections occur they often result in severe injury or fatalities • The frequency of misconnections in healthcare is unknown – many misconnections are not reported, especially the “near misses” recognized and corrected before patient injury occurs

16. Classification of Misconnections • Three types of lines in the patient area • tubes carrying liquids • tubes carrying gas • cables • Generally, misconnections involving gas and liquid lines are more severe because they involve direct bodily access routes

17. Misconnection Examples • Cable Misconnections • cable plugged into the wrong jack • cable plugged into the correct jack in the wrong orientation • cable not fully inserted • Outcome: at best a device that does not operate; in some cases, patient burn, equipment damage, electrocution; damage to plug and/or jack

18. Misconnection Examples • Gas misconnections • misconnecting a ventilator breathing circuit • delivering the wrong gas (e.g. N2O instead of Oxygen) • Outcome: serious injury, death

19. Misconnection Examples • Liquid Misconnections • delivering a substance through the wrong delivery route (e.g. enteral solution delivered intravenously, IV medication delivered epidurally) • Outcome: serious injury (sepsis) or death

20. Standards • Few design standards and regulations have addressed known misconnection problems • FDA requires electrode lead wires be protected to prevent connection to AC power sources • Currently almost no standards address the potential for Luer connector misconnections – CEN and AAMI standards are being developed which may restrict the use of Luer connectors to certain types of devices • Exception: ANSI/AAMI ID54 – requires enteral feeding set connectors and associated adapters not be compatible with Luer connectors to reduce the risk of an intravenous connection

21. Opportunities for Misconnection • Misconnecting devices outfitted with Luer connectors – many functionally incompatible devices share this common connector • Breathing circuit misconnections – often facilitated by adapters • Spiking pre-filled enteral feeding bags or sterile water bags with IV administration sets – even though the bags are labeled “not for IV use”, they’re often mistaken for IV fluids • Misconnecting gas or vacuum supply lines

22. What Can Hospitals Do? • Purchase well-designed devices • Develop a multidisciplinary “task force” to perform a hospital-specific misconnection risk assessment – this team should continue to track misconnection reports to identify areas needing improvement and report to SFDA • Alter policies and procedures to reduce misconnections

23. Device Design • Most effective strategy – make it physically impossible to make a misconnection • Locking connectors are preferred – they prevent disconnections and subsequent mistakes upon reconnecting lines • Good design incorporates more than one type of equipment design strategy • However, color coding or labeling are ineffective strategies by themselves – they rely on users to recognize and use prompts

24. Connector Design Examples • Good design – the 3 jacks look similar but have unique pin configurations which only accept the correct connector; jacks are also labeled • An even better design – the plug will only physically mate with one of the jacks; colors and shapes also serve as user prompts

25. Specific Purchasing Tips • Where possible, avoid buying non-IV equipment (nebulizers, pneumatic compression devices, NIBPs) that can mate with Luer connectors • Only purchase enteral feeding sets which do not mate with Luer connectors • Avoid purchasing sterile water and enteral feeding solutions in pre-filled bags which can be mis-spiked with IV tubing sets

26. Work Practices for Clinicians • Trace all lines back to their origins before making connections • Don’t force connections – if it takes a lot of effort to make a connection, chances are it’s the wrong one • Don’t use adapters unless they are clearly required for the application • Make sure you’ve been trained to use a device and its accessories – if unsure, ask for help • Report all misconnections – even near-misses – to SFDA

27. Policy Level Prevention • Encourage reporting of misconnections and ensure these reports are being tracked for trends and problem areas • Provide periodic training about misconnection prevention to all personnel • Conduct pre-purchase evaluations so nurses and clinical engineers can “play” with devices and identify misconnection hazards before devices are acquired • Inspection/maintenance procedures should look for unlabelled jacks or worn connectors

28. For More Information • This slide show summarizes information presented in the March 2006 issue of Health Devices • Guidance Article: Preventing Misconnections of Lines and Cables • Questions? Stephanie Joseph Senior Project Engineer ECRI Institute sjoseph@ecri.org