Compliance News: ECRI's Top 10 Health Technology Hazards for 2011

By David Stymiest, PE, FASHE, CHFM


Emergency Care Research Institute (ECRI) recently published a Health Devices guidance article entitled “Top 10 Technology Hazards For 2011” listing ten sources of potential danger that ECRI believes warrant the greatest attention in 2011 for protecting patients and staff. The article, available on www.ecri.org, provides detailed guidance for each of the following issues.

1.  Radiation Overdose and Other Dose Errors during Radia­tion Therapy* - Stating that this can take the form of deliver­ing the wrong dose, treating the wrong site on the patient, or treating the wrong patient, ECRI included specific recom­mendations for support, training, installation, commissioning, maintenance, procedures, oversight, and implementation of corrective actions. 

2.  Alarm Hazards* - Discussing alarm-related adverse incidents typically involving staff being overwhelmed by the number of alarms, alarm settings not being restored, and alarms not being properly relayed to ancillary notification systems, ECRI made specific recommendations for examining the entire alarm environment, establishing protocols for settings and response, implementing and monitoring policies to control alarm silencing, modification, and disabling. 

3. Cross-Contamination from Flexible Endoscopes* - Stat­ing that patient cross-contamination from improperly repro­cessed flexible endoscopes has affected large groups of patients at both large and small hospitals and can lead to life-threatening infections, ECRI recommended using, periodical­ly reviewing, training staff on, and monitoring compliance with detailed model-specific reprocessing protocols.

4. The High Radiation Dose of CT Scans* - Stating that the high radiation doses generated during computed tomogra­phy (CT) are believed to increase the patient’s risk of cancer, ECRI recommended educating referring physicians, monitoring and auditing radiation levels used in routine CT exams, ensuring adequate staff training, optimizing and controlling x-ray parameters (protocols), and investigating applicability of technologies designed to reduce x-ray dose.

5. Data Loss, System Incompatibilities, and Other Health IT Complications* - ECRI stated that the convergence of medi­cal technology and health information technology (HIT) is be­coming more commonplace and presents many benefits as well as many risks. ECRI also discussed FDA information that adverse events largely can be grouped into the following four categories: 1) errors of commission; 2) errors of omission or transmission; 3) errors in data analysis; 4) incompatibility between multivendor software applications and systems.

Based upon this, ECRI recommended carefully planning convergence-based projects with initial input from all involved parties, carefully wording contracts, using good project man­agement, change management, and risk management pro­cesses, educating staff on recognizing, reporting and docu­menting HIT-related problems, with appropriate software management, cybersecurity, testing, and the increased im­portance of help desk calls.

6. Luer Misconnections* - ECRI stated that tubing and catheter misconnections can be harmful to patients because they can allow gases or liquids to be introduced into the wrong lines or by unintended routes of administration, with the risk of such misconnections heightened when two func­tionally dissimilar devices each use Luer connectors. ECRI rec­ommended periodic training about misconnection prevention, prohibiting the use of adaptors, ensuring that only products in­corporating misconnection safeguards be used, identifying and managing conditions and practices that may contribute to healthcare worker fa­tigue, requiring tracing of all lines by clini­cal staff at specific times, and finally la­beling certain high-risk catheters so that staff can clearly see that they are making a connection to one of these devices.

7. Oversedation during Use of PCA Infusion Pumps* - Stating that the most significant danger when using patient-controlled analgesic (PCA) pumps is potentially life-threatening oversedation, ECRI recommended developing an ac­tion plan to implement effective physiologic monitoring of pa­tients on PCA therapy, reviewing how patients on PCA therapy are assessed by clinicians, considering implementing a policy on independent double-checking, and considering implement­ing other forms of pain management, instead of PCA, where ap­propriate.

8. Needlesticks and Other Sharps Injuries* - Stating that the number of needlesticks and other sharps injuries that occur each year remains staggering, ECRI recommended assessing inju­ries and current practices, defining specific objectives, establish­ing an action plan, implementing a full program, and periodically assessing the program’s effectiveness.

9. Surgical Fires* - Stating that ECRI’s research indicates that there are approximately 600 surgical fires per year in the United States, close to the same amount as wrong-site surgery, ECRI referenced its ECRI Health Devices October 2009 Guidance Ar­ticle and recommended implementing a surgi­cal fire prevention and management program, including training and implementing new clini­cal recommendations on oxygen delivery.

10. Defibrillator Failures in Emergency Resuscitation Attempts* - ECRI stated that failure of defibrillators to perform effectively may result in the death of a patient who could have been saved, and recommended ensur­ing that those responsible for using a defibril­lator perform the supplier’s recommended check list at least daily; verify that the installed battery is charged and that a spare battery is kept with the unit; verify that between uses the unit (or charger) is plugged in and batteries are charging. ECRI also provided detailed recommendations on actions to be taken if there are self-test failures, performance failures or error codes.

*Note: Read the entire ECRI article at www.ecri.org to obtain full details and recommendations on each topic listed above, including problem descriptions with numerous detailed recommendations supplemented by a list of resources that can be used by organizations to address the issues effectively.