ECRI Institute’s “Top 10 Health Technology Hazards” Part I

News / August 27, 2020

ECRI Institute is an independent, nonprofit research organization that researches the best approaches to improving patient care. Since 1971, ECRI Institute has been producing publications (i.e., Health Devices), reports and materials to help improve the effectiveness, safety, and economy of health services.1 Even though this list was compiled in the spring of 2018, the information remains very important for all healthcare facilities.

Through its comparative equipment evaluations, product ratings, patient safety alerts, and guidance articles, Health Devices provides independent, objective judgment for selecting, purchasing, managing, and using medical devices, equipment, and systems.2

Produced each year by ECRI Institute’s Health Devices Group, the “Top 10 Health Technology Hazards for 2017” list identifies potential sources of danger that warrant the greatest attention by healthcare personnel for the year and offers practical, proven recommendations for reducing those risks and improving patient outcomes. The list reflects the collective judgment of ECRI’s management team about which risks should receive immediate priority. All the items on the list represent problems that can be avoided or risks that can be minimized with the careful management of technologies, personnel and training. The 2017 “Top 10 Hazards” are:

1. Infusion Errors Can Be Deadly If Simple Safety Steps Are Overlooked
2. Inadequate Cleaning of Complex Reusable Instruments Can Lead to Infections (This was #8

on the list just 2 years ago)

3. Missed Ventilator Alarms Can Lead to Patient Harm
4. Undetected Opioid-Induced Respiratory Depression
5. Infection Risks with Heater-Cooler Devices Used in Cardiothoracic Surgery
6. Software Management Gaps Put Patients, and Patient Data, at Risk
7. Occupational Radiation Hazards in Hybrid ORs
8. Automated Dispensing Cabinet Setup and Use Errors May Cause Medication Mishaps
9. Surgical Stapler Misuse and Malfunctions
10. Device Failures Caused by Cleaning Products and Practices

 

The failure to thoroughly clean reusable surgical instruments is a major cause of surgical infections. According to the CDC, surgical infections cost over $57,000 to resolve, result in an additional 11 days of hospitalization, increase the chance of being placed in the ICU by 60% and cause more than 30,000 deaths annually.

ECRI Institute has received reports involving a variety of contaminated medical instruments that have been used, or almost used, on patients. Complex, reusable instruments—such as laparoscopic instruments, Kerrisons, cannulated drills, and arthroscopic shavers—are of particular concern. They can be difficult to clean and then disinfect or sterilize (i.e., reprocess) between uses, and the presence of any lingering contamination on, or in, the instrument can be difficult to detect.3

Medical device reprocessing personnel have always been told that “If it’s not clean, it can’t be sterile” The more accurate statement is that “If it’s not clean, it can’t be safe!” Just because you sterilize a device does not mean that it is safe to use, especially if it is still contaminated with residual bioburden prior to sterilization. A frequent cause of a surgical infection is dead, sterile bioburden that gets deposited into the body from a ‘sterile’ instrument that was not completely clean prior to sterilization.

The following are ECRI Institute’s recommendations to reduce the risk of a contaminated instrument being returned to use and infecting a patient:

1. Verify that both (a) staff responsible for precleaning at the point of use and (b) reprocessing staff has ready access to reprocessing instructions (IFUs) for the instruments they will encounter.
2. For complex instruments in particular—that is, for instruments featuring difficult-to-clean components such as lumens, hinges, cannulated blades, stopcocks, or O-rings—confirm that the reprocessing instructions are comprehensive. This documentation should include:
3. a) Instructions for precleaning the instrument immediately after use.
4. b) Information about any special accessories required for cleaning.
5. c) Information about compatible cleaning agents.
6. d) Instructions for disassembly and reassembly, if applicable (including photos or diagrams).
7. e) Information about the expected time required for each cleaning step.
8. When reprocessing instructions lack this information, contact the manufacturer and request the information needed. If the manufacturer is unable to provide the information, consider purchasing alternative instruments when replacement is required.

When it comes to protecting patients, this is a powerful and important recommendation from ECRI. Healthcare facilities today have an ethical, moral, financial and legal obligation to protect their patients from needless harm. If an instrument supplier can’t, or won’t provide a healthcare facility with the required IFUs, then that facility needs to look for a supplier that will.

1 ECRI web site (https://www.ecri.org )

2 Op.cit.

3 Op.cit.