Earlier this month the ECRI Institute published its executive brief on this year’s Top 10 Patient Safety Concerns. The ECRI (formerly the Emergency Care Research Institute) is an independent nonprofit organization that focuses on conducting independent medical device evaluations to advance patient safety and cost-effective health care...

1. The 2020 Top 10 Patient Safety Concerns for
Med Devices
By: Madison Wheeler
Earlier this month the ECRI Institute published its executive brief on this year’s Top 10 Patient
Safety Concerns. The ECRI (formerly the Emergency Care Research Institute) is an independent
nonprofit organization that focuses on conducting independent medical device evaluations to
advance patient safety and cost-effective health care.1 This yearly briefing is intended to support
manufacturers, health care professionals, and other med device organizations to identify and
mitigate risks to patient safety. The report spans safety concerns across all healthcare processes
(the need to standardize safety across a healthcare organization’s entire culture, for example) but
the most poignant for the med device community are sterile processing failures and missed
opportunities to respond and learn from device problems.
The report, which was based on an analysis of more than 3.2 million patient safety events, cites
that patient harm from medical devices occurred in 84 of every 1,000 admissions in one
hospital.2 The ECRI points out that it is critical for healthcare facilities and med device
manufacturers alike to have a comprehensive plan in place for investigating all device-related
incidents. If there is a thorough plan in place, it will allow the appropriate teams to respond in a
methodical way, which will increase the likelihood of gathering useful information and
preventing recurrence. Additionally, the ECRI highlights that initial key steps can sometimes be
missed after a device-related incident if there is no investigation plan in place. Specific details
such as what data logs are kept, how the equipment should be quarantined, and the investigation
of any additional devices which interface with the malfunctioning device can be crucial data
points but are easily overlooked if there are no protocols in place.
The ECRI also warns that device cleaning, disinfection, and sterilization are another huge risk to
patient safety and can result in the most devastating effects if not mitigated. Sterile processing
failures of surgical devices are one of the leading factors in surgical site infections which the
CDC associates with a 3% mortality rate and an estimated annual cost of $3.3 billion to
healthcare facilities and organizations.3 Beyond that, improperly reprocessed instruments can
result in citations from regulatory authorities and investigation from accrediting agencies and
certified bodies. The ECRI recommends establishing and analyzing workflows of sterile
1 ECRI (n.d.) About ECRI retrieved on 03/16/2020 from: https://www.ecri.org/about/
2 ECRI (March 2020) Top 10 Patient Safety Concerns 2020:Executive Brief retrieved on 03/16/2020 from:
https://assets.ecri.org/PDF/White-Papers-and-Reports/2020-Top-10-Patient-Safety-Executive-Brief.pdf
3 CDC (January 2020) National HealthcareSafety Network Patient Safety Component Manual retrieved on
03/16/2020 from: https://www.cdc.gov/nhsn/pdfs/pscmanual/pcsmanual_current.pdf

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processing departments, incorporating thorough quality checks, and providing continuing
education opportunities for all staff involved with the process.
While these are only two of the 10 that the ECRI highlighted for 2020, they are the two risks that
pose the most threat to all involved with the med device lifecycle, from the manufacturers to
patients. If you need help with the sterilization or incident investigation process for your medical
device, EMMA International can help! Give us a call at 248-987-4497 or email
info@emmainternational.com for more details.