The 2020 Top 10 Patient Safety Concerns for Med Devices

by | Mar 20, 2020 | CDC, FDA, Medical Devices, Requirements

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 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 for more details.

1ECRI (n.d.) About ECRI retrieved on 03/16/2020 from:

2ECRI (March 2020) Top 10 Patient Safety Concerns 2020: Executive Brief retrieved on 03/16/2020 from:

3CDC (January 2020) National Healthcare Safety Network Patient Safety Component Manual retrieved on 03/16/2020 from:

Madison Green

Madison Green

Director of Technical Operations - Mrs. Green serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Mrs. Green also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Mrs. Green holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

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