Letter to the Editor by Sherry K. Markwell to “Enhancing Patient Safety: Factors Influencing Medical Error Recovery Among Medical-Surgical Nurses”

Elimination of Barriers to RN Scope of Practice: Opportunities and Challenges

November 1, 2018

Response by Sherry K. Markwell to “Enhancing Patient Safety: Factors Influencing Medical Error Recovery Among Medical-Surgical Nurses” by Theresa A. Gaffney (September 30, 2016)

With Reply from Authors

Dear Editor:

I am writing in follow-up to an article published in your journal entitled Enhancing Patient Safety: Factors Influencing Medical Error Recovery Among Medical-Surgical Nurses (Gaffney, Hatcher, Milligan, & Trickey, 2016). The authors advocate for error identification and recovery as a means to enhance patient safety. I also would advocate for nurses and healthcare leaders to take an active role in their facility reporting medical device errors to FDA as a means to enhance patient safety at both the national and local levels.

In my experience, hundreds of thousands of medical device issues and events are reported to the Food and Drug Administration (FDA). However, very few of these are reported directly from healthcare facilities or healthcare providers. Most of these reports are submitted from the device manufacturer. Even fewer of these reports relate to a near-miss or potential for harm event because they are not mandatory events to report to FDA. There is room for improvement in the frequency of which front-line staff share their experiences in using medical devices with medical device manufacturers, FDA, patients, and their colleagues in healthcare.

FDA wants to know about medical device events that front-line staff experience, including ones in which there is potential for harm to a patient or a staff member even though these are not required reports. If staff and healthcare leaders do not speak up about the problems and concerns they see, then the root causes which contribute to these problems will remain stagnant and improvement to patient safety will be hindered (AHRQ, 2014).

It is well established that when healthcare leadership sets behavioral expectations and responsibilities, transparency is promoted and an active patient safety strategy emerges (Lewis, 2013). Through the utilization of the facility’s internal reporting system, front- line staff can notify appropriate team members within the facility of a medical device event. Leadership needs to identify and appoint the appropriate team members within their facility to regularly send device reports to FDA.

In addition to providing as much detail about the event and the involved devices in their report, front-line staff should be provided the means and location to save and sequester the device, packaging, and any other devices that may have caused or contributed to the device issue. Consider, for example, that some devices connect to others and work in concert with one another to provide care to the patient. Help your team to identify and understand that there may be more than one device involved in an event.

For information about MedSun, the FDA Medical Product Safety Network (MedSun) visit: http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/default.htm

For information about MedWatch, visit: http://www.fda.gov/Safety/MedWatch/default.htm

For information about Medical Device Reporting regulation, visit:  http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/

Sherry K. Markwell, RN, BSN, MM, CPHRM
Nurse Consultant, Food and Drug Administration
Silver Spring, MD


AHRQ measures patient safety culture in healthcare. (2014). Patient Safety Monitor Journal, 15(7), 8-10. Retrieved from http://search.proquest.com/docview/1542639692?accountid=458

Gaffney, T.A., Hatcher, B. J., Milligan, R., & Trickey, A. (2016) Enhancing Patient Safety: Factors Influencing Medical Error Recovery Among Medical-Surgical Nurses. Online Journal of Issues in Nursing, 21(3), 1. doi: 10.3912/OJIN.Vol21No03Man06

Lewis, R. B. (2013). Safety Culture: Building and Sustaining a Cultural Change in Aviation and Healthcare. Care Management Journals, 14(1), 74-75. Retrieved from http://search.proquest.com/docview/1346648126?accountid=458