Building Better, Safer Medical Devices

img_0614Technology has transformed medicine. Yet devices can also separate patients from caregivers—and health care from the compassion in caring. And with each new lifesaving tool the opportunity for error is compounded, as well.  It’s a conundrum the U.S. Food and Drug Administration (FDA) recognizes and is hoping to resolve with the help of MedStar Georgetown PFACQS.  

The FDA’s Medical Product Safety Network (MedSun) is an adverse event reporting program working collaboratively with the clinical community to identify, understand, and solve problems with the use of medical devices.  The program was initiated in 2002 as a partnership between the FDA and clinicians and clinical institutions nationwide to try to prevent device-driven medical errors before they occur. 

MedStar Georgetown Model

“More recently, MedSun has wanted to increase patient engagement in their process and they reached out to us for our input,” explains Yasmin Yusuf, MHA, Center for Patient Safety.  

Janet Camp, a representative of MedSun, was invited to a PFACQS meeting, introduced council members to MedSun’s work, heard first-hand the stories of community members—and watched the group in action. 

“She was very impressed and invited us to make a presentation at a MedSun meeting to talk about the development of our PFACQS and our accomplishments,” recalls Mary Herold, BSN, RN, risk management.  “She also asked Sandra Kaus to tell the group her personal story.”

Heart and Soul in Care

Kaus’s own late diagnosis of breast cancer put her on the road as a patient advocate and “change agent.”   As the community co-chair of PFACQS, she is intent on making hospital care a “hopeful experience” for patients, families and the health care team.  “I want to put the heart and soul into this effort.”

Kaus spoke with honesty and humor to an enraptured and hushed audience at the FDA.  “I talked about every aspect of my diagnosis and treatment—the biopsy, the awkward breast MRIs that leave you dangling upside down in the air for more than 35 minutes,” she says.  “I could literally hear some in the audience groan,” Kaus says laughing.

The presentation—and Kaus’s persuasive storytelling—touched the participants.  They understood how significant the patient perspective is to their efforts to improve care—and are now interested in creating their own patient engagement group.

“Mary and I were invited to come back to speak to a group and take them through our process, to tell them how we formed a PFACQS, what we have accomplished and where we are headed,” says Yusuf.  “They are using our council as the model—we’re teaching them how to engage patients in their efforts, how to hear their voices—and how to empower and educate patients, families and health care professionals from across the country.”