By Matt Tomory
The importance of being ISO 13485:2016 certified has been a popular topic in the medical device service industry for several years. Organizations that commit to the rigorous and costly process are signaling their commitment to operate at the highest possible quality level.
In the clinical environment within medical imaging, there is a standard similar to that of ISO. Radiology, cardiology and other departments which utilize imaging within a hospital or clinic have the option of becoming accredited for radiology practices and quality assurance systems by the American College of Radiology (ACR), the American Institute of Ultrasound in Medicine (AIUM) and the Intersocietal Accreditation Commission (IAC).
Accreditation requires demonstrating adherence to established standards for image quality testing, equipment maintenance, quality systems and that your medical personnel meet standards for interpretation of diagnostic examinations. It also shows you have audited your strengths and weaknesses and have taken any needed corrective actions to streamline efficiencies and operations to better serve patients. You may be unaware, but a portion of the responsibility for complying with these standards is dependent on clinical engineers.
Does this really matter?
More than you think. Patients are highly informed consumers and review performance studies on hospitals and caregivers provided by reporting organizations such as Health Grades and other sites which allow consumers to compare hospitals on many factors such as patient experience, timely and effective care, overall value and the use of medical imaging. Hospitals that don’t follow best-practices for imaging services are often flagged as conducting unnecessary services or missing vital diagnoses. Protecting reputations is just one of the important outcomes of accreditation for radiology departments, in addition to achieving greater efficiencies, operations and potentially reimbursements.
Clinical engineers play a vital role in achieving and maintaining accreditation, covering quality assurance and accountability for several processes and outcomes, including:
Even if your imaging departments are not currently accredited, aligning your teams’ activities with accreditation requirements can help avoid costly mistakes, downtime and other issues that can impact clinicians, diagnostic efficiencies, and patient satisfaction, all of which can impact your hospitals’ quality ratings and potentially insurance reimbursements.
An additional step you can take to protect your team and patients is to always work with repair providers that have proven their commitment to quality by becoming and maintaining ISO 13485:2016 certification. Companies maintaining this level of certification provide many added values non-certified providers cannot such as:
Confidence that medical device repairs are being performed according to well-defined processes, that their partners and suppliers are routinely reviewed and qualified, that a system of continuous quality improvement based upon risk analysis is in-place and that the organization is open to external bodies assessing their entire operations.
Assurance that all aspects of the device are addressed during repair to ensure longevity and safe and effective performance.
Knowledge that short-cuts are not being taken during the repair process, which although may be cheaper, could lead to premature or latent failures or, more importantly, compromised safety or performance.
For more information about certification from ACR, AIUM, IAC and ISO, download our summary of various accreditation programs, a PDF of our Webinar Wednesday on this topic at www.innovatusimaging.com, or email me directly at MattT@innovatusimaging.com.
Matt Tomory is Vice President of Ultrasound for Innovatus Imaging.
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