Understanding
Barriers To Medical Device Quality
Abstract of a report by the
United States Food and Drug Administration (FDA), Center for Devices and
Radiological Health (CDRH), October 31, 2011 with a purpose to provide a
perspective on the state of medical device quality, as well as the challenges
and opportunities for improvement.
In recent years, a growing number
of patients have suffered from adverse events due to medical devices. To better
understand the reasons for these lapses in quality and safety, the US FDA
conducted interviews with medical device industry thought leaders and FDA
leadership and in parallel analyzed FDA adverse event reports and recall data.
Their efforts revealed that there
are systemic gaps within the medical device industry’s quality approach that
result in these issues. Attempts to improve quality are hindered by challenges
within the industry as well as specific aspects of the Agency’s regulatory
approach. Moving toward greater visibility into device quality and properly
aligning FDA’s regulatory approach will be important to catalyzing industry
movement towards improved device quality. Investment by FDA now in a holistic
quality infrastructure will support a next generation of medical devices that
are as safe and well made as they are innovative.
Executive Summary
This report is the result of an
initiative launched by the United States Food and Drug Administration (FDA),
Center for Devices and Radiological Health (CDRH), as part of an effort to
assess and understand gaps in medical device quality. The work focuses on
marketed product quality assurance, rather than pre-market activities. Its
purpose is to provide a perspective on the state of medical device quality, as
well as the challenges and opportunities for improvement.
The work was conducted with input
from several sources: interviews with internal and external quality experts; a
set of blinded industry interviews, a scan of databases, relevant articles, and
conferences; and an outside press search.
These inputs uncovered several
key facts about marketed medical devices as well as potential catalysts for
quality improvement.
The medical device industry
has enjoyed tremendous growth in both revenues and the technical complexity
of the products that it produces over the past 10-20 years.
Serious adverse event reports
related to medical device use have outpaced industry growth by 8% per annum
since 2001.1
Quality risk is not evenly
distributed across the industry. This reflects the heterogeneity and
complexity of the devices, manufacturers, and use environments. Cardiovascular,
in vitro diagnostic (IVD), and general hospital/surgical devices account for
nearly 60% of adverse events reports. Only 20 of the 1189 active product
codes account for 65% of all serious adverse events reports between 2005 and
2009.
An analysis of root cause data
reveals that failures in product design and manufacturing process control
caused more than half of all product recalls. The root causes of quality
issues are tied closely to device type. Therapeutic area was not as strong a
predictor for recall root cause.
There are seven major
opportunities for improving quality within the industry:
Enhanced operating systems
a. Design and reliability
engineering – specifically, validation of actual product use,
design-for-reliability and manufacturability, and software robustness.
b. Robust postproduction
monitoring and feedback into design and manufacturing that goes beyond base
compliance requirements.1For purposes of this report, the term “serious adverse
events” encompasses death, life- threatening events, hospitalization,
disability, congenital anomalies, and/ or required interventions, and
disabilities. This term should not be confused with the regulatory definition of
“serious injury,” which is defined under the medical device reporting
regulations (21 CFR Part 803.3).
c. Supplier management
processes, particularly in material and process change controls.
Enhanced management
infrastructure
d. Quality metrics and
measurement systems that go beyond regulatory compliance measures.
e. Quality organization
that integrates cross-functionally throughout the organization, rather than
solely focused on compliance.
f. Performance management,
where those in key roles associated with quality outcomes, like design
engineers, are measured and incentivized around quality performance.
Enhanced mindsets and
behaviors
g. Quality culture can be
improved where companies have experienced severe quality-related issues.
• Broadly, companies are
experiencing three key challenges related to improving quality:
a. Low quality transparency,
driven by a lack of information for consumers and decision-makers around
comparative quality (i.e.,quality differences among competitor products), time
to market competition, and cost pressures, limits significant quality upgrades.
However, the economics of quality may be changing as risks and costs of
poor quality increase and transparency into comparative quality increases.
b. Increasing complexity of
medical devices and usage environments is straining the current quality
system infrastructure. Companies report that they have not systematically
upgraded their quality infrastructure due to the unclear economics and concerns
about regulation.
c. Companies perceive that the
regulatory framework is misaligned with assurance of quality outcomes, in
that compliance with regulations does not ensure quality, and that current
intervention practices may de-incentivize improved quality.
• Interviews and analysis also
identified several steps the FDA can take to accelerate momentum around adoption
of quality best practices. These steps should address seven key themes:
a. Focus regulatory
efforts to address industry quality gaps.
b. Enhance visibility of
comparative quality to harness market forces to drive quality.
c. Optimize consistency and
clarity of Agency expectations and requirements.
d. Learn from practices of
regulators of similar high-tech and complex industries.
e. Bolster data collection and
analysis to maximize potential impact.
f. Leverage wealth of Agency
data and analysis to continuously refine FDA’s compliance initiatives.
g. Increase level of engagement
and collaboration with industry around enhancing product quality.
Ref:
http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/
CDRHReports/UCM277323.pdf
|
