Weaving regulations into sound
value analysis processes
Barbara Strain, MA, SM(ASCP)
Director Value Management
University of Virginia Health System
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Learn key healthcare agency resources
Understand the importance of the relevant
guidance documents
Apply resource information to value analysis
processes
Know the role of the VAP in patient safety
New
Devices
Documentation
New Devices
&Drugs
Safety
Quality
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US FDA – Food and Drug Administration
◦ http://www.fda.gov/
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Master guidance resource for devices, drugs,
radiation emitting sources, other
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Expert assistance
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Incident follow up
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CDC Centers for Disease Control & Prevention
◦ http://www.cdc.gov
◦ NIOSH National Institute of Occupational Safety &
Health
http://www.cdc.gov/niosh/
http://www.cdc.gov/niosh/topics/bbp/
http://www.cdc.gov/niosh/topics/bbp/sharps.html
http://www.cdc.gov/niosh/npptl/topics/respirators/di
sp_part/n95list1.html
 http://www.cdc.gov/niosh/topics/latex/
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OSHA Occupational Safety & Health
Administration – US Dept of Labor; code of
regulations (CFR)
 http://www.osha.gov/
 Federal Register e.g. 29CFR Part 1910 Blood Borne
Pathogens
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Introduction of new devices
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evaluations,
use,
research,
manufacturer discussions,
physician discussions
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Assuring Quality
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Creating/Maintaining a culture of Safety
A Medical Device is:
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"an instrument, apparatus, implement, machine, contrivance,
implant, in vitro reagent, or other similar or related article,
including a component part, or accessory”
They range from simple tongue depressors and bedpans to
complex programmable pacemakers with micro-chip
technology and laser surgical devices as well as in vitro
diagnostic products, such as general purpose lab equipment,
reagents, and test kits, which may include monoclonal
antibody technology.
certain electronic radiation emitting products with medical
application and claims meet the definition of medical device.
E.g. diagnostic ultrasound products, x-ray machines and
medical lasers.
Device Classes and Regulatory Controls
 Class I General Controls
◦ With Exemptions
◦ Without Exemptions
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Class II General Controls and Special Controls
◦ With Exemptions
◦ Without Exemptions
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Class III General Controls and Premarket
Approval
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Classification is risk based, that is, the risk the device poses to the patient and/or
the user is a major factor in the class it is assigned. Class I includes devices with
the lowest risk and Class III includes those with the greatest risk.
The class to which a device is assigned determines the type of premarketing
submission/application required for FDA clearance to market. If your device is
classified as Class I or II, and if it is not exempt, a 510k will be required for
marketing. All devices classified as exempt are subject to the limitations on
exemptions. For Class III devices, a premarket approval application (PMA) will be
required unless the device is has been on the market prior to 1976 which in that
case, a 510k will be the route to market.
Device classification depends on the intended use of the device and also upon
indications for use. For example, a scalpel's intended use is to cut tissue. A subset
of intended use arises when a more specialized indication is added in the device's
labeling such as, "for making incisions in the cornea". Indications for use can be
found in the device's labeling*.
* on label use
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FDA has exempted almost all class I devices
premarket notification requirement, It is important to
confirm the exempt status and any limitations that
apply with 21 CFR Parts 862-8927.
If a manufacturer's device falls into a generic category
of exempted class I/II devices as defined in 21 CFR
Parts 862-8928, a premarket notification application
and FDA clearance is not required before marketing
the device in the U.S. However, these manufacturers
are required to register their establishment and list
the generic category or classification name.
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A new 510(k) submission is required for
changes or modifications to an existing
device, where the modifications could
significantly affect the safety or effectiveness
of the device or the device is to be marketed
for a new or different indication for use.
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Class III devices are those that support or sustain
human life, are of substantial importance in
preventing impairment of human health, or which
present a potential, unreasonable risk of illness or
injury. Due to the level of risk associated with Class III
devices, FDA has determined that general and special
controls alone are insufficient to assure the safety
and effectiveness of class III devices.
Premarket approval (PMA) is the FDA process of
scientific and regulatory review to evaluate the safety
and effectiveness of Class III medical devices.
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Class I exempt
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Class I non-exempt
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Class II exempt
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Class II non-exempt
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Class III
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Cotton tip applicator
Heel warmer; transport
media
Wheeled stretcher
IV pump accessories;
antigen reagents
Defibrillator, biologics,
hemodialysis catheters
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An investigational device exemption (IDE) allows the investigational
device to be used in a clinical study in order to collect safety and
effectiveness data.
Clinical studies are most often conducted to support a PMA.
Investigational use also includes clinical evaluation of certain
modifications or new intended uses of legally marketed devices.
All clinical evaluations of investigational devices, unless exempt,
must have an approved IDE before the study is initiated.
Clinical evaluation of devices that have not been cleared for
marketing requires:
◦ an IDE approved by an institutional review board (IRB). If the study involves
a significant risk device, the IDE must also be approved by FDA;
◦ informed consent from all patients;
◦ labeling for investigational use only
◦ monitoring of the study and;
◦ required records and reports.
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Evaluation, Research/IRB or Use
User facility must know what is in use
◦ Safety
◦ FDA approvals
◦ Device/Tissue tracking
 http://www.fda.gov/MedicalDevices/DeviceRegulation
andGuidance/GuidanceDocuments/ucm071756.htm
 Joint Commission: TS03.01.01 - .03
◦ Issue reporting
◦ Recalls
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Assure in-service education
Keep a log
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Problem reporting
◦ Internal- equipment, supplies, accessories
 Before use: foreign body in sterile packaging
 During use: bovie does not fire
 After use: observe brown liquid in basin leaching
out of a blue OR towel
 How to report: manually/electronically
 Saving the effected item
 Assess seriousness, trends, lot#, serial#
 Communicate
 Educate
◦ External
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Contact quality department at manufacturer
Follow instructions
Document
Communicate
◦ FDA reporting:
 Manufacturer and User Facility Device Experience (MAUDE)
“You are encouraged to report all serious adverse events and
product quality problems to FDA MedWatch at
www.fda.gov/medwatch/report.htm”
 MedSun
http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalPro
ductSafetyNetwork/default.htm
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Recalls, Market Withdrawals and Safety Alerts
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Where to find the most up to date info?
◦ http://www.fda.gov/Safety/MedWatch/SafetyInform
ation/SafetyAlertsforHumanMedicalProducts/default
.htm
◦ Subscription services: examples RASMAS, ECRI
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Who, what, when, where, why & how
Institutional policy
Key process owners
Well defined
Automated or manual
Centralized
Accountable
Log
Reporting up through institutional committee
structure
New
Devices
Documentation
New Devices
&Drugs
Safety
Quality