Transcript Product Recall

What you need to
know as Risk
Manager but are
afraid to ask!
MEDICAL EQUIPMENT MANAGEMENT
EOC/PATIENT SAFETY
COMMITTEE
MEDICAL EQUIPMENT
MANAGEMENT
Program Manager
Equipment
Inventory
Safe Medical
Device Act
Repair Services
Preventive
Maintenance/
Inspection
Equipment
Failure
Procedures
Product/Device
Recall
User/Maintainer
Education
What’s Happening
3/10/08 Jury Awards $40.1 Million after
medical device chars heart.
 Guidant settlement: $195 million for 4,000
claims
 Medtronic Defibrillators: $114 Million
settlement. Estimated 20,000 patients
required replacements.
 Stents, hernia patches, implants…….

What’s happened

ECRI vs. RASMAS
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One Lonely Materials Manager
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Closing the Loop on recalls
Joint Commission Requirements

EC.1.10
The organization ensures a process exists
for responding to product safety recalls by
appropriate organization staff.
Elements of Recall Program
Senior Recall Team
Recall Coordinator
Recall Responders
Pharmaceuticals
Recall Responders
Biomed Devices
Recall Responders
Laboratory
Recall Responders
(Domains)
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Biomedical Devices
Blood Products
Biologics
Engineering/Facilites
Food/Nutrition
Information Systems
Laboratory Products
Medical Supplies
OR Products
Pharmaceuticals
Radiology
Tissue
The Recall Process

Steris System One (SSI) Processor

Did you call together a Recall team?

Remember – The JC requires a process.
If your doing it take credit for it!
More about Steris….

Widely used system in surgery and endoscopy
for sterilization of endoscopes and medical
devices.

FDA actions not based on noscomial events or
strings of infections.

Early February 2010 FDA recommended 6
months for transition.
SS1…latest

FDA required transition to alternative
technology extended 18 months.

April 2010 – FDA announces agreement;
cash rebate or trade-in.

100% credit for SS1 accessories.
Risk Recommendations

Patience for evolving and new technology.

Accurate Inventory of areas with
sterilization/disinfection processes.

Be cautious of Glutaraldehyde!
Cidex vs. Cidex OPA

Cidex (active ingredient glutaraldehyde)

Cidex OPA (active ingredient orthoPhthalaldehyde)

Strong recommendation for Cidex OPA…no
environmental controls, no employee exposure
concern, destroys micobacterium TB in 12
minutes.
What now?

FDA directed recall of all Baxter
Colleague Infusion Pumps in US.

Estimated over 200,000 in use.

Recall directed due to “long standing
failure” to correct problems with pumps.
Internal Nosocomial exposures:
Isoflex Mattresses

Isoflex mattress investigation.

Physical plant employee identifies moisture and
possible mold growth on bottom of mattress.
Mattress cont…
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No known patient health effects at time of
investigation.

Investigation involved representative
sample of mattresses from several
facilities. 156 mattresses were inspected.
Mattresses cont…
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Results…..47 affected!

Cladosporium and aureobasidium primary molds
identified. (Cosmopolitan and bathroom molds).

Moisture source determined to be moisture
vapor condensation. Patient was determined to
be source.
Mattresses cont…
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Conclusions:

Moisture staining most prevalent issue limited
evidence of mold growth.
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Action: new cleaning, laundering (mattress
sock), applications of fungicide and monitoring
plan to include removal of mattresses.
What is Polidocanol?

Remember what you need to know but are
afraid to ask!!
Polidocanol

Considered by many Physicians to be the
safest most effective sclerosing agent with
the least side effects.

The drug was not FDA approved.
So…now we’re thinking Off Label,
informed consent right?
Polidocanol
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Problems:
Drug is no longer manufactured in the U.S.
Physicians are importing drug to personal
residences or Offices.
Importation of non FDA approved drugs is
illegal.
Administration of imported non FDA approved
drug to Medicare patients is Federal Crime.
Polidocanol Alert
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FDA approves: Asclera (Polidocanol
Injection) Summer, 2010

First sclerosant to be approved in 60
years!
Radiation Safety

Understanding the Computed Tomography
controversy!
Computed Tomography

Estimated CT’s account for 6,000
additional cancers per year

Rapid increase in use of CT Scanning

Crisis in Education and understanding of
Risk for Patients and Physicians
Computed Tomography

CT’s deliver a much higher dose than
common x-rays.

National Academy of Sciences
(government advisor) estimates a typical
CT exam incurs risk of 1 in 1,000 for
causing cancer with 50% mortality rate.
Recent Study at U.S. teaching
hospital (Lee et.al)
74% of referring ED Physicians and 74%
of radiologists underestimated CT’s
radiation dose.
 92% of patients given a CT in the ED
thought the radiation dose was similar to
or at most 10 times that of a regular x-ray.
 What’s the answer?
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Answer:
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A typical CT exam delivers a radiation dose between 100
and 400 times that of a single chest x-ray!
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CT’s simply present higher risks to patients than wrong
site surgery or surgical burns.
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Joint Commission Sentinel Event: “Radiation therapy
resulting in 25% greater dose than anticipated.
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Media attention, American College of Radiology, FDA
What are the regulatory limits for
patient doses?
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The NRC sets a regulatory limit for annual occupational
exposure to radiation. However, there are no regulatory
limits for patients receiving doses from medical
procedures.
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Medical Practitioners are responsible for keeping doses
as low as reasonably possible.
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Special risk for pediatric patients
What can we do:
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Understand doses. Displayed values on
scanners is the Dose Length Product
(scan preparation and calibration).

This is not the effective dose. (age, body
dimensions etc.)
Typical Doses
Head CT: 75 mGy
 Ab CT:
30 mGy
 Ped Ab:
20 mGy
 Chest CT: 25 mGy
 Brain Perfusion: CT: <500 mGy
 Anything above 500 mGy is very, very
high!
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Additional Risk Considerations:
Ensure technologists are trained to
understand references doses for typical
exams.
 Must be empowered to question doses or
patient concerns (more than one CT
recently?)
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CT Continued
Have CT’s been evaluated by Health
Physicist? Meet them.
 Consider QI Project:
 Are doses on scanners?
 Laminated Cards?
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Additional Risk Considerations:
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Consider accreditation (ACR)
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Encourage physicians to ask, “what other
diagnostic tool is available?” before
scheduling routine CT exams.