What you need to know as Risk Manager but are afraid to ask!

MEDICAL EQUIPMENT MANAGEMENTMEDICAL EQUIPMENT MANAGEMENT

EOC/PATIENT SAFETYCOMMITTEE

MEDICAL EQUIPMENTMANAGEMENT

Program Manager

EquipmentInventory

PreventiveMaintenance/

Inspection

Repair Services

EquipmentFailure

Procedures

Safe MedicalDevice Act

User/MaintainerEducation

Product/DeviceRecall

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

One Lonely Materials Manager

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 RespondersPharmaceuticals

Recall RespondersBiomed Devices

Recall RespondersLaboratory

Recall Coordinator

Recall Responders(Domains) 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 ortho-Phthalaldehyde)

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…

No known patient health effects at time of investigation.

Investigation involved representative sample of mattresses from several facilities. 156 mattresses were inspected.

Mattresses cont…

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…

Conclusions:

Moisture staining most prevalent issue limited evidence of mold growth.

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

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

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?

Answer:

A typical CT exam delivers a radiation dose between 100 and 400 times that of a single chest x-ray!

CT’s simply present higher risks to patients than wrong site surgery or surgical burns.

Joint Commission Sentinel Event: “Radiation therapy resulting in 25% greater dose than anticipated.

Media attention, American College of Radiology, FDA

What are the regulatory limits for patient doses?

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.

Medical Practitioners are responsible for keeping doses as low as reasonably possible.

Special risk for pediatric patients

What can we do:

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!

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?)

CT Continued

Have CT’s been evaluated by Health Physicist? Meet them.

Consider QI Project: Are doses on scanners? Laminated Cards?

Additional Risk Considerations:

Consider accreditation (ACR)

Encourage physicians to ask, “what other diagnostic tool is available?” before scheduling routine CT exams.