# Presentation: 222009

## Safety Steps in Eye Banking

- Ellen Heck, MT, MA, CEBT
- Transplant Services Center
- UT Southwestern Medical Center at Dallas

## Screening

- Sterility

- Asepsis

- Safety

**Notes:**
Combining Screening, Sterilization, and Aseptic Procurement and processing, Eye Banks work to deliver safe, effective, transplantable allografts.

## Screening SafetyDonor Recruitment

- Public Education
- leads to an
- Informed Historian

- Professional Education
- leads to
- Expert Resource

- Consent Process

**Notes:**
Screening safety begins with education on the needs and uses of corneas and sclera.  Interviews with donor family members, care givers, and health care providers allow information gathering on both medical and social histories.

## Consent Process

- Rejected
- (Initial screening with hospital personnel)

- Declined

- Screening
- (in-depth medical/social History & Review approximately 45 questions)

- Rejection

**Notes:**
This information also permits an acceptance or rejection of the potential donor at an early stage in the process.  Initial questions to hospital personnel include things like admitting diagnosis, temps, fluids/blood products, WBCs and any high risk behaviors or infections.

## EBAA Medical StandardsDecember 2001

- D1.120 Contraindications – Tissue from donors with the following are potentially health threatening for the recipient(s) or pose a risk to the success of the surgery and shall not be offered for surgical purposes.
- 2: Death with neurologic disease of unestablished diagnosis

**Notes:**
EBAA medical standards cover many contraindications to donation included those designed to help eliminate possible CJD donors.  The EBAA standard is concerned with both recipient and technician safety.

## EBAA Medical StandardsDecember 2001

- D1.120 Contraindications continued
- 3. Dementia, unless due to cerebrovascular disease, brain tumor, or head trauma.  Donors with toxic or  metabolic- induced dementia may be acceptable pending documentation of consultation with the Medical Director.  The approval of the Medical Director is required.

**Notes:**
In efforts to  eliminating possible CJD donors,  care must also be taken not to severely limit the donor pool by excluding acceptable donors; thus the wording of this standard.  Alzheimer  patients are not candidates, trauma patients may be.  

## Screening questions specific to CJD

- Any progressive change in mental status
- Loss of Memory
- Inappropriate Responses
- Confusion
- Gait changes
- History of
- Human Derived Pituitary Growth Hormone administration
- Dura Mater transplant

**Notes:**
Medical/Social history gathering can be prescribed but is also a skill – to obtain by sensitive yet through questioning the information that is needed.  This slide reviews some of the questions that may be ask.  However, it is realized that some of these symptoms may not be apparent until late in the progression of the disease.  Nevertheless, the question may provide useful information to prevent a possible inappropriate retrieval.

## Screening questions specific to CJD

- Personal or blood relative history of CJD
- Did the deceased suffer from:
- Alzheimer’s
- Seizures
- Brain tumors
- Other neurological disorders

**Notes:**
Our confidence with the diagnosis of Alzheimer’s and our “in the field ability to evaluate this progressive neurologic disorder, makes this a rule out even though we are not suggesting that it is transmissible.

## Physical Assessment

- of the Donor

- Rejection

- Screening

**Notes:**
Physical assessment of the donor is an important tool in the donor profile for risk behaviors and many other signs of disease.  However it is not of value in the CJD situation.

## Physical Assessment

- Testing
- Procurement

- Procurement
- Testing

- Rejection

- Rejection

- Previously unreported findings

- Procedure Deviation

- Review

**Notes:**
 Serology testing is perhaps the most heavily relied upon screening measure for most communicable diseases, but to date, this is not an option with CJD in the donor/transplantation circumstance.  Serology testing may occur prior to retrieval or ,most often, after retrieval.

## Review

- (review of medical chart, history, testing, and all available information)

- Rejection

- Rejection
- Process Deviation (excision error rim size)

- Rejection

- Processing

- Process Deviation (clear zone)

- New History or Testing Information

**Notes:**
Other possible areas where tissue may be rejected occurs with additional review processes during tissue evaluation and processing.  These rejections may be the result of some technical error that occurred or a tissue defect, e.g. too much stress on the rim at separation, or two few endothelia cells.  However it could also be receipt of addition medical/social history information.

## Final Labeling

- Release

- Transplant

- Recall

- Audit

**Notes:**
Before an allograft reaches the release point there may have been as many as 7 points where the graft could be determined unsuitable for transplant.
 Initial review with hospital personnel
Family obtained history
Chart review
Testing
Procurement review
Processing review
Final release review 

## The second safety step:

- Sterility or Sterilization

- Sterility

## Sterility: Safety

- One sterile instrument set per donor
- Outside (conjunctiva) instruments
- Inside (rim separation) instruments

**Notes:**
One set of sterile instruments is used per donor and the instruments are separated by function.  Originally adopted as a bacterial safeguard – the inside/outside instrument use prevents introducing the flora on the conjunctiva into the cornea with the blade or scissors. 

## Instrument Sterility

- Sterile Instrument Kits
- Post donation decontamination
- Rinse instruments and package them moist to return to laboratory
- Arrange one set of instruments per tray
- Sterilize instruments at 132° to135oC for 30 minutes

**Notes:**
To minimize prion survival, instruments are sterilized at increased temperatures in liquid as a decontamination step before additional cleaning.  Notice here on the autoclave recording strip, 135 degrees C for 30 minutes.

## Sterility

- Post donation decontamination continued
- Following sterilization wash instruments and scrub as required
- Check function
- Place in Cidex bath for 30 minutes
- rinse

**Notes:**
This sterilization is followed by more intense washing, a disinfectant, and...

## Sterility

- Post donation decontamination continued
- Place in milk bath for 30-45 seconds
- Rinse with 70% isopropyl alcohol
- Dry
- Lubricate
- Package and sterilize with either ETO or steam with spore test indicator appropriate to method

**Notes:**
Finally another sterilization.  The toll on the instruments is significant and we are working to get a suitable disposable instrument set.  However there are some quality and cost sacrifices associated with this and we do not want to adopt instruments that comprise effective surgical technique so we are continuing to evaluate options.

## The Third Safety Step:  Asepsis

- Asepsis

## Asepsis: Procurement

- Retrieval area (established for each donor)
- In situ
- Establish sterile field
- Don personal protective apparel
- Prep donor
- Sterile instrument kit
- Aseptic technique

**Notes:**
Finally aseptic retrieval is a primary step in controlling contamination of bacteria  or fungus but may do little or nothing for us with prions, other than to limit environmental  or technician exposure.  

## Processing Safety

- Removal/Processing Area
- Laboratory (performed between each donor)
- Clean hood
- Don personal protective apparel
- Establish sterile field
- Sterile instruments
- Aseptic technique

**Notes:**
The same is true in processing except as it may limit any cross-contamination in the laboratory as there is disinfection of surfaces and isolation of instruments.

## Slide 21

**Notes:**
Disinfection is most commonly with 10% bleach and 70% isopropyl alcohol.  This occurs before and after the each use of the hood and only tissue from one donor is in the hood at a time.

## Slide 22

## Processing Safety

- Labeling
- Single Patient Application
- 2 corneas = 2 grafts
- 2 sclera = 2 or 8 grafts

**BATCHING**

**Notes:**
Final utilization/transplantation is somewhat limited in number with a normal maximum of 10 recipients per eye donor.  Other precautions include labeling information,e.g.  Grafts are labeled as not sterile and for single patient use.

## Processing Safety

- graft is not considered sterile
- Is intended for single patient use
- Tamper resistant Seal

**Notes:**
Contains are also sealed with a tamper resistant seal.

## But...

- When the FDA speaks,
- Eye Banks jump!

## Without Safety we could not fulfill our mission !

**Notes:**
But, before the FDA spoke – we were well aware we could not accomplish our mission without safety.

## Slide 27

**Notes:**
And our mission effect thousands both those who give and those who received – and we are conscious of and concerned for both.  Just like these two children, one who received a transplant and one who was the sister of a donor.  We take this mission seriously.