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Old 12-04-2009, 12:03 PM
flatfish flatfish is offline
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Join Date: Oct 2006
Location: Bacliff, Texas
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Exclamation New DoH guidance on decontaminating lenses CJD AND vCJD

New DoH guidance on decontaminating lenses

December 4th, 2009

New guidance on decontamination of trial contact lenses and other contact devices has been revealed.

The latest recommendations from the Department of Health’s Advisory Committee on Dangerous Pathogens (ACDP) replace previous guidance issued amid fears that Creutzfeldt-Jakob Disease (CJD) and variant CJD (vCJD), the human form of bovine spongiform encephalopathy (BSE, ‘mad cow disease’), could theoretically be transmitted from person to person by contact lenses and other devices such as tonometer heads and diagnostic lenses.

Details were discussed at the British Contact Lens Association’s Pioneers’ Conference in London late in November.

Professor Roger Buckley (pictured), a member of the ophthalmology subgroup of the ACDP’s Transmissible Spongiform Encephalopathy Working Group established to review this advice, told BCLA members at the Royal Society of Medicine that there had been no known cases of transmission of CJD/vCJD resulting from contact lens wear or diagnostic examination, and there was now thought to be a low level of risk of infectivity of the cornea and ocular surface.

Under the new guidance, six steps are required to minimise the risk of transmission via re-used contact devices. The lens or device should be: decontaminated immediately after contact with the eye surface; rinsed in Water for Irrigation BP (not tap water) for not less than 30 seconds; cleaned on all surfaces with a liquid soap or detergent, then rinsed in Water for Irrigation BP for a further 30 seconds; immersed in a freshly-prepared solution of sodium hypochlorite providing 10,000ppm of available chlorine for ten minutes; rinsed in three changes of Water for Irrigation BP for a total of not less than ten minutes; shaken to remove excess water, dried with a disposable tissue, and stored dry in a suitable container.

Any further measure (such as autoclaving) can then be carried out, if this is necessary and if the device is designed to withstand such a process. Otherwise, it is ready for immediate re-use.

Transmissible Spongiform Encephalopathy Agents: Safe Working and the Prevention of Infection: Annex C ANNEX C General principles of decontamination and waste disposal


Ophthalmology The Ophthalmology subgroup met twice in 2008 on 7th April and 20th June to discuss issues relating to CJD infection control in ophthalmology. The following topic groups were identified: 17 • Anterior eye • Posterior eye • Assessment tool • Decontamination of ophthalmic surgical instruments • Examination, diagnostic equipment and contact lenses • CJD incident management Members were assigned to relevant topic groups, and discussions and research were coordinated by a topic group lead. The topic groups then produced draft guidance on their particular areas of expertise towards the end of 2008. Pathology (Annex K) The Working Group drafted guidelines for pathologists and pathology laboratories for the handling of tissues from patients with, or at risk of, CJD. This document (Annex K of the Working Group guidance) is aimed at pathologists and individuals working in pathology laboratories who handle tissues from patients. It aims to ensure that laboratory staff are aware of risk factors for CJD prior to carrying out procedures on tissues. The draft annex was sent out for a limited consultation with representatives from the Royal College of Pathologists, the Institute for Biomedical Sciences, the British Neuropathological Society and the Health and Safety Executive. The Annex was approved by the Working Group at their December 2008 meeting. Annex K has since been published at:

Pre-surgery assessment (Annex J) The updates to Annex J were approved for publication by the Working Group at their February 2008 meeting, subject to some minor adjustments. The Annex was then signed off by the ACDP Chairman and published on 1st May 2008 at:

see full text ;

Friday, July 17, 2009 Revision to pre-surgical assessment of risk for vCJD in neurosurgery and eye surgery units Volume 3 No 28; 17 July 2009


Wednesday, August 20, 2008 Tonometer disinfection practice in the United Kingdom: A national survey


CJD Human Cornea Tissue, Recall END OF ENFORCEMENT REPORT FOR AUGUST 5, 2009 Posted Aug 07 2009 6:32pm


From: TSS Subject: Tonometer prism sterilisation: A local and UK national survey (TSE) Date: August 24, 2007 at 1:24 pm PST

1: Cont Lens Anterior Eye. 2007 Aug 17; [Epub ahead of print]

Tonometer prism sterilisation: A local and UK national survey.

Chandra A, Barsam A, Hammond CJ. West Kent Eye Centre, Princess Royal University Hospital, Orpington, Kent BR6 8ND, UK.

PURPOSE: First to audit local adherence to a protocol of use of an alcohol wipe for each tonometry, and secondly to assess current practice nationally in the UK. METHOD: The audit was carried out at two units: The West Kent Eye Centre at the Princess Royal University Hospital (Orpington, UK) and Queen Mary's Hospital (Sidcup, UK). The standard set for this audit was 100% sterilisation. During a 1-week period in November 2005, the number of alcohol wipes was counted in each consultation room after outpatient clinics, with the doctors being assessed blind to the survey. The number of Goldman applanation tonometry intra-ocular pressures recorded by each clinician was counted by inspection of the medical records of patients seen. Secondly, departments listed in the UK Directory of Training Posts were contacted by telephone and the senior nurse was interviewed. They were asked directly about their department's tonometer prism sterilisation and management. RESULTS: The local audit showed only 54% of tonometry measurements were associated with sterilisation using an alcohol-impregnated wipe. The national survey included 140 of the 152 UK training departments. Thirty-three (23.6%) departments used disposable tonometer prisms routinely. The remaining 107 (76.4%) used non-disposable prisms. Eighty-five (60.7%) departments provided sodium hypochlorite for prism sterilisation, with 69 (81.2%) of these departments providing more than one prism/clinician to allow full exposure to the disinfectant. Twenty-two (15.7%) departments used alcohol wipes. Only 8 (7.5%) of the 107 departments using non-disposable prisms tracked these prisms, despite Royal College of Ophthalmologists guidelines that they should be. These same 8 (7.5%) departments replaced the non-disposable prisms as per manufacturer guidelines. 19.3% of charge nurses were aware of a policy for tonometry in patients with, or at risk of, prion disease. CONCLUSIONS: This study highlights that sterilisation of tonometer prisms was inconsistent in a local audit. Nationally, practices were varied. The majority of ophthalmology departments continued to use non-disposable tonometer prisms, but few seemed aware of the Royal College of Ophthalmologists' recommendation that disposable prisms are used in patients at risk of prion disease, and few track tonometer heads or replace them according to manufacturers guidelines. Use of disposable tonometer prisms would seem to reduce concerns about sterilisation, as well as prevent spread of common pathogens.

PMID: 17703987 [PubMed - as supplied by publisher]



M. Mangieri1, G. Giaccone1, L. Limido1, G. Di Fede1, S. Suardi1, R. Capobianco1, P. Fociani2, O. Bugiani1, F. Tagliavini1 1 Istituto Nazionale Neurologico Carlo Besta, Division of Neuropathology and Neurology 5, Milano, Italy and 2 Ospedale Luigi Sacco, Division of Pathology, Universit* di Milano, Milano, Italy


Creutzfeldt-Jakob disease (CJD) is marked by the presence of the protease-resistant prion protein (PrPres) in the brain. Studies of the retina and optic nerve in patients with CJD are scanty and on very small series of patients. We analysed ocular tissues of sporadic CJD patients (retina of 58 and optic nerve of 51), representing all combinations of PRNP codon 129 polymorphisms and PrPres types by Parchi, except VV1. Ocular tissue from 24 patients with other neurological diseases were used as controls. The ocular tissue was collected at autopsy and the samples were fixed in Carnoy solution or frozen. Before immunohistochemistry with 3F4 antibody, the sections were pretreated with proteinase K and guanidine thiocyanate. In all cases of sCJD the retina showed immunoreactivity for PrPres localized in the inner and outer plexiform layers, with a synaptic type of labelling. No difference in the pattern of labeling was detected between CJD patients with different PRNP codon 129 polymorphisms and PrPres types in the brain. In all cases with frozen retinal tissue available (n = 18), the immunoblot was positive for PrPres . Two out of the 51 sCJD showed the deposition of PrPres also in the optic nerve, corresponding to an immunostaining delineating stellate cells and associated with the presence of numerous CD68- and CD45-positive cells. Our results demonstrate the presence of the pathological form of prion protein not only in the retina of all sCJD cases analysed, but also in optic nerve in a small subset of sCJD patients, a finding previously described only in variant CJD and in experimental animal models. Moreover, our data suggest a correlation between the deposition of PrPres and inflammatory changes in the optic nerve in sCJD.


----- Original Message ----- From: "Terry S. Singeltary Sr." <[log in to unmask]> To: <[log in to unmask]> Sent: Thursday, December 28, 2006 10:23 AM Subject: Ophthalmic Surgery in Prion Diseases

Volume 13, Number 1–January 2007 Dispatch Ophthalmic Surgery in Prion Diseases Tsuyoshi Hamaguchi,*1 Moeko Noguchi-Shinohara,* Yosikazu Nakamura,*2 Takeshi Sato,‡2 Tetsuyuki Kitamoto,§2 Hidehiro Mizusawa,¶2 and Masahito Yamada*2 *Kanazawa University Graduate School of Medical Science, Kanazawa, Japan; *Jichi Medical University, Shimotsuke, Japan ‡National Center for Neurology and Psychiatry, Ichikawa, Japan; §Tohoku University Graduate School of Medicine, Sendai, Japan; and ¶Tokyo Medical and Dental University, Tokyo, Japan

Suggested citation for this article

Abstract Eleven (1.8%) of 597 patients underwent ophthalmic surgery within 1 month before the onset of prion disease or after the onset. All ophthalmologists reused surgical instruments that had been incompletely sterilized to eliminate infectious prion protein. Ophthalmologists should be aware of prion diseases as a possible cause of visual symptoms and use disposable instruments whenever possible.

Visual impairment occurs in 10% to 20% of patients with sporadic Creutzfeldt-Jakob disease (sCJD) during an early stage of the disease (Heidenhain variant) (1,2). Some patients with prion diseases may visit ophthalmologists with visual impairment due to prion diseases or with coexisting age-related eye diseases (3,4).

Infectious prion protein (PrPSc) was identified in the retina and optic nerve in patients with variant CJD (vCJD) and sCJD (5,6), and CJD has been transmitted by corneal transplantation (7,8). In the World Health Organization (WHO) guidelines, eyes were classified as highly infectious tissues (9).

Secondary transmission of PrPSc through ophthalmic surgery could possibly be prevented around the onset of prion diseases, although surgery that is performed long before the onset of prion diseases would not have that potential. It is important to understand the current status of ophthalmic surgery for patients with prion diseases and to clarify the clinical features of the patients with prion diseases who undergo ophthalmic surgery. Here, we describe the relevant data from CJD surveillance in Japan.

The Study.....snip full text ;

----- Original Message ----- From: "Terry S. Singeltary Sr." <[log in to unmask]> To: <[log in to unmask]> Sent: Wednesday, December 27, 2006 12:21 PM Subject: ABNORMAL PRION ACCUMULATION ASSOCIATED WITH RETINAL PATHOLOGY IN EXPERIMENTALLY INOCULATED SCRAPIE-AFFECTED SHEEP

Eye procedure raises CJD concerns

November 19, 2004 United Press International by STEVE MITCHELL

A New York man who died from a rare brain disorder similar to mad cow disease in May underwent an eye procedure prior to his death that raises concerns about the possibility of transmitting the fatal disease to others, United Press International has learned. The development comes on the heels of the announcement Thursday by U.S. Department of Agriculture officials of a possible second case of mad cow disease in U.S. herds.

Richard Da Silva, 58, of Orange County, N.Y., died from Creutzfeldt Jakob disease, an incurable brain-wasting illness that strikes about one person per million.

Richard's wife Ann Marie Da Silva told UPI he underwent a check for the eye disease glaucoma in 2003, approximately a year before his death. The procedure involves the use of a tonometer, which contacts the cornea -- an eye tissue that can contain prions, the infectious agent thought to cause CJD.

Ann Marie's concern is that others who had the tonometer used on them could have gotten infected.

A 2003 study by British researchers suggests her concerns may be justified. A team led by J.W. Ironside from the National Creutzfeldt-Jakob Disease Surveillance Unit at the University of Edinburgh examined tonometer heads and found they can retain cornea tissue that could infect other people -- even after cleaning and decontaminating the instrument.

"Retained corneal epithelial cells, following the standard decontamination routine of tonometer prisms, may represent potential prion infectivity," the researchers wrote in the British Journal of Ophthalmology last year. "Once the infectious agent is on the cornea, it could theoretically infect the brain."

Prions, misfolded proteins thought to be the cause of mad cow, CJD and similar diseases, are notoriously difficult to destroy and are capable of withstanding most sterilization procedures.

Laura Manuelidis, an expert on these diseases and section chief of surgery in the neuropathology department at Yale University, agreed with the British researchers that tonometers represent a potential risk of passing CJD to other people.

Manuelidis told UPI she has been voicing her concern about the risks of corneas since 1977 when her own study, published in the New England Journal of Medicine, showed the eye tissue, if infected, could transmit CJD.

At the time the procedure was done on Richard Da Silva, about a year before he died, she said it was "absolutely" possible he was infectious.

The CJD Incidents Panel, a body of experts set up by the U.K. Department of Health, noted in a 2001 report that procedures involving the cornea are considered medium risk for transmitting CJD. The first two patients who have a contaminated eye instrument used on them have the highest risk of contracting the disease, the panel said.

In 1999, the U.K. Department of Health banned opticians from reusing equipment that came in contact with patients' eyes out of concern it could result in the transmission of variant CJD, the form of the disease humans can contract from consuming infected beef products.

Richard Da Silva was associated with a cluster of five other cases of CJD in southern New York that raised concerns about vCJD.

None of the cases have been determined to stem from mad cow disease, but concerns about the cattle illness in the United States could increase in light of the USDA announcement Thursday that a cow tested positive on initial tests for the disease. If confirmed, this would be the second U.S. case of the illness; the first was detected in a Washington cow last December. The USDA said the suspect animal disclosed Thursday did not enter the food chain. The USDA did not release further details about the cow, but said results from further lab tests to confirm the initial tests were expected within seven days.

Ann Marie Da Silva said she informed the New York Health Department and later the eye doctor who performed the procedure about her husband's illness and her concerns about the risk of transmitting CJD via the tonometer.

The optometrist -- whom she declined to name because she did not want to jeopardize his career -- "didn't even know what this disease was," she said.

"He said the health department never called him and I called them (the health department) back and they didn't seem concerned about it," she added. "I just kept getting angrier and angrier when I felt I was being dismissed."

She said the state health department "seems to have an attitude of don't ask, don't tell" about CJD.

"There's a stigma attached to it," she said. "Is it because they're so afraid the public will panic? I don't know, but I don't think that the answer is to push things under the rug."

New York State Department of Health spokeswoman Claire Pospisil told UPI she would look into whether the agency was concerned about the possibility of transmitting CJD via tonometers, but she had not called back prior to story publication.

Disposable tonometers are readily available and could avoid the risk of transmitting the disease, Ironside and colleagues noted in their study. Ann Marie Da Silva said she asked the optometrist whether he used disposable tonometers and "he said 'No, it's a reusable one.'"

Ironside's team also noted other ophthalmic instruments come into contact with the cornea and could represent a source of infection as they are either difficult to decontaminate or cannot withstand the harsh procedures necessary to inactivate prions. These include corneal burrs, diagnostic and therapeutic contact lenses and other coated lenses.

Terry Singletary, whose mother died from a type of CJD called Heidenhain Variant, told UPI health officials were not doing enough to prevent people from being infected by contaminated medical equipment.

"They've got to start taking this disease seriously and they simply aren't doing it," said Singletary, who is a member of CJD Watch and CJD Voice -- advocacy groups for CJD patients and their families.

U.S. Centers for Disease Control and Prevention spokeswoman Christine Pearson did not return a phone call from UPI seeking comment. The agency's Web site states the eye is one of three tissues, along with the brain and spinal cord, that are considered to have "high infectivity."

The Web site said more than 250 people worldwide have contracted CJD through contaminated surgical instruments and tissue transplants. This includes as many as four who were infected by corneal grafts. The agency noted no such cases have been reported since 1976, when sterilization procedures were instituted in healthcare facilities.

Ironside and colleagues noted in their study, however, many disinfection procedures used on optical instruments, such as tonometers, fail. They wrote their finding of cornea tissue on tonometers indicates that "no current cleaning and disinfection strategy is fully effective."

Singletary said CDC's assertion that no CJD cases from infected equipment or tissues have been detected since 1976 is misleading.

"They have absolutely no idea" whether any cases have occurred in this manner, he said, because CJD cases often aren't investigated and the agency has not required physicians nationwide report all casesof CJD.

"There's no national surveillance unit for CJD in the United States; people are dying who aren't autopsied, the CDC has no way of knowing" whether people have been infected via infected equipment or tissues, he said.

Ann Marie Da Silva said she has contacted several members of her state's congressional delegation about her concerns, including Rep. Sue Kelly, R-N.Y., and Sen. Charles Schumer, D-N.Y.

"Basically, what I want is to be a positive force in this, but I also want more of a dialogue going on with the public and the health department," she said.

Cadaver corneal transplants -- without family permission Houston, Texas channel 11 news 28 Nov 99 Reported by Terry S. Singeltary Sr.son of CJD victim

Subject: RE-The Eyes Have It (cjd) and they could be stealing them from your loved one... "pay back time" Date: Sat, 16 Sep 2000 10:04:26 -0700 From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To:

######### Bovine Spongiform Encephalopathy #########

Greetings List Members,

I hate to keep kicking a madcow, but this still is very disturbing to me. Not only for the recipient of the cornea's, but as well, for the people whom would be operated on, using the same tools that were used to put those stolen cornea's in the recipient with. No history of this donor or his family (re-ffi), or anything would be known, using stolen organs and or tissue's. I just think this is not only wrong, but very dangerous to a great many other people, as this is one of the most infectious tissues of TSE's. It seems that this practice of stealing organ/tissue happens more than we think. Anyway, the family of the victim which had their cornea's stolen, are now suing. In the example I used with my Mother, if 3 months before, she would have been in a catastrophic accident (car wreck, whatever), no autopsy (for whatever reason), no family (for whatever reason), she lay in the morgue, and after 4 hours, they come steal the cornea's, lot of people could have been infected, just because of lack of medical history of donor/family. It may be hypothetical, but very real. We need to stop the spread of this disease.

kind regards, Terry S. Singeltary Sr., Bacliff, Texas USA ===========================================

Previous story--

Cadaver corneal transplants -- without family permission...


Sept. 15, 2000, 11:39PM

Slain woman's family sues over missing eyes

By BILL MURPHY Copyright 2000 Houston Chronicle

The family of a woman who was stabbed to death last year has filed a lawsuit accusing the Lions Eye Bank of Houston of removing the woman's eyes without permission and inserting plastic discs in their place.

Daisy Diaz's relatives were horrified when they saw her body and noticed her eyes were missing, said their lawyer, Duncan Neblett III.

"They're a Catholic family," Neblett said. "They have strong beliefs about the body and burial. They were really upset by this."

Dorey Zidrow, the eye bank's spokeswoman, said she could not specifically discuss the Diaz case because it was in litigation. But Zidrow said a state law allows doctors to remove corneas -- the dime-sized lens near the eye's surface -- from a corpse without the family's permission.

The eye bank's usual procedure calls for removing the corneas, Zidrow said, but not the entire eyes.

"There are an awful lot of people who benefit from this program in the state of Texas," she said.

Diaz, 25, was stabbed to death in her apartment in the 400 block of Thornton in October. Her brother-in-law, 30-year-old Raudel Quiroz, is charged in the killing but has not been caught.

Neblett said authorities have told him Quiroz may have returned to his native Guatemala.

Neither Diaz nor her family had given permission to donate any of her organs, Neblett said.

Although state law allows corneas to be removed from corpses without first gaining the family's permission, they cannot be removed over the family's stated objection.

The eye bank is located at, and staffed by, the Baylor College of Medicine, and receives part of its funding from the Lions Club.

The Diaz lawsuit is the second such suit to be filed against the eye bank in recent years.

The family of Levi Perry Jr., a Houston teacher shot to death in MacGregor Park in 1994, also alleged in their suit that Perry's eyes were removed. The family was awarded $345,000 from the eye bank in April 1999.

================================================== ========



Sec. 693.012. Removal of Corneal Tissue Permitted Under Certain Circumstances.

On a request from an authorized official of an eye bank for corneal tissue, a justice of the peace or medical examiner may permit the removal of corneal tissue if:

(1) the decedent from whom the tissue is to be removed died under circumstances requiring an inquest by the justice of the peace or medical examiner;

(2) no objection by a person listed in Section 693.013 is known by the justice of the peace or medical examiner; and

(3) the removal of the corneal tissue will not interfere with the subsequent course of an investigation or autopsy or alter the decedent's postmortem facial appearance.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Note: This information includes legislation enacted through the 75th Congress. The 76th session of the Texas Legislature has concluded. The State of Texas has not yet made the new codes available to the public. Until they do, search the bill text for any changes or amendments.

Search 1999 Legislation for: 693.012 -------------------------------------------------------- TEXAS STATUTES Sec. 693.003. Consent Required in Certain Circumstances.

(a) A medical examiner or a person acting on the authority of a medical examiner may not remove a visceral organ unless the medical examiner or person obtains the consent of a person listed in Section 693.004.

(b) If a person listed in Section 693.004 is known and available within four hours after death is pronounced, a medical examiner or a person acting on the authority of a medical examiner may not remove a nonvisceral organ or tissue unless the medical examiner or person obtains that person's consent.

(c) If a person listed in Section 693.004 cannot be identified and contacted within four hours after death is pronounced and the medical examiner determines that no reasonable likelihood exists that a person can be identified and contacted during the four-hour period, the medical examiner may permit the removal of a nonvisceral organ or tissue.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Note: This information includes legislation enacted through the 75th Congress. The 76th session of the Texas Legislature has concluded. The State of Texas has not yet made the new codes available to the public. Until they do, search the bill text for any changes or amendments.

Search 1999 Legislation for: 693.003 -------------------------------------------------------- PLEASE NOTE; the bottom would only pertain to those who know of the law. if you don't know about it, you cannot dispute, so in four hours, they can legally remove body organs, as long as they don't disfigure. and who is to know the difference? makes me wonder of some of my dead relatives, and if they were burried with their eye's and or any of their organs. This is very disturbing, if not for moral reasons, but for the risk of dangerous pathogens (human TSE's, etc.) to be transmitted. only time will tell, but i am very disturbed. these laws are not morally correct. They should be re-written as to they cannot so easily take your organs, with no one knowing. The Family or Victim, must consent. There should be some kind of research on donor/family medical history...TSS --------------------------------------------------------

Sec. 693.013. Persons Who May Object to Removal.

The following persons may object to the removal of corneal tissue:

(1) the decedent's spouse;

(2) the decedent's adult children, if there is no spouse;

(3) the decedent's parents, if there is no spouse or adult child; or

(4) the decedent's brothers or sisters, if there is no spouse, adult child, or parent.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Note: This information includes legislation enacted through the 75th Congress. The 76th session of the Texas Legislature has concluded. The State of Texas has not yet made the new codes available to the public. Until they do, search the bill text for any changes or amendments.

Search 1999 Legislation for: 693.013 ------------------------------------------------------- to cover one's butt....

Sec. 693.014. Immunity From Damages in Civil Action.

(a) In a civil action brought by a person listed in Section 693.013 who did not object before the removal of corneal tissue, a medical examiner, justice of the peace, or eye bank official is not liable for damages on a theory of civil recovery based on a contention that the person's consent was required before the corneal tissue could be removed.

(b) Chapter 104, Civil Practice and Remedies Code, applies to a justice of the peace, medical examiner, and their personnel who remove, permit removal, or deny removal of corneal tissue under this subchapter as if the justice of the peace, medical examiner, and their personnel were state officers or employees.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Note: This information includes legislation enacted through the 75th Congress. The 76th session of the Texas Legislature has concluded. The State of Texas has not yet made the new codes available to the public. Until they do, search the bill text for any changes or amendments.

Search 1999 Legislation for: 693.014

[[[as you can see, they knew it was wrong when they wrote the laws. or they would not have covered the rear-ends so well...TSS]]] --------------------------------------------------------- thanks again, kind regards, Terry S. Singeltary Sr.

############ ############

From: Terry S. Singeltary Sr. ( Subject: Trial Contact Lenses and RE-USE in the U.S. & CJD, no threat says FDA??? Date: October 7, 2000 at 9:19 am PST

Subject: Trial Contact Lenses and RE-USE in the U.S. & CJD, no threat says FDA??? Date: Sat, 7 Oct 2000 10:27:03 -0700 From: "Terry S. Singeltary Sr." Reply-To: Bovine Spongiform Encephalopathy To:

######### Bovine Spongiform Encephalopathy #########

Greetings List Members,

It just never ceases to amaze me, that the FDA and the rest of the different political governmental bodies that are suppose to protect us, but instead, choose to protect their best interest$ the corporate industries that donate all the cash$ there has been plenty of warning and tests to prove of some sort of infectivity in the eyes. the fda speaks of no test for the tears, well hell, there is no test that will detect it period, but yet you still die from it. does not mean it is not there. when will they wake up? sporadic CJD is coming from somewhere and they had better start looking as to where it is coming from. this is just more typical B.S.eee. please read the ignorance, below....

thank you, Terry S. Singeltary Sr., Bacliff, Texas USA

Subject: 09-018 - gsc - - concern of CJD transmission with trial contact lenses Date: Fri, 06 Oct 2000 14:49:24 -0400 From: "Clark, Geoffrey S." To: "''" CC: "Warburton, Karen" , "CDRH Small Manu. Assistance"

Terry S. Singeltary Sr.:

I have discussed your concerns with our Device Evaluation staff who have provided the following information:

The risk of CJD transmission through the use of trial (fitting) contact lenses is extremely low and at present unmeasureable. There have been no documented cases of CJD transmission via a contact lens or contact lens solution. It is highly unlikely that the CJD agent would be present on the surface of the cornea or present in the tears of an infected person. Additionally, the use of trial lens sets has been declining in the US over the past 10 years as the soft contact lens market has shifted to lenses dispensed in non-reusable blister packs. Therefore, a formal recommendation against the use of trial lenses because of potential CJD transmission is not appropriate at this time.

Please feel free to contact me if I can be of additional assistance.

=|<:"Geoff Clark from PC 5074275; Room 130H <> (HFZ-220) 1350 Piccard Dr., Rockville, MD 20850-4307 800.638.2041x122 fax.301.443.8818

================================================== =======================

From: Winston, F. Blix Sent: Tuesday, September 05, 2000 5:00 PM To: Clark, Geoffrey S. Subject: 09-018 - Geoff,

This came into the DSMA account. Would you please respond?

Thanks, Blix

-----Original Message----- From: WEBO@CDRH.FDA.GOV [SMTP:WEBO@CDRH.FDA.GOV]

Sent: Friday, September 01, 2000 9:27 AM To: DSMA@CDRH.FDA.GOV Subject: DSMA Email Form Response

Name: Terry S. Singeltary Sr. Phone Number: Na Fax Number: Na Email Address: Mailing Address: P.O. Box 42 Bacliff, Texas USA 77518

Questions/Comments: P990072 *In relation to human Transmissible Spongiform Encephalopathy and Contact Lens

i think it would be to everyone's best interest, "IF" the practice of "RE-USING" _display_ contact lens in the commercial aspect takes place in the U.S., this practice must be stopped. Please allow me to explain. In the U.K., the practice of having display of different colors of contact lens on display, for the consumer to try on, and see how they look with the different colors. These contact lens were then re-used over and over. No standard cleaning cleaning solution and or auto-claving procedure will kill the TSE agent. This is known fact. Plus, the U.K. has 'BANNED' this practice due to vCJD and sCJD (if i am not mistaken), but regardless, both can transmit the TSE agent. I will not waste my time trying to explain this in this box, will post a few URLS and you will see what i speak of if you care. But the eyes, brain, pituitary are the most infectious parts, of an infective species. Trust me, i know what i speak of....... thank you, Terry S. Singeltary SR. ======================= ISSUE 1490

Thursday 24 June 1999

CJD alert over contact lenses By David Brown, Agriculture Editor

PEOPLE risk catching the human form of mad cow disease from re-used contact lenses, scientists warned the Government yesterday. They urged the Department of Health to stop opticians re-using trial lenses among their clients to help prevent further outbreaks of the new variant Creutzfeldt-Jakob disease which has killed 41 people so far.

The warning came from the Spongiform Encephalopathies Advisory Committee, the independent team of scientists advising the Government on BSE and CJD. Ministers are expected to ban the re-use of these lenses as a precaution, which could mean higher prices for consumers.

In a statement, the committee said: "Any potential risk is probably very low, but the committee felt strongly that the Department of Health should encourage opticians to adopt, as a matter of best practice, the single use of trial lenses followed by safe disposal." Sir John Pattison, the committee's chairman, said it was surprised to learn that it was common practice among opticians to try the same contact lenses on several clients.

It was known that the classical variety of CJD, the kind which was known before the new variant (vCJD) was announced in 1996 and linked to BSE, had been spread in the past by transplants of infected corneas.

The committee noted that the eyes are directly connected to the brain, the main seat of BSE and CJD. The warning applied to vCJD and the classical variety of the fatal brain disease.


MARCH 26, 2003

RE-Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States

Email Terry S. Singeltary:

I lost my mother to hvCJD (Heidenhain Variant CJD). I would like to comment on the CDC's attempts to monitor the occurrence of emerging forms of CJD. Asante, Collinge et al [1] have reported that BSE transmission to the 129-methionine genotype can lead to an alternate phenotype that is indistinguishable from type 2 PrPSc, the commonest sporadic CJD. However, CJD and all human TSEs are not reportable nationally. CJD and all human TSEs must be made reportable in every state and internationally. I hope that the CDC does not continue to expect us to still believe that the 85%+ of all CJD cases which are sporadic are all spontaneous, without route/source. We have many TSEs in the USA in both animal and man. CWD in deer/elk is spreading rapidly and CWD does transmit to mink, ferret, cattle, and squirrel monkey by intracerebral inoculation. With the known incubation periods in other TSEs, oral transmission studies of CWD may take much longer. Every victim/family of CJD/TSEs should be asked about route and source of this agent. To prolong this will only spread the agent and needlessly expose others. In light of the findings of Asante and Collinge et al, there should be drastic measures to safeguard the medical and surgical arena from sporadic CJDs and all human TSEs. I only ponder how many sporadic CJDs in the USA are type 2 PrPSc?

Monitoring the occurrence of emerging forms of Creutzfeldt-Jakob disease in the United States 2003 revisited 2009

August 10, 2009

Thursday, November 05, 2009

Incidence and spectrum of sporadic Creutzfeldt-Jakob disease variants with mixed phenotype and co-occurrence of PrPSc types: an updated classification


Tuesday, August 11, 2009

Characteristics of Established and Proposed Sporadic Creutzfeldt-Jakob Disease Variants

Brian S. Appleby, MD; Kristin K. Appleby, MD; Barbara J. Crain, MD, PhD; Chiadi U. Onyike, MD, MHS; Mitchell T. Wallin, MD, MPH; Peter V. Rabins, MD, MPH

Background: The classic Creutzfeldt-Jakob disease (CJD), Heidenhain, and Oppenheimer-Brownell variants are sporadic CJD (sCJD) phenotypes frequently described in the literature, but many cases present with neuropsychiatric symptoms, suggesting that there may be additional sCJD phenotypes.

Objective: To characterize clinical, diagnostic, and molecular features of 5 sCJD variants.

Design: Retrospective analysis.

Setting: The Johns Hopkins and Veterans Administration health care systems.

Participants: Eighty-eight patients with definite or probable sCJD.

Main Outcome Measures: Differences in age at onset, illness progression, diagnostic test results, and molecular subtype.

Results: The age at onset differed among sCJD variants (P=.03); the affective variant had the youngest mean age at onset (59.7 years). Survival time (P.001) and the time to clinical presentation (P=.003) differed among groups. Patients with the classic CJD phenotype had the shortest median survival time from symptom onset (66 days) and those who met criteria for the affective sCJD variant had the longest (421 days) and presented to clinicians significantly later (median time from onset to presentation, 92 days; P=.004). Cerebrospinal fluid analyses were positive for 14-3-3 protein in all of the affective variants, regardless of illness duration. Periodic sharp-wave complexes were not detected on any of the electroencephalography tracings in the Oppenheimer-Brownell group; basal ganglia hyperintensity was not detected on brain magnetic resonance imaging in this group either. All of the Heidenhain variants were of the methionine/ methionine type 1 molecular subtype.

Conclusions: The classic CJD phenotype and the Heidenhain, Oppenheimer-Brownell, cognitive, and affective sCJD variants differ by age at disease onset, survival time, and diagnostic test results. Characteristics of these 5 phenotypes are provided to facilitate further clinicopathologic investigation that may lead to more reliable and timely diagnoses of sCJD.

Arch Neurol. 2009;66(2):208-215



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Friday, December 04, 2009

New guidance on decontamination of trial contact lenses and other contact devices has been revealed for CJD AND vCJD

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