Disinfection of Multi-Use Ocular Equipment for Ophthalmological Procedures: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines
Disinfection of Multi-Use Ocular Equipment for Ophthalmological Procedures: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines
CADTH Rapid Response Report: Summary with Critical Appraisal
Shirley S. T. Yeung and Mary-Doug Wright.
Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 Feb 19. Copyright and Permissions
Context and Policy Issues In ophthalmology, there are certain equipment that are used and reused across different patients within a medical practice that resulting in indirect contact between multiple patients.1 This could pose a risk of cross infection between patients, especially with viruses and bacteria.1 One example of such equipment would be the tonometer, a device to measure the intraocular pressure in patients to determine risk of glaucoma.1 The tonometer tip is in direct contact with the patient’s eye and studies have demonstrated the transmission of hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), and Creutzfeldt-Jakob disease can occur between patients.1 Therefore, equipment cleanliness is critical.
The Canadian Optometrists Association has a general infection control guideline; however, in general, among available guidelines, there is little consistency and guidance in what the best approach would be to reduce transmission of diseases between patients.2 In vitro studies compared various sterilization techniques to determine whether or not viral particles are removed from the ophthalmic equipment but it is important to evaluate the impact of these cleanliness techniques on clinically relevant outcomes, such as infection transmission.1 Various guidelines and recommendations exist but it is unclear if there is any association between these techniques and disease transmission between patients.
The objective of this review is to evaluate the comparative clinical and cost-effectiveness of various disinfection techniques and/or procedures for multi-use ocular equipment in ophthalmology patients, as well as the guidelines for its use.
Go to: Research Questions
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Summary of Findings Comparative clinical effectiveness No relevant evidence regarding the clinical effectiveness of various disinfection techniques and procedures for multi-use ocular equipment in ophthalmology patients was identified; therefore, no summary can be provided.
Cost-effectiveness One cost-effectiveness analysis was identified comparing Canadian patients from the hospital perspective which compared the cost-effectiveness between the use of alcohol swabs and peroxide bleach for cleaning of tonometry trips.6 Alcohol swabs are more cost-effective compared to peroxide bleach as the incremental cost-effectiveness ratio was $12,152 for each EKC case averted.6
Evidence-based guidelines Recommendations from the guidelines are summarized below and details are presented in Appendix 4.
The recommendations from the AORN guidelines are general and apply to all multi-use ophthalmic equipment in a surgical setting.7 The guideline indicates there is strong evidence to support the immediate cleaning of ophthalmic equipment according to the manufacturer’s instruction for use.7 There is moderate evidence to ensure the cleaning process is done in an adequate manner, including allowing enough time and personnel to ensure thorough cleaning and sterilization.7
Limitations Since no systematic reviews or primary studies were identified for this report, it is difficult to conclude the comparative clinical effectiveness for various cleaning and sterilization techniques for multi-use ocular equipment in ophthalmic patients. Of note, there were studies that were identified that included in vitro outcomes for various cleaning techniques, these are included in Appendix 5. There remains a research gap in identify the most clinically effective cleaning and sterilizing method for reducing transmission of potential diseases between patients in this setting.
One study examining the cost-effectiveness of various cleaning techniques was included and although it was a based on a Canadian population, the effectiveness outcomes were extrapolated from in vitro outcomes.6 This ultimately reduces the validity of these results as it may over or underestimate the magnitude of effect of the cleaning techniques. Additionally, little detail was provided on the exact cleaning procedures within this study, making it difficult for decision makers to determine what the cost-effective disinfection method may be.6
One guideline from the United States was identified and the recommendations are non-specific and do not provide much insight for policy makers as it was intended for a broad setting.6 Although there are a number of guidelines available in this particular area, many of them do not document rigorous methods or guideline development; therefore, are not included in this report but are listed in Appendix 5.
There remains a paucity of studies with patient relevant outcomes, ultimately making it difficult to inform clinical decisions.
Go to: Conclusions and Implications for Decision or Policy Making One cost-effectiveness study and one guideline were identified regarding cleaning techniques for the disinfection of multi-use ocular equipment.6,7
The identified cost-effective study indicated that the use of alcohol swabs was a more cost-effective technique compared to peroxide bleach as a cleaning method of tonometers for reducing epidemic keratoconjunctivitis in a Canadian population.6 However, no details on the cleaning procedures were provided.
One guideline recommends the importance of following the manufacturer’s instructions for use when cleaning and sterilizing ophthalmic equipment.7 It also stresses the importance of thorough and adequate cleaning and sterilization by ensuring the required conditions.7
No systematic reviews or primary studies were identified to answer the comparative clinical effectiveness between various cleaning techniques. Further research addressing various cleaning and sterilization techniques for multi-use ocular equipment, specifically for clinical outcomes in patients undergoing ophthalmology screening or treatment, would help to reduce uncertainty.
References
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Thank you kindly for this, i have been concerned and warning about this for 21 years.
yep, i said that 20 years ago about this very thing. but did anyone listen...no!
prepare for the storm...terry
year 1999 to 2000
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
######### 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...
Cadaver corneal transplants -- without family permission Houston, Texas channel 11 news 28 Nov 99
Reported by Terry S. Singeltary Sr.son of CJD victim
"It was a story about how the Lions eye bank were harvesting corneas from victims in the Morgue, without their consent. Under Texas law, this appears to be legal (remember Texas has the Veggie liable law). Even if Family says no, this appears to happen, from what the news story said.
They said the only way to prevent this, is to fill out a form, stating not to have this done. So if you don't fill out the form, they can do this. How many people don't know about the form?
This is not only disgusting and appalling, it could be highly infectious. Without proper background checking of the donors, on their physical history, checking on past dementia, and/or family history, some of these unfortunate victims, could be passing a human TSE.
Response Jill Spitler Clevelland Eye Bank:
"No, we are not stealing.........Yes, you do have such a law in the state of Texas, but not all your state Eye Banks utilize the law. The Eye Bank that you're speaking of is only one of 43 certified Eye Bank throughout the USA.
And there are measure taken per the Medical Standards of the Eye Bank Association of America, the certifying body for eye banks and per FDA regulations to address those concerns that you speak of.
I would suggest that those interested/concern with transplant contact their local agencies. The Eye Bank Association of America has a web. site . Further if anyone has problems contacting or finding out about their local organization(s), call me or e-mail me I would be glad to help. My e-mail address is jill@clevelandeyebank.org"
Terry Singeltary responds:
"Explain this to the family in Houston who went to their loved ones funeral, only to find out that the loved one that was in the casket, had their corneas removed without their permission, without the consent of the victim or it's family. They would not have known it, only for the funny look the victim had. So, they questioned, only to find out, the corneas, had in fact, been removed without consent.
I call that stealing, regardless what the law states. This type of legal grave robbing is not a logical thing to do without knowing any type of background of the victims medical past, which really will not prove anything due to the incubation period. Eye tissue being potentially a highly infective source, there are risks here.
Should they not at least know of the potential ramifications of TSE's (the person receiving the corneas)?
Should there not be some sort of screening?
Should there be some sort of moral issue here?
If this is the case, and in fact, they can come take your corneas, without your consent, then what will they start taking next, without your consent?
Lets look at a hypothetical situation:
What would happen if my Mom (DOD 12-14-97 hvCJD) would have gotten into a car wreck and died, before the symptoms of CJD appeared. Not much money, so there was no autopsy. What would have happened to that recipient of those infecting corneas?"
Comment (webmaster): Actual transmission of CJD by means of corneal transplant may or may not be rare. The incidence of infectivity in older people could be fairly high; this is not to be confused with the lower incidence of symptomatic (clinical) CJD. It is very unlikely that familial CJD would have been diagnosed in earlier generations; however, without interviewing the family even known kindreds would not be excluded.
In blood donation, a much stricter policy is followed, even though corneal transplant may be far more dangerous (being a direct link to the brain and not going through purification steps).
Since highly sensitive tests for pre-clinical CJD are now available, it would make sense to screen corneas for CJD, just as they are screened for AIDS, hepatitus, and a host of other conditions.
Eye procedure raises CJD concerns
BySTEVE MITCHELL, Medical Correspondent
WASHINGTON, Nov. 18 (UPI) -- 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 cases of 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.
Friday, December 04, 2009
New guidance on decontamination of trial contact lenses and other contact devices has been revealed for CJD AND vCJD
SUNDAY, JANUARY 17, 2016
Of Grave Concern Heidenhain Variant Creutzfeldt Jakob Disease
Thursday, January 29, 2009
***Medical Procedures and Risk for Sporadic Creutzfeldt-Jakob Disease, Japan, 1999–2008 (WARNING TO Neurosurgeons and Ophthalmologists)
Wednesday, August 20, 2008
***Tonometer disinfection practice in the United Kingdom: A national survey
TUESDAY, NOVEMBER 20, 2018
CDC Eyes of CJD patients show evidence of prions concerns for iatrogenic transmission
TUESDAY, NOVEMBER 20, 2018
CDC Eyes of CJD patients show evidence of prions concerns for iatrogenic transmission
Is the re-use of sterilized implant abutments safe enough? (Implant abutment safety)
Mª Angeles Sánchez-Garcés 1 , Marta Jorba 2 , Joan Ciurana 3 , Miguel Vinas 4 , Mª Teresa Vinuesa 5
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Despite only a few laboratories in the world are undertaking experimental work with prions, notably that of Stanley B. Prusiner (Nobel Prize in Physiology or Medicine, 1997), the work has led to several major concerns (14).
The first and most relevant in the current context is that prions need to be completely inactivated using harsher conditions than those used against bacteria and viruses. To ensure prion inactivation, the thermal sterilization should be combined with chemical treatment. It would appear that procedures used for routine sterilization of surgical instruments cannot inactivate prions (15,16), which already led to the development of new and more stringent recommendations for reprocessing instruments and these should eventually be applied to abutments (17). This has been reinforced by the discovery that prions that are responsible for bovine spongiform encephalitis (BSE) can be up to 1 million times more difficult to inactivate than the most commonly used hamster prions; thus, one cannot exclude the possibility that human prions are also much more resistant than the laboratory prions (10). These recommendations are based on conventional autoclaving (121ºC) combined with chemical attack; this may be achieved by autoclaving in the presence of 1 M sodium hydroxide, or by soaking in 2% bleach for 1 h. Such treatments are extremely corrosive and may cause irreversible damage to the surface of abutments (18). Prevalence of asymptomatic Creutzfeldt-Jakob disease (CJD) in UK population in people born from 1941 to 1985 is 1:2000 and prion iatrogenic transmission (blood transfusions, organ transplants and surgical instrumentation) is therefore possibility. Another source of prions could be bovine bone substitutes used widely for bone regeneration after or simultaneously to the dental implant placement. These materials keep some proteins, their manufacturing processes are not guaranty to the inactivation of the prion, and in consequence, Kim et al. (19) suggest abolishing the use of bovine bone.
The presence of organic carbon reported in our study means that organic material originating in the patient is adhered to the surface and, subsequently, the presence of prions cannot be ruled out.
In conclusion, we believe that, despite costs, the practice of reusing implant abutments should be abandoned, since it cannot be demonstrated to be safe enough.
Further studies trying to identify the source of the organic carbon adhered in the abutments are needed. In addition, it is worth elucidating if there could be any safe procedure to effectively remove all the organic material present in the titanium surfaces of the reused healing abutments.
http://www.medicinaoral.com/medoralfree01/aop/22967.pdf
HUNTERS, CWD TSE PRION, THIS SHOULD A WAKE UP CALL TO ALL OF YOU GUTTING AND BONING OUT YOUR KILL IN THE FIELD, AND YOUR TOOLS YOU USE...
* 1: J Neurol Neurosurg Psychiatry 1994 Jun;57(6):757-8
Transmission of Creutzfeldt-Jakob disease to a chimpanzee by electrodes contaminated during neurosurgery.
Gibbs CJ Jr, Asher DM, Kobrine A, Amyx HL, Sulima MP, Gajdusek DC.
Laboratory of Central Nervous System Studies, National Institute of
Neurological Disorders and Stroke, National Institutes of Health,
Bethesda, MD 20892.
Stereotactic multicontact electrodes used to probe the cerebral cortex of a middle aged woman with progressive dementia were previously implicated in the accidental transmission of Creutzfeldt-Jakob disease (CJD) to two younger patients. The diagnoses of CJD have been confirmed for all three cases. More than two years after their last use in humans, after three cleanings and repeated sterilisation in ethanol and formaldehyde vapour, the electrodes were implanted in the cortex of a chimpanzee. Eighteen months later the animal became ill with CJD. This finding serves to re-emphasise the potential danger posed by reuse of instruments contaminated with the agents of spongiform encephalopathies, even after scrupulous attempts to clean them.
PMID: 8006664 [PubMed - indexed for MEDLINE]
SATURDAY, MARCH 16, 2019
Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) Guidance for Industry and Food and Drug Administration Staff Document issued on March 15, 2019 Singeltary Submission
MONDAY, AUGUST 26, 2019
Creutzfeldt Jakob Disease CJD, TSE, Prion, Surveillance Update August 2019
http://creutzfeldt-jakob-disease.blogspot.com/
SUNDAY, SEPTEMBER 1, 2019
FDA Reports on VFD Compliance
Before and after the current Veterinary Feed Directive (VFD) rules took full effect in January, 2017, the FDA focused primarily on education and outreach to help feed mills, veterinarians and producers understand and comply with the requirements. Since then, FDA has gradually increased the number of VFD inspections and initiated enforcement actions when necessary.
THURSDAY, SEPTEMBER 05, 2019
Unique Profile of The Texas CWD TSE Prion isolates, the TSE Prion CWD, Scrapie, BSE in Livestock, and CJD in Humans
MONDAY, JUNE 24, 2019
APHIS, FSIS, USDA, FDA, Transmissible Spongiform Encephalopathy TSE, BSE, CWD, Scrapie, Camel TSE Prion Disease, CJD Humans
THURSDAY, AUGUST 08, 2019
Raccoons accumulate PrPSc after intracranial inoculation with the agents of chronic wasting disease (CWD) or transmissible mink encephalopathy (TME) but not atypical scrapie
FRIDAY, JULY 26, 2019
Chronic Wasting Disease in Cervids: Implications for Prion Transmission to Humans and Other Animal Species
MONDAY, FEBRUARY 25, 2019
MAD DOGS AND ENGLISHMEN BSE, SCRAPIE, CWD, CJD, TSE PRION A REVIEW 2019
WEDNESDAY, JULY 31, 2019
***> The agent of transmissible mink encephalopathy passaged in sheep is similar to BSE-L
IT would seem prudent to, do as to others, as you wish they would do unto you.
THE BSE TSE Prion Minimal Risk Region MRR policy is a incredibly failed policy. it was designed and set up to fail from the start.
now we have cwd tse prion saturating the USA, cwd tse prion spreading across from Europe, we have mad camel disease in Africa, and we now know that the cwd will transmit to pigs by oral routes. this is terrible. see;
Let's take a look at the facts shall we $BOVINE SPONGIFORM ENCEPHALOPATHY, SCRAPIE, CWD, CJD, NORTH AMERICA TYPICAL AND ATYPICALExperimental Transmission of H-type Bovine Spongiform Encephalopathy to Bovinized Transgenic Micesnip...see full text;IBNC BSE TSE Prion mad cow disease***however in 1 C-type challenged animal, Prion 2015 Poster Abstracts S67 PrPsc was not detected using rapid tests for BSE.***Subsequent testing resulted in the detection of pathologic lesion in unusual brain location and PrPsc detection by PMCA only.*** IBNC Tauopathy or TSE Prion disease, it appears, no one is sure ***Posted by Terry S. Singeltary Sr. on 03 Jul 2015 at 16:53 GMTWEDNESDAY, AUGUST 15, 2018
The agent of H-type bovine spongiform encephalopathy associated with E211K prion protein polymorphism transmits after oronasal challengeTUESDAY, JULY 30, 2019
Guidelines for reporting surveillance data on Transmissible Spongiform Encephalopathies (TSE) in the EU within the framework of Regulation (EC) No 999/2001 APPROVED: 9 July 2019
Alzheimer's and Iatrogenic transmission ??? ...never say never!
SUNDAY, MAY 26, 2019
Arguments for Alzheimer’s and Parkinson’s diseases caused by prions Stanley B. Prusiner
''From a large array of bioassays, we conclude that AD, PD, MSA, and the frontotemporal dementias, including PSP and CBD, are all prion diseases''
terry
posted by Terry S. Singeltary Sr. at
4:08 PM
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