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From: TSS ()
Subject: SEAC DRAFTS MINUTES 91st meeting held on 24th February 2006 ITEM 5 – MEDICAL IMPLANTS CONTAINING BOVINE MATERIAL OF USA ORIGIN BSE GBR III
Date: March 29, 2006 at 9:44 am PST

SPONGIFORM ENCEPHALOPATHY ADVISORY COMMITTEE

Draft minutes of the open session of the 91st meeting held on 24th

February 2006

snip...

Members agreed that this third case indicates that there is

relatively high risk of transmission of vCJD by blood

transfusion. It was not known whether a tonsil biopsy had

been conducted in this case. Such a biopsy was considered

important to help ascertain whether tonsil biopsy could be

used as a diagnostic test for clinical iatrogenic vCJD. It also

was considered important to conduct autopsies on these

remaining individuals on the event of their death to determine,

amongst other things, the prevalence of infection in this group.

Professor John Collinge (MRC – Prion Unit) considered it very

important that these individuals had access to best practice

care and counselling and be informed about clinical trials and

the development of potential therapies. Members agreed that

active approaches to obtaining tissues for testing and clinical

monitoring of these patients was important both to ensure best

practice clinical care and for enhancing understanding of risks.

• Interviews had taken place for two new members for SEAC.

The recommendations of the interview panel would be

submitted to Ministers shortly.

snip...

ITEM 5 – MEDICAL IMPLANTS CONTAINING BOVINE MATERIAL

(SEAC 91/2)

12. The Chair explained that the Medicines and Healthcare products

Regulatory Agency (MHRA) asked the committee to consider

issues around potential BSE risks to humans from medical

implants using bovine material from USA animals. SEAC was also

asked to comment on a scheme developed by a British Standards

Institution (BSI) committee to assess whether BSE risks associated

with medical devices are minimised.

13. MrJeremy Tinkler (MHRA) summarised the regulations on medical

devices containing animal materials in relation to TSE risks. The

regulations are based on the principle that TSE risks must be

eliminated or reduced as much as possible and residual risks must

be acceptable when weighed against the benefits to patients.

About 100 medical devices containing bovine material, which have

tissue contact with the recipient, are available in Europe. They

tend to be used to treat serious conditions and confer significant

clinical benefit, such as heart valves for paediatric cases. At

present there are no alternatives to the animal-derived materials

used in these products.

14. MrTinkler explained that, although regulations are in place, no

guidance exists on the acceptability of TSE risk control measures

applied to animal material in medical devices. Careful sourcing of

animal material tends to be the most practicable way of reducing

the TSE risk. The lack of guidance has led to inconsistent

interpretation of the regulations across Europe. This was recently

highlighted by the certification by a Notified Body in one Member

State of -cardiovascular implants sourced from open cattle herds in

the USA, recently reclassified as a Geographical BSE Risk (GBR)

level III country. Certification was on the grounds of a lack of

alternatives. However, the MHRA took the view that the TSE risk

associated with these devices had not been minimised since it

should be possible to source the material from another country or

from closed herds. Therefore, the MHRA felt that it was

inappropriate to market such products freely in Europe, and their

use should only be permitted on humanitarian grounds until the risk

had been minimised.

15. The MHRA wished SEAC to advise upon 3 issues. First, can the

TSE risk associated with medical implants utilising bovine material

sourced from USA cattle be estimated, given that it might vary over

time? Second, is there, or has there been a significant risk from

the use of such products that might warrant action in addition to

that already taken to limit use of the products? Third, can the

standards that support the regulations be altered to facilitate more

consistent decisions about the acceptability of products? To

address this third issue, a BSI committee has proposed a scheme,

outlined in SEAC paper 91/2, that consists of additional

requirements for acceptability of TSE risks in relation to medical

devices.

16. A member noted that there are a number of variables that influence

the overall risks and benefits from medical devices containing

bovine material. The presence of TSE agents in the implant is

influenced by the type of tissue used. The site of implantation also

affects TSE risk, implantation sites in contact with central nervous

system (CNS) or the blood supply could raise transmission risks.

In addition, the number of animals used per device would influence

transmission risks. The potential benefit to patients is also

influenced by the type of device, with the benefit ranging from life

saving (cardiovascular implants) to enhancement of quality of life

(orthopaedic footware). The range of availability of alternatives

may also vary considerably depending on the device. Taking all

these factors together there is likely to be a wide range in the risk :

benefit ratio between medical devices and a ‘one rule fits all’

approach was unlikely to be meaningful. Mr Tinkler noted that

sourcing, availability and safety measures for skin contact devices,

such as orthopaedic footwear tended to be similar to those for

consumer products, whereas more stringent safety and quality

assurance measures were employed for medical implants

(including collagen).

17. Members noted that the number of animals needed to source

material for implants such as heart valves was likely to be small. It

should be possible to reduce risks by sourcing these materials

from closed herds or herds managed carefully to prevent the

introduction of the BSE agent. Mr Tinkler agreed that it should be

possible to use closed herds. Additionally, it was suggested that it

may be possible to source materials from other species, such as

pigs. Mr Tinkler responded that heart valves from pigs had been

used in medical implants but porcine pericardium was too thin and

so bovine pericardium was used in most cases. Dr Matthews

explained that the cost of using animals from closed herds for

some devices may be prohibitively expensive, noting the material

for many devices is sourced from animals slaughtered for human

consumption. A member noted that if relatively few animals are

required this should not be prohibitive for potentially life-saving

devices.

18. Members asked about the age of the source cattle, noting that use

of material from younger animals would markedly reduce risks. Mr

Tinkler explained that animal age depended on the quality of the

tissue required for the intended use. For example, 6 month old

animals would be used to source pericardium or heart valves,

however collagen would be obtained from older animals. Members

suggested that age of animal be used as a risk reduction criterion.

TSE testing of the source animal could also be used as a risk

reduction measure, although such testing would not definitively

prove an animal to be uninfected. Mr Tinkler noted that BSE

testing had not been included as a requirement in the standard.

19. Members suggested that, because of the wide range of variables

that influence the risk in relation to medical devices, it is more

appropriate to conduct independent risk assessments on each

device. The characteristics of the device, the tissue and source

animal all influence the risk to varying extents.

20. Members considered that GBR status gives a very imprecise

indication of BSE risk. In relative terms, the BSE risk was likely to

be lower in a GBR I country compared with a GBR III country, but

the difference in risk cannot be quantified. In terms of a more

robust risk analysis, it is important to obtain a more reliable

estimate of the prevalence of BSE in a country than simply GBR

status, and have confidence in the quality of the surveillance data.

Since all the necessary BSE surveillance data from the USA are

not publicly available, it is not possible to accurately determine the

prevalence of BSE in the USA. Dr Matthews noted that at the time

the standard was developed, GBR status, while crude, was the

only tool available to assess risk and that it reflected the

uncertainties in the data available. In the future, the GBR

categorisation would to be replaced by a simplified classification in

line with an Office International des Epizooties (OIE)

categorisation. He pointed out that such schemes took into

account of exposure to the BSE agent from the UK or other

countries and that they were developed in the context of

uncertainty about the infectivity of particular tissues.

21. Dr Matthews noted that data are now available on the infectivity of

a wide range of bovine tissues. In September 2005, the World

Health Organisation had updated its assessment of the risk of TSE

infectivity in tissues. These data, although incomplete, should

increase confidence in the safety of particular tissues, particularly if

the age of the source animal is also considered. As a result, less

reliance need now be placed on the status of the country of origin.

Members agreed, but noted that it would be important to assess

the quality of the data on which assessments are based. As it

seems highly likely that blood, at least from humans infected with

vCJD, can be infectious, tissues and organs with a significant

blood supply may also confer higher risk.

22. Members noted that some of the definitions used in the BSI

scheme were poorly defined and non-quantitative. Furthermore,

there was no quantitation of the maximum acceptable risk - it was

not appropriate to consider that just because a risk has been

minimised by available techniques, the absolute risk was

acceptably low. In addition, the scheme appeared to attach similar

importance to each risk reduction method and selectively apply

them to each GBR status, which may be inappropriate.

23. In summary, the committee concluded that a risk assessment

should be conducted on each device because of the large number

of variables that influence associated TSE risks. Key factors which

should be considered when assessing risks are:

• the animal source. Use of material from closed herds or

from herds that are managed carefully to prevent the

introduction of the BSE agent.

• use of material from young animals would markedly lower

risk compared with older animals.

• the geographical risk of BSE. When assessing the

geographical risk of BSE, the GBR status of a country gives

an imprecise indication of BSE risk. It would be better to use

an estimated prevalence of BSE in a country based on data

from a robust surveillance system.

• the potential TSE infectivity of the source tissue(s) based on

a careful assessment of the available data on tissue

infectivity.

• the site of implantation. Sites with contact with the blood

supply or CNS may increase risk.

• whether TSE testing is undertaken on the source animal(s).

• the number of source animals used for each device.

snip...

http://www.seac.gov.uk/minutes/draft91.pdf

Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001
Date: Tue, 9 Jan 2001 16:49:00 -0800
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@uni-karlsruhe.de

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

Greetings List Members,

I was lucky enough to sit in on this BSE conference
call today and even managed to ask a question.
that is when the trouble started.

I submitted a version of my notes to
Sandra Blakeslee of the New York Times,
whom seemed very upset, and rightly
so.

"They tell me it is a closed meeting and
they will release whatever information
they deem fit. Rather infuriating."

and i would have been doing just fine,
until i asked my question. i was surprised
my time to ask a question so quick.

(understand, these are taken from my notes for now.
the spelling of names and such could be off.)

[host Richard Barns]
and now a question from Terry S. Singeltary of
CJD Watch.

[TSS]
yes, thank you,
U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?

[no answer, you could hear in the back ground,
mumbling and 'we can't. have him ask the question
again.]

[host Richard]
could you repeat the question?

[TSS]
U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?

[not sure whom ask this]
what group are you with?

[TSS]
CJD Watch, my Mom died from hvCJD and we are
tracking CJD world-wide.

[not sure who is speaking]
could you please disconnect Mr. Singeltary

[TSS]
you are not going to answer my question?

[not sure whom speaking]
NO

from this point, i was still connected, got to listen
and tape the whole conference. at one point someone
came on, a woman, and ask again;

[unknown woman]
what group are you with?

[TSS]
CJD Watch and my Mom died from hvCJD
we are trying to tract down CJD and other
human TSE's world wide. i was invited to
sit in on this from someone inside the USDA/APHIS
and that is why i am here. do you intend on banning
me from this conference now?

at this point the conference was turned back up,
and i got to finish listening. They never answered
or even addressed my one question, or even addressed
the issue. BUT, i will try and give you a run-down
for now, of the conference.

IF i were another Country, I would take heed to my
notes, BUT PLEASE do not depend on them. ask for
transcript from;

RBARNS@ORA.FDA.GOV
301-827-6906

he would be glad to give you one ;-)

Rockville Maryland,
Richard Barns Host

SNIP...END...TSS

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

Freas, William

Monday, January 08,200l 3:03 PM

Consultants Staff January 2001 Meeting (short version)

Last, but not least. The illegal/legal harvesting of body parts and tissues will come back to haunt you. Maybe not morally, but due to NO background checks and human TSEs, again it will continue to spread.

Stupidity, Ignorance and Greed is what fuels this disease. You must stop all of this and ACT AT ONCE...

http://www.fda.gov/ohrms/dockets/ac/01/slides/3681s2_09.pdf

40,000 human heart valves a year from BSE herds
Sun, 3 Sep 2000. Unpublished Inquiry documents obtained by CJD activist
Terry S. Singeltary Sr. of Bacliff, Texas


http://www.mad-cow.org/00/sep00_news.html#hhh


The documents below were provided by Terry S. Singeltary Sr on 8 May 2000. They are optically character read (scanned into computer) and so may contain typos and unreadable parts.

TIP740203/l 0424 CONFIDENTIAL

http://www.mad-cow.org/00/may00_news.html

From: Terry S. Singeltary Sr. (216-119-138-152.ipset18.wt.net)Subject: COMMERCIAL IN CONFIDENCE/BSE/SURGICAL IMPLANTS/BLOOD CONTACT DEVICES (1989)Date: August 31, 2000 at 1:46 pm PSTGreetings,thought i would make a comment on some of these old documentsi have been posting, still more to come. But i am trying to showthe pattern of deceipt and lies that surround this pendingenvironmental worldwide human/animal catastrophe. If i have not proven it yet, to EVERYONE, i will, just give me a little more time, my scanner and myself can only go so fast....thanks,Terry S. Singeltary Sr., Bacliff, Texas USA============================================COMMERCIAL IN CONFIDENCEMiss M Duncan From: Dr E HoxeyDate: 29 January 1990cc: Mr R BurtonDr N RichardsonMs K TurnerMs J DhellMr N WeatherheadBOVINE SPONGIFORM ENCEPHALOPATHY1. In your absence on sick leave, I chaired the STD BSE group meetingon 26th January 1990.2. The minutes of the meeting will be circulated shortly but I was askedto bring to your attention the concerns of the group regarding the BMSheart valve.3. This concern arose from a number of points on the agenda:-i) the______________decision to source all raw material for suturesfrom Australasia from January 1990.ii) the major cleandown and decontamination proposed for thefactory and the possibility of press interest that this may generate.iii) the indication in the Tyrell Report on Research that theinfective agent may be induced to cross the species barrier byintracerebral, intraperitoneal or intravenous injection.4. As you are aware, the____________situation has been a model which wehave observed closely.5. Reviewing the BMS situatien, we considered the incidence of BSE inthe herds used for materials, the processing received by the materialand the age of the cattle used. Given the number of uncertainties andlack of definitive information on BSE, the_______________model wasstill considered as a good one. The group were uncomfortable with theposition of BMS as the only company using UK sourced material.6. The group considered that it may be worthwhile arranging a furthermeeting with___________to confidentially make them aware that theywould now be the only company using UK sourced bovine material forproducts of this type.7. Clearly, __________and__________ are now in an exposed position inthis area and all the implications need te be considered. Could we haveyour news on this proposal please?Dr E V HoxeyPD STD PG1A716 RSQExt 335690/01.29/19.1==============B.S.E. GUIDELINES ON BOVINE IMPLANTS & BLOOD CONTACT DEVICES -MEETING WITH MANUFACTURERSDATE: 8 DECEMBER 1989DH REPRESENTATIVES Nigel RichardsonWill BurtonEammon HoxeyJeremy TinklerHelen CampbellCarol BleakleyBill WaineThe main purpose of the meeeting is to discuss the companies currentmanufacturing procedures, future plans and their compliance with theBSE guidelines. Their views were also sought as to the practicalfeasibility of the guidelines with respect to the manufacturingprocess, and any improvements that could be suggested.The meetings were held separately with each company. Neither hadreceived any queries concerning BSE from countries to which theirproducts are exported.CURRENT POSITION1.__________ have brought in a microbiologist as a technical scientificadviser, initially to inform them of the current understanding ofBSE. He is still available to them and keeps them up to date with newdevelopments.2. At present they produce bovine pericardial heart valves, & (a sistercompany) produces heparin coated products (from a porcine source). Inthe future it is possible that they will introduce a bovine patchproduced from bovine pericardium from the same source. They will keepthe Department informed of any progress in this area.SOURCE MATERIAL3. The source material for the manufacture of heart valves is bovinepericardial sacs. The cows used are 18-24 months old when slaughtered,the majority around 18 months. BMS have no knowledge of the actualage.4. The cows are killed using brain penetration. Dr Bleakley made thepoint that as far as she was aware this was the only method used inthis country. Meat inspectors are paid to obtain the bovinepericardium. They are paid a set rate but bonuses are given forincreased yields. Mr Burton expressed concern as to the conflict ofinterests that may arise as a result of this. Dr Bleakley did notbelieve that this was the case because of the relationship BMS haddeveloped with the inspectors.89/12.12/8.1============COMMENTS ON THE GUIDELINES14. Dr. Bleakley believed that the pericardium would not allow thereplication of the causative agent, and does not present a risk.15. She suggested that the guidelines were impossible to implementfrom the point of view of the manufacturing process for the followingreasons:--It is not possible to use closed herds simply because of the numbersof cattle involved. This is up to 800 each week.-Calves under 6 months old cannot be used as the pericardium is toothin to be incorporated into a valve.-For cows this in the age group used brain penetration is the onlymethod of slaughtering used in this country.PROPOSALS PUT FORWARD BY DR BLEAKLEY16. The goverment should fund research in this area. For example,investigating the presence or absence of the infectious agent inother parts of the body, such as the pericardium. Also to look at howthe slaughtering process affects the spread of the disease.17. Ideally the answer would be to take random tissue samples inorder to detect contaminated material. This is not currently feasiblewith the length of time required to conduct titre testing.COMMENTS ON THE REVIEW ON METHODS OF STERILIZATION FOR BSE18. Everything present reflected the published material, but thevalidity of some of this is questionable. It was pointed out that:--it was stated that different strains display different heatsensitivity, but this does not appear to be chemically related-the claim to be "effective' would depend on the type of material thatwas being used and the time involved.CURRENT POSITION19.____________ manufacture porcine valves and bovine pericardialpatches. The possibility of producing porcine conduits is currentlybeing investigated. This has not yet progressed.20. The material is obtained from 2 abattoires in this country:--Dorchester, where veal calves under 18 weeks are slaughtered forsourcing pericardium for ________________. These are used to producesmall patches of less than 90mm diameter, this may be divided into 4quadrants. This represents 80-90% of sales.-Fairham where cows between 5 and 10 years old are slaughtered toproduce larger patches and strips of 100mm by 45mm.89/12.12/8.2=============32. As a result of the concern voiced of direct inoculation of BSEvia sectioning instruments it was stated that it would be feasible touse new blades with each carcass.COMMENTS ON THE GUIDELINES33. Dr Waine was not convinced of the need for sterile sectioningequipment and separate packaging from the abattoire. He felt thatthis would merely have a cosmetic effect.34. He suggested that the possibility of bovine-human cross-infectionwas very remote.35. He did not believe that it was possible for manufacturers tofollow the guidelines as they stand.PROPOSALS36. Dr Waine felt that the steps taken by the Government had beenrealistic to control the outbreak.REVIEW37. Dr Waine did not believe that any sterilization treatmentproposed would retain the surgical usage of the pericardium.VALVES38. The response has been that this problem is restricted to the U.K.Thier material is obtained from the same Italian source as thepatches. There is no age specification on the cows but the preferenceis for the larger valves which would therefore come from the olderanimals.PORCINE VALVES39. There was a small discussion as to whether these products do fallunder the issued guidelines. The assumption had been made by thecompany that they are not included as pigs are not known to besusceptible to infection by a Scrapie-like agent. This was confirmedby Dr Hoxey.40. The pigs are electrocuted and the heart and pericardium obtainedprior to inspection.41. One abattoire supplies them with most of their porcine requirments.H CampbellPG2CRoom 312 RSQExt. 321212 December 198989/12.12/8.3============TIP740203/3 0241Bovine Spongiform Meeting Held On Friday 26th January 1990Present Dr E Hoxey {chairman)Mr W BurtonDr N RichardsonMrs J DhellMs K TurnerMS H CambellMr N Weatherhead (secretary)copies: Miss Duncan1.ApologiesApologies were received from Miss Duncan2.Minutes of the last meeting.The previous minutes were accepted.3.Matters arising not on the agenda.As agreed at the previous meeting the paper on "Inactivation ofScrapie-like Agents" was sent with a Covering letter drafted byDr Hoxey to all companies that use Bovine or Porcine materiais.4.Report on the STD meeting with ___________________The minutes of the meeting were discussed by the committee it wasnoted that:-a} _____________ now meet DH Guidelines as the devices produced fromthe calf material comply as that they are obtained from animals lessthan 6 months old.The company had written to confirm that they nowsource older animals from overseas.b) _____________ are unable to meet the DH Guidelines.and will not be doing so in the foreseeable future. The panel showedconcern over the stance that BMS are taking. The committee felt that itwas important to arrange a further meeting to inform them that theyare now the only company using UK sourced material. [see minutes of themeeting dated 8/12/89 attached). Dr Hoxey agreed to write separateyto Miss Duncan on this issue.action: Dr Hoxey5. Report on the CSM/MCA BSE working party meeting 10/1/90Mr Burton had produced a note of the above meeting as the minutes hadas yet not been distributed. The committee noted that:-90/01.26/20.1=============TIP740203/3 02421) _______________ has exceeded all expectations tn complyingwith DH Guidelines. They will be sourcing all raw material fromAustralasia from January 1990.2) _______________ are using an international expert _______________to advise them on factory decontamination at the change over of source.3) The use of Dr Taylor and the factory decontamination may qeneratepress interest.4) The offal ban has not yet been expanded to include Scotland.5) The CSM/MCA BSE working group agrees with the approach that STDare taking to Tissue Harvesting and wished to be kept updated.The note of the meeting is attached for reference.6. STD Database updatingMr Burton drafted a minute for signature by Mr Worroll.The object ofthe minute was to enable STD to keep a check on companies that useanimal material in their products.The control manual committee amended the minute and agreed that theaudit report procedure should include (if it does not already) astatement to the effect that the company information section shouldinclude details of raw materials used.The CMC suggested a sentence to the effect "Team leaders visitingBlue Guide companies should additionally take account of Mr Worroll'sminute of Jan 1990." The committee agreed with this sentence and passedit back for inclusion in the Base-line Documents.action N Weatherhead7. Review of the 'Interim Report of the Consultative Committee onResearch into BSE" (Tyrell committee report.)Mrs Dhell presented a summarized Version of the above document to thecommittee. It was noted that only the research studies catorqorisedhigh/medium priority would all somehow receive funding. The committeeexpressed a wish to find out:-1) Areas which have not been prioritised which have relevance toSTDS area of interest.2) Has any party taken up the study "Investigation into the fate ofbovine and ovine tissues and product that could lead to infection byas yet unrecognised routes."90/01.26/20.2==============TIP740203/3 02433. The protocol of work being carried out by the Clinical ResearchLaboratory in Harrow add proposed by the Neuropathogenesis unit inEdinburgh:a) Have they any plans to include pericardium. If not could PD suggestthat they miqht include it.b) What controls are they using.c) Will it be possible to arrange a visit.4) It was suggested that Dr Pickles be contacted as the DHrepresentitive on the Tyrell committee, to enquire if comments onthis document were being sought by the committee, as PD has a numberof points it wishes to raise.8. Incorporation of Guidance into Chemical Methods for the sterilizationof animal tissue Used in medical Devices.The draft paper on methods of validation in chemical sterilization wasshown to the BGRP for comments, these were later received. A copy wasalso forwarded to MCA and despite numerous reminders no reply had asyet been received.The committee recommended that the paper on "Chemical Methods for theSterilization of Animal Tissue Used in Medical Devices" should beamended include Tissue Harvesting. The BGRP will be informed of thisand a copy of tbe document will be presented to the next CMS/MCA BSEworking group which is to be held on 4th July l99O.Mrs Dhell to arrange a meeting to draft this ammendment.Mrs Turneraction:Hr TinklerMrs DhellDr Hoxey9. Possibility of sending STD paper 'Inactivation of Scrapie-likeAgents" to Dr Taylor and Dr Kimberlin for their comments.The committee felt that the paper should be sent to Dr Taylor andDr Klmberlin and that they should be invited to comment. If theysubsequently required payment for this work the committee felt thatthe Department should finance it if necessary.Mrs Dhell will draft a letter to accompany the report for Miss Duncanto sign.action: Mrs Dhell90/01.26/20.3==============TIP740203/3 024410. - presentation on current situationMiss Duncan's report was passed over until the next meeting.1l. Oral discussion on relevant media interest and media reports.The discussion mainly revolved around _____________ and the exposedposition PD would be in if the media became involved. The possiblepress coverage expected in relation to events at ___________ could alsoraise the profile of BSE in "medical" products.Mr Burton to obtain copies of any defensive briefings draftedby MCA in responce to the ______________ situation.N Weatherhead90/01.26/20.4############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############ i recieved the 1947 report of the Louping-ill vaccine incident and posted on www here; Louping-ill vaccine (scrapie transmission by vaccine) THE VETERINARY RECORD 516 No 47. Vol. 58 November 23rd, 1946 NATIONAL VETERINARY MEDICAL ASSOCIATION OF GREAT BRITAIN AND IRELAND ANNUAL CONGRESS, 1946 snip... The enquiry made the position clear. Scrapie was developing in the sheep vaccinated in 1935 and it was only in a few instances that the owner was associating the occurrence with louping-ill vaccination. The disease was affecting all breeds and it was confined to the animals vaccinated with batch 2. This was clearly demonstrated on a number of farms on which batch 1 had been used to inoculate the hoggs in 1935 and batch 2 to inoculate the ewes. None of the hoggs, which at this time were three- year-old ewes. At this time it was difficult to forecast whether all of the 18,000 sheep which had received batch 2 vaccine would develop scrapie. It was fortunate, however, that the majority of the sheep vaccinated with batch 2 were ewes and therfore all that were four years old and upwards at the time of vaccination had already been disposed of and there only remained the ewes which had been two to three years old at the time of vaccination, consequently no accurate assessment of the incidence of scrapie could be made. On a few farms, however, where vaccination was confined to hoggs, the incidence ranged from 1 percent, to 35 percent, with an average of about 5 percent. Since batch 2 vaccine had been incriminated as a probable source of scrapie infection, an attempt was made to trace the origin of the 112 sheep whose tissues had been included in the vaccine. It was found that they had been supplied by three owners and that all were of the Blackface or Greyface breed with the exception of eight which were Cheviot lambs born in 1935 from ewes which had been in contact with scrapie infection. Some of these contact ewes developed scrapie in 1936-37 and three surviving fellow lambs to the eight included in the batch 2 vaccine of 1935 developed scrapie, one in September, 1936, one in February, 1937, and one in November, 1937. There was, therefore, strong presumptive evidence that the eight Cheviot lambs included in the vaccine althought apparently healthy were, in fact, in the incubative stage of a scrapie infection and that in their tissues there was an infective agent which had contaminated the batch 2 vaccine, rendering it liable to set up scrapie. If that assumption was correct then the evidence indicated that:- (1) the infective agent of scrapie was present in the brain, spinal cord and or spleen of infected sheep: (2) it could withstand a concentration of formalin of 0-35 percent, which inactivated the virus of louping-ill: (3) it could be transmitted by subcutaneous inoculation; (4) it had an incubative period of two years and longer. Two Frenchmen, Cuille & Chelle (1939) as the result of experiments commenced in 1932, reported the successful infection of sheep by inoculation of emulsions of spinal cord or brain material by the intracerebral, epidural, intraocular and subcutaneous routes The incubation period varied according to the route employed, being one year intracerebrally, 15 months intraocularly and 20 months subcutaneously. They failed to infect rabbits but succeeded in infecting goats. Another important part of their work showed that the infective agent could pass throught a chamberland 1.3 filter, thus demonstrating that the infective agent was a filtrable virus. It was a curious coincidence that while they were doing their transmission experiments their work was being confirmed by the unforeseeable infectivity of a formalinized tissue vaccine. As a result of this experience a large-scale transmision experiment involving the ue of 788 sheep was commenced in 1938 on a farm specially taken for the purpose by the Animal Diseases Research Association with funds provided by the Agricultural Research Council. The experiment was designed to determine the nature of the infective agent and the pathogenesis of the disease. It is only possible here to give a summary of the result which showed that (1) saline suspensions of brain and spinal cord tissue of sheep affected with scrapie were infective to normal sheep when inoculatted intracerebrally or subcutaneously; (2) the incubation period after intracerebral inoculation was seven months and upwards and only 60 percent of the inoculated sheep developed scrapie during a period of four and a half years; (3) the incubation period after subcutaneous inoculation was 15 months and upwards and only about 30 percent of the inoculated sheep developed the disease during the four and a half years: (4) the infective agent was of small size and probably a filtrable virus. The prolonged incubative period of the disease and the remarkable resistance of the causal agent to formalin are features of distinct interest. It still remains to determine if a biological test can be devised to detect infected animals so that they can be killed for food before they develop clinical symptoms and to explore the possibilities of producing an immunity to the disease...

8. The Secretary of State has a number of licences. We understand that the inactivated polio vaccine is no longer being used. There is a stock of smallpox vaccine. We have not been able to determine the source material. (Made in sheep very unlikely to contain bovine ingredients). http://www.bseinquiry.gov.uk/files/yb/1989/02/14010001.pdf http://www.bseinquiry.gov.uk/files/yb/1989/02/14011001.pdf although 176 products do _not_ conform to the CSM/VPC guidelines. http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf


Super-ovulate cattle. (Not to forget about the potential for some BSE cases to come from vaccinations containing pituitary-derived SRMs.)

TWA LITTLE minute

http://www.bseinquiry.gov.uk/files/yb/1988/06/10001001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/06/13010001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/06/14006001.pdf

COMMERCIAL IN CONFIDENCE

http://www.bseinquiry.gov.uk/files/yb/1988/09/06005001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/10/06005001.pdf

NOT FOR PUBLICATION

http://www.bseinquiry.gov.uk/files/yb/1988/11/01012001.pdf

http://www.bseinquiry.gov.uk/yb/1988/11/04003001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/04/00007001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/07/00007001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/09/00004001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/10/00003001.pdf

http://www.bseinquiry.gov.uk/files/yb/1989/01/04001001.pdf

http://www.bseinquiry.gov.uk/files/yb/1989/01/26007001.pdf

http://www.bseinquiry.gov.uk/files/yb/1989/01/30001001.pdf

http://www.bseinquiry.gov.uk/files/yb/1989/09/06011001.pdf


NON-LICENSED HUMAN TISSUE DEVICES WERE NOT COMMERCIALLY AVAILABLE

snip...

I was quite prepared to believe in unofficial pituitary hormones, also in the 1970's, whether as described by Dr. Little, or in other circumstances, for animal use.

snip...

The fact that there were jars of pituitaries (or extract) around on shelves is attested by the still potent 1943 pituitaries, described in Stockell Hartree et al. (J/RF/17/291) which had come from the lab. at Mill Hill. Having taken the trouble to collect them, they were not lightly thrown out...

http://www.bseinquiry.gov.uk/files/ws/s467bx.pdf

more on the 1968 medicine act, they forgot to follow

http://www.bseinquiry.gov.uk/files/yb/1989/01/30008001.pdf

Draft cover letter to product licence holders (considered by Human and Vet Medicines including deer)

http://www.bseinquiry.gov.uk/files/yb/1989/02/22008001.pdf

http://www.bseinquiry.gov.uk/files/yb/1989/02/22011001.pdf

(It was noted with concern that hormone extracts could be manufactured by a veterinary surgeon for administration to animals under his care without any Medicines Act Control.)

http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/06/08011001.pdf

http://www.bseinquiry.gov.uk/files/yb/1988/06/07010001.pdf

TWA LITTLE STATEMENT 331

http://www.bseinquiry.gov.uk/files/ws/s331.pdf

25 Apr 2002 : Column WA58
Bovine Embryos and Live Cattle: Imports from North America

The Earl of Caithness asked her Majesty's Government:


When the ban on the importation of embryos and live cattle from North America will be lifted; and [HL3912]
What is the scientific evidence for the imposition of a ban on the importation of embryos and live cattle from North America. [HL3913]


Lord Whitty: Her Majesty's Government have not imposed a ban on imports of bovine embryos and live cattle from North America.

The European Parliament and European Council introduced legislation in May last year laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (TSEs). The legislation was introduced in response to the recommendations of the Office International des Epizooties (OIE—the international animal health organisation) and advice from the Commission's scientific comittees. The legislation (and the transitional measures which came into effect in October last year) includes requirement that imports into the EU of bovine embryos and live cattle must be accompanied by certification confirming that the feeding of ruminants with protein derived from mammals has been banned and that the ban has been effectively enforced. Some exporting countries, such as Canada and the USA, are currently unable to meet these new requirements.

http://www.publications.parliament.uk/pa/ld199900/ldhansrd/pdvn/lds02/text/20425w04.htm


BSE: US Export of Specified Risk Material

Lord Kennet asked Her Majesty's Government:


Whether the United States contends that under the provisions enforceable by the World Trade Organisation the European Union may not ban the import into Europe from the United States of "specified risk material" (that is, material at possible risk of BSE infection).

Lord Donoughue: Yes. But their position on the Specified Risk Material legislation is based on the assumption that the United States can safely be regarded as a "BSE free" country. Their case for such treatment has not been accepted by the EU Commission's Scientific Veterinary Committee.

http://www.publications.parliament.uk/pa/ld199798/ldhansrd/vo971215/text/71215w02.htm

Baroness Masham of Ilton: My Lords, as blood products which infected haemophiliacs with HIV came from the USA, is the Minister confident that something else nasty may not come again from imported blood from the USA? Is he aware that there are ways of cleaning blood to make it safer? I know that that is done in Vienna, in Austria. Will the Minister look into that? Following the question asked by the noble Lord, Lord Clement-Jones, about people using their own blood, I am sure that, when this Statement goes out into the wider community, people will want to know that information.

http://www.publications.parliament.uk/pa/ld199900/ldhansrd/pdvn/lds03/text/31217-09.htm

However, the Bio Products Laboratory who produce plasma products did export surplus products, under the Income Generation Regulations for the NHS, and used the income for the benefit of the health service.[21]

http://www.publications.parliament.uk/pa/cm200001/cmselect/cmpubacc/207/20703.htm#n21

43. Do you sell any of it abroad at all?
(Mr Gorham) No. The only circumstances in which we would export blood would be if there was an approach to the British Government and the British Government felt that it was appropriate to support an international emergency or something like that. We do supply the British Forces. We occasionally help out our colleagues in Wales and Scotland and they would reciprocate with us if that was appropriate. At the moment it is more or less totally contained within the United Kingdom.

http://www.publications.parliament.uk/pa/cm200001/cmselect/cmpubacc/207/1012904.htm


Blood and Blood Products

Mr. Hinchliffe: To ask the Secretary of State for Health what estimate he has made of the number of persons who have been inoculated with blood or blood products over the past three years in the United Kingdom. [61681]

Ms Jowell [holding answer 2 December 1998]: It is estimated that about one million people in the United Kingdom receive blood and blood products every year.

http://www.parliament.the-stationery-office.co.uk/pa/cm199899/cmhansrd/vo990210/text/90210w02.htm

Human vaccine prepared in animal brains
http://www.mad-cow.org/00/nov00_late_news.html#fff
http://www.whale.to/v/singeltary7.html
http://www.mad-cow.org/00/may00_news.html
http://www.mad-cow.org/00/jul00_dont_eat_sheep.html#hhh

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I_______________________________PRODUCTHuman Tissue for Transplantation, Recall # B-0432-6:a) Tricortical Wedge (R) 1.5 x 2.5 cm,Freeze Dried Irradiated;b) Tricortical Wedge ( L ) 1.7 x 3.0 cm,Fresh Frozen Irradiated;c) Cancellous Crushed 60.0 cc, Freeze Dried,Irradiated;d) Cancellous Crushed 30.0 cc Freeze Dried,Irradiated;e) Achilles Tendon OA ( R ) Fresh FrozenIrradiated;f) Achilles Tendon OA ( L ) Fresh FrozenIrradiated;g) Lumbar;h) Cancellous Crushed 30.0 cc Fresh Frozen,IrradiatedCODEa) Tissue 04091-002;b) Tissue 04113-003;c) Tissues 04091-008, 04101-008, 04103-002,04103-003, 04105-003;d) Tissues 04091-005, 04091-006, 04091-007,04101-006, 04101-007, 04102-004, 04102-005,04104-003, 04104-004, 04104-005, 04105-002,04109-003, 04109-004, 04120-004, 04124-003,04124-004, 04138-002, 04138-003, 04140-002,04143-002, 04143-003, 04146-001, 04152-001;e) Tissues 04101-003, 04123-004;f) Tissues 04101-004, 04123-003;g) Tissues 03049-001, 03051-001, 04091-001,04102-001, 04103-001, 04104-001, 04105-001,04106-001, 04107-001, 04108-001, 04109-001,04113-001, 04120-001, 04122-001, 04123-001,04124-001;h) Tissue 04108-002RECALLING FIRM/MANUFACTURERRecalling Firm: Central Texas Regional Blood & Tissue Center, Austin, TX, bytelephone on October 4, 2005, and by letter dated October 11, 2005.Manufacturer: Biomedical Tissue Services, Fort Lee, NJ, firm initiatedrecall is ongoing.REASONHuman tissues, procured from donors without adequate donor eligibilitydeterminations, were distributed.VOLUME OF PRODUCT IN COMMERCE51 allograftsDISTRIBUTIONTX and COPRODUCTHuman Corneal Tissues for Transplantation, Recall # B-0380-6CODETissues: CI044108 OD and CI044108 OSRECALLING FIRM/MANUFACTURERMichigan Eye Bank, Ann Arbor, MI, by letter dated November 22, 2005, and byfacsimile dated November 28, 2005. Firm initiated recall is complete.REASONHuman Corneas, collected from an ineligible donor, were distributed.VOLUME OF PRODUCT IN COMMERCE2 tissuesDISTRIBUTIONMI, CA and Germany_______________________________PRODUCTa) Red Blood Cells Leukocytes Reduced,Recall # B-0617-6;b) Red Blood Cells (Apheresis) Leukocytes Reduced(distributed as split product), Recall # B-0618-6;c) Platelets Leukocytes Reduced, Recall # B-0619-6;d) Fresh Frozen Plasma, Recall # B-0620-6;e) Cryoprecipitated AHF, Recall # B-0621-6;f) Plasma Cryoprecipitate Reduced, Recall # B-0622-6;g) Recovered Plasma, Recall # B-0623-6CODEa) Unit numbers: 1136792, 1040212, 1011245;b) Unit numbers: 1048247-1, 1048247-2;c) Unit numbers: 1040212, 1011245;d) Unit number: 1136792;e) Unit numbers: 1040212, 1011245;f) Unit number: 1040212;g) Unit number: 1011245RECALLING FIRM/MANUFACTURERHoxworth Blood Center, Cincinnati, OH, by letter dated September 6, 2005.Firm initiated recall is complete.REASONBlood products, collected from a donor considered to be at increased riskfor variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE12 unitsDISTRIBUTIONOH and FL_______________________________END OF ENFORCEMENT REPORT FOR MARCH 1, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00941.htmlPRODUCTRecovered Plasma, Recall # B-0643-6CODEUnit numbers: R170537, R165863, and R158308RECALLING FIRM/MANUFACTURERPuget Sound Blood Center, Seattle, WA, by facsimile on October 7, 2003. Firminitiated recall is complete.REASONBlood products, which were collected from an unsuitable donor based on riskfactors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE3 unitsDISTRIBUTIONAustriaEND OF ENFORCEMENT REPORT FOR FEBRUARY 22, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00940.htmlPRODUCTa) Product is 1.0 cc Regenaform® RT. SINGLE PATIENTUSE ONLY. Recall # Z-0481-06;b) OPTEFORM Allografts of varying sizes. SINGLE PATIENTUSE ONLY. Recall # Z-0482-06;c) Product is OPTEFORM Allograft Paste of varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0483-06;d) OPTEFORM® RT Moldable Allograft of varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0484-06;e) Osteofil + RT Allograft Paste in varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0485-06;f) Osteofil Allograft Paste (Bio) of varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0486-06;g) Osteofil IC Syringeable of varying sizes. SINGLEPATIENT USE ONLY. Recall # 0487-06;h) Osteofil ICM Moldable Strip of varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0488-06;i) Osteofil RT, ICM Allograft Paste of varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0489-06;j) OSTEOFIL® DBM Paste of varying sizes. SINGLEPATIENT USE ONLY. Recall # Z-0490-06;k) OsteoPack 3 FZ 22cc. SINGLE PATIENT USE ONLY.Recall # Z-0491-06;l) Regenafil IC. SINGLE PATIENT USE ONLY.Recall # Z-0492-06;m) REGENAFORM RT Allograft Paste, 1cc. SINGLEPATIENT USE ONLY. Recall # Z-0493-06;n) Product is REGENAFORM® Allograft Moldable Blocks,of varying sizes. SINGLE PATIENT USE ONLY.Recall # Z-0494-06;o) Product is RTI Allograft Paste of varying sizes.SINGLE PATIENT USE ONLY. Recall # Z-0495-06;p) Product is REGENAFIL® Allograft Paste, Syringe,0.5cc. SINGLE PATIENT USE ONLY. Recall # 0496-06;q) Product is 1.0cc flowable paste from donorapproved for distribution in Italy. SINGLEPATIENT USE ONLY. Recall # Z-0497-06;r) Product is OPTEFIL Allograft Paste of varyingsizes. SINGLE PATIENT USE ONLY. Recall# Z-0498-06;s) Product is OPTEFIL Allograft Paste, Syringeof varying sizes. SINGLE PATIENT USE ONLY.Recall # Z-0499-06;t) Product is OPTEFORM® Allograft Full Disc,5 x 90mm, 32cc, Frozen. SINGLE PATIENT USEONLY, Recall # Z-0500-06;u) Product is 2.0 cc Opteform® RT. SINGLEPATIENT USE ONLY. Recall # Z-0501-06CODE2879130 2879131 2879132 2879133 2879134 2879135 2879136 2879137 28791382879139 2879350 2879351 2879352 2879353 2879354 2879355 2879440 28794412879442 2879443 2879444 2879445 2879446 2879447 2879448 2879449 28794502879451 2879452 2879453 2879454 2879455 2879456 2879457 2879458 28794592886780 2886781 2886782 2886783 2886784 2886785 2886786 2886787 28867882886789 2886950 2886951 2886952 2886953 2886954 2886955 2886956 28869572886958 2886959 2962280 2962281 2962282 2962283 2962284 2962285 29622862962287 2962288 2962289 2963820 2963821 2963822 2963823 2963824 29638252963826 2963827 2963828 2963829 2963910 2963911 2963912 2963913 29639142963915 2963916 2963917 2963918 2963919 2963990 2963991 2963992 29639932963994 2963995 2963996 2963997 2963998 2963999 2965900 2965901 29659022965903 2965904 2965905 2965906 2965907 2965908 2965909 2965910 29659112965912 2965913 2965914 2965915 2965916 2965917 2965918 2974861 29748622974863 2974864 2974865 2974866 2974867 2974868 2974869 2974870 30218273021829 3021830 3021831 3021832 3021833 3021834 3021836 3021877 30218783021882 3021883 3021885 3023281 3023282 3023283 3023284 3023285 30232863023287 3023288 3023289 3030571 3030572 3030573 3030574 3031471 30314733031474 3031475 3031476 3031477 3031478 3031479 3031480;0756898 0756899 0774572 0829702 0829703 0829704 0829705 0829706 08297570829758 0829759 0829760 0829761 0849054 0849055 0849056 0849057 08490580849144 0849145 0849146 0849147 0849148 0849159 0849160 0849161 08491620849163 0849230 0849231 0849232 0849233 0849234 0850462 0850463 08504690850470 0850471 0852636 0852637 0852638 0852639 0852640 1483739 14837401483741 1483742 1494117 1494118 1494119 1494122 1494240 2121702 21217032121704 2121705 2121706 2121907 2121908 2121909 2121910 2121911 21219222121923 2121924 2121925 2121926 2125258 2125339 2125340 2125341 21253422125343 2147725 2147727 2147825 2147827 2147829 2147905 2147906 21479072147908 2147909 2147930 2147931 2147932 2147933 2147980 2147981 21479822147983 2147984 2147995 2147996 2147997 2147998 2147999 2151766 21517672151768 2151769 2151770 2151781 2151782 2151783 2151784 2151785 21518272151828 2151829 2151830 2151966 2151967 2151968 2151969 2151970 21531172153118 2153119 2153120 2153346 2153347 2153348 2153349 2153350 21533592153360 0843158 0843159 0843160 0843161 0843162 2124913 2124914 21249682124969 2124971 2124972 2135208 2135209 2135210 2135211 2135212 21352732135274 2135275 2135276 2135277 2135284 2135285 2135286 2135287 21353082135309 2135310 2135311 2135312 2135318 2135319 2135320 2135478 21424362142437 2142438 2142439 2145001 2145002 2145003 2145004 2145005 21451312145132 2145133 2145134 2145135 2161531 2161532 2161533 2161534 21616862161687 2161688 2161689 2161690 2166675 2166676 2188866 2188969 21889702188971 0837098 0837099 0837100 0837101 0837102 0837477 0837478 08374790837480 2040067 2040068 2040069 2174843 2174844 2174845 2174846 21748472995331 2995332 2995333 2995334 2997901 2997902 2997903 2997904 29979052997906 2997907 2997908 2997909 2997910;3043561 3043562 3043563 3043564 3043565 3043566 3043567 3043568 30435693043570 3047041 3047042 3047043 3051158 3051159 3051160 3051193 30511943051195 3051196 3051197 3051198 3051199 3051491 3051493 3051495 30514973050703 3050705 3050706 3050710 3056760 3060591 3027677 3027678 30276793044581 3044582 3044583 3044584 3044585 3044586 3044587 3044588 30445893044590 3044931 3044932 3044933 3044934 3044935 3044936 3044937 30449383044939 3044940 3044941 3044942 3044943 3044944 3044945 3044946 30449473044948 3044949 3044950 3045571 3045572 3045573 3045574 3045575 30455763045941 3045942 3045943 3045944 3045946 3045947 3045948 3045949 30463413046342 3046343 3046344 3046345 3046346 3046347 3046348 3046349 30463503046531 3046532 3046533 3046534 3046535 3046536 3046537 3046538 30465393046540 3046621 3046622 3046623 3046624 3046625 3046626 3046627 30466283046629 3046630 3046661 3046662 3046663 3046664 3046665 3046666 30466673046668 3046669 3046670 3046671 3046672 3046673 3046674 3046675 30466763046677 3046678 3046679 3046680 3046731 3046732 3046733 3046734 30467353046736 3046737 3046738 3046739 3046740 3046831 3046832 3046833 30468343046835 3046836 3046837 3046838 3046839 3046840 3046971 3046972 30469733046974 3046975 3046976 3046977 3046978 3046979 3046980 3046981 30469823046983 3046984 3046985 3046986 3046987 3046988 3046989 3046990 30474013047402 3047403 3047404 3047405 3047406 3047407 3047408 3047409 30474103051101 3051102 3051103 3051104 3051105 3051161 3051162 3051163 30511643051165 3051166 3051167 3051168 3051169 3051170 3051221 3051222 30512233051224 3051226 3051227 3051228 3051229 3051230 3051231 3051232 30512333051234 3051235 3051236 3051237 3051238 3051239 3051240 3051241 30512423051243 3051244 3051245 3051246 3051247 3051248 3051249 3051250 30512713051272 3051273 3051274 3051275 3051276 3051277 3051278 3051279 30512803051381 3051382 3051383 3051384 3051385 3051386 3051387 3051388 30513893051390 3051422 3051423 3051424 3051425 3051426 3051427 3060550 30605513060552;2613431 2613432 2613433 2613434 2613435 2613436 2613437 2613438 26134392613440 2613901 2613902 2613903 2613904 2613905 2613906 2613907 26148812614882 2614883 2614884 2614885 2614886 2614887 2614888 2614889 26148902653106 2653107 2653108 2654250 2654251 2654252 2654253 2654254 26542552654256 2654257 2654258 2654259 2699840 2699841 2699842 2699843 24852312485232 2485233 2485234 2485235 2485236 2485237 2485238 2485239 24852402595521 2595522 2595921 2595922 2595923 2595924 2595925 2595926 25959272595928 2595929 2595930 2978531 2978532 2978533 2978534 2978535 29785362978537 2978538 2978539 2978540 2983613 2983614 2983615 2983616 29838312983832 2983842 2983843 2983844 2984801 2984802 2984803 2984804 29848052984806 2984807 2984808 2984809 2984810 2985721 2985722 2985723 29857242985725 2985726 2985727 2985728 2985729 2985730 2985791 2985792 29857932985794 2985795 2985796 2985797 2985798 2985799 2985800 2985911 29859122985913 2985914 2985915 2985916 2985917 2985918 2985919 2985920 29859912985992 2985993 2985994 2985995 2985996 2985997 2985998 2985999 29860002986841 2986842 2986843 2986844 2986845 2986846 2986847 2986848 29868492986850 2986861 2986862 2986863 2986864 2986865 2986866 2986867 29868682986869 2986870 2987907 2987908 2999921 2999922 2999923;2488121 2488122 2488123 2488124 2488125 2488126 2488127 2488128 24881302497251 2497252 2497253 2497253 2497254 2497255 2497256 2497257 24972582497259 2497260 2497361 2497362 2497363 2497364 2497365 2497366 24973672497368 2497369 2497370 2501782 2501783 2501784 2501785 2501786 25017872501788 2501789 2501790 2501791 2501791 2501832 2501833 2501834 25018352501836 2501837 2501838 2501839 2501840 2501841 2501872 2501873 25018742501875 2501876 2501877 2501878 2501879 2501880 2501881 2502191 25021922502193 2502194 2502195 2502196 2502197 2502198 2502199 2502200 25598512559852 2559853 2559854 2559855 2559856 2559857 2559858 2559859 25599512559952 2559953 2559954 2559955 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3035951 3035952 3035953 3035954 3035959;2984056 2984062 2984064 2984065 2984067 2986825 2986827 2986829 29953212995322 2995323 2995324 2995325 2995326 2995327 2995328 2995329 29953302999692 2999693 2999694 2999695 2999696 2999697 2999698 2999699 29997002999924 2999925 2999926 2999927 2999928 2999929 2713387 2718732 27187362718737 2718738 2559751 2559752 2559753 2559754 2559755 2559756 25597572559758 2559759 2559760 2560031 2560032 2560033 2560034 2560035 25600362560037 2560038 2560039 2560040 2560271 2560272 2610521 2610522 26105232610524 2610525 2610526 2610527 2610528 2610529 2610530 2610541 26105422610543 2610544 2610545 2610546 2610547 2610548 2610549 2610550 26105812610582 2610583 2610584 2610585 2610586 2610601 2610602 2610603 26106042610605 2610606 2610607 2610608 2610609 2610610 2610611 2610612 26106132610614 2610615 2610616 2610617 2610618 2610619 2610620 2610761 26107622610763 2610764 2610765 2610766 2610767 2610768 2610769 2610770 26667402666741 2666742 2666743 2666744 2666745 2666746 2666747 2666748;2956993 2956994;2667541 2667542 2667543 2667548 2667981 2667983 2667984 2667985 26679872667988 2667989 2669552 2669553 2669554 2669556 2669559 2669633 26696362669639 2669640 2669965 2669967 2669968 2669969 2669981 2669983 2669985RECALLING FIRM/MANUFACTURERRegeneration Technologies, Inc., Alachua, FL, by letter on October 14, 2005.Firm initiated recall is ongoing.REASONThe tissue was collected from donors for whom there is no verifiableidentity or consent. The medical records and social histories of the donorscannot be ascertained. The devices which incorporate these donor bonetissues undergo processing, including sterilization, which has beenvalidated to inactivate and/or remove all viral diseases for which humantissue donors are tested.VOLUME OF PRODUCT IN COMMERCE5,320DISTRIBUTIONNationwide and InternationallyEND OF ENFORCEMENT REPORT FOR FEBRUARY 15, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00939.html_______________________________PRODUCTSource Plasma, Recall # B-0584-6CODEUnits VL53767, ZZ031076, ZZ030881, ZZ03046, VL151413, VL151144, VL50837RECALLING FIRM/MANUFACTURERBioLife Plasma Services LP, Shreveport, LA, by facsimile dated October 6,2003. Firm initiated recall is complete.REASONSource Plasma, collected from a donor who was at increased risk for variantCreutzfeldt-Jakob Disease (vCJD), was distributed.VOLUME OF PRODUCT IN COMMERCE7 unitsDISTRIBUTIONNCEND OF ENFORCEMENT REPORT FOR FEBRUARY 1, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00937.html_______________________________PRODUCTRed Blood Cells, Recall # B-0552-6CODEUnit number: 4426304RECALLING FIRM/MANUFACTURERFlorida's Blood Center, Inc., St. Petersburg, FL, by facsimile on July 8,2005. Firm initiated recall is complete.REASONBlood product, collected from a donor who may have been at increased riskfor new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.VOLUME OF PRODUCT IN COMMERCE1 unitDISTRIBUTIONFLEND OF ENFORCEMENT REPORT FOR JANUARY 25, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00936.htmlRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I_______________________________PRODUCTHuman Tissue for Transplantation, Recall # B-0322-6a) Alloquent CC Allograft (8, 9 & 10 mm);b) Achilles Tendon;c) Cancellous Bone 4-10 mm (15 & 30 cc);d) Patella Tendon-Hemi;e) Iliac Crest Wedge (14-17mm, 11-13mm,<10mm, and 18+mm);f) Tibialis TendonCODEa) Code: BS30-4008, BS30-4009, BS30-4010;b) Code: LATM;c) Code: LCISM & LCIPM;d) Code: LTTM;e) Code: LIWXLM, LIWLM, LIWMM, LIWSM;f) Code: LTTMRECALLING FIRM/MANUFACTURERRecalling Firm: Lost Mountain Tissue Bank, Kennesaw, GA, by letters datedOctober 12, and October 21, 2005.Manufacturer: Biomedical Tissue Services, Ltd., Fort Lee, NJ. Firm initiatedrecall is ongoing.REASONHuman tissues, procured from donors without adequate donor eligibilitydeterminations, were distributed.VOLUME OF PRODUCT IN COMMERCE283 tissuesDISTRIBUTIONNationwide and Turkey_______________________________PRODUCTPUROS Allograft Bone;Suspend Tutoplast Processed Fascia Lata,Recall # B-0375-6CODEa) U00000000045293 U00000000045294 U00000000045295 U00000000045296U00000000045297 U00000000045298 U00000000045299 U00000000045300U00000000045301 U00000000045302 U00000000045303 U00000000045368U00000000045369 U00000000045370 U00000000045371 U00000000045372U00000000045373 U00000000045374 U00000000045375 U00000000045425U00000000045426 U00000000045427 U00000000045428 U00000000045429U00000000045430 U00000000045532 U00000000045533 U00000000045534U00000000045535 U00000000045536 U00000000045537 U00000000045618U00000000045619 U00000000045620 U00000000045621 U00000000045622U00000000045623 U00000000045624 U00000000045625 U00000000045626U00000000045627 U00000000045628 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BM03K10421B017031504 BM03K10421C017031504BM03L11221A017020904 BM03L11421A017031504 BM03L11421B017031504BM03L12121A017031504 BM03L12221A017031504 BM04B10421A017051704BM03K10421A018031504 BM03K10421B018031504 BM03K11021A018031504BM03K11021B018031504 BM03K11021C018031504 BM03K11021D018031504BM03L10421A018020904 BM03L10421B018020904 BM03L11621A018031504BM03L11621B018031504 BM03L12121A018031504 BM03L12221A018031504BM04A11221A018041204 BM04A11321A018041204 BM04B10421A018051704BM03L11521A023020904 BM03L11521B023020904 BM03L11521D023020904BM03L11821A024031504 BM03L12321A024031504 BM04A11221A024041204BM03K10421A045031504 BM03K12121A045020904 BM03L10421A045020904BM03L10621A045020904 BM03L11621A045031504 BM03L11621B045031504BM03L12121A045031504 BM03J11421A048011904 BM03J11421B048011904BM03K12121A048020904 BM03L10621A048020904 BM03L10621B048020904BM03L11221A048020904 BM03L11521A048020904 BM03L11521B048020904RECALLING FIRM/MANUFACTURERRecalling Firm: Tutogen Medical, Inc., Alachua, FL, by telephone, facsimileand letter on October 14, 2005 and by letter dated October 24, 2005.Responsible Firm: Biomedical Tissue Services, Ltd., Fort Lee, NJ. Firminitiated recall is ongoing.REASONHuman Tissues, procured from donors without adequate donor eligibilitydeterminations, were distributed.VOLUME OF PRODUCT IN COMMERCEa) 5,676 allografts;b) 48 allograftsDISTRIBUTIONNationwide, and Canada_______________________________PRODUCTa) Red Blood Cells, LeukocytesReduced, Recall # B-0492-6;b) Recovered Plasma, Recall # B-0497-6CODEa) and b) Unit number: 4101212RECALLING FIRM/MANUFACTURERNorthwest Florida Blood Center, Inc., Pensacola, FL, by telephone andfacsimile on March 7, 2003. Firm initiated recall is complete.REASONBlood products, collected from an unsuitable donor due to a history oftravel to an area considered at increased risk of exposure to variantCreutzfeldt-Jakob Disease (nvCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE2 unitsDISTRIBUTIONFL_______________________________END OF ENFORCEMENT REPORT FOR JANUARY 18, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00935.htmlPRODUCTSource Plasma, Recall # B-0391-6CODEUnit number: 7030260750RECALLING FIRM/MANUFACTURERZLB Bioplasma, Inc., San Antonio, TX, by facsimile and telephone onSeptember 29, 2003. Firm initiated recall is complete.REASONBlood product, which was collected from a donor who was deferred due to riskfactors associated with variant Creutzfeldt-Jakob disease (vCJD) travel, wasdistributed.VOLUME OF PRODUCT IN COMMERCE1 unitDISTRIBUTIONFL_____________________________________________________________PRODUCTa) Red Blood Cells, Leukocytes ReducedRecall # B-0456-6;b) Recovered Plasma, Recall # B-0457-6CODEa) Unit number: 06FR39967;b) Unit numbers: 06FR37676, 06FR39967RECALLING FIRM/MANUFACTURERAmerican National Red Cross, Southern California Region, Pomona, California,by telephone on June 2, 2002, and by letter dated, June 20, 2002, and byfacsimile transmission dated June 19, 2002. Firm initiated recall iscomplete.REASONBlood products, collected from a donor who was at increased risk of variantCreutzfeldt-Jakob Disease (vCJD), were distributed.VOLUME OF PRODUCT IN COMMERCE3 unitsDISTRIBUTIONCA and Switzerland_______________________________END OF ENFORCEMENT REPORT FOR JANUARY 4, 2006###http://www.fda.gov/bbs/topics/enforce/2006/ENF00933.html

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