[Federal Register: December 19, 2006 (Volume 71, Number 243)]
[Rules and Regulations]
[Page 75865-75879]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19de06-11]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 800
[Docket No. 2003N-0056 (formerly 03N-0056)]
Medical Devices; Patient Examination and Surgeons' Gloves; Test
Procedures and Acceptance Criteria
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule
to improve the barrier quality of medical gloves marketed in the United
States. The rule will accomplish this by reducing the current
acceptable quality levels (AQLs) for leaks and visual defects observed
during FDA testing of medical gloves. By reducing the AQLs for medical
gloves, FDA will also harmonize its AQLs with consensus standards
developed by the International Organization for Standardization (ISO)
and ASTM International (ASTM).
DATES: This rule is effective December 19, 2008.
FOR FURTHER INFORMATION CONTACT: Casper E. Uldriks, Office of
Compliance, Center for Devices and Radiological Health (HFZ-300), Food
and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 240-
276-0100.
SUPPLEMENTARY INFORMATION:
I. Background
Since 1990, FDA has tested patient examination and surgeons' gloves
for barrier integrity in accordance with the sampling plans, test
method, and AQLs contained in Sec. 800.20 (21 CFR 800.20). The FDA
test method was adopted by the consensus standards organizations, ISO
and ASTM, who incorporated this method in ISO 10282, ISO 11193, ASTM
D3577, and ASTM D 3578. Subsequently, ISO and ASTM lowered
[[Page 75866]]
the AQLs in their consensus standards to be more stringent than the
criteria in the FDA test method. In the Federal Register dated March
31, 2003 (68 FR 15404), FDA published a proposed rule to amend the FDA
test method and harmonize the acceptance criteria with those in the
consensus standards. We provided a period of 90 days for comments from
interested parties. We received comments from several parties, which we
summarize and discuss below, and we have revised the final rule in
response to the comments as appropriate.
(Comment 1) FDA received several comments expressing concern that
the proposal to lower the AQLs in the FDA rule to match those in the
ASTM standard does not truly harmonize with ASTM because ASTM applies
the AQLs only to pinhole defects, whereas FDA applies the AQLs to both
pinhole and visual defects.
Historically, FDA has always considered visual defects that affect
barrier integrity as failures during glove testing. The visual analysis
of gloves while conducting water leak testing was specifically included
in the original FDA test method published in December 1990 and codified
at Sec. 800.20. Our experience with laboratory analyses of medical
gloves indicates that visual defects are relatively rare. However, due
to public health concerns, FDA cannot ignore visual defects when they
are observed. FDA will continue to consider visual defects affecting
barrier integrity as failures. FDA does not agree that including these
defects in the analysis will affect harmonization with currently
recognized consensus standards for the vast majority of samples.
FDA has, however, included language in the rule clarifying that
only visual defects that are likely to affect the barrier integrity
should be counted as failures and has described the main types of
visual defects that are likely to affect barrier integrity. FDA
understands the concerns of manufacturers that the lower AQLs could
result in more sample failures, especially if FDA analysts count visual
defects that do not affect barrier integrity. Therefore, FDA intends to
provide guidance to analysts on how to identify visual defects that
affect barrier integrity.
(Comment 2) One comment disagreed with the FDA statement ``Because
the standards organization updated their standards to reflect the
improvement in manufacturing technology, the consensus standards
currently have lower AQLs for medical gloves than FDA's regulations''
on the grounds that the consensus standards' AQLs do not count visual
defects. The commenter proposed that FDA reword this statement.
Until now, the AQLs in the consensus standards have been tighter
than those in the FDA test method, even when visual defects are
considered. As noted previously, visual defects are rarely observed.
Even when they are found, they may not increase the total number of
failures in an analysis because the tears and holes detected by means
of a visual examination would most likely leak if subjected to water
leak testing and count as failures. Other visually defective gloves,
such as adhering gloves, which often tear when pulled apart, might also
leak if subjected to water leak testing.
(Comment 3) FDA received a number of comments expressing concern
that the phrase ``other defects visible upon initial examination that
may affect the barrier integrity'' is subject to interpretation. Some
comments recommended a list of specific criteria for identifying
visually defective gloves. Other comments suggested adding the word
``obvious'' before ``defects.''
FDA understands these concerns and has revised the rule to include
more examples of specific visual defects that should be considered as
failures. However, FDA realizes that it cannot predict all possible
defects that may be encountered. Therefore, the phrase immediately
following the list of specifically identified visual defects has been
revised to read, ``or other visual defects that are likely to affect
the barrier integrity.'' FDA disagrees that adding ``obvious'' before
``defects'' would clarify the type of defects that should be counted or
reduce the risk of subjective interpretation.
(Comment 4) FDA received several comments requesting us to revise
the test procedure and acceptance criteria to have two sets of samples
per lot, one set for testing for pinhole defects and the second set for
testing or determining visual defects. The comments suggested that
visual defects should have less stringent AQLs than pinhole defects.
Also, one comment stated that the test certificates glove manufacturers
routinely issue generally categorize pinholes and visual defects
separately.
FDA disagrees with these comments. FDA is aware that glove
manufacturers routinely inspect their gloves for visual cosmetic
defects that may affect the acceptability of the gloves to buyers.
Since these defects are related to the cosmetic appearance of gloves
rather than safety, they are visually inspected at a lower AQL than
pinhole defects. In contrast, FDA analysis of medical gloves is
intended to ensure that gloves are safe and effective for their
intended use, barrier protection. The FDA test method includes only
those visual defects, such as tears, embedded foreign objects, etc.,
that are likely to affect the barrier integrity of the glove. As
previously stated, FDA has historically considered visual defects that
affect the barrier integrity as failures during glove testing and has
always included them in the total count of defective gloves. Sampling
and counting visual defects that affect barrier integrity separately
from gloves that leak during the water leak test would change
established FDA sampling procedures and could allow more total defects
in glove lots than were allowed under the previous AQLs. This would not
be consistent with the purpose of this rulemaking to improve the
quality of gloves on the U.S. market. Also, because visual defects that
affect barrier integrity are much less common than cosmetic visual
defects, they would probably not be present in the majority of samples.
Routinely taking two sets of samples when one sample is expected to
have no defects would be an inefficient use of resources for the FDA.
The increased time required for two analyses could also result in
delaying entry of imported products.
(Comment 5) Three comments noted that the ASTM standards for
patient examination and surgeons' gloves specify the use of single
normal sampling plans rather than the multiple normal sampling plans
used by FDA.
FDA understands that ASTM uses single normal sampling. However, the
same ISO document that ASTM references for its single sampling plans
(ISO 2859, ``Sampling Procedures for Inspection by Attributes'') also
provides multiple sampling plans that establish the acceptability or
non-acceptability of the lot with equivalent statistical confidence,
but generally using a much smaller total sample size. In view of the
volume of gloves that FDA must test each year, we cannot justify the
additional expense that would accompany the use of the single sampling
plans. Since the sampling plans are statistically very similar, we
consider the revised test method and acceptance criteria to be
harmonized with the ASTM standard.
(Comment 6) Another comment stated that it was unlikely that
manufacturers could supply medical gloves that meet the new AQLs
without any price increase. The comment further stated that tightening
the AQLs would cause manufacturers to test to even tighter in-house
specifications, which could lead to significant ``downgrading'' of some
lots of gloves.
It is FDA's understanding, based on representations made in 510(k)
[[Page 75867]]
submissions and interactions with glove manufacturers, that the glove
industry is already manufacturing gloves that meet the 1.5 and 2.5 AQLs
for surgeons' and patient examination gloves, respectively. FDA
recognizes that some manufacturers may decide to withhold from the
market or ``downgrade'' some glove lots in order to reduce the risk of
failing the FDA test. However, our analysis, described in section III.E
of this document, indicates that the actual number of lots that would
have to be withheld in order to maintain the current failure risk level
is a small percentage of the total number of gloves manufactured and,
consequently, will have a minimal impact on the industry.
(Comment 7) We received several comments that pointed out that an
AQL value should not reference a percentage because it is technically a
number without a unit. The comments suggested that we remove the
reference to percent.
FDA agrees with this comment. The AQL values in the final rule do
not refer to percent.
(Comment 8) One comment requested that the effective date of this
rule be delayed until the year 2010.
FDA disagrees with this comment. ASTM lowered its AQLs for
surgeons' and patient examination gloves in 1998. FDA believes that
manufacturers have had sufficient time to adapt their manufacturing
process to conform to these standards and that, in fact, the vast
majority of currently manufactured gloves already meet the new AQLs.
(Comment 9) One comment suggested the use of normal sampling plans
in ISO 2859 for reconditioned lots instead of the tightened sampling
plans proposed by FDA. This comment maintained that the normal
inspection plans were the optimal plans for glove lots and that these
same sampling plans should also be used for reconditioned lots for both
technical and economic reasons.
FDA disagrees with this comment. When testing reconditioned lots,
FDA needs greater assurance that the gloves are safe and effective
because there has already been an initial failure and an appearance of
adulteration. It is important, therefore, that the tightened sampling
plans be used to test reconditioned lots.
(Comment 10) One comment advised that the sampling plan for
Surgeons' Gloves at 1.5 AQL Normal Sampling and a lot size of 1,201 to
3,200 does not provide for lot acceptance for the first 32 gloves
sampled.
FDA agrees and has revised the chart.
(Comment 11) One comment asked why the tables for both the
Surgeons' and Patients Examination Gloves were changed from the
original rule to list increasing quantities of gloves from top to
bottom rather than from bottom to top.
This change was made to harmonize with the tables in the ISO-2859
sampling plans.
(Comment 12) One comment noted that the leak test materials and set
up described in Sec. 800.20 are an example of what might be used in
small scale testing environments, but that the use of these materials
and set up in high volume test environments is not realistic. Another
comment pointed out that many manufacturers use opaque cylinders rather
than clear plastic cylinders, as described in paragraph Sec.
800.20(b)(2)(i). A suggestion was made to note that the materials and
set up described in Sec. 800.20(b)(2) and (b)(3)(ii) are only
examples.
FDA agrees that the materials and set up described in the
referenced section are only examples and may not be realistic for high
volume test settings and, therefore, has changed the wording in Sec.
800.20(b)(2) Leak test materials, to ``FDA considers the following to
be the minimal materials required for this test.'' FDA will continue to
use clear cylinders to remain harmonized with the ASTM consensus
standard D5151 for detection of holes in medical gloves.
(Comment 13) One comment recommended that FDA define the elongation
and tensile strength required for medical grade gloves.
This comment is beyond the scope of this rule. This rule describes
a barrier test method applicable to gloves of all materials and not a
physical properties test method that will necessarily vary for
differing materials.
(Comment 14) A suggestion was made to increase the water leak test
duration to 3 minutes from the current 2 minutes because there are some
gloves that begin to leak shortly after the 2 minute mark, usually at 2
minutes and 30 seconds.
Changes to this rule are intended to harmonize with the current
consensus standards. Harmonization would not be accomplished if FDA
were to increase its water leak test duration to 3 minutes. Moreover,
there are no reliable data justifying the increase.
(Comment 15) One comment suggested that Sec. 800.20(b)(2)(iv)
should be moved to the preamble because it is a guidance.
It is important that FDA's test method for analyzing gloves be
presented in a coherent manner that thoroughly describes the method in
a way that is understandable. FDA believes that deleting Sec.
800.20(b)(2)(iv) from the codified language would make the test method
more difficult to understand and, therefore, disagrees that it should
be moved to the preamble.
(Comment 16) A suggestion was made to move ``Record the number of
defective gloves'' from (b)(3)(iii)(B) to a new paragraph
(b)(3)(iii)(C). The rationale for this suggestion was that the data are
generated in both (b)(3)(iii)(A) and (b)(3)(iii)(B), and not in just
(b)(3)(iii)(B). Therefore, it appeared that the recording requirement
should be in a separate paragraph.
FDA agrees and has removed ``Record the number of defective
gloves'' from section (b)(3) (iii)(B) and added a new section
``(b)(3)(iii)(C), Record the number of defective gloves.''
(Comment 17) Another comment stated that the preamble should
discuss the relationship between Import Alert 80-04 and Sec. 800.20.
This rule describes FDA's analytical test method for determining
whether individual gloves are defective and acceptance criteria for
determining whether lots of medical gloves are adulterated. It applies
equally to medical gloves offered for import and medical gloves already
in domestic distribution. While the results of analysis could cause a
firm to be placed on Import Alert 80-04, this rule is not intended to
describe or modify FDA's current guidance to FDA field personnel
regarding ``Surveillance and Detention Without Physical Examination of
Surgeon's and or Patient Examination Gloves,'' which is contained in
Import Alert 80-04.
(Comment 18) One comment suggested that we add the following or
equivalent language to (d)(2)(ii) ``Adulteration levels and acceptance
criteria for reconditioned gloves'': ``FDA considers the reconditioned
lot of medical gloves tested by an independent laboratory under
tightened sampling to meet the AQLs which will provide additional
assurance to the consumers. If the retest result has been determined to
be acceptable, the initial analysis of the failed lot before
reconditioning shall be nullified.''
FDA disagrees with this comment. When a collection of gloves that
has been seized or refused entry based on a violative sample is
``reconditioned,'' some of the problematic sizes or lots of the gloves
may have been removed (segregated) from the reconditioned sample. When
this occurs, and the reconditioned sample passes the test under the
tightened sampling plan, FDA will consider the remaining/reconditioned
lots in the collection of gloves to be acceptable, as described in
Sec. 800.20. However, FDA believes that, in the situation described
previously, FDA
[[Page 75868]]
cannot ignore the initial failure which is part of the firm's
historical record.
(Comment 19) Several comments mentioned that the rule would result
in increased costs to consumers of gloves. These comments asserted that
manufacturing and production changes at manufacturing sites would
entail significant costs that would ultimately be passed on to
consumers in the form of price increases.
FDA disagrees with these comments. As stated in section III of this
document, most lots of imported gloves already meet the lower AQLs.
This implies that significant changes in the manufacturing processes
will not be necessary. In addition, there is no universal economic
presumption that costs are passed on to consumers in order to maintain
a constant profit margin to manufacturers. Market conditions will
dictate the specific degree to which regulatory costs are borne by
various economic sectors, i.e., manufacturers, distributors,
purchasers, payers, or consumers. Because of the competitive nature of
this industry and the relatively small proportion of gloves affected by
this rule, FDA believes that these costs are not likely to be directly
passed on in the form of price increases.
II. Environmental Impact
The agency has determined under 21 CFR 25.30(i) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
III. Analysis of Impacts
A. Introduction
FDA has examined the final rule under Executive Order 12866, the
Regulatory Flexibility Act (5 U.S.C. 601-602), and the Unfunded
Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866
directs agencies to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). FDA has determined that
this final rule is not a significant regulatory action under the
Executive order.
If a rule has a significant economic impact on a substantial number
of small entities, the Regulatory Flexibility Act requires agencies to
analyze regulatory options that would minimize the impact of the rule
on small entities. Because this final rule will not result in economic
impacts on domestic small entities, the agency certifies that the final
rule will not have a significant economic impact on a substantial
number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act requires that
agencies prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing a final rule that
includes any Federal mandate that may result in the expenditure of
State, local and tribal governments, in the aggregate, or the private
sector of $100 million or more (adjusted annually for inflation) in any
one year. The current threshold after adjustment for inflation is $118
million, using the most current (2004) implicit price deflator for the
Gross National Product. The agency does not expect this final rule to
result in a 1-year expenditure that would meet or exceed this amount.
The information in the following sections sets forth the bases for
the above conclusions. We show the expected annual costs and benefits
of this final rule next in Table 1. The average annualized costs of the
final rule are estimated to be $6.6 million using either a 3 percent or
7 percent discount rate. Average annualized benefits are expected to be
between $14.8 million and $15.1 million, depending on the discount
rate. Average annualized net benefits are between $8.2 million and $8.5
million.
Table 1.--Average Annualized Costs and Benefits (in millions)\1\
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Annual Discount Rate Costs Benefits Net Benefits
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3 Percent $6.6 $14.8 $8.2
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7 Percent $6.6 $15.1 $8.5
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\1\Annualized over a 10-year evaluation period.
B. Objective of the Final Rule
The objective of the final rule is to reduce the risk of
transmission of blood-borne pathogens (particularly human
immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV)
infections). The rule accomplishes this objective by ensuring that
medical gloves (surgeons' and patient examination gloves) maintain a
high level of quality with respect to the level of noted defects. FDA
is also harmonizing its level for acceptable defects with consensus
quality standards developed by ISO and ASTM.
C. Current Risks of Blood-Borne Illness
Unnecessary exposures to blood-borne pathogens are of great
importance to the health care community because contact with
contaminated human blood or tissue products has led to increased cases
of HIV, HBV, and HCV infections.
Available data cannot precisely quantify the number of new HIV
cases that this final rule will prevent. This analysis, however,
attempts to derive a conservative estimate. For the year 2000, the
Centers for Disease Control (CDC) reported a cumulative total of
approximately 900,000 persons in the United States who had contracted
HIV, of which 775,000 cases had progressed to Acquired Immunodeficiency
Syndrome (AIDS) (Ref. 1). Of those patients whose conditions had
progressed to AIDS, almost 450,000 (58 percent) had died as of December
2000. For the year 2000, the CDC identified 21,704 new cases of HIV
infection.
Approximately 5 percent of the reported HIV/AIDS cases were among
health care personnel (Ref. 2). However, in an indepth analysis of
occupational risk, the CDC reported that between 1992 and 2002 there
had been 56 identified incidents of occupational transmission of the
HIV pathogen and all but 7 of these cases (12.5 percent) were due to
percutaneous cuts or needlesticks. In addition, there were 138 other
cases of HIV infection or AIDS among health care workers with
occupational exposures to blood who had not reported other risk factors
for HIV infection (Ref. 2). Assuming the same 12.5 percent rate for
these workers implies that 17 additional cases of HIV transmission to
health care workers during this period might have been caused by
cutaneous contact in an occupational setting. Consequently, a total of
24 incidents of occupational transmission of HIV to health care
personnel may have occurred over the
[[Page 75869]]
10-year period (or 2.4 per year) due to problems with the barrier
protection properties of gloves used in health care settings.
The CDC also reports approximately 80,000 new cases of HBV for the
latest available reporting period (1999) (Ref. 3). There are
approximately 1.25 million people in the United States chronically
infected with HBV. While only 6 percent of those who contract hepatitis
B after the age of 5 will develop chronic conditions, 15 to 25 percent
of those that do will die prematurely. Health care personnel are at
some risk from this pathogen, but the availability of a vaccine has
reduced the risk of negative outcomes due to exposure.
FDA has no direct data for estimating the rate of new HBV
infections in health care personnel. While the CDC has reported the
risk to health care workers as ``low,'' there is no definition of that
term (Refs. 3 and 4). FDA estimates that as many as 4,000, or 5
percent, of all new incidents of HBV occur in health care personnel.
Because occupational transmissions for HBV may be approximately 5 times
more likely than that for HIV, FDA imputes approximately 140 annual
cases of occupational transmission of HBV to health care personnel (HIV
rate of 7.3/1,085 x 5 x 4,000.) CDC analyses have stated that ``most''
of the occupational transmissions are due to percutaneous injuries
(Ref. 4). Because 2.4 of the 7.3 annual HIV cutaneous contact
transmissions (33 percent) were believed to be attributable to glove
defects, FDA similarly expects about one-third of the 140 annual
occupational transmissions of HBV infections (approximately 40 cases)
may potentially be associated with the current quality level of medical
gloves. If only 6 percent of these cases develop chronic conditions,
then an average of 2.4 annual cases of chronic HBV are associated with
defective medical gloves.
HCV currently infects 3.9 million persons in the United States
(Ref. 3). Over 2.7 million patients have reported chronic conditions.
More than 40,000 new cases were reported in 1999. The risk of exposure
to health care workers, however, appears to be extremely low. In fact,
according to the CDC, other than from needle stick punctures, there has
been no documented transmission of HCV to health care personnel from
intact or non-intact skin exposures to blood or other fluids or tissues
(Ref. 4). Thus, there is little evidence that glove defects are
associated with HCV exposures.
As a result, FDA estimates the overall annual transmission of
blood-borne pathogens due to defects in glove barrier protection in
health care settings to include 2.4 cases of HIV infection and 2.4
cases of HBV infection. Increasing the AQL of gloves by lowering the
rate of acceptable defects should reduce the transmission rates of
these pathogens.
D. Baseline Conditions
The previous AQL (being replaced by this rule) for medical gloves
allowed a defect rate of 4.0 percent for patient examination gloves and
2.5 percent for surgeons' gloves. The AQL represents the proportion of
sampled gloves from a given lot that may include defects such as leaks
or foreign material and still be accepted for entry into the
marketplace. Currently, if more than 4 percent of the sampled patient
examination gloves exhibit defects in accordance with the sampling
criteria, the entire lot of gloves is considered adulterated. Surgeons'
gloves are sampled to a higher quality level (lower AQL requires a
higher proportion of non-defective gloves in order to pass inspection),
because these products have a higher likelihood of contact with bodily
fluids. Of course, medical glove lots that fail to meet the AQL may be
marketed as household or other products. If a sample of gloves fails to
meet the AQL, the marketer may request resampling of the lot. The
required sampling plan for a lot originally found to be out of
compliance is more intensive than the original sampling plan for a
randomly selected lot. Lots initially found to be out of compliance are
either resampled and subsequently offered as medical devices after
meeting the current AQL, offered as nonmedical gloves, or sold in
foreign markets.
Approximately 39.2 billion medical gloves were imported into the
United States during 2004 (Ref. 6). According to FDA records, there are
over 400 manufacturers of medical gloves. Malaysian manufacturers
supply almost 40 percent of the medical gloves in the United States
while Chinese manufacturers supply approximately 30 percent (Ref. 7).
Surgeons' gloves accounted for only about 15 percent of all imported
medical gloves during 2004, and the impact of the final rule on this
sector is negligibly different from overall patient examination gloves.
Therefore, this analysis focuses exclusively on patient examination
gloves.
FDA expects the demand for medical gloves to increase by the same
rate as employment in the medical services industry. The Bureau of
Labor Statistics has projected annual employment growth of 2.6 percent
for this industry (North American Industry Classification System 6200)
(Ref. 8), which implies an annual volume of over 50 billion medical
gloves in 10 years. (A 2.6 annual growth rate results in an expected
increase of 29.3 percent in 10 years.)
Medical glove lot sizes may vary from as few as 25 gloves to as
many as 500,000. According to discussions with manufacturers (Eastern
Research Group, Inc. (ERG) 2001), a typical production or import lot
from a foreign manufacturer contains an average of 325,000 gloves
(either patient examination or surgeons'). This implies that the U. S.
medical glove market currently imports over 120,600 lots of gloves per
year. FDA currently samples only about 1.5 percent of all glove lots,
or 1,800 lots per year. Within 10 years, FDA expects the number of lots
offered for import to increase to 156,000. If the compliance sampling
rate remains constant, FDA would sample about 2,300 lots during that
year.
FDA's Winchester Engineering and Analysis Center (WEAC) analyzed
results from samples collected from 2000 and 2001. These samples
represent approximately one-third of FDA's total sampling effort for
the period. A total of 98,067 gloves were tested from 942 separate
lots. Of these gloves, 2,354 were defective, which implies that 2.4
percent of marketed gloves are likely to be defective. If so, then
approximately 940 million defective medical gloves are currently
marketed (39.2 billion gloves x 0.024). At the current AQL of 4.0, 28
lots (2.97 percent) failed. Consequently, approximately 53 annually
sampled lots are defective (1,800 sampled lots x 0.0297). By the 10th
year, in the absence of the final regulation, 1.21 billion defective
gloves would be marketed and 68 of the sampled lots would fail to meet
the AQL.
FDA allows glove lots that fail to meet the AQL to be resampled.
Sponsors usually attempt to resample the glove lot rather than divert
the entire lot to alternative markets. According to discussions with
industry sources and testing laboratories, the cost of glove lot
resampling and retesting for leakage and tensile strength is
approximately $1,400. The current annual industry cost of resampling
glove lot failures with the current AQL is approximately $74,000 (53
lots times $1,400 per lot). This resampling and retesting cost would
equal $95,000 within 10 years.
E. Costs of the Final Rule
FDA expects that the final rule will result in changed shipping
practices by medical glove manufacturers. Currently, manufacturers use
the target AQLs as a guide for releasing production lots of
[[Page 75870]]
gloves for export to the United States because the release criteria are
lower in the United States than in other markets. Manufacturers attempt
to avoid having three failures within a 24-month period, because this
may result in refusal of future imports under Level 3 detention
described in FDA's current policy, ``Surveillance and Detention Without
Physical Examination of Surgeon's and/or Patient Examination Gloves.''
Thus, to maintain an uninterrupted supply of gloves to customers, and
to guard brand loyalty while avoiding Level 3 detention, manufacturers
would be expected to raise their level of quality control to at least
maintain the current average lot rejection rate of 2.97 percent. FDA
also expects the rule to increase the costs of sampling by requiring
larger and more detailed sampling plans to assure the lower AQL is met
for each inspected glove lot. FDA does not envision increased
regulatory oversight costs because the rate of inspections is not
expected to change. Costs have been analyzed and discounted using the
methodology suggested by OMB's Circular A-4 (September 2003).
1. Costs of Quality Control
Manufacturers currently conduct quality control tests on glove lots
prior to release. These tests include water-tight leak and tensile
strength assays. According to interviews with glove manufacturers, the
current cost of conducting these tests at the manufacturing site is
approximately $310 per lot, while the more stringent quality control
testing required by this rule may cost an additional $45 per lot. The
additional cost is for increased inventory and larger sample sizes to
ensure more precise measurements at the lower AQL. Because
approximately 120,600 lots are currently imported per year, the
expected costs are $5.4 million (120,600 lots x $45 per lot). The
expected increase in the demand for medical gloves by the 10th
evaluation year will result in a compliance cost of meeting this
increased quality level of $7.0 million. Over the 10-year period, the
average annualized cost of this increased level of testing, at a 3
percent annual discount rate, is $6.2 million and, at a 7 percent
annual discount rate, is $6.2 million.
2. Increased Sampling Costs
A lower AQL will result in increased sampling costs for imported
glove lots. The increased sampling costs will result from the need to
test greater quantities of gloves in order to ensure sufficient
statistical power. Based on reported costs from U.S. testing
laboratories, ERG, an independent economic contractor, estimated that
increased testing would add approximately $200 to the current costs of
$1,400 per sample. (The difference between this increased cost and the
$45 increased quality control cost is attributable to lower costs in
foreign countries that produce medical gloves.) FDA currently samples
about 1.5 percent of the 120,600 lots imported annually, or 1,800
samples. Thus, the increased sampling costs due to this final rule are
$0.4 million (120,600 lots x 0.015 x $200). Within 10 years, this
increased cost will equal $0.5 million (due to expected increases in
the number of inspected glove lots). The average annualized sampling
cost increase at a 3 percent annual discount rate is $0.4 million, and
at a 7 percent annual discount rate is $0.4 million.
3. Withheld Lots
The lower AQL in this final rule is also likely to result in an
increase in the number of lots of medical gloves that are not released
for shipment to the U.S. medical market. For example, manufacturers may
attempt to maintain a target compliance level in order to avoid FDA's
Level 3 detention under ``Surveillance and Detentions Without Physical
Examination of Surgeon's and or Patient Examination Gloves.'' FDA's
WEAC laboratory sampled 942 lots and discovered that 28 failed using
the current AQL while 79 lots failed using the lower AQL in this final
rule. To maintain the original 0.0297 (28/942) lot failure rate, the 53
lots with the highest defect rate would have to be held back by the
affected manufacturers (.056)\1\.
---------------------------------------------------------------------------
\1\The current lot failure rate (28/942 = 0.0297) is reached by
removing 53 defective lots from the sample. If only the 51
additional failing lots are removed, the overall failure rate is
0.0314 (28/891). The expected future failure rate is 0.0292 (26/
889). FDA expects the withheld lots to include those with the
highest defect rates.
---------------------------------------------------------------------------
Therefore, FDA anticipates that under the lower AQL in the final
rule, approximately 6,900 lots will be held back by manufactures. In
order to meet the expected demand in 10 years, FDA expects that 9,000
lots will be held back. FDA believes that glove lots that fail to meet
the lower AQL in this final rule for medical quality standards will
most likely be sold as nonmedical gloves. FDA believes that, although
manufacturers and distributors may experience some loss of revenue from
this shift (because of the price premium commanded by medical gloves),
the loss will be inconsequential.
4. Costs of FDA Inspections
FDA does not envision increased inspection costs due to the final
rule. The rate of sampled glove lots is not expected to differ and FDA
resources are not expected to increase over the evaluation period.
5. Total Costs
In sum, FDA estimates that the final rule will have an average
annualized cost of about $6.6 million using either a 3 percent or 7
percent annual discount rate. Table 2 presents the costs for each year
of the evaluation period.
Table 2.--Costs per Year of the Final Rule (in millions)
----------------------------------------------------------------------------------------------------------------
Costs for Quality Costs for
Year Control Sampling Total Costs
----------------------------------------------------------------------------------------------------------------
Current $5.4 $0.4 $5.8
----------------------------------------------------------------------------------------------------------------
1 $5.6 $0.4 $6.0
----------------------------------------------------------------------------------------------------------------
2 $5.7 $0.4 $6.1
----------------------------------------------------------------------------------------------------------------
3 $5.9 $0.4 $6.3
----------------------------------------------------------------------------------------------------------------
4 $6.0 $0.4 $6.4
----------------------------------------------------------------------------------------------------------------
5 $6.2 $0.4 $6.6
----------------------------------------------------------------------------------------------------------------
[[Page 75871]]
6 $6.3 $0.4 $6.7
----------------------------------------------------------------------------------------------------------------
7 $6.5 $0.4 $6.9
----------------------------------------------------------------------------------------------------------------
8 $6.7 $0.4 $7.1
----------------------------------------------------------------------------------------------------------------
9 $6.8 $0.5 $7.3
----------------------------------------------------------------------------------------------------------------
10 $7.0 $0.5 $7.5
----------------------------------------------------------------------------------------------------------------
Present Values 3%-$53.2 3%-$3.6 3%-$56.8
7%-$43.4 7%-$2.9 7%-$46.3
----------------------------------------------------------------------------------------------------------------
F. Benefits of the Rule
The final rule will result in public health gains by reducing the
frequency of blood-borne pathogen transmissions due to defects in the
barrier protection provided by medical gloves. Based on an implied
societal willingness to pay (WTP), FDA expects that an annualized
monetary benefit of $14.8 million (using a 3 percent discount rate) or
$15.1 million (using a 7 percent discount rate) will be realized due to
fewer pathogen transmissions and unnecessary blood screens. Fewer glove
defects will reduce the cost and anxiety associated with unnecessary
blood screens (i.e., those that would yield negative results for health
care personnel). Benefits have been analyzed and discounted using the
methodology suggested by OMB's Circular A-4 (September 2003).
1. Reductions in the Number of Marketed Defective Gloves
As noted in the previous paragraphs, FDA has determined that
approximately 940 million defective gloves are marketed each year in
the United States, or 2.4 percent of all medical gloves. In the absence
of this rule, FDA expects that the number of defective medical gloves
marketed in the United States would increase to 1.21 billion per year
within 10 years. The final rule will substantially reduce this figure.
WEAC's analysis of 98,067 medical gloves from 942 sampled lots
collected in 2000 and 2001 resulted in approximately 3 percent lot
failures with an AQL of 4.0 (28 lots would fail). This lot failure rate
was associated with 2,356 defective gloves, or 2.4 percent of the total
number of sampled gloves. Under the lower AQL of 2.5 in the rule, the
WEAC analysis concluded that 51 additional lots would fail (a total of
79 failed lots), increasing the lot failure rate from 2.91 percent to
8.39 percent.
As previously mentioned, FDA provides a Level 3 detention status in
its guidance, ``Surveillance and Detentions Without Physical
Examination of Surgeon's and or Patient Examination Gloves.''
Manufacturers on Level 3 detention are not allowed to import medical
gloves because they have repeatedly failed analysis. To avoid the
denial of entry, manufacturers may be expected to hold a sufficient
number of defective lots from shipment in order to maintain the same
target lot failure rate (approximately 3 percent) with a new AQL. If
so, removing the 53 most defective lots in the testing sample would
result in 26 lot failures from 880 total lots, thereby maintaining the
original 2.92 percent lot failure rate. This scenario leaves 85,172
total gloves in the sample, of which 1,512 were defective, resulting in
a glove defect rate of 1.78 percent. The final rule, therefore, could
reduce the proportion of marketed defective medical gloves from 2.4
percent of all marketed gloves to 1.78 percent of all marketed gloves.
The implications of this expected reduction in defective gloves are
significant. The current AQL is associated with 940 million glove
defects during the present year (based on 2004) and within 10 years
would result in 1.21 billion marketed defective medical gloves. When
the lower AQL is in place, the current number of defective gloves will
approximate 700 million and within 10 years will result in 900 million
defective marketed gloves. The number of defective gloves, therefore,
should be reduced by more than 25 percent due to the new AQL.
2. Reductions in Blood-Borne Pathogens
FDA has estimated that there are potentially 4.8 annual
transmissions of blood-borne pathogens associated with medical glove
defects (section IV.C of this document). These transmissions include
2.4 cases of HIV and 2.4 cases of chronic HBV. Because there are
currently no documented cases of cutaneous transmission of HCV that
would be affected by improving glove quality levels, this analysis does
not consider potential HCV transmission.
a. Reductions in HIV transmission. While the direct relationship
between defective medical gloves and the transmission of HIV is
unknown, FDA believes it is reasonable to apply the proportional
reduction in the number of defective gloves due to the final rule
(about 25 percent) to the annual transmission rate of the HIV pathogen
to health care personnel. In the absence of this rule, the current
expectation of 2.4 annual cases of HIV transmission to health care
personnel would likely increase to 3.1 annual cases within 10 years due
to the expected growth of employment in the health services industry.
However, with the new AQL in place, FDA forecasts the expected annual
transmission of HIV to health care personnel to equal 1.8 cases in
current conditions and 2.3 cases by the 10th evaluation year (based on
the expected proportionate decrease in marketed defective gloves). Over
the entire 10-year evaluation period, these assumptions suggest that
the rule should prevent approximately seven cases of HIV transmission
to health care personnel.
b. Reductions in HBV transmissions. Hepatitis B transmissions to
health care personnel are more common than cutaneous HIV transmissions.
However, little specific data are available to identify affected
patient populations and routes of transmission. FDA has estimated that
as many as 2.4 cutaneous transmissions of chronic HBV may be due to
defective medical gloves each year. In the absence of this rule, this
number would be expected to increase to 3.1 annual transmissions within
10 years, based on the expected employment growth in the health
services industry.
Implementation of the final rule should decrease these
transmissions by about 25 percent. FDA expects 1.8 HBV transmissions
under current conditions,
[[Page 75872]]
a reduction of 0.6 transmissions from baseline conditions. By the 10th
evaluation year, FDA expects that there will be 2.3 chronic HBV
transmissions with the lower AQL, or a total of 0.8 fewer cases.
Overall, about seven transmissions of chronic HBV will be avoided due
to the final rule over a 10-year evaluation period.
3. Reductions in the Number of Blood Screening Tests
As the number of defective gloves marketed in the United States
decreases due to this rule, corresponding reductions would be expected
in the number of unnecessary blood screens. FDA contacted several
research hospitals to ascertain how frequently health care personnel
identify glove failure as a reason for initiating blood screens.
Respondents stated that about 5 percent of all glove failures are
noticed by the user and about 1 percent of these identified failures
are reported to the facility for additional screening (Ref. 9 and 10).
Respondents noted that the glove failure could occur prior to patient
contact. Therefore, the additional screening may apply to the affected
health care personnel or the patient. The great majority of these
screens result in negative findings.
As shown in the previous paragraphs, when the final rule is in
effect, FDA expects the number of defective gloves marketed to decrease
from 940 million to 700 million, a reduction of 240 million defective
gloves. By the 10th year, the number of defective gloves is expected to
decrease from 1.21 billion to 900 million, a reduction of 310 million
defective gloves. At the rates of potential identification (5 percent)
and reports of contact with pathogens (1 percent) obtained from the
research hospital sector, the final rule should result in 120,000 fewer
unnecessary blood screens under current conditions (240 million fewer
defects x 0.05 x 0.01). By the 10th year, 155,000 fewer annual blood
screens are expected. Over the entire evaluation period, the rule could
result in over 1.4 million fewer unnecessary blood screens.
4. Cost-Effectiveness of the Final Rule
We analyzed the cost-effectiveness of the final rule using both the
cost per transmission of blood-borne pathogen avoided and the cost per
unnecessary blood screen avoided. The annual numbers of future avoided
transmissions and tests were compared to the present values of the
costs for the evaluation period and shown in Table 3. Table 3 shows the
expected annual reductions in blood-borne pathogens and unnecessary
blood screens due to the final rule.
Table 3.--Expected Annual Reductions in Blood-Borne Pathogen
Transmissions and Unnecessary Blood Screens
------------------------------------------------------------------------
Reduction in
Year Reduction in Blood-Borne Unnecessary Blood
Pathogen Transmission Screens
------------------------------------------------------------------------
Current 1.2 120,000
------------------------------------------------------------------------
1 1.2 120,000
------------------------------------------------------------------------
2 1.2 125,000
------------------------------------------------------------------------
3 1.4 135,000
------------------------------------------------------------------------
4 1.4 135,000
------------------------------------------------------------------------
5 1.4 140,000
------------------------------------------------------------------------
6 1.4 145,000
------------------------------------------------------------------------
7 1.6 150,000
------------------------------------------------------------------------
8 1.4 145,000
------------------------------------------------------------------------
9 1.6 155,000
------------------------------------------------------------------------
10 1.6 155,000
------------------------------------------------------------------------
Although these reductions should continue beyond the evaluation
period, we have analyzed only through the 10th year. Each year's
expected number of reduced blood-borne pathogen transmissions and
unnecessary blood screens are discounted (using both a 3 percent annual
discount rate and a 7 percent annual discount rate) to arrive at an
equivalent number of reductions if valued during the first evaluation
year. The present values of the regulatory costs (shown in Table 4) are
divided by the present values of the expected reductions to arrive at
the cost per avoided event. This is shown in Table 4.
Table 4.--Regulatory Cost-Effectiveness per Incidence of Blood-Borne Pathogen Transmission Avoided and
Unnecessary Blood Screen Avoided
----------------------------------------------------------------------------------------------------------------
Cost per Blood-
Annual Discount Present Value of Present Value of Borne Pathogen Present Value of Cost per Blood
Rate Costs (in Blood-Borne Avoided (in Blood Screens Screen Avoided
millions) Pathogens Avoided millions) Avoided
----------------------------------------------------------------------------------------------------------------
3 percent $56.8 12.2 $4.7 1,191,000 $48
----------------------------------------------------------------------------------------------------------------
7 percent $46.3 9.8 $4.7 971,000 $48
----------------------------------------------------------------------------------------------------------------
The cost-effectiveness of the final rule is $4.7 million per
transmission of blood-borne pathogen avoided, or $48 per unnecessary
blood screen avoided for both discount rates. We note that both
reductions should occur and the allocation of costs to each outcome
would reduce the costs per avoided event for both.
5. Value of Avoiding Blood-borne Pathogens
a. Quality adjusted life-years. The economic literature includes
many attempts to quantify societal values of health. A widely cited
methodology assesses wage differentials necessary to attract labor to
riskier occupations. This research indicates that society appears to be
WTP approximately $5 million to avoid the probability of a statistical
death (Refs. 11, 12, and 13). That is, social values appear to show
that people are WTP a significant amount to reduce even a small risk of
death; or similarly, to demand significant payments to accept
marginally higher risks.
Because this estimate is predominantly based on blue-collar
occupations that mainly attract males
[[Page 75873]]
between the ages of 30 and 40, FDA adjusted the life-expectancy of a
35-year-old male to account for future bed and non-bed disability
(Refs. 14, 15, and 16), and amortized the $5 million (at both 3 percent
and 7 percent discount rates) over the resulting quality-adjusted life
span. The results were estimates of $213,000 per quality adjusted life-
year (QALY) using a 3 percent discount rate and $373,000 per QALY using
a 7 percent discount rate, which implies that society is WTP between
$213,000 and $373,000 for the statistical probability of a year of
perfect health, depending on the discount rate.
b. Value of morbidity losses. In theory, loss of health reduces the
willingness to pay for additional longevity. Many studies have
attempted to estimate the relative loss of health for many different
conditions of morbidity. One method utilizes the Kaplan-Bush Index of
Well-Being. This index assigns relative weights to functional states,
and then adjusts the resulting weighted value by the problem/symptom
complex that contributed to loss of function (Refs. 16 and 17).
Functional state is measured in three areas: Mobility, social activity,
and physical activity. For example, with most treatment, chronic HBV is
unlikely to have a major impact on any of these functions; a patient
could drive a car, walk without a physical problem, and conduct work,
school, housework and other activities. However, because a patient with
HBV has an ongoing problem/symptom complex the relative weight of this
functional state is 0.7433\2\.
---------------------------------------------------------------------------
\2\The implication is that an ideal health state is valued as
1.0000 and mortality at 0.0000. Each functional state between these
extremes is a proportionate value of ``perfect'' health.
---------------------------------------------------------------------------
This methodology then adjusts the weighted value of the functional
state by the most severe problem/symptom complex contributing to that
state. In the case of chronic HBV, the most common symptom is general
tiredness, weakness, or weight loss. This complex has a derived
relative weight of +0.0027, which when added to the weighted functional
state value results in a relative weight of 0.7460. The loss of
relative health due to HBV, therefore, is expected to equal 1.0000
minus 0.7460, or 0.2540 of perfect health. When this relative health
loss is applied to the derived value of a QALY, it implies that society
would be WTP between $54,000 (3 percent) and $93,000 (7 percent) per
year to avoid a case of HBV (QALY value x 0.2540). This value includes
the potential costs of treatment and additional prevention, as well as
any perceived pain and suffering.
FDA compared this methodology to a variety of published estimates
of preference ratings of morbidity prepared by the Harvard Center for
Risk Analysis (HCRA) (Ref. 17a). The published ratings of 14 studies of
chronic HBV ranged from 0.75 to 1.00 (no impact). While the estimate
used in this analysis (0.746) is in the low end of collected published
studies, FDA notes that most of the expressed preferences that were
derived from time trade-off and standard gamble methodologies, as
compared to author judgment, were closer to the FDA estimate. A health
care worker who may contract HBV may typically have a life expectancy
of approximately 40 years (as of 2000, a 40-year-old female had a
future life expectancy of 41.1 years (Ref. 14)). The present value (PV)
of $54,000 (3 percent) and $93,000 (7 percent) for 40 years implies
that society is WTP $1.25 million (3 percent) or $1.24 million (7
percent) to avoid the statistical likelihood of a case of chronic HBV
in health care personnel.
Deriving society's implied WTP to avoid HIV is more complicated.
The CDC has published data indicating that approximately 80 percent of
all HIV infections progress to AIDS within 5 years. Of the cases of
AIDS, over half (approximately 60 percent) result in mortality within
an additional 5 years. Thus, for a 10-year period, FDA tracked 3
potential outcomes: Patients who contract HIV but do not progress to
AIDS (20 percent), patients who contract HIV and progress to AIDS in 5
years and survive (32 percent), and patients who contract HIV, progress
to AIDS within 5 years and then die within an additional 5 years (48
percent).
HIV infection is not expected to affect either mobility or social
activity. However, such an infection is likely to somewhat inhibit
physical activity. HIV patients are expected to be able to walk, but
with some physical limitations. This functional state has a relative
weight of 0.6769. The main problem/symptom complex of HIV is general
tiredness (as for HBV), so the selected functional weight is adjusted
by +0.0027 to result in relative well-being of 0.6796. As a result, the
relative societal willingness to pay to avoid the statistical
probability of a case of HIV in health care personnel is approximately
$68,000 (3 percent) or $120,000 (7 percent) per year (QALY value x
[1.0000 minus 0.6796]). According to the collected preference scores
(ref. 17a) in the HCRA's Catalog of Preference Scores, the average
estimated published preference rating for HIV infection was 0.7 (range
0.3 to 1.00).
If HIV progresses to AIDS, a patient's functional state is likely
to be more restricted. An AIDS patient requires some assistance with
transportation, is limited in physical activity, and is limited in
work, school, or household activity. The relative weight for this
functional state is 0.5402. The main problem/symptom of AIDS remains
general tiredness and loss of weight (as with HIV and HBV), so the
adjusted health state is 0.5429. This results in a derived societal
willingness to pay to avoid the statistical probability of a case of
AIDS of about $97,000 (3 percent) or $170,000 (7 percent) per year
(QALY value x (1.0000 minus 0.5429)). The HCRA's Catalog of Preference
Scores (ref. 17a) reports average preference ratings of 0.375 for cases
of AIDS with ranges from 0.0 to 0.5.
As discussed earlier, the derived societal willingness to pay to
avoid a statistical mortality has been estimated to equal approximately
$5 million.
Using these estimates, the WTP to avoid the statistical probability
of an HIV transmission in health care personnel is calculated as the
sum of:
20 percent of the PV (at 3 percent and 7 percent discount
rates) of avoiding 40 years of HIV infection.
32 percent of the sum of the PV of avoiding 5 years of a
HIV infection plus the PV of avoiding 35 years of AIDS infection
occurring 5 years in the future.
48 percent of the sum of the PV of avoiding 5 years of HIV
infection plus the PV of avoiding 5 years of AIDS infection occurring 5
years in the future plus the discounted WTP of avoiding a statistical
mortality occurring 10 years in the future.
The PV of avoiding 40 years of health loss valued at $68,000 per
year (3 percent) is approximately $1.6 million and if valued at
$120,000 per year (7 percent) is also approximately $1.6 million.
Twenty percent of this figure equals $320,000.
The PV of avoiding 5 years of health loss to due HIV infection is
equal to $311,000 (3 percent) or $492,000 (7 percent). The PV of
avoiding the health loss expected from 35 years of AIDS infection
(valued at $97,000 (3 percent) and $170,000 (7 percent) per year) is
equivalent to $2.1 million (3 percent) and $2.2 million (7 percent).
The present values of these amounts occurring 5 years in the future are
$1.8 million (3 percent) and $1.6 million (7 percent). When added to
the PV of avoiding the health loss associated with 5 years of HIV
infection ($311,000 (3 percent) and $492,000 (7 percent)), the total
estimated PV of the societal willingness to pay to avoid a statistical
case of this outcome is about $2.1
[[Page 75874]]
million (for both 3 percent and 7 percent discount rates). Thirty-two
percent of this figure equals $660,000.
The PV of avoiding the health loss associated with 5 years of AIDS
infection ($445,000 (3 percent) and $700,000 (7 percent)) occurring 5
years in the future is equivalent to $384,000 (3 percent) and $497,000
(7 percent). The PV of the societal value of avoiding a statistical
mortality ($5 million) 10 years in the future is $3.72 million (at 3
percent) and $2.54 million (at 7 percent). The total societal WTP to
avoid a case of HIV with mortality as an outcome, therefore, is $4.4
million using a 3 percent discount rate ($311,000 plus $384,000 plus
$3.72 million) and $3.5 million using a 7 percent discount rate
($493,000 plus $497,000 plus $2.54 million). Forty-eight percent of
these figures equals approximately $2.1 million (3 percent) and $1.7
million (7 percent).
Summing the weighted amounts of the three expected outcomes for a
case of HIV infection equals an estimated societal willingness to pay
of $3.08 million using a 3 percent discount rate ($320,000 plus
$660,000 plus $2.1 million) and $2.68 million using a 7 percent
discount rate ($320,000 plus $660,000 plus $1,700,000).
In sum, the estimated societal values of avoiding morbidity and
mortality due to transmission of blood-borne pathogens are estimated to
be equivalent to $1.25 million per transmission of chronic HBV and
$3.08 million per transmission of HIV using a 3 percent discount rate
and $1.24 million per transmission of HBV and $2.68 million per
transmission of HIV using a 7 percent discount rate. FDA notes that
other cost-effectiveness research (Ref. 18) has determined cost-
effectiveness estimates (excluding pain and suffering) of $2.1 million
per avoided case of HIV.
FDA believes the methodology used to estimate the value of avoided
HBV and HIV infection is reasonable and supportable. However,
comparative methodologies that demonstrate both higher and lower values
on avoidance have been reported. FDA acknowledged these differences in
the proposed rule and solicited comment on other appropriate measures
for estimating the societal value of avoiding blood-borne pathogens.
FDA received no responses.
c. Benefit of morbidity avoidance. The rule is expected to reduce
both HBV and HIV transmissions by reducing the prevalence of defective
medical gloves used as barrier protection. During the first evaluation
year, the rule is expected to result in 0.6 fewer chronic HBV
transmissions to health care personnel. Applying the assumed societal
WTPs of $1.25 million (3 percent) and $1.24 million (7 percent) to
avoid the probability of an HBV infection, the expected benefit of
avoiding these transmissions is $0.8 million (3 percent) and $0.7
million (7 percent). By the 10th evaluation year, 0.8 annual
transmissions are expected to be avoided at a value of $1.0 for either
discount rate. The PV of avoiding approximately 7 chronic HBV
transmissions over a 10-year period equals $7.6 million (at 3 percent
discount rate) and $6.1 million (at 7 percent discount rate). This is
equal to an average annualized value of $0.9 million for the entire 10-
year evaluation period at either discount rate.
Also, in the first evaluation year, FDA expects that the final rule
will result in the probability of 0.6 fewer transmissions of HIV caused
by defective gloves. Assuming that society is WTP $3.08 million (at 3
percent discount rate) and $2.68 million (at 7 percent discount rate)
to avoid the probability of a single HIV transmission, the benefit of
avoiding these transmissions equals $1.8 million (3 percent) and $1.6
million (7 percent). By the 10th evaluation year, FDA expects the final
rule to result in 0.8 fewer HIV transmissions, which are valued at $2.5
million (3 percent) and $2.1 million (7 percent). The societal PV of
avoiding seven transmissions of HIV over the 10-year evaluation period
is $18.8 million (at 3 percent discount rate) and $13.1 million (at 7
percent discount rate). These values are equivalent to average
annualized benefits of $2.2 million (at 3 percent discount rate) and
$1.9 million (at 7 percent discount rate).
In sum, FDA estimates that the reduction in blood-borne pathogen
transmissions due to this final rule should produce health benefits
valued at $3.1 million (at 3 percent discount rate) and $2.8 million
(at 7 percent discount rate) per year. Most of this benefit (over 67
percent) is attributable to reducing the incidence of HIV.
6. Value of Avoiding Unnecessary Blood Screens
The expected decline in the number of defective medical gloves
should lead to fewer unnecessary blood screens and thereby provide two
potential benefits. First, the direct cost of conducting screens to
determine whether the pathogen was transmitted to health care personnel
should decrease. Second, the psychological anxiety and stress that
accompanies the possibility that a pathogen was transmitted to an
individual should also decrease.
a. Cost of conducting blood screens. FDA has collected data from
the American Red Cross (Ref. 5) on the costs of conducting blood
screening tests in order to ensure the safety of the blood supply.
These estimates include the costs of collection (including personnel,
needles, bags, and other supplies) at $47.66 per sample; sample testing
at $25.16 per sample; and overhead at $3.26 per sample. The estimated
direct testing cost per blood sample is the sum of these amounts, or
$76 per test.
b. Anxiety and stress associated with potential transmission of
pathogens. The psychological literature has noted that levels of
anxiety and stress impact participation in public health screening
programs and thereby affect physiological health (Refs. 19, 20, and
21). Also, patients with high levels of uncertainty about whether they
have contracted serious, threatening diseases experience heightened
levels of stress and anxiety until they learn the results of any
testing screens are negative (Ref. 20). According to one measurement
scale of well-being, reduced mental lucidity, depression, crying, lack
of concentration, or other signs of adverse psychological sequelae may
detract as much as 8 percent from overall feelings of well-being (Ref.
16) and have outcomes similar to physiological morbidity. Scaling of
the relative stress caused by events shows that concerns about personal
health, by themselves, are likely, on average, to contribute
approximately one-sixth of the total weighting required to trigger a
major stressful episode (Refs. 20, 21, and 22). Thus, FDA approximates
that increased stress and anxiety concerning possible exposure to
pathogens may reduce overall sense of well-being and result in health
loss of approximately 1.3 percent (0.013).
As described earlier, FDA has calculated an assumed WTP of $213,000
(at 3 percent) and $373,000 (at 7 percent) for a statistical QALY.
These figures imply that the probability of each day of quality
adjusted life has a social value of about $585 (at 3 percent discount
rate; $213,000 divided by 365) and $1,020 (at 7 percent discount rate;
$373,000 divided by 365). If blood test results are usually obtained
within 24 hours, the resultant loss of societal well-being for each
test subject is valued at approximately $8 (at 3 percent discount rate;
$585 x 0.013) and $13 (at 7 percent discount rate, $1,020 x 0.013).
c. Benefit of test avoidance. By combining avoided direct costs of
tests and the value of avoided anxiety and stress, FDA estimates that
the societal benefit of avoiding an unnecessary blood test is $84 per
sample (at 3 percent discount rate) and $89 per sample (at 7 percent
discount rate).
[[Page 75875]]
During the first evaluation year, FDA expects that there will be
120,000 fewer unnecessary blood screens because of the expected
reduction in defective medical gloves due to the final rule. The
implied societal WTP to avoid these unnecessary screens is $10.1
million (3 percent) and $10.7 million (7 percent). During the 10th
evaluation year, approximately 155,000 fewer unnecessary blood screens
are expected with a resultant benefit of $13.0 million (3 percent) and
$14.0 million (7 percent). The PV of each year's reduced cost of
testing and anxiety totals $100.0 million (at 3 percent discount rate)
and $86.4 million (at 7 percent discount rate). The average annualized
equivalent amounts are $11.7 million (3 percent) and $12.3 million (7
percent). Between 85 percent and 90 percent of the average annualized
amounts represent reductions in the direct testing costs rather than
the reduced anxiety associated with possible infection by a contagious
agent.
7. Total Benefits
FDA estimates that the final rule will reduce the availability of
defective medical gloves by over 25 percent, resulting in over 2.8
billion fewer defective gloves over a 10-year period. During this time,
FDA expects that the reduction in defective gloves will result in
approximately 7 fewer cases of chronic HBV, 7 fewer cases of HIV, and
1.4 million fewer unnecessary blood screens. Based on an implied
societal WTP, the average annualized benefits of the fewer pathogen
transmissions and unnecessary blood screens should equal $14.8 million
(at 3 percent annual discount rate) and $15.1 million (at 7 percent
discount rate).
G. Conclusion
As noted in the introduction to the analysis of impacts section,
FDA is certifying that the final rule will not have a significant
impact on a substantial number of small entities. We provided the above
information to explain the costs and benefits of the rule. There are
currently over 400 manufacturers of medical gloves, a vast majority of
which are foreign and not covered by the Regulatory Flexibility Act.
There will be little to no impact on domestic entities. Moreover, FDA
does not expect any increased manufacturer costs to be directly passed
on to end users because the cost increases will affect only a minority
of global manufacturers and, therefore, competition will likely force
these manufacturers to absorb these costs.
The estimated annualized costs equal $6.6 million using either a 3
percent annual discount rate or a 7 percent annual discount rate.
Benefits of avoiding transmissions of blood-borne pathogens and
unnecessary blood screens have been estimated to equal $14.8 million
(using a 3 percent discount rate) or $15.1 million (using a 7 percent
discount rate). The final rule is estimated to result in average
annualized net benefits of $8.2 million (using a 3 percent discount
rate) or $8.5 million (using a 7 percent discount rate).
IV. Paperwork Reduction Act of 1995
This final rule contains no collections of information that are
subject to review by OMB under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520). The information collection described in
this rule regarding testing to establish the reconditioning of
adulterated gloves is exempted from the requirements of the PRA under 5
CFR 1320.4(a)(2) and (c): The rule describes testing to be conducted on
specific lots of adulterated gloves ``during the conduct of an
administrative action, investigation, or audit involving the agency
against specific individuals'' (1320.4(a)(2)) and ``after a case file
or equivalent is opened with respect to a particular party''
(1320.4(c)).
V. References
The following references have been placed on display in the
Division of Dockets Management and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday. FDA has verified the
Web site addresses, but is not responsible for subsequent changes to
the Web site after this document publishes in the Federal Register.
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Post-Exposure HIV Chemoprophylaxis Program for Blood Exposures in
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List of Subjects in 21 CFR Part 800
Administrative practice and procedure, Medical devices, Opthalmic
goods and services, Packaging and containers, Reporting and
recordkeeping requirements.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
800 is amended as follows:
PART 800--GENERAL
0
1. The authority citation for 21 CFR part 800 continues to read as
follows:
[[Page 75876]]
Authority: 21 U.S.C. 321, 334, 351, 352, 355, 360e, 360i, 360k,
361, 362, 371.
0
2. Section 800.20 is amended by revising paragraphs (b), (c), and (d)
to read as follows:
Sec. 800.20 Patient examination gloves and surgeons' gloves; sample
plans and test method for leakage defects; adulteration.
* * * * *
(b)(1) General test method. For the purposes of this part, FDA's
analysis of gloves for leaks and visual defects will be conducted by a
visual examination and by a water leak test method, using 1,000
milliliters (ml) of water.
(i) Units examined. Each medical glove will be analyzed
independently. When packaged as pairs, each glove is considered
separately, and both gloves will be analyzed.
(ii) Identification of defects. For this test, defects include
leaks detected when tested in accordance with paragraph (b)(3) of this
section. A leak is defined as the appearance of water on the outside of
the glove. This emergence of water from the glove constitutes a
watertight barrier failure. Other defects include tears, embedded
foreign objects, extrusions of glove material on the exterior or
interior surface of the glove, gloves that are fused together so that
individual glove separation is impossible, gloves that adhere to each
other and tear when separated, or other visual defects that are likely
to affect the barrier integrity.
(iii) Factors for counting defects. One defect in one glove is
counted as one defect. A defect in both gloves in a pair of gloves is
counted as two defects. If multiple defects, as defined in paragraph
(b)(1)(ii) of this section, are found in one glove, they are counted as
one defect. Visual defects and leaks that are observed in the top 40
millimeters (mm) of a glove will not be counted as a defect for the
purposes of this part.
(2) Leak test materials. FDA considers the following to be the
minimum materials required for this test :
(i) A 60 mm by 380 mm (clear) plastic cylinder with a hook on one
end and a mark scored 40 mm from the other end (a cylinder of another
size may be used if it accommodates both cuff diameter and any water
above the glove capacity);
(ii) Elastic strapping with velcro or other fastening material;
(iii) Automatic water-dispensing apparatus or manual device capable
of delivering 1,000 ml of water;
(iv) Stand with horizontal rod for hanging the hook end of the
plastic tube. The horizontal support rod must be capable of holding the
weight of the total number of gloves that will be suspended at any one
time, e.g., five gloves suspended will weigh about 5 kilograms (kg);
(v) Timer capable of measuring two minute intervals.
(3) Visual defects and leak test procedures. Examine the sample and
identify code/lot number, size, and brand as appropriate. Continue the
visual examination using the following procedures:
(i) Visual defects examination. Inspect the gloves for visual
defects by carefully removing the glove from the wrapper, box, or
package. Visually examine each glove for defects. As noted in paragraph
(b)(1)(iii) of this section, a visual defect observed in the top 40 mm
of a glove will not be counted as a defect for the purpose of this
part. Visually defective gloves do not require further testing,
although they must be included in the total number of defective gloves
counted for the sample.
(ii) Leak test set-up. (A) During this procedure, ensure that the
exterior of the glove remains dry. Attach the glove to the plastic fill
tube by bringing the cuff end to the 40 mm mark and fastening with
elastic strapping to make a watertight seal.
(B) Add 1,000 ml of room temperature water (i.e., 20 (deg)C to 30
(deg)C) into the open end of the fill tube. The water should pass
freely into the glove. (With some larger sizes of long-cuffed surgeons'
gloves, the water level may reach only the base of the thumb. With some
smaller gloves, the water level may extend several inches up the fill
tube.)
(iii) Leak test examination. Immediately after adding the water,
examine the glove for water leaks. Do not squeeze the glove; use only
minimum manipulation to spread the fingers to check for leaks. Water
drops may be blotted to confirm leaking.
(A) If the glove does not leak immediately, keep the glove/filling
tube assembly upright and hang the assembly vertically from the
horizontal rod, using the wire hook on the open end of the fill tube
(do not support the filled glove while transferring).
(B) Make a second observation for leaks 2 minutes after the water
is added to the glove. Use only minimum manipulation of the fingers to
check for leaks.
(C) Record the number of defective gloves.
(c) Sampling, inspection, acceptance, and adulteration. In
performing the test for leaks and other visual defects described in
paragraph (b) of this section, FDA will collect and inspect samples of
medical gloves, and determine when the gloves are acceptable as set out
in paragraphs (c)(1) through (c)(3) of this section.
(1) Sample plans. FDA will collect samples from lots of medical
gloves in accordance with agency sampling plans. These plans are based
on sample sizes, levels of sample inspection, and acceptable quality
levels (AQLs) found in the International Standard Organization's
standard ISO 2859, ``Sampling Procedures For Inspection By
Attributes.''
(2) Sample sizes, inspection levels, and minimum AQLs. FDA will use
single normal sampling for lots of 1,200 gloves or less and multiple
normal sampling for all larger lots. FDA will use general inspection
level II in determining the sample size for any lot size. As shown in
the tables following paragraph (c)(3) of this section, FDA considers a
1.5 AQL to be the minimum level of quality acceptable for surgeons'
gloves and a 2.5 AQL to be the minimum level of quality acceptable for
patient examination gloves.
(3) Adulteration levels and accept/reject criteria. FDA considers a
lot of medical gloves to be adulterated when the number of defective
gloves found in the tested sample meets or exceeds the applicable
rejection number at the 1.5 AQL for surgeons' gloves or the 2.5 AQL for
patient examination gloves. These acceptance and rejection numbers are
identified in the tables following paragraph (c)(3) of this section as
follows:
Accept/Reject Criteria at 1.5 AQL for Surgeons' Gloves
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number Defective
Lot Size Sample Sample Size Number Examined -------------------------------------
Accept Reject
--------------------------------------------------------------------------------------------------------------------------------------------------------
8 to 90 Single sample ................. 8 0 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
91 to 280 Single sample ................. 32 1 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 75877]]
281 to 500 Single sample ................. 50 2 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
501 to 1,200 Single sample ................. 80 3 4
--------------------------------------------------------------------------------------------------------------------------------------------------------
1,201 to 3,200 First 32 32 -- 4
Second 32 64 1 5
Third 32 96 2 6
Fourth 32 128 3 7
Fifth 32 160 5 8
Sixth 32 192 7 9
Seventh 32 224 9 10
--------------------------------------------------------------------------------------------------------------------------------------------------------
3,201 to 10,000 First 50 50 0 4
Second 50 100 1 6
Third 50 150 3 8
Fourth 50 200 5 10
Fifth 50 250 7 11
Sixth 50 300 10 12
Seventh 50 350 13 14
--------------------------------------------------------------------------------------------------------------------------------------------------------
10,001 to 35,000 First 80 80 0 5
Second 80 160 3 8
Third 80 240 6 10
Fourth 80 320 8 13
Fifth 80 400 11 15
Sixth 80 480 14 17
Seventh 80 560 18 19
--------------------------------------------------------------------------------------------------------------------------------------------------------
35,000 First 125 125 1 7
Second 125 250 4 10
Third 125 375 8 13
Fourth 125 500 12 17
Fifth 125 625 17 20
Sixth 125 750 21 23
Seventh 125 875 25 26
--------------------------------------------------------------------------------------------------------------------------------------------------------
Accept/Reject Criteria at 2.5 AQL for Patient Examination Gloves
----------------------------------------------------------------------------------------------------------------
Number Defective
Lot Size Sample Sample Size Number Examined -------------------------------------
Accept Reject
----------------------------------------------------------------------------------------------------------------
5 to 50 Single sample ................. 5 0 1
----------------------------------------------------------------------------------------------------------------
51 to 150 Single sample ................. 20 1 2
----------------------------------------------------------------------------------------------------------------
151 to 280 Single sample ................. 32 2 3
----------------------------------------------------------------------------------------------------------------
281 to 500 Single sample ................. 50 3 4
----------------------------------------------------------------------------------------------------------------
501 to 1,200 Single sample ................. 80 5 6
----------------------------------------------------------------------------------------------------------------
1,201 to 3,200 First 32 32 0 4
Second 32 64 1 6
Third 32 96 3 8
Fourth 32 128 5 10
Fifth 32 160 7 11
Sixth 32 192 10 12
Seventh 32 224 13 14
----------------------------------------------------------------------------------------------------------------
3,201 to 10,000 First 50 50 0 5
Second 50 100 3 8
Third 50 150 6 10
Fourth 50 200 8 13
Fifth 50 250 11 15
Sixth 50 300 14 17
Seventh 50 350 18 19
----------------------------------------------------------------------------------------------------------------
10,001 to 35,000 First 80 80 1 7
Second 80 160 4 10
[[Page 75878]]
Third 80 240 8 13
Fourth 80 320 12 17
Fifth 80 400 17 20
Sixth 80 480 21 23
Seventh 80 560 25 26
----------------------------------------------------------------------------------------------------------------
35,000 and above First 125 125 2 9
Second 125 250 7 14
Third 125 375 13 19
Fourth 125 500 19 25
Fifth 125 625 25 29
Sixth 125 750 31 33
Seventh 125 875 37 38
----------------------------------------------------------------------------------------------------------------
(d) Compliance. Lots of gloves that are sampled, tested, and
rejected using procedures in paragraphs (b) and (c) of this section,
are considered adulterated within the meaning of section 501(c) of the
act.
(1) Detention and seizure. Lots of gloves that are adulterated
under section 501(c) of the act are subject to administrative and
judicial action, such as detention of imported products and seizure of
domestic products.
(2) Reconditioning. FDA may authorize the owner of the product, or
the owner's representative, to attempt to recondition, i.e., bring into
compliance with the act, a lot or part of a lot of foreign gloves
detained at importation, or a lot or part of a lot of seized domestic
gloves.
(i) Modified sampling, inspection, and acceptance. If FDA
authorizes reconditioning of a lot or portion of a lot of adulterated
gloves, testing to confirm that the reconditioned gloves meet AQLs must
be performed by an independent testing facility. The following
tightened sampling plan must be followed, as described in ISO 2859
``Sampling Procedures for Inspection by Attributes:''
(A) General inspection level II,
(B) Single sampling plans for tightened inspection,
(C) 1.5 AQL for surgeons' gloves, and
(D) 2.5 AQL for patient examination gloves.
(ii) Adulteration levels and acceptance criteria for reconditioned
gloves. (A) FDA considers a lot or part of a lot of adulterated gloves,
that is reconditioned in accordance with paragraph (d)(2)(i) of this
section, to be acceptable when the number of defective gloves found in
the tested sample does not exceed the acceptance number in the
appropriate tables in paragraph (d)(2)(ii)(B) of this section for
reconditioned surgeons' gloves or patient examination gloves.
(B) FDA considers a reconditioned lot of medical gloves to be
adulterated within the meaning of section 501(c) of the act when the
number of defective gloves found in the tested sample meets or exceeds
the applicable rejection number in the tables following paragraph
(d)(2)(ii)(B) of this section:
Accept/Reject Criteria at 1.5 AQL for Reconditioned Surgeons' Gloves
----------------------------------------------------------------------------------------------------------------
Number Defective
Lot Size Sample Sample Size -------------------------------------
Accept Reject
----------------------------------------------------------------------------------------------------------------
13 to 90 Single sample 13 0 1
----------------------------------------------------------------------------------------------------------------
91 to 500 Single sample 50 1 2
----------------------------------------------------------------------------------------------------------------
501 to 1,200 Single sample 80 2 3
----------------------------------------------------------------------------------------------------------------
1,201 to 3,200 Single sample 125 3 4
----------------------------------------------------------------------------------------------------------------
3,201 to 10,000 Single sample 200 5 6
----------------------------------------------------------------------------------------------------------------
10,001 to 35,000 Single sample 315 8 9
----------------------------------------------------------------------------------------------------------------
35,000 and above Single sample 500 12 13
----------------------------------------------------------------------------------------------------------------
Accept/Reject Criteria at 2.5 AQL for Reconditioned Patient Examination Gloves
----------------------------------------------------------------------------------------------------------------
Number Defective
Lot Size Sample Sample Size -------------------------------------
Accept Reject
----------------------------------------------------------------------------------------------------------------
8 to 50 Single sample 8 0 1
----------------------------------------------------------------------------------------------------------------
51 to 280 Single sample 32 1 2
----------------------------------------------------------------------------------------------------------------
[[Page 75879]]
281 to 500 Single sample 50 2 3
----------------------------------------------------------------------------------------------------------------
501 to 1,200 Single sample 80 3 4
----------------------------------------------------------------------------------------------------------------
1,201 to 3,200 Single sample 125 5 6
----------------------------------------------------------------------------------------------------------------
3,201 to 10,000 Single sample 200 8 9
----------------------------------------------------------------------------------------------------------------
10,001 to 35,000 Single sample 315 12 13
----------------------------------------------------------------------------------------------------------------
35,000 and above Single sample 500 18 19
----------------------------------------------------------------------------------------------------------------
Dated: December 12, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-21591 Filed 12-18-06; 8:45 am]
BILLING CODE 4160-01-S