[Federal Register: March 31, 2003 (Volume 68, Number 61)]
[Proposed Rules]
[Page 15404-15417]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31mr03-39]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 800
[Docket No. 03N-0056]
Medical Devices; Patient Examination and Surgeons' Gloves; Test
Procedures and Acceptance Criteria
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the sampling plans, test method, and acceptable quality levels (AQLs)
for medical gloves contained in its medical device regulations. As
prescribed by its regulation, FDA samples patient examination and
surgeons' gloves and examines them for visual defects and water leaks.
Glove lots are considered adulterated if they do not meet the specified
quality levels. The objective of the proposed regulation is to improve
the barrier quality of medical gloves on the U.S. market. The updated
regulation would accomplish this by reducing the acceptable level of
defects observed during FDA testing of medical gloves. By reducing the
AQLs for medical gloves, FDA would also harmonize the level with
consensus standards developed by the International Organization for
Standardization (ISO) and the American Society for Testing Materials
(ASTM).
DATES: Submit written or electronic comments by June 30, 2003. See
section VII of this document for the proposed effective date of a final
rule based on this proposal.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments
.
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, 301-
594-4692.
SUPPLEMENTARY INFORMATION:
I. Background
With the advent of the human immunodeficiency virus (HIV)
infections and the progression of infections into acquired immune
deficiency syndrome (AIDS), scientists and medical and public health
experts developed risk reduction strategies, including protective and
preventive strategies for health care workers. These strategies were
based on the etiology, and mechanisms and routes of transmission, of
HIV infections.
A. Routes and Mechanisms of HIV Transmission
HIV is transmitted primarily through sexual contact. However,
nonsexual transmission occurred in health care settings as a result of
contact with infected blood. HIV was also isolated from other body
fluids. The prevalence of HIV infections in health care settings and
the risk of clinical transmission of other infections increased the
importance of using effective procedures and barriers. The potential
for infection heightened the importance of the quality of the barriers
selected for protection.
B. The Need for Precautions in Health Care Settings
On August 21, 1987, the Centers For Disease Control (CDC) published
a report emphasizing the need for all health care workers to routinely
use appropriate universal precautions when they expect to come into
contact with blood or other body fluids of any patient (Ref. 1). This
report recommended that health care workers wear medical gloves when:
(1) Touching blood or other body fluids, mucous membranes, or non-
intact skin of patients; (2) handling items or surfaces soiled with
blood or other bodily fluids; and (3) performing venipuncture and other
vascular access procedures. The collective term, medical gloves,
includes patient examination and surgeons' gloves (see 21 CFR 880.6250
and 878.4460).
C. The Need for Testing
After the publication of the CDC's recommendations, and the rise in
HIV infections, health care workers increasingly relied on surgeons'
gloves and patient examination gloves as a barrier to the transmission
of HIV and other blood- and fluid-borne infectious agents. The CDC's
recommendations clearly recognized that defects in medical gloves had
the potential of resulting in transmission of HIV between patients and
health care workers.
Consequently, FDA reviewed and evaluated the quality control
procedures that manufacturers used in making medical gloves. FDA
concluded that manufacturers could only meet reasonable expectations of
barrier protection by establishing adequate specifications for medical
gloves, and adequate test procedures to detect defects in gloves. Glove
defects include rips, tears, embedded foreign objects in the glove that
may cause the glove to rip or tear upon stretching, or holes that allow
the passage of fluids and fluid-borne microorganisms. Each of these
defects compromises the glove barrier integrity and may expose health
care workers and patients to infectious agents. Articles written by
health care professionals who studied glove quality and the use of
gloves as a barrier to infectious agents noted that gloves with defects
may not provide this protection (Refs. 2 through 6). In 1989, when FDA
proposed Sec. 800.20 (21 CFR 800.20), FDA's position was that existing
consensus standards did not establish adequate test methods and
acceptance criteria for patient examination or surgeons' gloves (54 FR
48218, November 21, 1989). Therefore, the agency concluded that it
needed to communicate clearly the test procedures and the acceptance
levels it would use to determine whether medical gloves were
adulterated.
D. The Setting of Adulteration Levels
In the Federal Register of December 12, 1990 (55 FR 51254), FDA
issued a final rule that identified minimum AQLs for both patient
examination and surgeons' gloves, and established the sample plans and
test method for determining whether a lot of gloves were acceptable.
This rule defined defects as ``leaks, tears, mold, embedded foreign
objects, etc.'' The definitions, sampling plans, test methods, and
adulteration levels identified in the
[[Page 15405]]
1990 Federal Register are currently codified in title 21 of the Code of
Federal Regulations in Sec. 800.20.
II. Proposed Changes
A. Rationale and Summary of Changes
1. Continuing HIV/AIDS Incidence and Need for Protective Measures for
Health Care Workers
In a May 1998 report, CDC reaffirmed its expectation that health
care workers should use medical gloves as an effective barrier to HIV,
hepatitis B virus, and other blood-borne infections, and that these
gloves should provide effective protection against exposure to
pathogenic microorganisms in blood and other body fluids (Ref. 7).
In the December 10, 1999, Morbidity and Mortality Weekly Report
(MMWR), CDC estimated that the prevalence of HIV at the end of 1998
ranged from 800,000 to 900,000 infected persons. CDC estimated that, of
these 800,000 to 900,000 persons, HIV infection or AIDS was diagnosed
in approximately 625,000 of the individuals (Ref. 8). In a fact sheet
posted on the Internet in June 1999, CDC reported that 54 documented
cases of HIV seroconversion resulted from occupational exposure to HIV
(Ref. 9). In April 2002, CDC reported that, as of December 31, 1999,
22,218 out of 437,407 adults reported diagnosed with AIDS were health
care workers (Ref. 10). FDA concluded that medical gloves play an
important role in the prevention of infectious disease transmission in
health care settings, and that lowering the acceptable level of defects
is necessary to further reduce the risk of transmission of such
diseases and to harmonize the quality of gloves sold in the United
States with international consensus standards.
2. Harmonization With Consensus Standards
Following the publication of Sec. 800.20, several consensus
standards organizations, such as the ISO and the ASTM, adopted the FDA
test methodology and acceptance criteria for patient examination and
surgeons' gloves. As glove manufacturing capabilities improved, these
consensus standards organizations lowered the minimum acceptance
criteria for holes/leaks for these gloves. In 1994, ISO published
standards for surgeons' and patient examination gloves with AQLs of 1.5
and 2.5, respectively. ASTM adopted these same acceptance criteria in
April 1998, and March 1999, for surgeons' and patient examination
gloves, respectively. Because the standards organizations updated their
standards to reflect the improvement in manufacturing technology, the
consensus standards currently have lower AQLs for medical gloves than
FDA's regulation (Sec. 800.20).
The consensus standards differ from the current FDA regulation in
two other respects: (1) They use metric units for specifying
dimensions, and (2) they refer to sampling plans from the ISO's
document ISO 2859, ``Sampling Procedures for Inspection by
Attributes,'' instead of the MIL-STD-105E sampling plan that is
currently referenced in Sec. 800.20.
FDA believes that, whenever feasible, it is important to harmonize
its requirements with consensus standards. Harmonization helps ensure
an acceptable standard of safety and effectiveness for all
manufacturers and allows manufacturers to market their products more
efficiently in a global economy. FDA has recognized the ASTM standards
for patient examination and surgeons' gloves for the purpose of
premarket notification submissions (510(k)s), and believes that it is
appropriate to use the same standards for determining the acceptability
of lots of medical gloves.
3. Interpretation of Defects
Since issuing Sec. 800.20, FDA has received many questions from
FDA field laboratories, glove manufacturers, importers, and private
laboratories regarding the definition of defects in the current
regulation. Many questions concerned whether lumps of latex material on
or beneath the glove surface are considered defects. These questions
arise because the definition of defects in Sec. 800.20 refers to
``embedded foreign objects,'' and latex is not ``foreign'' to a latex
glove. Other questions were whether ``mold'' is an appropriate defect
to be included in a sampling plan intended primarily to detect physical
defects. FDA believes these questions are valid and has addressed them
in the proposed amendments.
4. Tightened Sampling Plans for Reconditioned Gloves
FDA recognizes the difficulty of adequately representing a large
lot of gloves with a relatively small sample size. FDA has sometimes
allowed manufacturers and importers to segregate and retest portions of
the lot(s) or sizes of reconditioned gloves that initially failed FDA
or private laboratory analysis to identify those portions of the larger
lot(s) or sizes that meet quality requirements. The agency recognizes,
however, that passing a retest does not provide the same assurance of
quality as when the lot passes the initial analysis. This is due, in
part, to the nature of the standard sampling plans, and in part to the
fact that retesting is performed to identify acceptable portions of the
larger lot(s) after failing the initial test. Recognized consensus
standard sampling plans address the issue of previous test failures by
allowing tightened sampling during retesting in order to provide
additional assurance to the consumer. FDA proposes to apply this
principle to testing of reconditioned lots that have failed an initial
analysis.
5. Proposed Reclassification of Medical Gloves
On July 30, 1999, FDA published a proposed rule in the Federal
Register (64 FR 41710) that addressed several issues pertaining to
medical examination gloves, including their reclassification from class
I to class II in order to provide reasonable assurance of safety and
effectiveness. To provide this assurance, appropriate special controls
(applicable to class II medical devices) were also proposed. The
proposal to reclassify medical examination gloves reflects the
increased importance of these devices in the health care arena and is
consistent with the changes FDA is now proposing for Sec. 800.20.
However, this proposal to lower the acceptable level of defects in
medical gloves is an independent initiative that will go forward as FDA
continues to review the comments it received on the reclassification
proposal.
Therefore, in summary, FDA is proposing to: (1) Lower the AQL to
which the level of defects in lots of gloves is tested, thereby
assuring improved quality of gloves; (2) lower the AQLs, convert units
of measure to the metric system; eliminate references to obsolete
sampling plans, and reference current ISO standards; thereby
harmonizing with recognized consensus standards; (3) clarify visual
defects and current methodology for conducting water leak testing; and
(4) provide tightened sampling plans for testing reconditioned lots of
medical gloves that have already failed one analysis.
Specifically, FDA is proposing to lower the AQL for surgeons'
gloves from 2.5 to 1.5, and is proposing to base the sampling plans on
the tables in the ISO sampling standard, ISO 2859-1995.
FDA is also proposing to lower the AQL for patient examination
gloves from 4.0 to 2.5, and is proposing to base the sampling plans on
the tables in ISO sampling standard, ISO 2859-1995. Lowering the AQLs
for medical gloves will reduce the allowable defect level for patient
examination gloves. Further, FDA is proposing to amend the regulation
to tighten sampling plans for reconditioned lots of medical gloves
[[Page 15406]]
that have failed to meet the 1.5 or 2.5 AQL level. These reconditioned
gloves would have to be sampled under a more stringent inspection
standard in order to provide additional assurance that they meet the
AQLs. This practice is consistent with the ISO sampling plans, which
allow for tightened sampling when failures occur under normal sampling.
B. Paragraph by Paragraph Changes
1. Current Test Method (Sec. 800.20(b)) as Proposed General Test
Method (Sec. 800.20(b)(1))
(Change 1) FDA proposes to rename and renumber current Sec.
800.20(b), Test method as Sec. 800.20(b)(1), General test method. FDA
is revising the substance of the first sentence of current paragraph
(b) to add the following language: ``For the purposes of this
regulation, FDA's analysis of gloves for leaks, and certain other
visual defects, will be conducted by an initial visual examination and
by a water leak test method, using 1,000 milliliters (ml) of water.''
The purpose of these changes is to recognize that there are other
visual defects addition to leaks, and that these defects can sometimes
be detected by visual examination.
(Change 2) For clarification, FDA would reorganize the remaining
elements of current paragraph (b) into paragraphs (b)(1)(i) through
(b)(1)(iii) of proposed Sec. 800.20(b)(1), as follows:
[sbull] The current second and third sentences would be
reorganized, without revision, in proposed Sec. 800.20(b)(1)(i), Units
examined.
[sbull] The current fifth, sixth, and seventh sentences would be
reorganized and revised in proposed Sec. 800.20(b)(1)(ii),
Identification of defects.
[sbull] The current fourth sentence would be revised and
reorganized, together with the current seventh and eighth sentences, in
proposed Sec. 800.20(b)(1)(iii).
(Change 3) Proposed Sec. 800.20(b)(1)(ii) changes the definition
of defects from the current ``leaks, tears, mold, embedded foreign
objects, etc.'' to ``tears, embedded foreign objects, or other defects
visible upon initial examination that may affect the barrier integrity
or leaks detected when tested in accordance with paragraph (b)(3) of
this section.''
FDA is proposing to remove ``mold'' as a defect in proposed Sec.
800.20(b)(1)(ii). The agency considers the presence of visible mold on
sampled gloves as evidence that the lot is adulterated under section
501(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
351(a)), in that it consists in whole and/or in part of any filthy,
putrid, or decomposed substance. The revised section removes the
abbreviation, ``etc.'', as being indeterminate.
The phrase, ``other defects visible upon initial examination that
may affect the barrier integrity,'' would be added in proposed Sec.
800.20(b)(1)(ii), to encompass various other defects that may arise,
including, but not limited to:
a. Extrusions of glove material on the exterior or interior surface
of, or within, the film of the glove. FDA believes that such extrusions
or material lumps can contribute to rips or tears near the site of the
lump, during routine donning or other stretching of the glove.
b. Gloves that are fused together so that individual glove
separation is impossible.
c. Gloves that adhere to each other and tear when separated into
individual gloves.
(Change 4) In proposed Sec. 800.20(b)(1)(iii), the fourth sentence
in current paragraph (b) would be revised and reorganized into two
sentences for clarity, reading, ``One defect in one glove is counted as
one defect. A defect in both gloves in a pair is counted as two
defects.'' Other proposed changes to Sec. 800.20(b)(1)(iii) include:
[sbull] To confirm current counting practices, FDA would add the
clarifying sentence, ``If multiple defects, as defined in paragraph
(b)(1)(ii) of this section, are found in one glove, they are counted as
one defect.''
[sbull] For further clarification, FDA is adding the sentence,
``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.'' The substance of this sentence is in current Sec.
800.20(b)(2); however, FDA is changing the unit of measure, 1 1/2
inches, to the corresponding metric unit of measure, 40 millimeters
(mm), used by most standards setting organizations.
2. Current Untitled (Sec. 800.20(b)(1)) as Proposed Leak Test
Materials (Sec. 800.20(b)(2))
(Change 5) FDA proposes to rename current Sec. 800.20(b)(1) as
proposed Sec. 800.20(b)(2), Leak test materials. To conform current
U.S. measurement units to metric measurement units used by most
standards setting organizations, FDA proposes to change the current
language, ``2 3/8 inch by 15-inch'' to ``60 mm by 380 mm'' and ``11
pounds'' to ``5 kilograms (kg).'' No other change would be made to
current Sec. 800.20(b)(1).
3. Current Untitled (Sec. 800.20(b)(2)) as Proposed Visual Defects and
Leak Test Procedure, Visual Defects Examination, and Leak Test Set-Up
(Sec. 800.20(b)(3)(i) through (b)(3)(ii))
(Change 6) FDA is proposing to renumber and revise current Sec.
800.20(b)(2) into the following new paragraphs:
[sbull] (b)(3) Visual defects and leak test procedures.
[sbull] (b)(3)(i) Visual defects examination.
[sbull] (b)(3)(ii) Leak test set-up.
(Change 7) FDA is also proposing to revise current Sec.
800.20(b)(2) in proposed paragraph (b)(3) to reorganize the section for
clarity to read, ``(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:''.
(Change 8) FDA is also proposing to revise current Sec.
800.20(b)(2) in proposed paragraph (b)(3)(i) to incorporate metric
units of measure, reflecting the harmonization of the test method to
international standards. The revisions would read as follows:
(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; however, they must be included in the total number
of defective gloves counted for the sample.
(Change 9) In proposed Sec. 800.20(b)(3)(i) in the third sentence,
``1 1/2 inches'' would be changed to ``40 mm'', to reflect the
corresponding metric unit of measure used by most standards setting
organizations.
(Change 10) FDA proposes to add the following statement to Sec.
800.20(b)(3)(ii) Leak test set up, ``During this procedure, ensure that
the exterior of the glove remains dry.'' This method conforms to the
``Standard Test Method for Detection of Holes in Medical Gloves'' found
in ASTM D5151. The reason for including this step is that a leak can be
detected more easily on a dry surface.
(Change 11) For ease of reading, FDA is proposing to reorganize
current Sec. 800.20(b)(3) into three paragraphs in proposed
(b)(3)(iii) Leak test examination. The first three current sentences
would be in the first paragraph, the current fourth sentence would be
in the second paragraph, and the remaining three current sentences
would be in the third paragraph.
[[Page 15407]]
4. Current Sample Plan (Sec. 800.20(c)) as Proposed Sampling,
Inspection, Acceptance, and Adulteration (Sec. 800.20(c))
(Change 12) FDA is proposing to rename current paragraph Sec.
800.20(c) paragraph, ``(c) Sampling, inspection, acceptance, and
adulteration,'' and to reorganize the section as follows:
[sbull] (c)(1) Sample plans.
[sbull] (c)(2) Sample sizes, inspection levels, and minimum AQLs.
[sbull] (c)(3) Adulteration levels and accept/reject criteria.
(Change 13) Proposed introductory paragraph Sec. 800.20(c) would
retain the element of current paragraph (c), which identifies how FDA
will sample and examine lots of gloves to determine whether the gloves
are considered adulterated under section 501(c) of the act. Proposed
paragraph Sec. 800.20(c) would be revised as follows: ``(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.''
(Change 14) Proposed Sec. 800.20(c)(1) retains the elements of
current paragraph (c) that identify the sampling plans, inspection, and
AQLs used by the agency in its determination of adulteration. In Sec.
800.20(c)(1), FDA is proposing to change the standard of sampling
procedures and inspection tables from ``MIL-STD-105E'' to ``ISO 2859''
because ``MIL-STD-105E'' is no longer in effect. The use of ISO 2859 is
consistent with the agency's recognition of this standard as provided
in section 514 of the act (21 U.S.C. 360d) (see FDA's Internet Web site
at http://www.fda.gov/cdrh/stdsprog.html).
(Change 15) Proposed Sec. 800.20(c)(2) retains the same ``single
normal sampling,'' ``multiple normal sampling,'' and ``general
inspection level II'' that are in current paragraph (c). In proposed
paragraph (c)(2), FDA proposes lowering the minimum AQL for surgeons'
gloves from the current 2.5 AQL to a 1.5 AQL. Additionally, FDA
proposes to lower the minimum AQL for patient examination gloves from a
4.0 AQL to a 2.5 AQL. These changes would reduce the allowable level of
defective gloves in sampled lots of medical gloves and harmonize FDA
adulteration criteria with the recognized consensus standards for
medical gloves.
(Change 16) FDA is proposing to remove the current table entitled
``ADULTERATION LEVEL AT 2.5 FOR SURGEONS' GLOVES'' and the current
table entitled ``ADULTERATION LEVEL AT 4.0 FOR PATIENT EXAMINATION
GLOVES,'' and replace them with the table entitled ``ACCEPT/REJECT
CRITERIA AT 1.5 AQL FOR SURGEONS' GLOVES'' and the table entitled,
``ACCEPT/REJECT CRITERIA AT 2.5 AQL FOR PATIENT EXAMINATION GLOVES,''
following proposed Sec. 800.20(c)(3).
5. Current Untitled (Sec. 800.20(d)) as Proposed Compliance (Sec.
800.20(d))
(Change 17) For purposes of clarification, FDA is proposing to
revise Sec. 800.20(d) as follows:
[sbull] (d) Compliance.
[sbull] Add (d)(1) Detention and seizure,
[sbull] Add (d)(2) Reconditioning,
[sbull] Add (d)(2)(i) Modified sampling, inspection, and
acceptance,
[sbull] Add (d)(2)(ii) Adulteration levels and acceptance criteria,
and adulteration levels for reconditioned gloves; and
[sbull] Add tables, ``ACCEPT/REJECT CRITERIA AT 1.5 AQL FOR
RECONDITIONED SURGEONS' GLOVES'' and ``ACCEPT/REJECT CRITERIA AT 2.5
AQL FOR RECONDITIONED PATIENT EXAMINATION GLOVES'', following paragraph
(d)(2)(ii).
(Change 18) Proposed introductory Sec. 800.20(d) retains the
regulatory element of current paragraph (d), which establishes that
medical gloves that are ``rejected,'' i.e., fail to meet acceptance
criteria in proposed Sec. 800.20(c)(3) when tested as described in
proposed Sec. 800.20(b), are adulterated in accordance with section
501(c) of the act.
(Change 19) Detention under section 801(a) of the act (21 U.S.C.
381(a)) and seizure under section 304(b) of the act (21 U.S.C. 334(b))
are common administrative or enforcement actions FDA has taken against
medical gloves that are in violation of section 501(c) of the act. FDA
may detain and refuse entry to medical gloves that are presented for
import and found to be adulterated under section 501(c) of the act.
Medical gloves found to be adulterated while in domestic interstate
commerce are subject to seizure. Agency regulatory procedures for the
reconditioning of domestically manufactured gloves seized in interstate
commerce are found in the FDA/ORA (Office of Regulatory Affairs)
Regulatory Procedures Manual (RPM), Chapter 6 Judicial Actions,
Subchapter--Seizure, Disposition of Seized Articles, Reconditioning
Operations. Regulatory procedures for detained imported gloves are in
RPM Chapter 9 Import Operations/Actions, Subchapter--Reconditioning.
When appropriate, FDA may take other regulatory actions, such as
injunction, civil money penalties, or criminal prosecution of
manufacturers and individuals responsible for adulterated products. FDA
is proposing to add revised Sec. 800.20(d)(1) to include the detention
and seizure of gloves that are adulterated under section 501(c) of the
act because the quality falls below the level it is represented to
have. Under the authority of section 801(b) of the act for imported
gloves and section 304(d)(1) of the act for seized domestic articles,
FDA is proposing to add revised Sec. 800.20(d)(2) to provide the
importer of record, owner, or consignee an opportunity to recondition
the gloves as a lot or part of a lot, whether they are foreign or
domestic gloves.
(Change 20) In Sec. 800.20(d)(2)(i), FDA is proposing a modified
sampling plan. The rationale for the plan is based on the agency's
experience with reconditioned gloves, the need for greater assurance
that reconditioned gloves meet minimum AQLs given the initial finding
of adulteration, and the provisions in ISO 2859 for tightened sampling
plans.
FDA samples medical gloves that are often presented for import in
large quantities. When the ``sampling lots'' are large and include
several glove sizes and manufacturing lots, FDA attempts to have each
sample adequately represent each size in the proportion it occurs in
the ``sampling lot.'' On occasion, manufacturers and importers have
claimed that a single size or lot code may have contributed to a
disproportionate number of defects that caused the sample to fail, and
have requested FDA to allow the rest of the shipment to be salvaged,
based on retesting of each of the segregated sizes or lot codes. Such
segregation and retesting is considered reconditioning.
FDA district offices review reconditioning proposals on a case by
case basis. In determining, whether to approve a reconditioning
proposal, the district offices exercise discretion in considering the
nature and type of defects, the degree of noncompliance with minimum
AQLs, the compliance history of the manufacturer, the qualifications
and reliability of the independent testing laboratories, and any other
relevant factors.
When FDA has permitted manufacturers/importers of gloves that have
failed FDA or private laboratory analysis to segregate and retest
portions of the lot(s)/size(s), the agency's experience has been that
the segregated lot(s)/sizes(s) almost always pass the retest, resulting
in two contradictory
[[Page 15408]]
conclusions about the analyzed lot. Statistically, a passing retest
result is not unexpected due to the nature of the normal sampling
plans, which minimize producer risk. When failures occur under normal
sampling, ISO 2859 recommends the use of tightened sampling plans for
resubmitted lots in order to reduce the risk to the consumer (see part
1 section 7.4 of ISO 2859). FDA is proposing that single normal
sampling plans and the tightened level of inspection, found in ISO
2859, be used in resampling and retesting medical gloves that have been
reconditioned. The proposed modifications would increase the size of
the sample and the number of units examined, while lowering the number
of defects required for rejection. FDA believes that this would provide
greater statistical assurance that reconditioned lots meet minimum
AQLs.
(Change 21) FDA proposes to add Sec. 800.20(d)(2)(ii) to establish
accept/reject criteria and adulteration levels for reconditioned
surgeons' gloves and patient examination gloves based on the tightened
sampling plans proposed in paragraph (d)(2)(i). For convenience, FDA is
adding tables following Sec. 800.20(d)(2)(ii), which describe the
number of units to examine and the accept/reject criteria for various
lot sizes.
III. 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.
IV. Analysis of Impacts
A. Introduction
FDA has examined the proposed rule under Executive Order 12866 and
the Regulatory Flexibility Act (5 U.S.C. 601-612) (as amended by
subtitle D of the Small Business Regulatory Enforcement Fairness Act of
1996 (Public Law 104-121)), 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, distributive impacts and equity). Under the
Regulatory Flexibility Act, if a regulation has a significant economic
impact on a substantial number of small entities, the agency must
analyze regulatory options that would minimize the impact on small
entities. Section 202(a) of the Unfunded Mandates Reform Act requires
that agencies prepare a written statement of anticipated costs and
benefits before proposing any regulation that may result in expenditure
by State, local, and tribal governments, or by the private sector of
$100 million in any one year (adjusted annually for inflation).
Currently, such a statement is required if costs exceed $110 million
for any one year.
The proposed regulation is consistent with the principles set forth
in Executive Order 12866 and the two statutes. As explained in the
following paragraphs, FDA does not believe the proposed regulation is a
significant regulatory action, as defined in Executive Order 12866. In
addition, FDA certifies under the Regulatory Flexibility Act that the
proposed regulation would not result in a significant economic impact
on a substantial number of small entities. The expected cost of this
proposed regulation is under $110 million in any one year and is
therefore not considered a major regulatory action as defined by the
Unfunded Mandates Reform Act.
B. Objective of the Proposed Regulation
The objective of the proposed regulation is to reduce the risk of
transmission of blood-borne pathogens (particularly HIV and hepatitis B
(HBV) and C (HBC) infections). The regulation would accomplish 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. By so doing, FDA also would harmonize its
standard 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 proposed rule would prevent. This analysis, however,
attempts to derive a conservative estimate. For the year 2000, the 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 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, since 1992, there have been
only 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 needle sticks. 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 personnel 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 10-year period (or 2.4 per year)
due to problems with the glove 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 HBV 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 of
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 transmission of HBV may be approximately 5 times
more likely than 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 (cuts)
(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 that
[[Page 15409]]
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.
HBV currently infects 3.9 million persons (Ref. 3). Over 2.7
million patients have reported chronic conditions. More than 40,000 new
cases were reported during 1999. The risk of exposure to health care
workers, however, appears to be extremely low. In fact, according to
the CDC, for other than needle stick punctures, no transmission of HCV
for health care personnel has been documented from intact or no 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 would reduce the transmission rates of these
pathogens.
D. Baseline Conditions
The current AQL for medical gloves allows a defect rate of 4.0
percent (0.04) for patient examination gloves and 2.5 percent (0.025)
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, the entire lot of gloves may not be sold as
medical devices. Surgeons' gloves are sampled to a higher quality level
(the lower AQL requires a higher proportion of nondefective 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
petition for resampling of the lot. The required resampling 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 gloves after meeting the current AQL, offered as
nonmedical gloves, or sold in foreign markets.
Approximately 30.8 billion medical gloves were sold in the United
States during the year 2000 (Ref. 6). According to FDA records, there
are 417 manufacturers of medical gloves. Of these, only six are
domestic firms. Malaysian manufacturers supply almost 44 percent of the
medical gloves in the United States (Ref. 7). Only 250 million surgical
gloves are imported each year (0.8 percent of the medical glove market)
and the impact 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 (BLS) projects annual employment growth of 2.6 percent
for this industry (NAICS 6200) (Ref. 8), which implies an annual demand
for almost 40 billion medical gloves within 10 years. (A 2.6 percent
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 about 95,000 lots of gloves per
year. FDA currently samples only about 1.5 percent (0.015) of all glove
lots, or 1,400 lots per year. Within 10 years, FDA expects the number
of lots offered for import to increase to 122,500 per year. If the
compliance sampling rate remains constant, FDA would sample 1,850 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
that period. A total of 98,067 gloves were tested from 942 separate
lots. Of these gloves, 2,354 (0.024) were defective, which implies that
2.4 percent of marketed gloves are likely to be defective. If so, then
approximately 740 million defective medical gloves are currently
marketed (30.8 billion gloves x 0.024). At the current AQL of 4.0
percent, 28 lots failed (0.0297) the WEAC analysis. Consequently,
approximately 42 of the annually sampled lots are defective (1,400 x
0.0297). By the 10th year, in the absence of the proposed regulation,
955 million defective gloves would be marketed and 55 percent 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 domestic lot
resembling and retesting for leakage and tensile strength equals
approximately $1,400. The current annual industry cost of resampling
glove lot failures with the current AQL, therefore, is approximately
$59,000 (42 lots x $1,400 per lot). This resampling and retesting cost
would equal $77,000 within 10 years.
E. Costs of the Proposed Regulation
FDA expects that the proposed regulation would result in changed
shipping practices by medical glove manufacturers. Currently,
manufacturers use the target AQLs as a guide for releasing production
lots of gloves for export to the United States because the release
criteria are lower in the United States. Manufacturers attempt to avoid
having three lot inspection failures within a 24-month period, because
this results in rejection of future imports under FDA's current
recidivist policy. Thus, to maintain an uninterrupted supply of gloves
to customers, and to guard brand loyalty while avoiding the recidivist
list, 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 regulation to increase the costs of
sampling by requiring larger and more detailed sampling plans to assure
that the lower AQL is met for each inspected glove lot. FDA does not
envision increased regulatory oversight costs because the number of
inspections is not expected to change.
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, whereas more stringent quality control
testing 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 95,000 lots of
medical gloves are imported per year,
[[Page 15410]]
the expected costs are $4.3 million (95,000 lots x $45 per lot). Due to
the expected increase in the demand for medical gloves by the 10th
evaluation year, the compliance cost of meeting this increased quality
level will equal $5.5 million. Over the 10-year period, the average
annualized cost of this increased level of testing (at a 7 percent
discount rate) is $4.9 million.
2. Increased Sampling Costs
A lower AQL would result in increased sampling costs for imported
glove lots. The increased sampling costs would result from the need to
test greater quantities of gloves 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 $310 increased import
sampling cost is attributable to lower costs in the foreign countries
that produce medical gloves.) FDA currently samples about 1.5 percent
of the 95,000 annual imported lots, or 1,400 samples. Thus, the
increased sampling costs due to the proposal are $0.3 million ($1,400 x
$200). Within 10 years, this increased cost will equal $0.4 million
(due to expected increases in the number of inspected glove lots) and
the average annualized sampling cost (at a 7 percent discount rate)
increase is $0.3 million.
3. Withheld Lots
In addition, the proposed AQL is 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 recidivist
listing. FDA's WEAC research laboratory sampled 942 lots and discovered
that 28 failed using the current AQL while 79 lots failed using the
proposed AQL. 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\. Therefore, FDA expects,
that under the proposed AQL, approximately 5,500 lots would be held
back by manufacturers. In order to meet the expected demand in 10
years, 7,000 lots would be held back. FDA believes that glove lots that
fail to meet the proposed AQL medical quality standards would most
likely be sold as nonmedical gloves. Manufacturers and distributors
would experience some loss of revenue from this shift, because of the
price premium commanded by medical gloves. FDA believes this loss would
be inconsequential.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
4. Costs of FDA Inspections
FDA does not envision increased inspection costs due to the
proposed regulation. The rate of sampled glove lots is not expected to
change and FDA resources are not expected to increase over the
evaluation period.
5. Total Costs
In sum, therefore, FDA estimates that the proposed regulation would
have an average annualized cost of about $5.2 million.
F. Benefits of the Proposed Regulation
The proposed regulation would 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), an annualized monetary
benefit of $12.3 million would be saved due to fewer pathogen
transmissions and unnecessary blood screens. Moreover, fewer glove
defects would reduce the number of, and, therefore, the cost and
anxiety associated with, unnecessary blood screens (i.e., those that
yield negative results for health care personnel).
1. Reductions in Marketed Defective Gloves
As noted in the previous paragraphs, FDA finds that approximately
740 million defective gloves are marketed each year in the United
States, or 2.4 percent of all medical gloves. In the absence of this
regulation, FDA expects that the number of defective medical gloves
marketed in the United States each year would increase to 955 million
gloves within 10 years. The proposed regulation would 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 under the current AQL of 4 percent (28 failed lots). This lot
failure rate was associated with 2,356 defective gloves, or 2.4 percent
of the total number of sampled gloves. Under the proposed AQL of 2.5
percent, the WEAC analysis concluded that 51 additional lots would fail
(a total of 79 failed lots), increasing the lot failure rate from 2.97
percent to 8.39 percent.
As discussed earlier, FDA maintains a recidivist policy under which
manufacturers are denied import entry if three lots fail statistical
sampling within a 24-month period. 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. For example, removing
the 53 most defective lots in the testing sample would result in 26 lot
failures from 889 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 gloves were defective, resulting in a glove
defect rate of 1.78 percent. The proposed regulation, 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 740 million glove
defects in the present year and within 10 years would result in 955
million annually marketed defective medical gloves. If the proposed AQL
were in place, the current annual number of defective gloves would
approximate 548 million and within 10 years would reach 709 million.
The number of defective gloves, therefore, would be reduced by more
than 25 percent due to the new AQL.
2. Reductions in Blood-Borne Pathogens
FDA has estimated that, on average, 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 cases.
a. Reductions in HIV transmission. While the direct relationship
between defective medical gloves and HIV is unknown, FDA believes it is
reasonable to apply the proportional reduction in the number of
defective gloves due to the proposed regulation (about 25 percent) to
the annual transmission rate of the HIV pathogen to health care
personnel. In the absence of this regulation, 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
[[Page 15411]]
years due to the expected growth of employment in the health services
industry. However, if the proposed AQL were in place, FDA forecasts the
expected value of the annual transmission of HIV in health care
personnel to equal 1.8 cases during the first effective year and 2.3
cases by the 10th year (based on the expected proportionate decrease in
marketed defective gloves). Over the entire 10-year evaluation period,
these assumptions suggest that the regulation would 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. 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 is 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 proposed regulation would decrease these
transmissions by about 25 percent. Under the new standard, FDA expects
1.8 HBV transmissions during the first evaluation year, a reduction of
0.6 transmissions from baseline conditions. By the 10th evaluation
year, FDA expects 2.3 chronic HBV transmissions under the proposed AQL,
a total of 0.8 fewer cases. Overall, about seven transmissions of
chronic HBV would be avoided due to the proposed regulation over a 10-
year 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 regulation, 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 (Refs. 9
and 10). Respondents noted that the glove failure could occur prior to
patient contact. The additional screening may apply to the affected
health care personnel or the patient if identified. The great majority
of these screens result in negative findings.
As shown in the previous paragraphs, during the first evaluation
year under the new rule, FDA projects the number of defective gloves
marketed in the United States to decrease from 740 to 548 million, a
reduction of 192 million defective gloves. By the 10th year, the annual
number of defective gloves is expected to decrease from 955 to 709
million, a reduction of 246 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
proposed regulation would result in 96,000 fewer unnecessary blood
screens during the first year (192 million fewer defects x 0.05 x
0.01). By the 10th year, 123,000 fewer annual blood screens are
expected. Over the entire period, the regulation could result in
1,095,000 fewer unnecessary blood screens.
4. Value of Avoiding Blood-Borne Pathogen Transmissions
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 workers to
riskier occupations. This research indicates that society is willing to
pay approximately $5 million to avoid a statistical death (Refs. 11,
12, and 13). That is, social values appear to show that people are
willing to pay a significant number of dollars to reduce even a small
risk of death; or similarly, to demand significant payments to accept
even marginally higher risks.
Because this estimate is predominantly based on blue-collar
occupations that mainly attract males between the ages of 30 and 40,
FDA adjusted the life-expectancy of a 35 year-old male to account for
future bed and nonbed disability (Refs. 14, 15, and 16), and amortized
the $5 million (at a 7 percent discount rate) over the resulting
quality-adjusted life span. The result yields an estimate of $373,000
per quality adjusted life-year (QALY), which implies that society is
willing to pay $373,000 for the statistical probability of a year of
perfect health.
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 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 treatment, chronic HBV may not
have a major impact on any of these functions; a patient could drive a
car, walk without a physical problem, and participate in 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 estimated at 0.7433.\2\
---------------------------------------------------------------------------
\2\ Note: The implication is that an ideal health state is
valued as 1.0000 and mortality at 0.0000.
---------------------------------------------------------------------------
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 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
is willing to pay $93,000 per year to avoid a case of HBV ($373,000
times 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 the 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
has a future life expectancy of 41.1 years (Ref. 14)). The present
value of $93,000 per year for 40 years at a 7 percent discount rate
implies that society is willing to pay $1.24 million 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
[[Page 15412]]
(approximately 60 percent) result in mortality within an additional 5
years. Thus, for a 10 year period, FDA tracked three 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 the next 5 years (48 percent).
HIV infection may not affect either mobility or social activity.
However, such an infection may somewhat inhibit physical activity. HIV
patients are 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 estimated at approximately $120,000 per year
($373,000 times [1.0000 minus 0.6796]). According to the collected
preference scores (Ref. 17a) in the Car'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 $170,000 per year ($373,000 times [1.0000 minus 0.5429]).
The Car'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:
[sbull] 20 percent of the percent value (PV) (at 7 percent discount
rate) of avoiding 40 years of HIV infection.
[sbull] 32 percent of the sum of the PV of avoiding 5 years of HIV
infection plus the PV of avoiding 35 years of AIDS infection occurring
5 years in the future.
[sbull] 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 $120,000 per
year is approximately $1.6 million (at 7 percent discount). Twenty
percent of this figure equals $320,000. The PV of avoiding 5 years of
health loss to due HIV infection is equal to $492,000. The PV of
avoiding the health loss expected from 35 years of AIDS infection
(valued at $170,000 per year) is equivalent to $2.2 million. The
present value of this amount occurring 5 years in the future (at 7
percent) is $1.6 million. When added to the PV of avoiding the health
loss associated with 5 years of HIV infection ($492,000), the total
estimated present value of the societal willingness to pay to avoid a
statistical case of this outcome is about $2.1 million. Thirty-two
percent of this figure equals $660,000. The PV of avoiding the health
loss expected from 5 years of AIDS infection ($700,000) occurring 5
years in the future is equivalent to $497,000 (at 7 percent discount
rate). The PV of avoiding a statistical mortality ($5 million) 10 years
in the future is $2.54 million (at 7 percent discount). The total
societal WTP to avoid a case of HIV with mortality as an outcome,
therefore, is $3.5 million ($493,000 plus $497,000 plus $2.54 million).
Forty-eight percent of this figure equals approximately $1.7 million.
Summing the weighted amounts of the three expected outcomes for a case
of HIV infection ($320,000 plus $660,000 plus $1,700,000) equals an
estimated societal willingness to pay $2.68 million to avoid a
statistical transmission of HIV.
In sum, the estimated societal values of avoiding morbidity and
mortality due to the transmission of blood-borne pathogens are
estimated to be equivalent to $1.24 million per transmission of chronic
HBV and $2.68 million per transmission of HIV. FDA notes that other
recent cost-effectiveness research (Ref. 18) has reported cost-
effectiveness estimates (excluding pain and suffering) of $2.1 million
per avoided case of HIV.
FDA believes the methodology to estimate the value of avoided HBV
and HIV infection is reasonable and supportable. Nevertheless,
comparison with reported published preferences show some estimates to
place higher values on avoidance and some lower than the average
collected weight. FDA acknowledges these differences and solicits
comment on other appropriate measures for estimating the societal value
of avoiding blood-borne infections.
c. Benefits of morbidity and fatality avoidance. The proposed
regulation would reduce both HBV and HIV transmissions by reducing the
prevalence of defective medical gloves used as barrier protection.
During the first evaluation year, the regulation would result in 0.6
fewer chronic HBV transmissions to health care personnel. Applying the
assumed societal WTP of $1.24 million to avoid the statistical
probability of one chronic HBV infection, the expected benefit of
avoiding these transmissions is $0.7 million. By the 10th evaluation
year, 0.8 annual transmissions would be avoided at a value of $1.0
million. The PV of avoiding almost seven chronic HBV transmissions over
a 10 year period equals $6.1 million (at a 7 percent discount rate),
which is equivalent to an average annualized value of $0.9 million for
the entire 10-year evaluation period.
Also, in the first evaluation year, FDA expects that the proposed
regulation would result in the probability of 0.6 fewer transmissions
of HIV caused by defective gloves. Assuming that society is willing to
pay $2.68 million to avoid the probability of a single HIV
transmission, the benefit of avoiding these transmissions equals $1.6
million. By the 10th evaluation year, FDA expects the proposed
regulation to result in 0.8 fewer HIV transmissions, which are valued
at over $2.1 million. The societal PV of avoiding seven transmissions
of HIV over the 10-year evaluation period is $12.9 million (at 7
percent discount rate) and is equivalent to an average annualized
benefit of $1.8 million.
In sum, FDA estimates that the reduction in blood-borne pathogen
transmissions due to this proposed rule would produce health benefits
valued at $2.7 million per year. Much of this benefit (almost 67
percent) is attributable to reducing the incidence of HIV.
5. Value of Avoiding Unnecessary Blood Screens
The expected decline in the number of defective medical gloves
would lead to a smaller number of 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 would fall. Second, the psychological anxiety and stress
that accompanies the possibility that a pathogen was transmitted to an
individual would decrease.
a. Cost of conducting blood screens. FDA has collected data from
the
[[Page 15413]]
American Red Cross (Ref. 5) on the costs of conducting blood screening
tests designed 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 who experience high levels of uncertainty due to
the possibility of contracting serious, threatening diseases experience
heightened levels of stress and anxiety until the results of the
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 sequence 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 of 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 $373,000
for a statistical QALY. This figure implies that the probability of
each day of quality adjusted life has a social value of $1,022
($373,000/365). 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 $13 ($1,022 times 0.013).
c. Benefit of test avoidance. By combining the avoided direct cost
of tests and the value of avoided anxiety and stress, FDA estimates
that the societal benefit of avoiding an unnecessary blood test is $89
per sample. During the first evaluation year, FDA expects 96,000 fewer
unnecessary blood screens because of the expected reduction in
defective medical gloves due to the proposed regulation. The implied
societal WTP to avoid these unnecessary screens is $8.5 million. During
the 10th evaluation year, approximately 123,000 fewer unnecessary blood
screens are expected with a resultant benefit of $10.9 million. The PV
of each year's reduced cost of testing and anxiety totals $66.5 million
for the entire period (at a 7 percent discount rate) and an average
annualized amount of $9.6 million. Of the average annualized amount,
$8.2 million represents reductions in the direct testing costs and $1.4
million represents reduced anxiety associated with possible infection
by a contagious agent.
6. Total Benefits
FDA estimates that the proposed regulation would reduce the
availability of defective medical gloves by over 25 percent, resulting
in over 2.2 billion fewer defective gloves over a 10-year period.
During this time, FDA expects that reduction in defective gloves would
result in almost 7 fewer cases of chronic HBV, 7 fewer cases of HIV,
and 1.1 million fewer unnecessary blood screens. Based on an implied
societal WTP, the average annualized benefits of the fewer pathogen
transmissions and unnecessary blood screens would equal $12.3 million.
G. Small Business Impact--Initial Regulatory Flexibility Analysis
FDA finds that the proposed regulation would not have a significant
impact on a substantial number of small entities. There are currently
417 manufacturers of medical gloves, of which 411 are foreign. Because
medical gloves are almost exclusively manufactured by foreign firms,
there would not be a significant economic impact on a substantial
number of domestic small entities. Moreover, FDA does not expect the
increased manufacturer costs to be directly passed on to end users,
because the cost increases would affect only a minority of global
manufacturers and, therefore, competition would require these
manufacturers to absorb these costs.
H. Conclusion
FDA has conducted an analysis of the proposed regulation, using
outside economic consultants. The estimated annualized costs equal $5.2
million, while the estimated annualized benefits equal $12.3 million.
FDA certifies that the proposed regulation would not have a significant
economic impact on a substantial number of small entities because
medical gloves are imported from foreign manufacturers not subject to
the Regulatory Flexibility Act. All six domestic manufacturers of
medical gloves employ more than 1,200 workers. The Small Business
Administration designates as small any entity with fewer than 500
employees in this industry.
V. Submission of Comments and Proposed Effective Date
Interested persons may submit to the Dockets Management Branch (see
ADDRESSES), written or electronic comments regarding this document.
Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments
or two copies of any mailed comments, except that
individuals may submit one hard copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the Dockets Management
Branch between 9 a.m. and 4 p.m., Monday through Friday.
FDA proposes that any final rule that may issue based on this
proposal become effective 90 days after its date of publication in the
Federal Register.
VI. Paperwork Reduction Act of 1995
This proposed rule contains information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520).
No burden has been estimated for the requirements in Sec. 800.20
because recordkeeping of tests and samples is a usual and customary
business practice. Under 5 CFR 1320.3(b)(2), the time, effort, and
financial resources necessary to comply with a collection of
information are excluded from the burden estimate if the reporting,
recordkeeping or disclosure activities needed to comply are usual and
customary because they would occur in the normal course of activities.
VII. References
The following references have been placed on display in the Dockets
Management Branch 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.
1. U.S. Centers for Disease Prevention and Control, ``HIV/AIDS
Fact Sheet,'' www.cdc.gov, 2002.
2. U.S. Centers for Disease Prevention and Control,
``Surveillance of Health Care Workers With HIV/AIDS,'' Oct. 25,
2001.
3 U.S. Centers for Disease Prevention and Control, ``Hepatitis
Fact Sheet,'' www.cdc.gov, 2002.
4. U.S. Centers for Disease Prevention and Control, ``Updated
U.S. Public Health Service
[[Page 15414]]
Guidelines for the Management of Occupational Exposures to HBV, HCV,
and HIV and Recommendations for Postexposure Prophylaxis, Morbidity
and Mortality Weekly Report, July 17, 2002.
5. American Red Cross, Washington Post, June 12, 2001.
6. U.S. International Trade Commission, ``Import Statistics,''
www.usitc.gov, 2001.
7. Eastern Research Group, ``Labeling and Related Testing Costs
for Medical Glove Manufacturers,'' April 17, 2002.
8. U.S. Bureau of Labor Statistics, ``Industrial Outlooks,''
www.bls.gov, 2002.
9. Bonel, L., Johns Hopkins University, correspondence with John
Farnham, July 12, 2002.
10. Budnick, L., Michigan State University, correspondence with
John Farnham, July 19, 2002.
11. Viscusi, K., ``Fatal Tradeoffs: Public and Private
Responsibilities for Risk,'' Oxford University Press, 1992.
12. Fisher, A., L. Chestnut, et al., ``The Value of Reducing
Risks of Death: A Note on New Evidence,'' Journal of Policy,
Analysis, and Management, 8(1):88-100, 1989.
13. Mudarri, D., EPA, ``The Costs and Benefits of Smoking
Restrictions: An Assessment of the Smoke-Free Environment Act of
1993 (HR 3434),'' 1994.
14. U.S. National Center for Health Statistics, ``Vital
Statistics of the United States,'' 2002.
15. Chen, M., J. Bush, et al., ``Social Indicators for Health
Planning and Policy Analysis,'' Policy Sciences, 6:71-89, 1975.
16. Kaplan, R., J. Bush, et al., ``Health Status: Types of
Validity and the Index of Well-Being,'' Health Services Research,
winter, 478-507, 1976.
17. Kaplan, R. and J. Bush, ``Health Related Quality of Life
Measurement for Evaluation Research and Policy Analysis,'' Health
Psychology, 1(1):61-80, 1982.
17a. Harvard Center for Risk Analysis, 2002, ``CUA Database:
Catalog of Preference Scores,'' Harvard School of Public Health,
www.hcra.harvard.edu/pdf/preferencescores.pdf, accessed October 26,
2002.
18. Marin, M., J. Van Lieu, et al., ``Cost-Effectiveness of a
Post-Exposure HIV Chemoprophylaxis Program for Blood Exposures in
Health Care Workers,'' Journal of Occupational and Environmental
Medicine, 41:9, 754-60, 1999.
19. Radloff, L., ``The CES-D Scale: A Self-Report Depression
Scale for Research in the General Population,'' Applied
Psychological Measurement, 1(3):385-401, 1977.
20. Shrout, P., ``The Scaling of Stressful Life Events,'' (in)
Stressful Life Events and their Contents, B. S. Dohrenwend and B. P.
Dohrenwend (eds), Rutgers University Press, 1984.
21. Holmes, T. and R. Rahe, ``The Social Readjustment Rating
Scale,'' Journal of Psychosomatic Research, 11:213-218, 1967.
22. Davis, M., E. Eshelman, et al., ``The Relaxation and Stress
Reduction Workbook,'' MJF Books, 1995.
List of Subjects in 21 CFR Part 800
Administrative practice and procedure, Medical devices, Ophthalmic
goods and services, Packaging and containers, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 800 be amended as follows:
PART 800--GENERAL
1. The authority citation for 21 CFR part 800 continues to read as
follows:
Authority: 21 U.S.C. 321, 334, 351, 352, 355, 360e, 360i, 360k,
361, 362, 371.
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 certain other visual defects will be
conducted by an initial visual examination and by a water leak 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 are defined
as tears, embedded foreign objects, or other defects visible upon
initial examination that may affect the barrier integrity, or 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.
(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. The following materials are required for
testing:
(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).
(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,
however, 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 shall 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 addition of
the water to the glove. Use only minimum manipulation of the fingers to
check for leaks. Record the number of defective gloves.
(c) Sampling, inspection, acceptance, and adulteration. In
performing the test
[[Page 15415]]
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 Number -----------------------
Size Sample Sample Size Examined
Accept Reject
------------------------------------------------------------------------
8 to Single .............. 8 0 1
90 sample
------------------------------------------------------------------------
91 to Single .............. 32 1 2
280 sample
------------------------------------------------------------------------
281 to Single .............. 50 2 3
500 sample
------------------------------------------------------------------------
501 to Single .............. 80 3 4
1,200 sample
------------------------------------------------------------------------
1,201 First 32 32 0 4
to
3,200
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 First 50 50 0 4
to
10,00
0
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 First 80 80 0 5
to
35,00
0
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
and
above
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
----------------------------------------------------------------------------------------------------------------
[[Page 15416]]
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
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 Number -------------------------------
Examined Accept Reject
----------------------------------------------------------------------------------------------------------------
13 to 90 Single sample .............. 13 0 1
----------------------------------------------------------------------------------------------------------------
[[Page 15417]]
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 Number -------------------------------
Examined Accept Reject
----------------------------------------------------------------------------------------------------------------
8 to 50 Single sample .............. 8 0 1
----------------------------------------------------------------------------------------------------------------
51 to 280 Single sample .............. 32 1 2
----------------------------------------------------------------------------------------------------------------
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: March 21, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-7601 Filed 3-28-03; 8:45 am]
BILLING CODE 4160-01-S