Import Alert 80-04

"Surveillance and Detention Without Physical Examination of Surgeon's and Patient Examination Gloves"

NOTE:
Revision of this Import Alert dated 10/20/2010 updates the Guidance section to reflect current terminology and also updates the contact information. Changes are bracketed by asterisks (***).


CDRH has determined that many foreign manufacturers and shippers of medical gloves have failed to consistently provide medical gloves of adequate quality for distribution in the U. S. surgeon's and examination gloves are widely used by health care professionals and others as a barrier to blood-borne diseases and pathogens. Defective medical gloves present a potential hazard to health for users as well as patients. Therefore, continuous monitoring of these medical gloves is needed.

Districts may detain without physical examination, all shipments of surgeon's and patient Examination Gloves from the manufacturers/shippers listed on this alert.

Surveillance sampling of other manufacturers/shipper's surgeon's and patient Examination Gloves per the most recent guidance is indicated.

NOTE:
Because the presence of defects in medical gloves represents a potential hazard to health, only one (1) violative sample is needed to submit a recommendation for detention without physical examination to the Division of Import Operations & Policy (DIOP). DIOP has direct reference authority for detention without physical examination of these medical gloves. Violative medical gloves are subject to RPM Chapter 9, Detention Without Physical Examination, subchapter Recommendations Based on One Sample.

The following strategy has been established to address those manufacturers/shippers who are found to repeatedly ship violative medical gloves to the U.S. (recidivist firms.)

*** Level 1 Detention (INDICATED BY * on the Red List) ***

When a district encounters a shipment of medical gloves which is found violative for defects by FDA analysis, the shipment should be detained and a recommendation for detention without physical examination should be forwarded to DIOP, HFC-170.

If the recommendation meets current guidance, the manufacturer/shipper will be placed on the Red List with a single asterisk (*) in the notes field, and subsequent medical glove shipments from that manufacturer/shipper may be detained without physical examination under this import alert. This is referred to as Level 1 detention. The manufacturer/shipper may obtain admission of subsequently detained shipments of medical gloves by presenting evidence that the individual shipments are not adulterated, such as sample analyses performed by an independent testing laboratory, following sampling plan and test method contained in FDA guidance.

*** In order for the responsible manufacturer's/shipper's name to be removed from the Red List, documentation should be provided with sufficient evidence that their medical gloves are not adulterated (for example, five consecutive non-violative shipments analyzed as described in the preceding paragraph may be considered adequate evidence for manufacturers/shippers to be removed from Level 1 detention). ***

*** Level 2 Detention -- (Recidivist firms which are currently on Level 1 detention, or which have been removed from Level 1 detention) (INDICATED BY ** on the Red List) ***

*** If a manufacturer/shipper, while on Level 1 detention, has a violative sample analyzed by a private laboratory, the district should notify DIOP and submit supporting documentation. DIOP will place the firm on Level 2 detention and identify the manufacturer/shipper on the Red List with two asterisks (**) in the notes field. ***

*** Similarly, if a manufacturer/shipper that has been removed from Level 1 detention has a violative sample analyzed by FDA within 24 months from the date they were removed from Level 1 detention, the district should notify DIOP and submit supporting documentation. DIOP will verify the manufacturer/shipper was listed under Level 1 detention during the past 24 months and if confirmed will place the manufacturer/shipper on Level 2 detention and identify the manufacturer/shipper on the Red List with two asterisks (**) in the notes field. ***

DIOP will bring this action to the attention of CDRH.

Based on this second listing within 24 months, CDRH has agreed to notify the foreign firm in writing of FDA's about potential deficiencies in the manufacturing practices and process controls which may be affecting the quality of the medical gloves shipped to the U.S. A copy of the Good Manufacturing Practices (GMP) Regulations will be provided with the letter for their information.

Once a manufacturer/shipper is placed on Level 2 detention, FDA may need greater assurance that the medical gloves are not adulterated before removing the manufacturer/shipper from detention without physical examination status. For example, 10 consecutive non-violative shipments, analyzed by an independent testing laboratory, may be considered adequate evidence that the manufacturer/shipper is shipping medical gloves to the U.S. which are not adulterated. Other types of evidence to remove the appearance of a violation will be evaluated by CDRH on a case-by-case basis.

*** Level 3 Detention -- (Recidivist firms which are currently on Level 2 detention, or which have been removed from Level 2 detention) (*** IN THE NOTES FIELD OF THE RED LIST DENOTES A WARNING LETTER IS BEING CONSIDERED BY CDRH). ***

If a manufacturer/shipper, while on Level 2 detention, has another violative sample analyzed by an independent testing laboratory, the district should notify DIOP and submit supporting documentation.

Similarly, if a manufacturer/shipper removed from Level 2 detention has another violative sample analyzed by FDA within 24 months from the date they were removed from Level 1 detention, or the date they were placed on Level 2 detention, DIOP will bring these instances to the attention of CDRH.

Based on the failure of the manufacturer's/shipper's medical gloves to pass FDA analysis [Section 501(c)] after being listed on Level 2 detention, or having failed an independent testing laboratory examination while under Level 2 detention, CDRH may then issue a Warning Letter to the firm. Additionally, after reviewing the manufacturer/shipper's export and inspectional history, CDRH may elect to charge the firm for failure to conform with GMPs [Section 501(h)], based on the recurring GMP deficiencies as revealed by the repeated failures of analyses. If CDRH determines a warning letter should issue to the foreign manufacturer/shipper, DIOP will place the manufacturer/shipper on Level 3 detention.

*** Non-violative analyses may not be sufficient to remove the appearance of a violation for manufacturers/shippers on the Red List. Manufacturers/shippers will remain on Level 3 detention until evidence is provided to CDRH which demonstrates that the medical gloves are being manufactured in accordance with Good Manufacturing Practices (for example, an acceptable FDA inspection or a written certification from the manufacturer/shipper together with the results of an independent audit performed by a qualified third party). ***

*** Once a foreign manufacturer/shipper satisfactorily demonstrates that the apparent GMP deviations have been corrected, the manufacturer/shipper will be placed on the Red List under the Level 1 detention for individual shipment analysis to confirm their medical gloves do not contain defects until they provide adequate evidence to be removed from Level 1 detention (see above). ***

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 443-3320 or 3007.

*** For questions concerning 21 CFR 800.20, CPG 7124.31, medical glove labeling, or other compliance issues, contact Valerie Flournoy, 301-796-5770, CDRH, Office of Compliance, Division of Enforcement A, General Hospital Devices Branch or email the CDRH Import Safety Group at CDRH OC Import Mailbox (cdrhocimport@fda.hhs.gov). ***
SAMPLING:
See 21 CFR 800.20(c) for sample plans.

All sizes should be represented as closely as feasible to the proportion which they exist in the shipment; however, exact statistical representation is not necessary. If the sample is found violative, all sizes should be detained.

When an entry consists of only one size, attempt to collect as many lot numbers as possible. For example, if during a random sample collection three lot numbers are observed, represent them all as subs within one sample. If the sample is found violative, all lots should be detained.

If a shipment is detained based on the analysis of one lot and subsequently it is learned that there were 10 lot numbers present, the detention stands.


REVISED BY:
John E. Verbeten, DIOP, 6/1/2010
LCDR Christopher T. Smith, DIOP, 6/1/2010
*** LCDR Christopher T. Smith, DIOP, 10/20/2010
Theresa Thompson, DIOP, 10/20/2010 ***

Surgeon's and patient examination gloves.

"The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to contain defects/holes [Adulteration, section 501(c)]."

OASIS charge code - HOLES

When FDA has documented repeated violations, and the manufacturer/shipper has been issued a Warning Letter and listed in Attachment B of the Recidivist Policy describe below, future shipments ma be detained charging the following:

"The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities and controls used for, the manufacture, packaging, storage, or installation of the device do not conform with Good Manufacturing Practices [Adulteration, section 501(h), Good Manufacturing Practices, Section 520(f)]."

OASIS charge code - DEVICE GMP