From: Elong [elong@mrepc.com] Sent: Monday, June 30, 2003 4:26 AM To: fdadockets@oc.fda.gov Subject: Medical Devices:Patient Examination and Surgeons' Glove; Test Procedures and Acceptance Criteria (Docket No 03N-0056) Date: 29 June, 2003 FROM : Malaysian Rubber Export Promotion Council (MREPC) 11th Floor, Bangunan Getah Asli, 148, Jalan Ampang, 50450 Kuala Lumpur, Malaysia Fax: 603-2166 8018 E-mail: elong@mrepc.com TO: Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Reference: Docket No. 03N-0056. Federal Register: March 31, 2003 (Volume 68, Number 61) (Proposed Rules) (Page 15404-15417) 21 CFR Part 800 Proposed Rule : 800.20 Medical Devices ; Patient Examination and Surgeons' Gloves; Test Procedures and Acceptance Criteria. The Malaysian Rubber Export Promotion Council is an agency set up by the Ministry of Primary Industries of Malaysia in 2000 with the aims of promoting the exports of rubber products. MREPC has set up an office in Washington D.C. in 2001 to promote Malaysian rubber gloves especially the Standard Malaysian Glove (SMG) and a host of other rubber products in the US Malaysia exports about 1.2 billion pairs surgeons' gloves and 8.7 billion pairs examination gloves to the Unites States in year 2002. The Malaysian Rubber Export Promotion Council (MREPC) has reviewed the Proposed Rule on 21 Code of Federal Regulations, Part 800.20 on Test Procedures and Acceptance Criteria for Medical Devices: Surgeons' Gloves and Patient Examination Gloves dated March 31, 2003 and wishes to submit the following comments for the consideration of the Food and Drug Administration (the FDA). 1. MREPC supports the FDA's continuing effort to improve the healthcare standard through the import and distribution of safe and quality disposable medical gloves. MREPC also wishes to commend the FDA for taking the positive action to harmonize the existing rule of the 21 CFR Part 800.20. with those there international consensus such as the ASTM and ISO. 2. On Harmonization With Consensus Standards (See Preamble II. Proposed Changes, A. 2.), while MREPC agrees with the need to tightening the AQL levels for both surgical and patient examination gloves to be in harmonization with ASTM and ISO, MREPC would like to point out that bringing the AQL of the existing rule from 4.0 to 2.5 for patient examination gloves does not harmonize with ASTM's AQL 2.5. This is because the ASTM's AQL 2.5 applies only to pinhole defects whereas FDA's proposal applies to both pinhole and visual defects. MREPC is concerned that in the case of pinhole defects, there have been several discussions by experts of the ASTM working groups before the pinhole test was accepted, and there are scientific studies linking barrier performance of patient examination gloves to pinhole defects, however, this was not the case for visual defects. The determination of visual defects is subjective and some of the visual defects are linked more to donnability of gloves and not to barrier integrity. That is, the visual defects actually would not impact the barrier integrity. The proposed rule may lead to situations whereby gloves that pass pinhole AQL on ASTM standard will be failed by the FDA due to presence of visually defective gloves sampled. The same comment and argument applies to surgeons' gloves. 3. MREPC would like to propose that the pinhole test and visual defects be determined separately using two different sets of samples per lot. For surgeons' gloves and patient examination gloves, the pinhole AQL would be 1.5 and 2.5 respectively in harmonization with ASTM. In the case of visual defects, the corresponding AQL will be 2.5 and 4.0 respectively. 4. MREPC also wishes to point out that while ASTM uses the single normal sampling plan for the test of pinhole defects, the Proposed rule specifies the multiple normal sampling plan. MREPC believes that this does not lead to full harmonization. This is because when different sampling plans are used, the specified AQL, although numerically the same, could mean differently. 5. On Interpretation of Defects (Preamble II, A. 3.), MREPC is concerned on the inclusion of the phrase 'other defects visible upon initial examination that may affect the barrier integrity' as part of the definition. MREPC is of the opinion that this will bring about a lack of objectivity on how visual defects are classified. In the absence of scientific data, the interpretation of certain visual defects linking to barrier integrity is subjective. It would be useful if the proposed rule will provide a clearer definition of the various types of known defects that can affect barrier integrity. 6. On Cost of the Proposed regulation (Preamble IV, E.), MREPC agrees with the view of expressed that manufacturers would incur additional costs of quality control and sampling costs due to tightening of the AQL. However, MREPC believes that the additional cost cannot be borne by the manufacturers. The cost for the improved quality is going to be substantial, the preamble has indicated that it may be in the region of US 5 million per year. As the current glove price is at its low level and many manufacturers are not making ends meet, any suggestion that the possibility of supplying gloves without any price increase is going to be unrealistic. Otherwise, the quality of gloves will be affected and it will give rise to further rejection of gloves that may be inspected as defective by FDA leading to shortage of gloves. 7. The Preamble of the Proposed rule suggested that the implementation of the tightening of AQL would involve a saving of annually US $12.3 million from fewer pathogen transmissions and unnecessary blood screens. Part of this savings should be utilized to subsidize the increased testing cost. 8. For reconditioned gloves, MREPC agrees to the Proposed rule of using Tightened Sampling Plans. This will allow manufacturers and importers to recondition a lot or part of a lot of gloves for re-testing that will help to decrease the likelihood of false judgment regarding a statistical Type I sampling error, i.e., a good lot being rejected as a bad lot. The above comments are the concerns of MREPC on the recommended changes, and the rationale for the suggested amendments to the Preamble and the Regulation. MREPC sincerely hopes that FDA will consider these comments favorably. Sincerely Yours, (Dr Ong Eng Long) Deputy CEO, Malaysian Rubber Export Promotion Council