August 28, 1996

[Name Withheld]

Dear [Name Withheld]:

This is in response to your letter dated December 5, 1995, concerning the SPS "Needle-Eater" and accessory sharps "transfer container." As we have discussed, the "Needle-Eater" was referred to us by OSHA regional staff who raised concerns about its use and the safe handling of sharps.

This letter provides our interpretation of the Bloodborne Pathogens Standard, 29 CFR 1910.1030 as it pertains to this device. In general, the Occupational Safety and Health Administration (OSHA) does not review products as you have requested. The final determination of compliance must take into account all factors pertaining to the use of the device at a particular worksite. This must include an evaluation through direct observation of employee work practices as well as an evaluation of the equipment or device alone. In this case, however, we must inform you that the device does not meet the intent of the Bloodborne Pathogens Standard (29 CFR 1910.1030).

The Bloodborne Pathogens Standard addresses reusable sharp containers at paragraph (d)(4)(iii)(A)(4):

Reusable containers shall not be opened, emptied, or cleaned manually or in any other manner which would expose employees to the risk of percutaneous injury.

Based on our review of the device and accompanying literature, we must interpret the "transfer carrier" to be a reusable container designed to temporarily hold used sharps. The "transfer carrier" must be opened twice, once for inserting a single contaminated sharp and again when the sharps are dumped into the "Needle-Eater" for grinding. Another concern is that when the "Needle-Eater" is jammed or blocked it must be "unplugged" by hand.

For the reasons identified above, we conclude the device fails to achieve the intent of the Bloodborne Pathogens Standard. For your information, the container must be approved by the Food and Drug Administration (FDA) as a sharps container and the "Needle-Eater" must also receive FDA approval. We have been informed by the FDA that the Needle-Eater and the sharp container have not been approved by FDA.

If you have further questions on this issue, please feel free to contact this office (202) 218-8036. We appreciate your interest in worker safety and health.

Sincerely,



Ruth McCully, Director
Office of Health Compliance Assistance

(For Needle-Eater Data Sheet, Click Here)

(For State Approval Listing, Click Here)

(For MSDS Sheet, Click Here) DRAFT GUIDANCE ON THE CONTENT AND FORMAT OF PREMARKET NOTIFICATION [510(k)] SUBMISSIONS FOR SHARPS CONTAINERS October 1993 Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Division of General and Restorative Devices Infection Control Devices Branch DRAFT

A. Scope

This document pertains to sharps containers and secondary sharps containers. A secondary container holds the sharps container, if leakage is possible (refer to OSHA regulation 29 CFR 1910.1030(d)(4)(iii)(A)(3)).

B. Introductory Information

1. The labeling or promotional material for the sharps container may not state that the device is FDA approved or cleared. The applicant may be able to claim the device meets OSHA regulations on Bloodborne Pathogens, 29 CFR 1910.1030, if such a statement is permitted under OSHA regulations and statutes.

2. FDA 510(k) clearance does not preclude OSHA from finding the device and/or its use to be violative under OSHA regulations. If the design is found deficient by OSHA, subsequent to a finding of substantial equivalence by FDA, and it is modified to render it acceptable to OSHA, then a new 510(k) should be submitted noting the modifications.

3. FDA and OSHA are working together to implement adequate infection control practices to reduce the risk of bloodborne infections. FDA is not enforcing the OSHA regulations, per se. Rather, FDA evaluates whether a sharps container has features that are consistent with current good infection control practices, for instance, as expressed in the OSHA Bloodborne Pathogen regulations related to engineering and work practice controls. OSHA engineering controls are controls that isolate or remove the bloodborne pathogens from the workplace. OSHA work practice controls are intended to help ensure that sharps containers are used in a manner that will reduce the likelihood of an exposure to infectious material by altering the manner in which sharps disposal is performed (e.g., recapping contaminated sharps only when no alternative is feasible or when such action is required by a specific medical procedure, placement of containers, and routine replacement).

4. This document is fashioned in a checklist format for use by FDA reviewers, and it is also a guide for applicants. In the blank spaces next to the requested information the FDA reviewer should indicate "Y" when the information is acceptable, "N" when not acceptable, and "NA" when not applicable. Applicants may wish to reproduce portions of the guidance and include it in the 510(k) application, with supporting information, to facilitate the review process.

5. The applicant should respond to each of the items in the guidance. Provide the information requested, state why the information is not applicable, or provide alternative information that is commensurate with the data requested.

6. Be advised that FDA has determined that devices which remove sharps off the needle hub, typically by means of an electrical charge or heat, present a new type of safety and effectiveness issue (potential for toxic emissions), and are therefore not substantially equivalent devices. The devices are Class III products requiring premarket approval, or reclassification to Class I or II before they may be marketed.

C. Standards

There are no FDA regulatory standards for sharps containers. The applicant may choose to indicate that the device meets a standard. The following are examples of standards and reference information that are relevant to sharps containers:

1. Occupational Safety and Health Administration - Occupational Exposure to Bloodborne Pathogens; final rule (29 CFR 1910.1030; Federal Register 1991 December 6; 56, No. 235:64175-82.

2. British Standard Institution - Specification for Sharps Containers (BS 7320:1990)

3. Australia Standard - Non-Reusable Containers for the Collection of Sharps Medical Items Used in Health Care Areas (AS 4031 - 1992, 1992)

4. American Society for Testing and Materials (ASTM) - Standard for puncture resistance being considered (ASTM Task Force F04.65.01)

5. Canadian Standard being considered (CAN/CSA Z316.6)

6. Health Devices, August-September 1993, ECRI, Vol. 22 Nos. 8-9.

D. Cover Letter

State at the top of the cover letter "510(k) Notification"

__ 1. Trade/Proprietary Name (Model Name and

Number):________________________________________

__ 2. Common/Usual Name: Sharps container and/or secondary

container should be noted, as applicable.

3. Classification name (select one):

____ accessory to hypodermic needle

____ accessory to blood collection device (if dedicated to that use)

____ other: describe

4. Reason for Submission

____ new device

____ modified device

____ other: describe

__ 5. Classification: Class II for accessories noted in item

3 above.

__ 6. Panel/Procode: 80 FMI for a needle accessory

__ 7. Registration #: ____________________

E. Labeling

Provide copies of labels, labeling, and promotional material, All claims will be closely scrutinized for supportive information (e.g., disease prevention claims, comparative performance claims).

_____ Biohazard labels with visible location on device

_____ General Labeling Information required under 21 CFR 801 (e.g., manufacturers name and address)

_____ Disposal Procedures

_____ Assembly/Mounting Instructions

_____ Operating Instructions

F. General Description

Provide a detailed description of the sharps container.

__ Pictures or detailed drawings (labeling may suffice)

__ Volume

__ Dimensions

__ Empty Weight

Describe the materials and form of construction

_____ Description of Materials (type of plastic, metal, cardboard, etc)

_____ Thickness of Materials (provide variations in thickness that may exist in different parts of device, and tolerances)

_____ How Device is Formed (molded, glued edges, etc.)

_____ Reusable (labeling and design must address safe disposal of sharps per OSHA regulations, i.e., no manual processing)

_____ Clarity of Material (clear, opaque, etc.)

__ Intended Location for Use (OR, patient room, etc.)

__ Describe any unique features in detail.

G. Design Features of Containers for Contaminated Sharps

Indicate if the device meets the following design features, when applicable. The basis for the list is the OSHA regulations.

__ 1. Closable

__ 2. Puncture resistant

__ 3. Leakproof on the sides and bottom

4. Labeled or color-coded:

_____ a. BIOHAZARD warning label

fluorescent orange or orange-red or predominantly so, with lettering or symbols in a contrasting color

  _____ b.  affixed as close as possible to the container by
            string, wire, adhesive, or other method that
            prevents loss or unintentional removal

_____ c. red container may substitute for labels

__ 5. Capable of maintaining stable, upright position

__ 6. No feature to bend, break, or shear needle (includes

blunting and melting of needle).

__ 7. OSHA Compliance Directive On Needle Unwinders

Feature to recap the needle, or remove the needle off the hub of the syringe (i.e., an unwinder as characterized by OSHA) provides for a one-handed technique (i.e. does not require holding container with the free hand).

Container with unwinder is designed so that it is stabile (secured to a wall, table, or tray) to prevent slipping during use.

The unwinder is designed to provide for a secure capture.

__ 8. Container for reusable sharps shall not be designed to

require employee to reach by hand into the container to retrieve the contaminated reusable sharps

__ 9. Container is designed to easily and safely determine if

the container is full.

10. Optional features/accessories:

_____ locked enclosure

_____ holder to secure to wall, table, etc.

H. Design Features of Secondary Containers

Indicate if the device meets the following design features, when applicable. The basis for the list is the OSHA regulations.

__ 1. Closable

__ 2. Constructed to contain all contents and prevent leakage

during handling, storage, transport, or shipping.

__ 3. Labeled or color-coded as above in G.4.

I. Specifications of Design Features

State the specifications for each of the following features. The specification should be objective and quantitative, when appropriate (e.g., puncture resistance). Refer to any standard the specification meets.

__ Impact Resistance

__ Puncture Resistance (base, sides, closure, top)

__ Overfill Detection

__ Leak Resistance (sides and bottom)

__ Sharps Access and Closure

__ Stability (maintaining upright position)

__ Mounting Accessories and any Locking Mechanism

__ Handling (safe transportation features)

__ Capacity

__ Feature to Minimize Aerosolization

__ OTHER (as applicable, e.g., electrical):

J. Design Validation Test Methods

Summarize the test methods for each of the specifications noted in item I above. The protocol must indicate pass-fail criteria and the safety and effectiveness basis for the criteria (e.g., a standard). There are tests methods indicated in the referenced standards.

K. Comparison to a Legally Marketed Sharps Container

Persons submitting 510(k)s must compare their device to a legally marketed device. FDA has recently decided to actively regulate sharps containers. FDA formal announcement of this initiative is imminent and it may provide a grace period for submission of 510(k)s.

There will be a period of time during this transition in regulatory control where some currently marketed containers are still pending FDA clearance, making confirmation of legality of a predicate device problematic in the short term Still, the applicant should provide a comparison of their device to ones available on the market and to available standards noted in item C above.

Provide a side by side comparison of design features and specifications of containers that most closely match the device being submitted for clearance.

L. Safe Medical Devices Act 510(k) Statement of Safety and

Effectiveness or 510(k) Summary of Safety and Effectiveness

__ Provide either the statement or summary as required under 21 CFR 807.92 or 807.93 (see attached).

M. Address

Submit duplicate copies (two copies) to the following address:

              FDA
              Document Mail Center
              HFZ-401
              1390 Piccard Dr.
              Rockville, MD  20850

N. Contact for Questions

If there are any questions, please call:

              Branch Chief
              Infection Control Devices Branch
              (301) 594-1307

O. Attachment

21 CFR 807.87 - 807.94.

 

MEMORANDUM

DATE:          November 16, 1994

FROM:          Chief, Infection Control Devices Branch, Pilot
              Device Evaluation Staff, HFZ-413

THROUGH:       Acting Director, Pilot Device Evaluation Staff, HFZ-410

SUBJECT:       Clarification on the Type of Sharps Containers to
              Be Regulated

TO:            DSMA

The purpose of this memorandum is to clarify and define the type of containers that are to be regulated by FDA and that require a 510(k) submission.

Any container that includes sharps waste disposal as an intended use is a regulated sharps container and requires a 510(k) submission. Sharps waste is defined per the OSHA Regulations on Bloodborne Pathogens (29 CFR Part 1910.1030) as follows:

"Contaminated sharps means any contaminated object that can penetrate the skin including, but not limited to, needles, scalpels, broken glass, broken capillary tubes, and exposed ends of dental wires."

Also, any tubing or other accessories associated with the sharps may be disposed of in a sharps container.

The document, Guidance on the Content and Format of Premarket Notification [510(k)] for Sharps Containers (October 1993), is available and indicates the type of information and data which are needed in a 510(k) submission for a sharps container. A separate 510(k) submission is required for each different container design and/or material.

Any container which claims disposal of sharps waste as an intended use, must meet the OSHA requirements for sharps containers. The container must be:

         - closable;
         - maintained upright during use;
         - puncture resistant;
         - leakproof at sides and bottom; and
         - properly labeled with the biohazard symbol and legend or color
           coded.

In addition, containers with mechanisms that bend, break, incinerate, or shear needles will not be found substantially equivalent and will require a PMA approval before they can be marketed. Any needle unwinder or recapper associated with a sharps container must use a one-handed technique. The intended use of these sharps containers must not include disposal of personal protection equipment, such as gowns, since other procedures are required for disposal of such items.

The label on the primary container should clearly inform the user that the container may contain sharps waste. Either an icon, the phrase Infectious Sharps Waste, or a similar indication should be included on the container label.

Any secondary container into which a sharps container is placed for disposal or transport must also meet OSHA requirements for Bloodborne Pathogens and should be:

         - closable;
         - able to prevent leakage; and
         - properly labeled with the biohazard symbol and legend or color
           coded.

Chiu S. Lin, Ph.D.



September 13, 1995

Jean Druckenmiller, PH Educator
Wisconsin Division of Health
Bureau of Public Health
1414 East Washington Ave.
East Madison, WI 53703-3044

Dear Jean,

Following our telephone conversation today regarding the Needle-Eater, I have enclosed the information I received about the product. Miller Medical, which is a durable medical and medical supply store in Eau Claire, brought this information to our office.

I am sure you will get calls from other agencies, or other agencies will purchase the Needle-Eater because the information states that this is in full compliance with EPA and OSHA regulations. Its confusing to know just what to do at times.

Thanks for your help today.

Sincerely,



Karen Levandoski, RN
Director



 

Date:               October 13, 1995

Memorandum For:     Ruth McCully
                   Director
                   Office of Health Compliance Assistance

From:               William Q. Wiehrdt
                   Assistant Regional Administrator
                   Technical Support

Subject:            Needle Eater

It is our opinion that this advertisement and/or product does not reflect appropriate OSHA standards relative to the safe handling of sharps. Because of its potential National impact, we are forwarding it to you for your review and any action you deem appropriate.

We would appreciate knowing your opinion in this matter so that we may provide guidance to our field offices.

Attachments


 

Date:               October 13, 1995

Memorandum For:     Timothy Kobernat
                   District Supervisor
                   Eau Claire District Office

From:               William Q. Wiehrdt
                   Assistant Regional Administrator
                   Technical Support

Subject:            Needle Eater

Thank you for the information you sent us regarding the above subject. We believe your concerns are justified. Because of its potential National impact we have forwarded your information to the National Office for a response and/or comments (see attachment).

Attachment

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