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Altering of Safer Medical Devices - State of Michigan

By Brittany Black,2014-07-09 23:14
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Altering of Safer Medical Devices - State of Michigan

Subject: Bloodborne Infectious Diseases

    Topic: Altering of Safer Medical Devices

    Question: Can a person alter a safety device in any way? With the changes we have made to comply with the needlestick safety and prevention act over the last few years, and continue to make, I have noticed some of our

    people taking off part of the safety devices on our needles because they don’t like them. I am trying to enforce the standard and would like to know if there is any rule stating that the device cannot be altered. Can I get an

    interpretation on this mater?

    Answer: Neither the Michigan Bloodborne Infectious Diseases (BIDs) standard, MIOSHA Part 554 or the compliance directive for interpretation of Part 554 indicate that a safer medical device cannot be altered.

Concerning safer medical devices, the BIDs standard indicates:

    Rule 325.70004(d)(i) The exposure control plan is reviewed and updated at least annually considering

    and implementing use of safer medical devices.

    Rule 325.70004(h) Non-managerial employees will have input in identification, evaluation and

    selection of effective controls.

    Rule 325.70015(12) A sharps injury log must be maintained.

    If the exposure plan was reviewed, safety medical devices considered, and the employees have continuing input into selection of controls; why are the employees now altering the devices? Also, does the sharps injury log indicate that the altered device is more or less prone to causing injury than the original device?

Concerning marketing of safer medical devices, the FDA is responsible for clearing medical devices for

    marketing, but indicated that the clearing alone is not enough to guarantee the device will be effective. Specific design features the FDA listed in Supplementary Guidance on the Content of Pre-market Notification

    Submissions for Medical Devices with Sharps Injury Prevention Features lists:

    ; The safety feature is an integral part of the device and not an accessory.

    ; The safety feature is in effect before disassembly and remains in effect after disposal to protect

    users and trash handlers, and for environmental safety.

Thus, alterations could violate the required design features listed above.

If a progressive employee noted a method of improving a device, the correct method would be to make the

    improvement and register the device for marketing with the FDA.

    Additionally, the Michigan Occupational Safety and Health Act (i.e., Public Act 154 of 1974), Section 408.1012(b), “Duties of Employee,” states, “An employee shall not remove, displace, damage, destroy, or

    carry off a safeguard furnished or provided for use in a place of employment, or interfere in any way with the use thereof by any other person.” This particular situation would only be cited as a General Duty Clause citation (i.e., a serious hazard) when evidence exists to a related injury to the hazard.

    This type of citation is called a General Duty Clause citation, and is normally only issued if there is evidence of a related injury.

Employers always have the option of making requirements that go beyond the limits of the MIOSHA

    standards. We recommend that safer medical devices not be altered. If during the annual review of your

    exposure control plan employees indicate that a device is not appropriate; alternative devices should be provided, used, and their use evaluated.

Applicable Construction Safety Standard/Rule:

Applicable General Industry Safety Standard/Rule:

    Applicable Occupational Health Standard/Rule: MIOSHA Part 554. Bloodborne Infectious Diseases

Additional Resources:MIOSHA General Industry Standards Webpage

    Michigan Public Act 154 of 1974, Section 408.1012

    For complimentary MIOSHA consultation please contact our office at (517) 322-1809 or submit a Request for Consultative Assistance (RCA).

Date Posted: April 20, 2007 Click Here to Read Disclaimer

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