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CADTH » Search All Products » Environmental Scanning » Environmental Scans » Issue 8 » Appendix 1and 2

Appendix 1: Study Characteristics and Outcomes

First Author, Year, Country

Study Design

Number of Patients

Outcomes

Conclusions

Gartner, 2008, Germany4

Blind, randomized, single-centre trial

New ultrasound scissors = 51
Resterilized ultrasound scissors = 49
  • Optimal force of activation: new = 94.1% (48/51) versus resterilized = 95.9% (47/51), P = 1.000
  • Optimal cutting action:
    new = 86.3% (44/51) versus resterilized = 87.8% (43/49), P= 1.000
  • Optimal coagulation effect: new = 88.2% (45/51) versus resterilized = 87.8% (43/49), P= 1.000
  • Number of unacceptable error messages: new = 4 versus resterilized = 4, P= 1.000
  • Number of error messages and disturbing noises: new = 7.8% (4/51) versus resterilized = 6.1% (3/49),
    P= 1.000
  • Number of scissors to be replaced during operation due to persistent problems: new = 11.8% (6/51) versus resterilized = 4.1% (2/49),
    P= 0.269

The functionality and handling of the new versus resterilized ultrasound scissors was comparable.

Sung, 2008, US3

Randomized controlled trial

New external fixation frames = 50
Refurbished external fixation frames = 46
  • Incidence of pin tract infections: new = 46% (23/50) versus refurbished = 52% (24/46), P= 0.32
  •   Loss of fixation: new = 4% (2/50) versus refurbished = 4% (2/46), P= 0.70
  • Loosening of components: new = 1% (5/413) versus refurbished = 1% (4/333),
    P= 1.0

The refurbishment of external fixation devices is safe and effective. The authors indicated a potential cost savings of 25% for the cost of all new external fixation frames.

Appendix 2: Environmental Scan of SUD Policies in Canada

Jurisdiction

Position on Reuse and Reprocessing of SUDs (verbatim)

British Columbia

Policy:

  • All health authorities must eliminate the reprocessing and reuse of critical contact single-use devices unless they have been reprocessed by a licensed third-party reprocessor, certified by a national regulatory authority, such as Health Canada or the US Food and Drug Administration (FDA).5

Alberta

Standards:6

  • Critical or semi-critical single-use medical devices that are labelled by their manufacturers as single-use shall not be reused on any client unless reprocessed by a third-party reprocessor in a manner that ensures that the devices is safe and will function as intended by the manufacturer.
  • Exception: Semi-critical single-use medical devices may be reused for a single client, where appropriate as determined by the health professional, in the client’s home, if the device can be cleaned and maintains function.
    • The semi-critical single-use medical device reused for a single client shall be cleaned between each use.

Saskatchewan

  • Developing a policy on reprocessing SUDs that is consistent with Accreditation Canada standards — prohibiting on-site reprocessing, while potentially allowing use of licensed third-party reprocessors under specific circumstances.

(Valerie Phillips, Patient Safety Project, Health — Government of Saskatchewan, Regina: personal communication, 2010 May)

Manitoba

Policy:5

  • Hospitals are not permitted to reuse “critical contact” SUDs (those that contact the bloodstream or a sterile body activity).

Ontario

Recommendations:7

  • The health care setting must have written policies regarding single-use medical equipment/devices.
  • Critical and semi-critical medical equipment/devices labelled as single-use must not be reprocessed and reused unless the reprocessing is done by a licensed reprocessor.
  • Needles must be single-use and must not be reprocessed.
  • It is strongly recommended that catheters, drains, and other medical equipment/devices with small lumens (excluding endoscopy equipment) must be designated single-use and not be reprocessed and reused, even if designated as reusable by the manufacturer.
  • Home health care agencies may consider reusing single-use semi-critical medical equipment/devices for a single client in their home when reuse is safe and the cost of replacing the equipment/device is prohibitive for the client.

Quebec

Position statements:8

  • Reuse may be justifiable and even desirable in some circumstances.
  • Hospitals wishing to reuse SUDs are required to develop a policy and procedures governing reuse and to have them approved by their board of directors.

Recommendations:9

  • Health care institutions should stop their in-house reprocessing of critical or semi-critical SUDs until the requirements for making this practice comply with the highest standards of quality can be met in the Québec context.
  • Institutions wishing to reuse critical or semi-critical SUDs should subcontract reprocessing to a third-party reprocessor certified by a regulatory authority and qualified to supply a final product that meets the standards and requirements applicable to all manufacturers of SUDs, and should ensure that they meet the requirements related to this option.
  • The ministère de la Santé et des Services sociaux:
  • Should closely keep track of ongoing federal, provincial, and territorial initiatives regarding the regulatory and legislative framework for the reprocessing and reuse of SUDs; and
  • Should amend its policy on the reuse of SUDs to make it more precise and better adapted to the context prevailing today, and should ensure its implementation.

Nova Scotia

Policy:

  • Critical and semi-critical medical devices that are labelled by their manufacturers as being represented for single-use must not be reprocessed in hospitals and health care facilities.
  • Should it be necessary to reprocess these devices for use in hospitals or health care facilities, they must be reprocessed by a certified third-party reprocessor in a manner that ensures that the device is safe and will function as intended by the manufacturer.

(Patsy Rawding, Department of Health, Halifax: personal communication, 2010 Jun)

New Brunswick

Policy:

  • Regional health authorities (RHAs) will not reprocess critical or semi-critical medical devices, which are labelled single-use.
  • RHAs that wish to have any SUDs reprocessed by a third-party reprocessor must ensure that the reprocessor’s facilities and procedures have been certified by a regulatory authority to ensure the cleanliness, sterility, safety, and functionality of the reprocessed devices.
  • FDA, US standards will be used to ensure patient and staff safety until Canadian regulatory standards have been developed and are in legislation.

(Suzanne Jones, Department of Health, Fredericton: personal communication, 2010 Jun)

Prince Edward Island

  • The Queen Elizabeth Hospital does not reprocess any single-use devices.

(J. David White, Queen Elizabeth Hospital, Charlottetown: personal communication, 2010 Jun)

Newfoundland and Labrador

Policies:

  • In the Eastern Health Authority, no reuse or reprocessing of single-use devices is permitted. (Merlee Steele-Rodway, Eastern Health, St. John’s: personal communication, 2010 Jun)
  • The Central Health Authority does not support the reprocessing or reuse of medical devices labelled as single-use by the manufacturer. (Penny Ralph, Central Health, Grand Falls-Windsor: personal communication, 2010 Jun)
  • No response received from the Western and Labrador-Grenfell Health Authorities.

Nunavut

  • No response received.

Northwest Territories

Regulation:10

  • A disposable device, intended to be used on a patient during a single procedure, shall not be used on a patient for more than one procedure and shall not be used on another patient.

Yukon

  • No response received.