ARCHIVED

July 16, 2012

RE: Stop Order for IMS Plungers

Stop use order with respect to named plunger has been lifted:

MR-6 Needle Injector

Manufacturer: Electro-Therapeutics Devices Ltd.

Per letter dated July 16, 2012 from Chief Medical Officer of Health, Alberta Health and Wellness:

news_update_ims_plungers_july_16_2012_1

Stop order remains in effect for all other reusable IMS plungers.

Pending update information from manufacturers.

November 22, 2010

RE: Device Safety Alert

As a valued member, iSTOP would like to keep you informed about safety issues regarding the treatment of Chronic Pain.  This is to notify you that the Piezo-DX Quartz Stimulator device is currently being recalled from the Canadian market.  This particular medical device has been sold in Canada since 2002.

This medical device is now being recalled by Health Canada because the manufacturer of the Piezo-DX Quartz Stimulator (ITO Company Ltd.) does not have a current Medical Device License from Health Canada.

In accordance with section 64 of the Canadian Medical Device Regulations, if you own one or more Piezo-DX Quartz Stimulators, please discontinue all clinical and/or personal usage and distribution of this particular medical device.

If you have in the past purchased this medical device from iSTOP or other suppliers for resale distribution, please contact your customers regarding this recall as instructed above.

March 2008

RE: IMS Plunger - Stop Order Reconfirmed

Alberta Health and Wellness (AHW) recently reconfirmed a stop order on reusable IMS plungers remain until validated cleaning and reprocessing instructions are received from IMS manu-facturers/distributers. The decision was communicated to IMS manufacturers/distributors along with the necessary steps required before the stop order can be lifted. The stop order was issued by Alberta’s Acting Chief Medical Officer of Health because of the risk of transmitting blood borne infections from patient to patient and manufactures instructions

with some IMS plungers were not sufficiently detailed to enable users to determine the required process to correctly reprocess for safe re-use.

Office of the Chief Medical Officer of Health

Alberta Health and Wellness, Government of Alberta

Audrey Lowe PT, MScPT, BScPT

Competence and Professional Practice

College of Physical Therapists of Alberta

Edmonton, Alberta, Canada

www.physiotherapyalberta.ca

Protecting Albertans through effective regulation and leadership

Needling Precaution Procedures and Sterilizing of Instruments

It Is The Responsibility of the IMS Practitioner To Contact Their Local Health Authority For

Information And Guidelines On Sterilizing Protocols.   This Should Be Done At Least Twice A Year As Practice Procedures Are Constantly Being Updated. Any sterilizer used to process IMS needle plungers, must be validated for narrow lumen devices.

Needling Precaution Procedures:

The following procedures must be strictly adhered to when doing Intramuscular Stimulation (IMS) - for

your own protection, and that of the patients.

Single disposable needle use:

1. Wash your hands before examination and / or treatment of all patients.  If you leave a patient and then return, wash again before attending to the patient.  Anti-bacterial soap should be available in all treatment rooms.
2. All needles must be counted going in and matched against the number coming out.  Used
   needles must immediately be placed in the sharps container.  No needles are to be placed on counters, beds or elsewhere.
3. Extra caution should be taken when removing blankets, moving pillows etc, as needles can
   become caught and pose a risk.
4. Used alcohol swabs, cotton swabs, etc should be placed in the waste container.  Nothing is to be left on the counters or beds.
5. It is your responsibility to ensure your Hepatitis and other vaccinations are current for your own protection and that of your staff.

Plunger use

As a plunger is a hollow tubed or lumened instrument, sterilizing must be done in an autoclave which has been validated for sterilizing narrow lumen devices, for example a pressure / pulse or fractionated vacuum sterilizer.  The Statim 2000 unit has been tested to confirm full sterilization of straight hollow instruments (such as the plunger) with both wrapped and unwrapped loads.

Plungers Must Be Sterile

1. Plungers must be sterilized prior to initial use.
2. After sterilization, a sterile needle may be placed in the plunger.
3. During treatment, frequently check to see needle is not bent – if so, replace with another sterile needle.
4. The needle is disposed of in the sharps container after the treatment! 
5. The plunger is to be sterilized after each use.
6. Plungers are reusable but must be sterilized after each use as described in the sterilization protocol.

Sterilizing of Instruments

SOURCE:  Ministry of Health British Columbia, Patient Safety Branch

“Best practice Guidelines for the Cleaning, Disinfection and Sterilization of Medical Devices in Health Authorities” March 2007

All reprocessing of devices must meet these best practices.

Reprocessing:  the steps performed to prepare used medical devices for use – cleaning, disinfection and sterilization.

Best practices must include:

Verification of current methodology:

The Manufacturer must supply device specific recommendations for cleaning and reprocessing of equipment.

Also, recommendations for auditing the recommended process must be given.

Plunger is classified as a Critical Device i.e. enters tissue including the vascular system.  This requires cleaning followed by sterilization.

ISTOP must provide written information regarding the safe and appropriate reprocessing of the medical device.

DISASSEMBLING AND CLEANING REUSABLE MEDICAL DEVICES

“Cleaning is always essential prior to disinfection or sterilization. An item that has not been cleaned cannot be assumedly disinfected or sterilised” Health Canada

The process should include written protocols. 

Cleaning is always essential prior to disinfection or sterilization. An item that has not been cleaned cannot be assuredly disinfected or sterilized.

The process of cleaning is to physically remove contaminants from the equipment / device, rather than to kill or damage microorganisms.  If an item is not cleaned, soil (eg blood, body fluids, dirt) can protect the micro microorganisms organisms from the action of the disinfection or sterilization process making it ineffective, as well as inactivating the disinfectant or sterilant so that it does not work.  Disinfectants that become overloaded with soil can become contaminated and may themselves become a source for transmission of microorganisms.

                     -  remove soil using brushes

                     -  employ ultrasonic cleaning after gross soil has been removed

                     -  ultrasonic washes are recommended for critical medical device that has joints,

                        crevices or lumens. Manufacturers’ instructions must be followed for the use of the

                        ultrasonic cleaner and solution should be changed at least daily.

                     -  Brushes must be cleaned and disinfected after use

STERILIZATION OF REUSABLE MEDICAL DEVICES

Sterilization is the elimination of all disease – producing microorganisms.

All sterilization processes must ensure that the manufacturers instructions are followed plus regular maintenance.

The process must be validated and documented with written policies and procedures.

The process requires testing, monitoring and auditing.

Sterility must be maintained until point of use and stored in a clean, dry location.

Integrity of packaging must be checked and validity of monitors.

For all sterilizers:

Statim 2000 Cassette Autoclave – The Wrapped Cycle is used to sterilize up to 1.0kg (2.2 lbs) of solid and hollow metal instruments which have been sealed in paper/paper, or paper/plastic autoclave bags. The sterilization temperature in the cassette is 135°C (275°F) and the holding time is 10 minutes.  The Air Dry Cycle starts automatically after each sterilizing cycle and runs for 60 minutes.

              4 Parameters must be completed:

• Mechanical Monitoring – time and temperature
• Chemical Monitoring - CSA recommends both internal and external visible chemical indicators
• Biologic Monitoring – spore-laden strips or vials must be used with each load.  Recommended test is Geobacillus Stearothermophilus for steam sterilizers.  ISTOP uses EZ test biological indicators once a week and incubates it for 48 hrs.

• The sterilization unit MUST be validated for a lumen device and manufacturer’s instructions MUST be followed. 

Staff MUST document the daily operation of the sterilizer.

Henry Schein Ash Arcona  

1-800-668-5558 – Mircobex Instrubex-E (kills Bactericidal, Fungicidal, TB, HIV-1 Virus), STEAMPlus Integrator SPSmedical, brushes for lumens, Statim 2000, Ultrasonic Cleaning System (UC125)

Regency

1-800-663-1012 – sterilizing bags, EZ test biological indicators and incubators