The following advisories are taken from either the Health Canada or insulin pump manufacturers web sites.  If you suspect the advisory relates to you, check with your Health Care Professional or go directly to the Health Canada or manufacturer's web sites.

May 29, 2007

IMPORTANT:  BUYING MEDICAL DEVICES OVER THE INTERNET -  A Health Canada Document, ISBN # 0-662-43877-9, August 2006.  The following is the text of a document  from Health Canada that applies to Insulin Pumps which are a Class III device.  To view the official document check the web addresses at the end of the following text.

BUYING MEDICAL DEVICES OVER

THE INTERNET

The Issue

A growing number of Canadians are buying medical devices over the Internet. Many of the Web sites that 

sell medical devices are lawful businesses that provide a useful service.

However, others sell devices that may pose serious health risks, and some may

take your money and send no product at all. If you plan to buy a medical device over the

Internet, there are steps you can take to minimize your risks and protect your health.

Background

There are nearly 1,800 generic types of medical devices on the Canadian market.

They range from pacemakers to diagnostic kits (e.g., pregnancy tests), contact lenses and

condoms. Canada ’s Food and Drugs Act defines a medical device as any article,

instrument or apparatus intended to diagnose, treat, manage or prevent disease

or other health conditions.

All medical devices sold in Canada must meet the requirements of the Canadian

Medical Devices Regulations. This helps ensure that the products are safe and

effective when used as directed. There are four

classes of medical devices. According to the Regulations, Class II, III and IV devices must

be licensed before they are sold in Canada . For more information on how medical devices

are classified in Canada see the link in the Need More Info section. Class I devices pose

a lesser risk and do not require a licence. In general, medical devices are best used as

part of an overall approach to health that is supervised by a doctor or other health care

professional. Medical devices can help you maintain and improve your health, but they

are not intended to replace professional health care.  The potential benefits of buying medical

devices online include convenience, privacy and pricing. However, the online purchase

of these health products can also pose certain risks.

  Risks of Buying Medical Devices Online

If you buy a medical device from a Web site that is not trustworthy, any of the following

could happen:

• You may get a device that does not meet Health Canada ’s requirements for safety,

effectiveness and quality. Many types of medical devices, such as automatic

blood pressure monitors and blood glucose monitors, require a Canadian

Medical Device Licence before they may be sold legally in Canada . When

devices like these are sold online, they may not have the required licence.

• You may get a product that has been recalled due to safety concerns.

• You may get a counterfeit device (e.g., a lower-quality product falsely labelled as

being a higher-quality brand).

• You may receive a product that has not been stored properly. Some medical

devices must be refrigerated until used, while others should never be frozen or

exposed to heat. When you order a device from an unreliable Web site, you

do not know where the product has been stored or for how long.

• If you buy a second-hand (used) medical device, you may get a product with parts

missing, no warranty or no instructions.  There may also be safety issues related

to cleanliness.

Other potential problems related to the online sale of medical devices

include:

• the sale of licensed devices (e.g., contact lenses, hearing aids) that have not been fitted by

a health care professional, and

• unproven claims for certain products (e.g., claims that magnets can cure carpal tunnel

syndrome and arthritis pain).

These situations could pose the following risks to your health:

• You may not receive the medical treatment that you need.

• You may change treatment doses or make lifestyle changes based on faulty results of

devices that do not work properly(e.g., blood pressure monitors, glucose test kits, etc.)

• You may get an incorrect diagnosis that causes needless worry. It could also lead to

further medical tests that are unnecessary and may pose a risk of side effects.

• You may try to use a medical device that can harm your health (e.g., contact lenses that may

damage your eyes if they have not been prescribed and fitted by a health care professional).

There is also a risk that some Web site operators will cheat you by taking your money and sending you nothing in return.

  Minimizing Your Risk

Before you buy a medical device online:

• Ask your health care provider if the device you have in mind isright for your condition.

• If you are buying a device that requires a Canadian Medical Device Licence before it may

legally be sold in Canada , make sure the device has the required licence. Glucose test kits (including blood glucose meters and test strips) and other medical test kits for home use require

licences. So do automatic blood pressure monitors, battery-operated toothbrushes and hearing

aids. You can find out whether a device is licensed for sale in Canada or if the device has

been recalled by visiting Health Canada ’s Web site. See the Need More Info? section for

more on this.

• Ask the seller these questions:

• Is the device new or used?  How old is it? Does it have an expiry date? Does it have all of its parts? Is there a warranty?

• Will the device come with its original packaging / labeling and a full set of instructions?

• Has the device been stored properly (e.g., kept at the right temperature)?

• Is the device intended for use by health care professionals? (If so, the instructions may be hard to understand and you may not be able to use the device properly or interpret the results correctly.)

• Is the device easy to set up, operate, clean and maintain?  Are replacement parts required? If so, how often?  Where can you get the parts and how much do they cost?

When making a purchase online:

• Make sure the Web site is credible and reliable. Choose sites that post privacy and security

policies that are easy to find and read. Avoid giving out personal information (e.g., Social

Insurance Number, credit card number or medical history) unless you are certain the Web

site will keep it private and will not sell it without your permission.

• Never do business with a Web site that:

• refuses to give you a street address or a working telephone number; or

• claims to have a “miracle cure” for any serious condition.

After you buy a medical device online (or elsewhere):

• Follow up with your health care provider to make sure the device fits, works properly and that you are using it the right way.

• Do not make drastic changes to your treatment without consulting your health care provider.

• Report any problems with medical devices to Health Canada ’s Hotline at 1-800-267-9675

(toll-free in Canada ).

Health Canada ’s Role

Health Canada regulates the safety, effectiveness and quality of medical devices imported and sold in Canada . This is achieved through a combination of a pre-market review prior to licensing, and post-market surveillance of adverse events after licensing. As part of this work,

Health Canada monitors complaints about medical devices sold in Canada , and communicates safety information about medical devices to health care professionals and the public.

Need More Info?

Contact:

Marketed Health Products Directorate

Health Canada

Tunney’s Pasture

Ottawa , ON K1A 0K9

Telephone: 613-954-6522

Fax: 613-952-7738

E-mail: MHPD_DPSC@hc-sc.gc.ca

Also, see Health Canada ’s information sheet on Medical Devices at:

http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/3kit-fiche/factsheet_fichesinfo_14_e.html

For information on how medical devices are classified in Canada go to:

http://strategis.ic.gc.ca/epic/internet/inmd-am.nsf/en/hi00047e.html

To find out whether a Class II, III orIV medical device has a licence from

Health Canada , do an online search of Health Canada ’s Medical Devices

database at: http://www.mdall.ca/ If your specific device is not listed,

check to see if similar devices have been licensed by typing the generic

name (e.g., “automatic blood pressure monitor”) in the “device name”

field. If there are similar licensed devices, it means that your device

also requires a Canadian Medical Device Licence. You can also send

your questions by e-mail to device_licensing@hc-sc.gc.ca

or by fax to 613-957-6345 .

For information on reporting problems with medical devices, visit

Health Canada ’s Health Product and Food Branch Inspectorate Web site at:

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/prob-report-rapport/index_e.html

For a list of Health Canada ’s Advisories, Warnings and Recalls related to medical devices, visit:

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/index_e.html

Also, see the following It's Your Health articles:  Buying Drugs over the Internet at:

http://www.hc-sc.gc.ca/iyh-vsv/med/internet_e.html

Medical Test Kits for Home Use at:

http://www.hc-sc.gc.ca/iyh-vsv/med/medtest_e.html

For additional articles on health and safety issues, go to the

It's Your Health Web site at:

http://www.hc-sc.gc.ca/iyh-vsv/index_e.html

You can also call toll free at

1-866-225-0709

or TTY at 1-800-267-1245*

July 13, 2006

Issue

Disetronic is conducting this recall of Disetronic D-TRONplus Power Packs because the power packs for the D-TRONplus insulin pumps have a potential to shut down the pump without warning. The battery’s design was changed by its manufacturer. As a result, the pump does not have enough time to recognize the power supply decrease, and the pump may shut down before the audible and vibrating low power alarms are triggered. This can lead to an interruption of insulin delivery, which may lead to uncontrolled diabetes mellitus, resulting in elevated blood glucose levels (hyperglycemia). In the event that insulin delivery is interrupted, it is possible that patients may experience adverse events, which may result in serious patient injury and/or death. Adverse events may range from nausea and vomiting to diabetic ketoacidosis and coma.

Warning

Until further notice, you must put a new power pack into your insulin pump every two weeks to prevent your pump from turning off without any warning. It is important you do not extend the two week period.

Disetronic will supply power packs free of charge to all D-TRONplus users until corrective actions have been implemented. Every user is receiving, via Disetronic directly or from their distributor, a power pack together with detailed instructions by UPS Next Day shipment. Disetronic and their distributors will also provide every user with a new power pack and instructions every two weeks until further notice. Distribution of these power packs will begin today, Thursday, July 13, 2006. If you are a physician or a patient who has experienced a problem with any Disetronic D-TRONplus Power Packs, please notify Disetronic at 1-800-688-4578.

If your D-TRONplus insulin pump shuts down without warning please replace your power pack and call Disetronic Medical Systems Pump Support at 1-800-688-4578 as soon as possible.

This is a temporary fix for the power pack problem until adequate supplies of the corrected power pack design are available for shipment. We will notify all users when this situation is resolved and when the new power packs are available. We have performed testing and maintain results to verify a two week power pack life for this temporary fix.

For any questions regarding this recall or this notification you may call Disetronic Medical Systems Pump Support at 1-800-688-4578.

Actions Required

Additional Information

Please check glucose levels throughout the day as instructed by your Healthcare Professional/Provider. Interruption of insulin delivery for this or any other reason may lead to uncontrolled diabetes mellitus, which may result in elevated blood glucose levels (hyperglycemia). Indicative signs and symptoms may include, but are not limited to the following:

If you experience these symptoms, please check your blood glucose to ensure that it is within an acceptable range as defined by your healthcare team. Please notify your healthcare provider and seek medical attention as soon as possible.

Questions

This Urgent Product Recall is being made with the knowledge of Health Canada. Any suspected adverse reaction can also be reported to Health Canada at 1-800-267-9675. If you have further questions about the information contained in this Urgent Product Recall, please contact Pump Support at 1-800-688-4578, 24 hours a day, 365 days a year.