Notice: New Requirements for Medical Device Licence Applications for Lancing Devices and Blood Glucose Monitoring Systems

September 26, 2014
File Number: 14-111696-560

Application

This notice applies to manufacturers of:

• lancing devices;
• blood glucose meters;
• continuous glucose monitoring systems;
• insulin infusion pumps;
• other medical devices that display blood glucose readings.

Purpose

The purpose of this notice is to inform manufacturers that:

• Health Canada now recognizes ISO 15197:2013, "In vitro diagnostic test systems -- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus". Manufacturers are granted a one-year transition period from the date this Notice is published to conform to the 2013 edition of the standard for new devices. Those previously licensed will not be subject to this requirement, and
• Health Canada has updated its position on specific information that should be included in new and amendment Medical Device Licence applications for lancing devices and blood glucose monitoring systems. A blood glucose monitoring system may consist of a blood glucose meter, lancing device and test strips.

1. New requirements for lancing devices

A lancing device is an instrument used to hold a lancet and trigger it to prick the skin to obtain a blood sample. Lancing devices can be auto-disabling, (for single-use only) or can be used multiple times (with the lancet changed for every use). Currently, some manufacturers are labelling their multi-use lancing devices as being intended for multi-patient use. However, multi-patient use of lancing devices has been documented to pose the risk of disease transmission, even if a new lancet is used for every patient.

Health Canada has issued a number of communications on this issue between 2006 and 2009. Archived notices may be found by searching for safety alerts on lancing devices in the Healthy Canadians website.

Despite multiple advisories, incidents continue to occur where lancing devices intended for use on a single patient are used to obtain blood samples from multiple patients.

While there have been no documented cases of disease transmission, the most recently reported incident in Canada of misuse of a lancing device occurred in May 2012, where blood glucose testing was performed on 72 staff and high school students using a lancing device designed for single-person use only.^{Footnote 1}

To mitigate the risk of transmission of blood borne pathogens by lancing devices, Health Canada has taken the following measures:

• Health Canada will license lancing devices only if they are labelled as:
  • auto-disabling or;
  • for single patient use.
• Home use blood glucose meters intended for use on a single patient may be licensed for use with single patient multi-use lancing devices or auto-disabling single use lancing devices.
• Point-of-care blood glucose meters intended for use on multiple patients will only be licensed for use with auto-disabling single use lancing devices.
• Labelling for point-of-care blood glucose meters used on multiple patients must include instructions on the correct lancing device to use and must advise health care personnel to change gloves between testing of patients.
• Lancing devices must be assessed for disinfection effectiveness and robustness, as outlined in more detail in the next section. This information should be submitted as part of the medical device licence application along with the labelling, even if the lancing devices are Class II medical devices sold separately from the Class III blood glucose monitoring system.

2. New disinfection procedures for blood glucose monitoring systems

Despite measures to reduce disease transmission, incidents can occur when blood glucose monitoring systems are used on multiple individuals or by care givers assisting a patient. Blood glucose monitoring systems may include a glucose meter, lancing device and test strips.

For example, a study of the use of blood glucose meters in United States hospitals found that the overall mean frequency of glucose meters with blood contamination was in the order of 30%.^{Footnote 2} In addition, there have been incidents of transmission of Hepatitis B Virus (HBV) attributed to contaminated blood glucose meters.^{Footnote 3,Footnote 4a,Footnote 4b}

Whenever possible, blood glucose meters should not be shared and users should perform a self-measurement using a personal lancing device and blood glucose meter. If this is not possible, blood glucose meters should be properly cleaned and disinfected after every use according to the manufacturer's instructions. It is important that users follow the manufacturer's instructions for disinfection because it has been demonstrated that some common disinfectants may cause damage to some meters, including screen failure and breakdown of rubber control keys.^{Footnote 5}

Health Canada wishes to inform manufacturers of its current practice to assess disinfection procedures for blood glucose meters and reusable lancing devices, whether sold separately or as part of the meter system. Manufacturers submitting a new or amendment medical device licence application for a blood glucose meter and/or lancing device must include evidence of effectiveness of the disinfection procedure, robustness of the device to withstand disinfection over its anticipated life cycle, and labelling information as outlined below.

Disinfection Procedure

Evidence that cleaning and disinfection procedures are effective for human Hepatitis B virus (HBV) must be provided. HBV was selected as a model virus since it is the most common virus observed in disease transmission outbreaks due to blood glucose meters, is difficult to kill, and is known to remain viable on contaminated surfaces for one week or longer.^{Footnote 6} In addition, evidence must be provided that the meter and lancing device can withstand multiple cleaning and disinfection cycles over their anticipated service life.

Demonstration of disinfection effectiveness should be made through viral challenge of material used to fabricate the meter. Test samples of the meter housing material may be used for these studies instead of the assembled meter. A limit of detection should be determined for the testing as per CLSI EP17-A2, Protocols for Determination of Limits of Detections and Limits of Quantitation, since licensed clinical assays are not intended for testing environmental samples.

Multiple cleaning and disinfection cycles should be performed that are representative of normal use over the lifetime of the meter and lancing device, normally considered to be 3-5 years. It should be demonstrated that repeated cleaning and disinfection will not adversely affect the performance of the meter and lancing device, nor induce physical deterioration that could degrade their function. The port for the test strip should be given particular consideration in this assessment.

The recommended disinfectant should be effective against human immunodeficiency virus (HIV), Hepatitis C virus (HCV) and HBV, and must have a Canadian Drug Identification Number (DIN) indicating its approval for use in Canada. Evidence of disinfection using commercial disinfectants that have the same active ingredient, composition and strengths as products that have a Canadian DIN will also be accepted. Disinfectants approved by Health Canada are listed on the Drug Product Database.

Additional guidance to conduct these assessments may be found in the following documents:

• ASTM E1053-97 (2002): Standard Test Method for Efficacy of Virucidal Agents Intended for Inanimate Environmental Surfaces
• ASTM E2362-09: Standard Practice for Evaluation of Pre-saturated or Impregnated Towelettes for Hard Surface Disinfection
• CLSI EP17-A2: Protocols for Determination of Limits of Detection and Limits of Quantitation
• Duck hepatitis B virus (DHBV) may be used as a surrogate for HBV. Refer to the United States Environmental Protection Agency document "Protocol for testing the efficacy of disinfectants used to inactivate duck hepatitis B virus and to support corresponding label claims".

Labelling

In the labelling, the statement of intended use must clearly indicate whether the blood glucose monitoring system is intended for use by health care professionals on multiple patients or for individual self-assessment.

If the same meter may be used by multiple users and by a single user, distinct device names, user manuals, quick reference guides and catalogue numbers must be provided.

For guidance on how to structure your medical device licence applications, please contact the Device Licensing Services Division at devicelicensing-homologationinstruments@hc-sc.gc.ca or 613-957-7285.

Labelling must indicate the trade name of the validated disinfectant wipes or the active ingredients and concentrations of disinfectant that were validated.

Labelling must include clear instruction on why, how and when users should clean and disinfect the meter and lancing device, including what disinfectant product may be used and the disinfectant contact time. The labelling must instruct people assisting users to wear gloves during testing and to change gloves between patients.

3. New check list for medical device licence applications for blood glucose monitoring systems

As additional guidance, Health Canada is making available a screening check list of technical information required for medical device licence applications for blood glucose monitoring systems.  Applications that do not include all of this information will receive a Screening Deficiency Letter.  The list of technical requirements given below is not exhaustive, and manufacturers are also encouraged to refer to the Guidance document Preparation of a Premarket Review Document for Class III and Class IV Device Licence Applications V.2.

Screening Check List of Technical Information for Blood Glucose Monitoring Systems

Where applicable, the following information should be included in an application for a new or amended Medical Device Licence for a blood glucose monitoring system.

• Safety and Reliability Testing (A DOC may be submitted where appropriate)
  • ISO 61010-1
  • Electromagnetic compatibility
  • IEC 61326-1 and IEC 61326-2-6 (as per ISO 15197:2013 Section 5.4)
  • Vibration: IEC 60068-2-64
  • Drop Test: IEC 61010-1
  • Temperature/humidity
  • ISO 15197:2013, Sections 5.11 and 5.12
• Software validation
  Unit of measurement exclusively millimoles per litre (mmol/L)
  Analytical performance studies
  • Repeatability: ISO 15197:2013, Section 6.2.3
  • Intermediate precision: ISO 15197:2013, Section 6.2.4
  • Accuracy: ISO 15197:2013, Section 6.3
  • Interference (glucose specificity) : ISO 15197:2013, Section 6.4
  • Hematocrit: ISO 15197:2013, Section 6.4.3
  • High altitude assessment
  • Linearity
  • Sample size verification (if applicable)
  • Sample re-application verification (if applicable)
  • Validation of operation under specified range of temperature and humidity
• Clinical performance information^{Footnote 7}
  • Arterial and/or venous samples (if applicable)
  • Neonatal samples (if applicable)
  • Near patient clinical studies (intended users): ISO 15197:2013, Section 8
  • Alternate Site Testing (if applicable) for all indicated sampling sites
• Disinfection and Robustness
  • Lancing Device - Robustness
  • Lancing Device - Disinfection Efficacy
  • Meter - Robustness
  • Meter - Disinfection Efficacy
• Stability
  • Methodology as outlined in EN 13640:2002
  • Validation of Transport stability includes testing at a minimum temperature range of -20 °C to 37°C or validation of an alternate claim.
• Labelling
  • Quick reference guide refers users to meter manual
  • English and French labelling materials for single patient use blood glucose monitoring systems.
  • Indications: Include alternate sites (if applicable), multiple users or single user
  • Contraindications: Not for diagnosis of diabetes, not for neonatal testing when applicable
  • Icodextrin interference warnings for glucose dehydrogenase pyrroloquinoline quinone method
  • Test strip package insert includes mediator type
  • Prominent, clear warnings for lancing device (for example, highlighted, black box, warning sign): Single patient use only, not to be shared
• Control solution available
  If meter may be used by multiple users and a single user, provide separate catalogue numbers, distinct device names, and separate User Manuals and Quick Reference Guides for each of the meter systems
• Talking Meter
  • Near patient study with intended population (visually impaired)

4. Reminder on units of measurement for medical devices that display blood glucose results

In Canada, the standard unit of blood glucose measurement is millimoles per litre (mmol/L), which conforms to the International System of Units (SI). In other countries, the standard unit of measure may be milligrams per decilitre (mg/dL). Some medical devices display results only in mmol/L or mg/dL, but others are capable of displaying results in either unit of measure.

Historically, medical device models that display results in either unit of measure have been approved for sale in Canada. Manufacturers are reminded that since 2010, Health Canada requires all devices sold in Canada to display glucose results solely in mmol/L. This applies to blood glucose meters and any device that displays blood glucose results, such as continuous blood glucose monitoring systems, infusion pumps and software.

The rationale for this policy is that Health Canada has received reports that the displayed units of measure in some blood glucose meters could change inadvertently if the device was dropped, the batteries were changed, or even without any apparent cause. Results displayed in mg/dL may be 18 times higher than the same results expressed in mmol/L. If diabetic patients overestimate their blood glucose reading accordingly, they may self-administer too much insulin which could lead to dangerously low blood glucose levels and loss of consciousness or seizure.

In 2005, Health Canada communicated product-specific safety information about unintended changes in the units of measurements. In 2005 and 2006, manufacturers issued additional product-specific communications describing incidents in which blood glucose meters switched the units of measurement from mmol/L to mg/dL. To mitigate the risk of occurrence of this type of event, in August 2006, Health Canada issued an Information Update to advise diabetic patients about the risk of misinterpreting test results on blood glucose monitoring systems.  Archived versions of this information may be found by searching the recalls and safety alerts section of the Healthy Canadians website.

A subsequent Notice published in March 2010 informed manufacturers of Health Canada's new requirements for new or amendment medical device licence applications for devices that display blood glucose results.

This notice serves as a reminder that devices that display blood glucose results:

• must display blood glucose concentration only in units of mmol/L;
• must not permit the units of measure be changed by the user; and
• must have software that displays results only in units of mmol/L.

Additional Information

For questions or clarification on the content of this notice, please contact:

• Device Evaluation Division
  Medical Devices Bureau
  Therapeutic Products Directorate
  Health Canada
  2934 Baseline Road, Tower B
  Ottawa, ON
  K1A 0K9
• Telephone: 613-954-0297
  Fax: 613-957-9969
  E-mail: MDB_Enquiries@hc-sc.gc.ca