Revised: 8 May 2013
Safety Information
Archived Medical Device Safety Issues
| 1 February 2001 | Ministry Issues Warning about
Adrenaline Kit (please use the back button in your browser to return to this page) |
| November 2000 | Finger Pricking Devices - Important Notice - Questions and Answers |
| July 1999 | Amalgam and other Dental Filling Materials |
Finger Pricking Devices - Important Notice
22 November 2000
Dear Health Professional/Provider
IMPORTANT NOTICE ABOUT FINGER-PRICKING DEVICES
Diabetes New Zealand and the Ministry of Health would like to remind all health professionals of the currently accepted good practice when using finger-pricking devices.
A recent survey of hospitals found that some health professionals are using a finger-pricking device which is intended for use by one person to test multiple patients, discarding only the lancet between tests. This means that some patients could have been exposed to the risk of infection from diseases such as hepatitis B.
The Ministry considers that there is an extremely small risk of transmitting Hepatitis B from these devices and that the risk of infection from other disease is negligible. The Ministry is not aware of anyone in New Zealand having contracted hepatitis B from the incorrect use of finger-pricking devices.
The Ministry is, however, aware that cross-infection from these devices has occurred overseas. Over the past ten years there have been four episodes reported worldwide of disease being transmitted through the use of individual-use devices on more than one person. Three of those episodes were in the United States of America and one in Europe.
It is understood that in each of these cases only the lancet of the finger-pricking device had been replaced, potentially allowing blood to remain in the end cap which may cause cross infection.
We would therefore like to advise all health professionals of the following.
- It is preferable that patients / clients bring in and use their own finger pricking devices. Another alternative is to use a disposable blood sampling device (which can be used only once) such as Easy-Let Safety™, Unistik II™ and Single-let™. This list may not be exhaustive because medical devices are not currently required to be registered with the Ministry before they can be promoted and sold.
- If a spring-loaded device is to be used, it is important that care
is taken in choosing a device that is appropriate for the purpose:
- If you are using a finger-pricking device on more than one patient, it is important that you use a device that has both a disposable lancet and plastic tip, so that any part of the device which comes into contact with the patient's skin is discarded between tests. Examples of these devices are Glucolet 2™, and Softclix Pro™.
- It is no longer considered appropriate to depend on cleaning / disinfecting of non-disposable plastic parts to prevent cross-infection, when suitable equipment is readily available for the purpose.
- If only one patient is using a finger-pricking device then it is appropriate they use a device that requires only the lancet to be disposed of. Examples of these devices are the B-D Lancet Device™, Glucocard Auto Lancet™, Microlet™, Medisense Precision™ and Softclix II™.
- Due to the risk of spreading infection, the single-patient device
should not be used on more than one person, even if the lancet is changed
between each patient. Traces of blood can remain in the end cap and
may cause cross infection.
- This procedure may potentially transmit disease, particularly the virus infections hepatitis B, hepatitis C and HIV from contaminated equipment, gloves, hands or surfaces. Appropriate infection control procedures should be adopted. Hepatitis B is by far the most likely of these to be transmitted by cross-infection and the risk is extremely low.
What to do if concerned patients approach you
If patients approach you expressing concerns that they may have been exposed to infection through the inappropriate use of a finger pricking device, the Ministry's advice is that you:
- advise patients that only some devices are causing concern and it is only when these are used inappropriately that there is any risk
- reassure patients that the risk of cross-infection is extremely low
- advise that the Ministry of Health is not recommending routine recall of patients for virus testing
- arrange for them to have a blood test, if they remain concerned
- encourage individual patients to continue using their own finger pricking devices as instructed and not to share them with other people.
Below is a Question and Answer sheet that can be used to supplement the above information.
There is also a media release. As a result of this release, there may be publicity that results in patients approaching you for advice. The Ministry would appreciate your assistance in reassuring patients as outlined above.
The Ministry of Health and Diabetes New Zealand are keen to ensure that all health professionals follow current accepted good practice so that all patients receive quality health services. We would like to thank you for your help on this matter.
Yours sincerely
President
Diabetes New Zealand
Dr Bob Boyd
Chief Advisor
Safety and Regulation
Finger Pricking Devices - Questions and Answers
November 2000
What is Currently Accepted Good Practice?
Current Accepted Good Practice involves the efficient and effective use of available resources to achieve quality outcomes for the patient (ref: Infection Control Standard NZS 8142:2000).
In terms of the practice regarding finger-pricking devices, health professionals are advised that it is preferable to use a single use totally disposable device when testing more than one person and to dispose of it safely after use. Alternatively they should use a device in which all parts which come in contact with the client's skin and which may become contaminated with blood are disposable and are replaced between cases to reduce the risk of transmission of infectious disease. Both lancet and plastic tip should be disposed of safely after use.
Individuals monitoring their own blood sugar levels should use their own device and not share them with others.
Has the accepted practice changed?
Yes. During the last publicity about this issue in 1998 the spokesman for the General Practitioner's Association was reported as saying that he would continue using the device designed for individual patient use to carry out monitoring in his surgery and depend on washing the plastic parts which may have got contaminated between tests. Most practitioners today, given the ready availability of the safer disposable equipment and the wider awareness of possible risk would no longer find that acceptable.
What are the finger-pricking devices used for?
These devices are used to collect a drop of blood for sampling. Most commonly they are used by people with diabetes to monitor their own blood glucose. However, they are also used in hospital clinics, when only a small amount of blood is needed to carry out the analysis. They are also used by a variety of people from individuals to health professionals in hospitals, GP surgeries, marae health services, clinics, laboratories, and rest homes.
Most finger-pricking devices resemble a ball point pen and contain a sharp, spring loaded lancet which momentarily pierces the skin.
There are two types of finger-pricking devices produced by a variety of manufacturers. There are finger-pricking devices for individual use by people such as people with diabetes who use it to collect a drop of blood to monitor their glucose level. These devices for individual use have a disposable lancet. And there are finger-pricking devices intended for use on more than one person. These have both a disposable lancet and disposable plastic tip surrounding the lancet, so that all parts, which come into contact with the patient's skin, can be discarded to minimise the risk of transmission of disease. Both lancet and plastic tip should be safely disposed of after use.
Why are Diabetes New Zealand and the Ministry of Health issuing another reminder to health professionals about this device?
In November 2000, the Ministry of Health was advised that Hutt Valley Health had used a finger-pricking device designed to be used by an individual patient on eight children, contrary to the instructions which accompanied the device. The lancet had been replaced after each use, but the plastic tip which comes into contact with the skin was not. The Ministry sent a questionnaire to hospitals to find out whether similar practices were occurring in other hospitals. The survey indicated that the use of that brand of individual use finger-pricking device on more than one patient was widespread, despite publicity two years ago from Diabetes New Zealand about accepted good practice.
How long has this been happening in New Zealand and how many people are affected?
It is difficult to determine how long the practice of using individual finger-pricking devices on more than one person has been occurring in New Zealand or how many people may be affected. However, we do know that finger-pricking devices have been available in New Zealand for at least 10 years. Devices intended for use on more than one person were introduced sometime later, as people became more aware of the risk of transmission of disease through using individual finger-pricking devices on more than one person.
What is the risk of potential transmission of viral disease from a finger-pricking device?
Finger-pricking devices are safe when individuals are using their own device. A risk of cross-infection can only occur when the blood of an infected patient remains on the device and contaminates the sharp lancet as it pierces the skin of the next patient. This risk can be eliminated by disposing of all parts in contact with the patient's skin between tests or by using totally disposable equipment. It is no longer necessary to depend on cleaning or disinfection of the device, because the safer disposable equipment is readily available.
Advice to date suggests the risk of transmitting any infectious disease is extremely low and any risk, albeit a very small one, would relate only to Hepatitis B.
What is Hepatitis B (HBV)?
Hepatitis B is a blood borne viral infection that causes inflammation of the liver. People who live on the western side of the Pacific Ocean have relatively high rates of infection and it is particularly common in Maori, Pacific Island and Asian people, especially young men aged between 15-40 years. This infection can be passed from person to person through blood contamination. An estimated 1 to 2 percent of the New Zealand population are HBV carriers
What are the symptoms of HBV?
- your eyes or skin may turn yellow
- you may lose your appetite
- you may have nausea, vomiting, fever, stomach or joint pain
- you may feel extremely tired and not be able to work for weeks or months.
How can you test for HBV?
You can have a blood sample tested for the presence of HBV antibodies (which represent previous infection) and for the presence of HBV (indicating current infection or carrier state)
How is HBV treated?
Hepatitis B can be prevented through immunisation or prophylactic immunoglobulin injections.
New Zealand has had a universal vaccination programme for hepatitis B since 1988. Most children over the age of 12 will be protected through immunisation. Some people who are carriers of the infection can benefit from treatment with alpha interferon.
Has anyone in New Zealand contracted Hepatitis B from use of individual finger-pricking devices on more than one person?
The Ministry is not aware of anyone in New Zealand having contracted hepatitis B from use of an individual finger pricking device on more than one person.
Have there been any problems overseas?
Over the past 10 years worldwide, there have been four episodes reported where Hepatitis B was thought to have been transmitted through use of individual finger pricking devices on more than one person. In each case only the lancet had been replaced.
If I have had a finger-pricking device used on me, which was not for my own individual use, what should I do?
The Ministry is advised that the risk of infection through use of individual finger-pricking devices on more than one person is extremely low. The Ministry is not recommending that people who have had blood tests carried out in this way should be recalled for viral blood testing. However, if people are concerned they should contact their doctor and discuss whether a blood test is appropriate for them.
Where can the finger-pricking devices be purchased?
Finger-pricking devices can be purchased from medical wholesalers, pharmacies and Diabetes New Zealand's National Supply Scheme Office, PO Box 54, OAMARU; phone (03) 434 8110; e-mail: info@diabetes.org.nz
Amalgam and other Dental Filling Materials
July 1999
Background
The Ministry of Health continually monitors the international literature for reports of harmful effects to health from the mercury in dental amalgam and from other dental filling materials. In 1998 a report Dental Amalgam, was published by a Working Group for the European Commission (EC). This report concluded that the mercury from dental amalgam will not cause an unacceptable health risk to the general population. Local reactions to dental amalgam and other dental filling materials do occur but are relatively rare. The EC report stated that there was no need for clinically satisfactory dental amalgam fillings to be removed except in cases of a confirmed diagnosis of allergy to this material. A February 1999 report Dental Amalgam and Mercury in Dentistry, was published by the Australian National Health and Medical Research Council. This report concluded that dental amalgam continues to be a useful filling material and stated that "while low levels of mercury are released from dental amalgams, there is no convincing evidence of adverse health effects except for rare cases of contact hypersensitivity".
Benefits and risks
All medical and dental procedures have benefits and potential risks. Tooth restoration with dental amalgam is no exception. Amalgam remains an important filling material in dentistry although its usage is decreasing as tooth decay declines and the quality of other materials improves. These other newer filling materials are more technically demanding and expensive than amalgam and most are not as durable in some locations in the mouth. The newer filling materials remain to be fully assessed for their long-term effects on health. For conventional dentistry amalgam remains an affordable material for routine tooth repair.
Mercury absorption
Studies show that small amounts of mercury vapour from amalgam fillings are partially absorbed into the blood. Release of mercury vapour is increased by chewing food and grinding teeth, and when amalgam fillings are placed and removed. The acceptable, safe or tolerable level of total mercury exposure - from amalgam, diet and other sources - is still debated medically and scientifically.
Most medical and scientific opinion considers that exposure of the general population is within safe limits, others promote the view that mercury in amalgam fillings can adversely affect the health of some individuals.
International view
Some countries have restrictions on the use of amalgam as a dental restoration (Austria, Canada, Germany and Sweden) because of wider environmental effects of mercury or the possibility of adverse affects on some individuals even from low mercury intakes. In April 1998 the United Kingdom Department of Health issued a media statement advising that it was prudent to avoid the placement or removal of amalgam fillings during pregnancy until appropriate research data on its safety was available.
Ministry of Health Policy
The adult population
Most New Zealanders more than 30 years old, have or have had multiple dental amalgams. Despite widespread use of amalgam for many years there is no convincing evidence of adverse health effects. Local reactions to dental amalgam and other dental filling materials do occur but are relatively rare. These cases are generally contact hypersensitivity.
Dental fillings and pregnancy
Women of childbearing age should maintain good oral health. There is no scientific evidence that the placement or removal of amalgam fillings during pregnancy is harmful. It is prudent however, during pregnancy to minimise health interventions involving exposure of the foetus to foreign substances, including dental materials. Therefore, the Ministry of Health considers that it may be prudent during pregnancy to avoid, where clinically reasonable, elective dental procedures including the placement or removal of any filling material.
Children
The Ministry considers that the best strategy to reduce the potential risk from dental filling materials is through the prevention of dental decay. The most effective methods to achieve this are the fluoridation of water supplies and the use of fluoride-containing toothpastes and this is resulting in significant reductions in dental fillings.
There is no scientific evidence that dental amalgam or other restorative material when used in children is harmful. There is, however, increasing use of non amalgam materials in children. It should be taken into account that alternative materials may require more frequent replacement and less is known of their long-term effects on health.
Replacement of amalgam
The Ministry considers that widespread replacement of amalgams without other clinical indications by alternative filling materials, which are less long-lasting and more expensive cannot be justified on the basis of presently available clinical and scientific evidence.
The Ministry does not recommend amalgam removal or replacement for health reasons except where an individual has an allergy or hypersensitivity reaction to amalgam. Allergy or hypersensitivity reaction to amalgam is localised and relatively rare.
Informed Consent
Patients should be informed of the comparative risks and benefits of amalgam use when compared with other filling materials before they receive any restorative material or treatment. This is an obligation under the Code of Health and Disability Services Consumers’ Rights. It is recognised that there are limitations on the information available on all dental filling materials. Patients should also be informed of the international discussion on issues involving dental filling materials. The Ministry considers the best way to do this is through informed consent in selecting the appropriate filling material.
Monitoring
The Ministry of Health will continue to monitor the international scientific literature for reports of possible harm to health from amalgam and other filling materials used in dentistry.
