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Phillida Bunkle Address Medical Industry Assoc

12 July 2000

Phillida Bunkle Speech Notes

Opening Address to the Medical Industry Association Conference
Waipuna Hotel
Auckland


I have been asked to speak to you today on the practice of reusing or reprocessing of products designated "single use only" by the manufacturer. I fully understand your concerns that you may not be able to guarantee the product's integrity if it is altered through a sterilisation process. The concerns are equally grave when the complexity of the product prevents acceptable levels of sterilisation.

More recently your attention on this issue may have been drawn to two incidents that recently came to light, on the re-use of single use devices. In both cases syringes, were apparently re-used.

TIMARU MAN INVENTED DISPOSABLE SYRINGE TO ELIMINATE RISKS!
To perhaps add a little perspective, allow me to take you back to the invention of the disposable syringe. It's of course thanks to Kiwi ingenuity that this product exists. You may or may not already know that the disposable syringe was invented by Timaru man Colin Murdoch, specifically to eliminate the risks involved in reusing syringes.

Colin Murdoch, when talking about the benefits of his invention in 1993 stated that previously:

“Dangerous bacteria and viruses were transferred from one patient to another by doctors who used improperly sterilised reusable glass hypodermic syringes and needles to inject other patients.

“It is impossible to comprehend the catastrophic consequences of this situation if such practices were still occurring today. Diseases of such ultimate incurability and virulence as the HIV and AIDS virus, hepatitis A,B,C and most recently a new D form, and TB to name just a few."

Murdoch designed the syringe specifically to be thrown away after one use – he did not design it to be able to be cleaned and sterilised. He is still alive to see his great advance misused by a few, and health consumers exposed to the very risks he sought to eradicate.

THE CONSUMER ISSUES IN HEALTH AND MEDICINES
As manufacturers I am sure it is of great concern that a device clearly labelled good for one use only, would be reused by someone in the health profession.

I don’t think we’re in a situation in New Zealand (unlike other countries) where we are defending the reuse of such devices as an acceptable practice.

Under the Fair Trading Act and Consumer Guarantees Act, all products must be safe (will not cause death or injury). I believe it is accepted that patients are exposed to minimal risks by being treated with a used device such as a syringe.

Now if devices are being used against the clearly stated specifications of manufacturers, you might argue, what more could you do?

I believe the medical industry needs to be more conscious of its relationship with individual health consumers, even if it is a somewhat, indirect relationship. Many of your businesses may in fact, be in dealing directly with health professionals. It isn't appropriate for me to discuss the nature of that relationship here today.

What I would like to do is examine your connection with health consumers. In supplying medical devices and products, you indirectly, create a relationship with health consumers – frontline customers you might call them.

THE SPIRIT OF CONSUMER LAWS AND LIMITATIONS OF APPLICATION
Now if we were to apply the spirit of the Fair Trading Act and Consumer Guarantees Act to this particular field, the individual health consumer would ideally be promised the safety and quality of the product.

Currently, there is doubt about the application of consumer law to the “health and medicines market”. Consumer law applies to interactions in trade, but not to private health.

I would personally like to see a clarification of consumer law in the health area. I believe there is merit in looking into whether consumers should given the same protections in trade, when their transactions in medicine take on a similar form.

For example, if you are billed for private health care, and the bill includes the cost of a device, say a disposable syringe, it would appear you have paid for this device. What then is available to the consumer when that device has been sold to them as new, when in fact it has been re-used? This is a fascinating area that I am keen to hear more discussion about.

CUSTOMER IS ALWAYS RIGHT
As Minister of Consumer Affairs, I often get to remind people of a well-known business adage. In my line of business, the customer is always right – at least in my book, the customer comes first.

I would like your industry to give more acknowledgment of your indirect relationship with consumers. Part of looking after consumer concerns is ensuring there is a form of re-dress should something go wrong.

DR PERERA AND GISBORNE
Again you might suggest that the transgression wasn't yours to make in the first place. In the case of the two recent reported incidents of reusing syringes - you would probably be correct in saying that that couldn't possibly be a fault with the manufacturer.

I am unable to go into the case of the Canadian locum who worked at Gisborne as it is subject to an investigation by the Health and Disability Commissioner into standards, procedures and other matters at Gisborne Hospital.

As for the case of Dr Perera at Whangarei Hospital, health officials have clearly stated they were mystified at his practice of reusing syringes. It wasn't the accepted procedure or practice and he appeared to have acted alone. So the question again for you the industry is, what then do you do?

WHAT YOUR INDUSTRY CAN DO
I would personally like to see you develop work towards two areas that help ensure the health consumer gets a better deal.

Awareness:
Does the consumer know that such products are for single use only? I would suggest that promotion of available options, and rights to access, and safe use of products, is a core part of information any consumer needs to know.

Perhaps your industry could play a greater role in public awareness of such issues.

And what about the individuals who ignore the "single use" warnings you clearly label? There again, I don’t believe everything has been done to prevent such practices. I would like to think that some of your industries are out there trying to improve on Colin Murdoch's Kiwi ingenuity by seeking the perfect design for a syringe that cannot be reused.

Ask again, why on earth would one individual opt to reuse devices designed for one use only?

There are those who might suggest that an environment of cost-cutting generated by the last government, might have had something to do with it.

STORY ABOUT PRIVATE NURSE WHO HAD TO DILUTE SOLUTION
I am reminded of a story that a nurse once told me of her experience working at a private hospital. One of her duties was to make up the solution in which devices were sterilised - following the manufacturers instructions for dilution. One day the manager came to her and told her to dilute the solution further.

The nurse said she didn't believe the manager's suggested solution would guarantee proper sterilisation, as it was much weaker than the manufacturer specified. The manager said that the solution cost the hospital money, whereas if a patient developed an infection, their subsequent treatment with antibiotics could be accessed through the public system, at no cost to their hospital.

PROTECTION FOR THOSE WHO SPEAK OUT AGAINST COLLEAGUES
As a long time champion of health consumer issues, I think it needs to be said that it's crucial to give support to those who speak up against their colleagues for misconduct or unacceptable practices.

There needs to be a culture that allows workers to speak up and advocate for health consumers. It has been highlighted in the recent case of Dr Morgan Fahey and again during the Gisborne Inquiry into cervical screening, which is of course continuing.

This government is proceeding, with the Protected Disclosures Bill, or the Whistleblower's protection bill, which will offer more support for those speaking up against colleagues and gives a clear signal that this is what is expected.

THE ENVIRONMENT
Going back to the single use devices, it's interesting to note that other countries use the environmental flag as a reason to argue in favour of being able to reuse single use devices.

While that clearly isn't the case here – remember we have talked about individuals who have gone against standard and accepted practices – there is a real issue here of the disposal of hospital waste.

Currently hospital waste is burned, releasing dioxins into the air. The best form of disposal, in my view, is sterilisation by steam or radiation.

But putting aside the disposal issue, I think we all agree that there is simply no reason to reuse devices meant for one use only. The risks are unfair to on the unknowing consumer.

I urge you to consider some of the ideas I have put before you. Remember the business adage about the customer always being right or always coming first. Why let the business of health be any different?

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