Standards Go Global

3 April 2008 (Last Updated April 3rd, 2008 18:30)

With more and more devices appearing on the market, sterilisation of medical equipment can be a complex issue. But one country is aiming to kick-start global standardisation. Will Hawkes talks to Stephen Dibert of MEDEC to see how Canada is leading the way.

Standards Go Global

Ensuring medical equipment is fully sterilised is one of the most important tasks that any hospital or medical facility can be faced with. The complexity of the issue means that healthcare workers can easily be confused as to the best way to deal with a certain piece of equipment.

A full dialogue between manufacturers and the medical world is vital to keep standards as high as they need to ensure the wellbeing of hospital users.

The problems that medical institutions around the world face is that while new risks are continually evolving (such as Creutzfeldt-Jakob Disease, HIV and exotic viruses), which require constant and informed vigilance, specialist reusable devices are entering the market place in rapid succession.

While these allow for less-invasive procedures, better patient quality of life and swifter recovery times, the presence of these reusable devices represents a great economic and logistical challenge to the healthcare system in order to ensure their safe use.

Diffferent types of sterilisation include:

  • Steam sterilisation or autoclaving. A relatively simple process that exposes the device to saturated steam at 121ºC for a minimum of 20 minutes at a pressure of 121kPa.
  • EtO sterilisation. Used routinely to sterilise materials that cannot withstand the high temperatures of autoclaving. The EtO sterilisation procedure involves drawing a vacuum in the sterilisation vessel, after which EtO is injected at a concentration of 600–1,200mg/l.
  • Radiation sterilisation. Utilises ionising radiation to sterilise medical devices. Either gamma rays from a cobalt-60 (60Co) isotope source or machine-generated accelerated electrons can be used.
  • Plasma-based sterilisation. A promising alternative for low-temperature sterilisation of biomedical devices. Cold plasma is a partially ionised gas comprising ions, electrons, ultraviolet photons and reactive neutrals such as radicals, excited and ground-state molecules. It is created by the application of an electric or magnetic field to a solution such as hydrogen peroxide (H2O2).

THE CANADIAN SOLUTION

In Canada, they are working hard to address this issue, following several instances of breaches of reprocessing in 2003/4 in healthcare facilities that may have exposed patients to infectious agents. Several thousand patients were recalled and in a few cases, serious infection occurred following procedures involving inadequately reprocessed devices. Several class action lawsuits were subsequently launched.

MEDEC, the national association created by and for the medical device industry in Canada, and the primary source for advocacy, information and education on the medical device industry for members, the greater healthcare community, industry partners and the general public, organised a one-day policy summit in October 2006 on cleaning and sterilisation. Their aim was to continue and foster dialogue with the various stakeholders involved in cleaning and sterilisation and to find solutions to the issues involved in the reuse of medical devices.

The summit involved senior representatives from government, the clinical setting and industry, who reviewed the issue of sterilisation of reusable medical devices. Each participant was well known in his or her respective field of specialisation, with many years of experience in the areas of operations, device manufacturing, training, safety and the development of standards in device sterilisation.

Prior to the summit, Health Canada had created a Scientific Advisory Panel on the Reprocessing of Medical Devices (SAP-RMD) which had two mandates: one on single-use devices, the other on multiple-use devices. Stephen Dibert, the president of MEDEC who spoke at the one-day policy summit, says: "They [the scientific advisory panel] were to act as a forum for advice and a sounding board for the management and scientists at Health Canada.

"They wanted to provide scientific advice on current and emerging issues related to reprocessing. They addressed two issues, one of which involved the current problems encountered in reprocessing reusable medical devices, and some solutions to those.

"The panel worked for about three years and it has made a series of recommendations to Health Canada. In response to their concerns, we got our members together and experts from the industry – international as well as Canadian – to meet and put forward the perspective of the medical device industry.

"They also wanted to raise awareness of the issue with others so we held a stakeholder summit, where we brought in academics and users and industry people. They presented their various perspectives on sterilisation. Then we worked with the Canadian Standards Association, which develops various standards for healthcare and other areas.

"We are currently working on a joint committee with them to address issues that the users have with cleaning-related issues. It is just the beginning – we are sharing information at this point and trying to look for solutions to ensure that patients are kept safe and the equipment is clean and sterilised."

COLLABORATION AND PROVIDING INFORMATION

The one-day summit concluded that collaborative, ongoing forums on device safety through sterilisation must continue between government, hospitals, and industry to ensure patient safety.

MEDEC's own position on the issue is clear: patient safety is a priority for MEDEC members, therefore it is critical for healthcare facilities that reprocess reusable devices to follow manufacturers" recommended instructions for use on the proper cleaning and sterilisation of these devices.

It is important that healthcare facilities recognise the variation among devices, and that a "one process fits all" approach will not work and may in fact place patients at increased risk. All devices should be sterilised according to manufacturers' specifications for the safest possible outcomes.

Dibert says: "The issues that [healthcare facilities] had was that they felt that they weren't adequately getting the information required to properly clean and sterilise the equipment from the companies that supply the health technology.

"Users need to be secure that they are able to provide the proper process to ensure that patients aren't put at risk."

"So what we have addressed with our members is their position – the hospital says 'we don't get proper instructions', the industry says 'we provide instructions but you don't follow them'. There's that 'he said, she said' thing going on all the time."

MEDEC believes the industry needs to provide clear and accurate instructions but healthcare facilities need to ensure that devices are reprocessed according to those instructions. "Facilities need to be sure that their staff are properly trained to use the equipment and then the healthcare facility needs a quality system in place to ensure what they've done can be validated and it actually is sterilised," adds Dibert.

"So we've put forward several suggestions to both the regulator (Health Canada) and our Canadian Standards Association partners to try and address some of these issues."

DIFFICULTIES CAUSED BY DEVICE VARIATION

One of the problems is that the sterilisation and cleaning of reusable devices is determined by several variables, including device type and design, material characterisation and device maintenance. Reusable devices are designed for specific uses and thus vary widely.

Material, volume, surface texture and features all create a need for different cleaning and sterilisation procedures. Manufacturers provide specific instructions for cleaning and sterilising devices based on the particular properties and features of the device.

A single reprocessing protocol, MEDEC points out, does not work for all types of devices. MEDEC also argues that it is also unreasonable to expect industry to design or validate its products to fit one particular reprocessing protocol given the wide variances in types of devices and manufacturers. Hospitals should therefore ensure they have adequate resources and training for staff to cover the various reprocessing protocols that exist for different types of devices.

The sterilisation of medical devices is a complex issue, as Dibert acknowledges. "One of the issues for people who sterilise is the weights of the load," he says.

"The medical staff complain that they're too heavy. So what is a standard weight that we can use? What we are discussing is that, while it is important for the Canadian healthcare facilities to have a standard, we want to have a global standard if possible."

Because the manufacturers of the technologies are not Canadian companies, but multinational, what is being done globally is important. MEDEC aims to collaborate with its international colleagues to determine a standard that is suitable for everyone.

"That's one area and I expect there will be some decisions on that this year," says Dibert. "We're following what's happening on the joint discussions with the US – we have our own joint discussions here."

Another issue is that of cycle times, as Dibert explains: "One of the problems is that cycles vary greatly between different products. We are trying to see if there are maybe two, three or four cycles that health facilities can use for the technologies, as opposed to the many recommendations that are out there now.

"The challenge is that technology varies in complexity: some devices are relatively easy to sterilise and some are harder to ensure that they are completely clean."

Manual decontamination of devices must be heavily regulated:

  • Staff must be properly trained and supervised
  • Wear gloves, personal protective clothing and eye protection
  • Use dedicated equipment/receptacles
  • Follow the instructions provided by the device manufacturer, including:
    − choice, use and compatibility of decontaminants
    − dismantling and reassembly of instruments
  • Ensure that water used is of a suitable quality and at the correct temperature – ask microbiologist or SSD manager for advice
  • Avoid splashing and the generation of aerosols
  • Ensure that sterilisers are properly sited, maintained and used

FOLLOWING CANADA'S EXAMPLE

The focus on these issues in Canada means the country is setting a standard for others to follow. "I think the attention that is being paid [to sterilising medical equipment in Canada] is probably leading the way," says Dibert.

"I'm not sure we're at leading-edge practice yet but we have started the process of change. We have all the different players at the table and are having discussions about how to solve this issue."

The issue of sterilisation is not just a Canadian one. Every country in the world has the same issues. Users need to be secure that they are able to provide the proper process to ensure that patients aren't put at risk.

Even within Canada, Dibert points out, there is variation in how keenly provinces address the problem. "British Columbia has introduced a cleaning policy that requires the regions to significantly change their process to improve the quality," he says.

"They are required to have quality systems in place where they can actually check and see whether or not the processes they are using – both the technical as well as the manual processes – are effective. So far they are the only province to introduce that."

Interaction with foreign medical and industry bodies is very important, Dibert believes. "We've always wanted to speak with our colleagues [around the world] about the things that we and others do. There is a group called the Global Medical Technology Network that has been in existence for about six years and brings together global medical device associations.

"We all communicate and meet to share information and this [sterilisation of medical equipment] is one topic that will be on the next agenda."

Another suitable setting for discussion of sterilisation standards could be the Global Harmonization Task Force, which looks at global regulations for medical devices.

"It is unreasonable to expect industry to design or validate its products to fit one particular reprocessing protocol."

However, often sterilisation of medical devices is not regulated, so the topic does not match the group's mandate. But it does not match the mandate of the Global Medical Technology Network either, which tends to look at global issues such as competitive tending and reimbursement and funding issues.

Dibert is keen to see more international sharing of information. "I would like to see more communication between all the players," he says.

"What we're doing here is a good model to use in other jurisdictions. Where you're able to get the industry with users, the regulator and standards developer all in the same room at the same time, to share information about what is best practice, what could be used to ensure that patients are not put at risk, that's a good process."

Hopefully, the future of devices will see further discussion and collaboration between manufacturers from all over the globe.