Machine checks inadequate — health watchdog
A health watchdog has warned that checks being carried out on “high risk” medical equipment in Bermuda are inadequate and do not guarantee public safety.
Ricky Brathwaite, programme manager for health economics at Bermuda Health Council, likened a proposed new system for inspecting such machinery to the health and safety checks carried out on restaurants.
“No one complains about the inspections and the regulations that restaurants have and that's just for the food you eat,” he said. “This is the same thing that we are looking to do with this regulation of the healthcare system and we think healthcare is even more important than the restaurant industry.
“We are talking about healthcare as a life-and-death thing and the tests that are received and given, how are you going to ensure that there are some kind of standards in place so everyone can trust the system?”
Dr Brathwaite told The Royal Gazette that though the Department of Health was responsible for inspecting equipment which emits ionising radiation, such as X-ray machines, it was “not enough” and other machinery, such as imaging equipment like MRI and CT scanners, did not have to be regularly checked under legislation.
Proposed new regulations, which have drawn criticism from some doctors and are now under review, would require the island's 300 or so healthcare providers to pay an annual fee, based on their workload and regardless or not of whether they have any high-risk equipment, to the health council.
The fees would go into a pot used to pay for a formal inspection system for high-risk health technology and other regulation of the healthcare industry, such as reviewing complaints about quality. The proposed annual budget for such a regulatory system is $250,000.
“The cost would be spread across the facilities on an annual basis, so some people would pay $500, some would pay $1,000,” said Dr Brathwaite. “They are putting into a pool that would add up to $250,000. These are proposed [fees]. The idea is that everyone would contribute.”
King Edward VII Memorial Hospital, as the island's largest healthcare provider, would be the biggest contributor to the pot and Dr Brathwaite said there had been “no pushback” from the hospital regarding the proposals.
Some physicians have “pushed back”, however, and the regulations and associated draft legislation were temporarily withdrawn from the House of Assembly in July by health minister Jeanne Atherden to allow for further consultation.
One vocal critic was Ewart Brown, the former Premier, who claimed aspects of the bill were specifically aimed at undermining his businesses, Bermuda Healthcare Services and the Brown-Darrell Clinic, the only medical facilities other than the hospital to have MRI and CT scanners.
Dr Brown told this newspaper the system already in place for checking machinery such as X-ray and ultrasound machines was enough.
“Long before the health council came into being, the health minister will not issue a certificate of safety to anyone who operates radiation equipment without a physicist coming to check,” he said.
He said all his equipment was regularly checked for safety and described the proposed regulations as “unnecessary”. “On the one hand, you want to save money, but you want to shift a cost to the operators — that's unfair.”
But Dr Brathwaite said: “The current system is inadequate in that it does not cover all the types of equipment that need to be maintained to ensure high levels of accuracy and safety in their function.
“There are inspections that are done by the Department of Health. Typically, if a concern is raised, there is someone who can go out and check. There may not be the resources in place for them to do regular inspections.”
He added: “The system right now is not adequate . . . it's not enough. I don't think it's enough to ensure public safety 100 per cent. We do need some additional resources, we do need some additional expertise, by which we can have regular checks.
“There are technologies that, if you don't maintain them properly and you are using them for diagnostic reasons or treatment reasons, they can cause harm to a patient. It's any piece of equipment that if you don't maintain or calibrate properly, can pose a risk to a patient or public safety.
“We are not talking about scalpels, we are not talking about stethoscopes. We are talking about things that, if you don't maintain them right, may cause issues.”
He said there had been “stories about X-ray machines [that] have leaked radiation in the past into public settings”, adding: “It's not that these things happen on a regular basis, but we do need to put standards in place.”
Dr Brathwaite said the healthcare system in Bermuda needed “resetting” and it was recognised globally that certain equipment should be closely monitored by regulators.
“The Department of Health does have an inspector that they use,” he said. “He is a person that is used now. Whether he has the capacity or has had the capacity in the past to fully cover all the different areas, that is a very good question, [as is] whether the structure is in place to ensure that if a complaint or a red flag is seen that he is prioritising or guiding in the right direction and whether we do need additional resources.
“I know fees have been an issue with the legislation. [But] unless you have some funding to bring in the proper people and to ensure public safety, then you are just grabbing at straws.”
He added: “The council is continuing to collaborate with physicians to review components of the legislation. This review does include, specifically, parts related to health technology. As the discussions for review are ongoing with physicians, we are all working collaboratively towards a system that is best for Bermuda.”
The US Food & Drug Administration classifies medical devices based on the risks associated with the device as either class I, II or III, with class I being low risk and class III being the highest risk. The health council is proposing to regulate class II and III devices and term them “high risk”.
The Department of Health is responsible under the Radiation Act 1972 for annually inspecting and licensing equipment that emits ionising radiation. A spokeswoman said the last inspections were in March and April this year and the next were due in spring 2017.
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