Friday, April 13, 2012

How best to ensure safety of medical devices

Apr 12, 2012
By Andy Ho

THE Health Sciences Authority's (HSA) latest move to get doctors to register all medical devices from January this year has upset the medical community.

The HSA says its move is to ensure patient safety. But doctors ask if the registration replicates approvals that regulators like the United States Food and Drug Administration (FDA) have given.

The HSA requires an 'abridged' evaluation for devices already approved by a reputable foreign authority like the FDA or its European equivalent. But doctors say it takes too long, costs too much and requires too much paperwork to get medical devices cleared for use.

The regulator charges $25 to clear a low-risk device while medium- and high-risk ones incur fees ranging from $2,300 to $11,900.

Because many inexpensive devices are not used in enough numbers to merit the fees, doctors may find it no longer worthwhile to import them. The process also requires detailed input from the manufacturer, which may not bother with Singapore's tiny market.

The medical profession is right to demand a better and economically viable system that ensures patient safety. The HSA is actively engaging doctors to work out solutions.

There is one aspect of this issue, though, on which the HSA is on strong grounds: its insistence that having an American FDA stamp of approval does not automatically mean a particular device is safe to use.

In the last decade, the FDA's shortcomings were exposed by a series of safety issues. Last year, the FDA's processes were scrutinised by the Institute of Medicine, medical advisers to the US government, but the FDA has yet to implement changes.

The devil is in the details.

Currently, the FDA requires low-risk devices such as surgical gloves to simply adhere to labelling rules and good manufacturing practices.

By contrast, high-risk devices such as heart valves or stents must be approved before use through a process that is akin to that for new drugs. The FDA demands lots of good clinical data from extensive clinical trials using the new device in humans. Such trials usually entail follow-up of human subjects for at least two years.

Non-risky items do not pose a problem to patient safety. Nor are very risky devices a big concern. This is because in 2009, for example, only 20 such devices were submitted to the FDA for approval.

As the FDA does not have enough specialist reviewers for every possible device, it calls up relevant experts from academe and industry to form an advisory committee for each risky device. So the process for risky devices is thorough, although time-consuming and very costly.

It is medium-risk devices that are a potential safety concern. In 2009, some 3,600 medium-risk devices such as infusion pumps were submitted to the FDA for approval. Such devices are approved by its internal reviewers, a workforce that has shrunk in size because of budgetary constraints. And it is the way that medium-risk devices are approved through the 510(k) process that is cause for serious concern.

In 510(k), the device maker just has to show that its new device is 'substantially equivalent' to one that has been on the market for about the same use. (The latter is called the 'predicate'.)

If FDA reviewers decide that the new device is substantially equivalent to an existing one, they approve it without calling for an advisory committee. If not, the device is reclassified as a risky one, for which an advisory committee comprising outside experts is then formed.

Last year's study found that the 510(k) process allows manufacturers to cite inappropriate predicates. Some may be outdated and no longer in clinical use. Some are downright unsafe and have been recalled from the market, but don't show up in FDA data systems as having been recalled. Some got their past approvals based on past predicates. The chain can go back for decades.

The review concluded that the 510(k) process does not establish device safety and effectiveness. It also found the FDA's collection and analysis of data concerning device safety in actual patient use to be sorely lacking.

Given these shortcomings, local doctors should not assume that all FDA-approved devices must be safe to use. Doctors should use them advisedly.

At the same time, given Singapore's limited resources, the HSA should also not simply replicate the FDA's work in approving devices pre-market, so as not to reinvent the wheel for a tiny market.

Singapore, to be sure, is not alone in facing this issue. Different countries adopt different standards for regulating medical devices.

One approach is to give doctors wider latitude in importing devices, but monitor their use and safety issues. For example, the HSA can mandate the reporting of adverse events by doctors and promote their reporting by patients for devices.

In clinical matters, patients and their doctors may be in a better position than regulators to decide whether a certain device should be used in any particular case. Even as the regulators and doctors continue to find ways to resolve this issue, one common concern must bind them: a commitment to patient welfare. This means giving patients access to medical devices for health care that is affordable while ensuring their safety.

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