May 26, 2008

Hospitals Reusing Single-Use Medical Devices: Are Patients at Risk?

A number of Canadian hospitals are reusing "single-use" medical devices (SUDs) that are supposed to be disposed of after being used. Worse yet, the vast majority of hopitals that are reusing the medical devices are sterilizing the devices in-house. Infection control experts have criticised the practice as being "fraught with risk", according to a story by the Canadian Press.

...tragedies like the tainted blood scandal and cases of variant Creutzfeldt-Jacob disease -- the human form of mad cow disease -- linked to reuse of tools used in brain surgery have deepened the understanding of infection risks and raised the bar for infection control in hospitals.
No Regulations:

The story reports that while there appears to be consensus among health care professionals that a national policy is needed and that the practice of in-house reprocessing ought to be banned, a regulatory void means that in many parts of the country hospitals can do as they wish when it comes to reuse of single-use medical devices.

Saving Money vs. Patient Safety:

The cost of health care has become so astronomical that hospitals have been forced to find any way they can to save money. Some would say by cutting corners at the expense of patient safety.

The Canadian Agency for Drugs and Technologies in Health (CADTH) is a national body that provides Canada’s federal, provincial and territorial health care decision makers with impartial advice and evidence-based information about the effectiveness and efficiency of drugs and other health technologies.

Reuse Poses Legal Liability Issues:

CADTH has produced a series of reports on reprocessing of SUDs that address concerns about possible risks to patients of infection or other complications, legal liability issues, and uncertainties regarding cost-effectiveness.

CADTH concluded that there is:

"Insufficient evidence to establish safety and effectiveness "of reusing SUDs.

Reuse Endangers Patient Safety: United States:

Almost three years ago the Washington Post published a story about the dangers of reusing SUDs. The report documented dozens of cases of patient injuries and device malfunctions after single-use devices were reused.

Government Investigates Health Risks:

The practice has become so widespread that the United States Government Accountability Office prepared a report on the issue. The title of the report concludes that FDA has increased its regulation of the reprocessing of SUMDs and "available information does not indicate that use presents an elevated health risk".

But on the very first page of the report the authors state:

Neither existing FDA data nor studies performed by others are sufficient to draw definitive conclusions about the safety of reprocessed SUDs compared to similar original devices.

How comforting.

February 11, 2008

Dangerous Drivers in Canada Not Being Reported: Why are Doctors Ignoring the Law?

Dangerous drivers suffering from alcohol abuse, cardiac disease and neurologic disorders are not being reported by their doctors; and doctors may be committing medical malpractice for failing to comply with provincial laws.

A recent report in the medical journal Open Medicine found that between 1996 and 2001 37% of drivers admitted to a trauma unit with injuries from car accidents had a reportable medical condition that made them unfit to drive.

Most of the patients (85%) had seen a doctor in the year before the crash, and 14 per cent had even seen a doctor a week before their crash. But only three per cent of these had been reported to the Ontario Ministry of Transportation.

The author of the report Dr. Donald Redelmeier of Toronto's Sunnybrook Health Sciences Centre, was quoted by CTV as saying:

"There's sort of a historical tradition where a lot of physicians didn't believe road safety was a part of public health...Globally, motor vehicle crashes account for almost 1 million fatalities, far eclipsing malaria for the first time in the history of the planet."

All Canadian provinces and territories have enacted some form of legislation requiring doctors to report patients who are believed to be unfit to drive a motor vehicle. In some jurisdictions, the duty is mandatory; in others, it is discretionary. In either case, the duty to report is an exception to the normal rules in respect of doctor-patient confidentiality.

The authors suggest a number of reasons why doctors may not be following the law requiring them to report unfit drivers:

Uncertainty as to whether a patients impairment is serious enough to report;

Concerns over how their patients will react;

Being too busy;

Lack of training; and

The view that road safety isn't a medical problem.

Based on their findings, the authors conclude that mandatory reporting in Ontario "does not achieve its stated purpose."

Innocent victims of car accident have filed personal injury claims against doctors for failing to report unfit drivers who subsequently caused car accidents. See for example Toms v. Foster

Whatever the reason, a doctors failure to report can have serious consequences, not only for the innocent victims of car accidents caused by unfit drivers, but to the doctors who fail to report them.