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

by John McKiggan

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.

2 Responses to “Hospitals Reusing Single-Use Medical Devices: Are Patients at Risk?”

December 31, 1969 at 6:00 pm, malcolm rawlings said:

You should update this posting to inlcude more recent info such as the GAO report that came out in 2008 stating that after looking at SUD reprocessing for a further 6 years there is no evidence to suggest SUDs reprocessed by a regulated 3rd party reprocessor pose any additinal patient or operator risk.

December 31, 1969 at 6:00 pm, John McKiggan said:

Thank you for your comment Mr. Rawlings. Are you the same Malcolm Rawlings that works for Eastern Medical Services? It would appear you are familiar with the medical devices industry.

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