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.
Comments
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.
Also, in 2007 the FDA issued a MAUDE report that found reprocessed single use devices are 99.997% adverse event free.
It is importnat that the public have all the correct and up to date information.
And as lawyers you surely must know that there has never been a litigation against a 3rd party reprocessor. How many of the large medical companies that continue to rape the healthcare system make that claim?
Finally, I think you will find that vast majority of canadian hospital reporcessing single use devices are now using a regulated 3rd party reprocessor and not doing it in-house.
Please be objective and not selective in the info you post. The public deserve the full story.
Thank you.
Posted by: malcolm rawlings | June 5, 2011 9:25 AM
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.
The study to which I referred indicates that there are risks involved in reusing medical instruments. I don't belive we disagree on that issue.
The article is most concerned about "in-house" reprocessing, because it is unregulated. I think you and I can probably agree that a regulated process is better than an unregulated one.
As the article points out, the bigger risk lies with the unregulated reuse of single use medical devices.
Of course the fact that there has been no litigation against third party re-processors does not mean there have been no adverse events or that there is no increase in the risk to patients.
The underlying principle in medicine has always been, and must always be: "First do no harm."
Any increase in risk to a patient is unacceptable if there are reasonable ways to avoid or limit the risk.
The studies indicate there is an increased risks to patients when resuing single use devices. the question is whether those risks can be eliminated or reduced. If not, then patients should be given the oppotunity to make a fully informed choice as to whether they want to assume the increased risk.
Posted by: John McKiggan | June 10, 2011 12:04 PM