Woffling On

Friday, June 30, 2006

Many Hospital Dangers Go Unnoticed

An FDA Alert received a couple of days ago referred to a problem with a product supplied to hospitals for direct patient contact. I didn't mention it. Like so many alerts, I let it slip under the radar, so to speak. That may not really serve your best interests however, so I am raising the issue here.

The fact is, since the product's manufacturer doesn't supply to retail outlets and the product is far from glamorous, this Alert will probably pass beneath the radar of all media outlets. This is good news for the manufacturer but it does consumers a disservice. The product in question is a perineal care washcloth. The problem is quite serious -- it is contaminated with dangerous microorganisms.

The argument that it mainly poses a risk to people already weakened by sickness, especially if immunosuppressed (having lowered immune function and therefore less able to deal with infections) is far from reassuring. Why is that? It's because that is exactly the type of people found in hospitals!

So I ask you to read the press release below. You may be one of very few who do!

To be honest though, my point is not directly related to this particular product's problems. My point is that things such as this do happen quite frequently yet very few people actually find out. Even though the company covers itself with a press release, there is every liklihood that the problem will go unreported -- effectively unnoticed.

What is the problem with that? I suggest he problem is that people then live with a totally false sense of security, assuming that hospitals are safe places. The truth is, they are not. Modern hospitals are almost as dangerous today as were the hospitals of the pre-Crimeans war period. That's pretty bad.

FOR IMMEDIATE RELEASE -- Cary, IL -- June 23, 2006 -- Sage Products Inc., of Cary, Illinois, is initiating a voluntary recall of specific lots of Comfort Shield Perineal Care Washcloth product codes due to contamination with Burkholderia cepacia. See identified lots, below.



Code #

Lot #

Dates shipped

7403

1301

02/10/06 - 02/13/06

7403

1312

02/13/06 - 03/02/06

7403

1312

02/13/06 - 03/02/06

7403

1457

02/24/06 - 03/01/06

7403

1677

05/02/06 - 05/03/06

7408

1848

04/18/06

7503

1999

05/03/06 - 05/16/06

7524

2070

05/01/06 - 05/15/06

7524

2086

05/11/06 - 05/15/06

7905

1766

03/22/06 - 06/12/06

7503-M

1702

04/13/06

7503-M

1995

04/13/06 - 05/19/06

Burkholderia cepacia can cause serious infections including pneumonia and bacterial sepsis in immunocompromised persons, persons with cystic fibrosis (CF), in hospitalized patients in general as well as certain other patient groups. No other lots of Comfort Shield Perineal Care Washcloths from Sage Products are known to be affected by this recall.

The product was distributed to hospitals, medical centers and long-term care facilities in the U.S. and Canada. There was no known distribution through retail sales. Sage Products initiated this recall after receiving and investigating a Canadian complaint on lot 1457 of off odor. At the present time, Sage Products Inc has received no reports of patient injury. This voluntary recall is being conducted with the knowledge of the Food and Drug Administration.

Customers who have the affected lots of these products should stop usage, sale and distribution, and should contact Sage Products to coordinate product return and replacement. Product is available for immediate replacement and no stock outage is anticipated. To arrange for product replacement, contact Customer Service at 1-800-323-2220. Return affected product only, to Sage Products Inc, 3909 Three Oaks Road, Cary, IL 60013, attention: Customer Service.

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