Some people say any media exposure is a good thing. However, Advanced Sterilization Products (ASP) must be starting to feel uncomfortable with all the recent attention its products have been receiving. The manufacturer has been the subject of several FDA enforcement reports since October. This California based technology firm has initiated multiple recalls – each for a different product. So far, all of these sterilizer recalls are classified as level 2. This means that the potential malfunction of one of the devices in question is not likely to cause irreversible or serious adverse health problems.
The latest company recall was posted in mid-February and refers to the Sterrad 50. This model features hydrogen peroxide gas plasma technology. It is a low temperature unit specifically designed to sterilize delicate medical instruments such as endoscopes. A rapid cycle time combined with unit portability make this option attractive for many other uses as well. The manufacturer recently discovered a problem with the design that they say poses a potential (but unlikely) risk of fire. This might occur if a capacitor in the sterilizer’s vacuum pump overheats. Consumers can contact ASP to check whether or not the serial # on their Sterrad 50 unit is in the affected group.
Additional Product Recalls
FDA enforcement reports from November and December of 2008 show several other ASP products that are potentially harmful. The automatic endoscope reprocessor is one of these. This self contained equipment is designed to flush out and sanitize endoscopes for reuse. It performs this sterilization using solutions such as paracetic acid, gluteraldehyde, or ASP’s own specialty formula – CIDEX OPA (ortho-phthalaldehyde). Unfortunately, it is the residue that may be left behind by these toxic chemicals that is the cause for the FDA’s interest. Chemical burns and irritation to delicate mucous membranes have been cited as two potential concerns regarding the use of this equipment.
The Sterrad 100S and Sterrad NX have both been recalled for issues with inadequate sensors/detectors. It has been shown that the 100S may run sterilizer cycles that do not contain sufficient hydrogen peroxide. The door on this model may also continue to close even if there is an obstruction in the pathway. It is possible for an operator’s hand to be caught and pinched by the door as a result. There are over 6,000 of these units currently in use and recall efforts may prove costly. The NX, on the other hand is a model with only about 50 units in place. A defective UV lamp power supply is the culprit revealed in the October notification letter ASP sent out. This defect could potentially cause an inaccurate reading on the hydrogen peroxide monitor.
Even when consumers are reimbursed for the cost of repaired or replaced products, the down time presented by a recall can be a problem. Having access to reliable and safe equipment is a necessity for clinics and hospitals that require a constant supply of sterile instruments. To find out more about what type of sterilizer will present the optimal solution for your location, take a moment to read our free report.