FDA Patient Safety News: Show #7, August 2002

FDA Clears Computer-Connected Glucose Meters

Here's another new diagnostic product, this one sold over the counter for people with diabetes. FDA recently cleared for marketing two glucose test meters for use in conjunction with hand-held computers. The computer technology allows diabetics to do a better job of tracking and managing their blood sugar levels. The devices are the FreeStyle Tracker Diabetes Management System, by TheraSense, Inc., of Alameda, California, and the Accu-Check Advantage Module, by Roche Diagnostics Corporation, of Indianapolis.

These products, for the first time, combine a glucose test meter with a hand-held computer, in this case a compatible personal digital assistant, or PDA. The new system not only measures and tracks glucose levels, it's also able to monitor and record other important data, such as insulin usage, food intake, exercise, and medications.

The patient uses the device by first inserting a glucose meter module into the hand-held computer. Then a test strip is inserted into the meter and a blood sample is collected and placed onto the test strip. The glucose levels are then read by the meter. The computer displays the results and saves them in a database which has the ability to store up to 2500 entries. The results can be uploaded to a PC and printed out, or viewed at a later time.

Of course, it's important that patients know how to operate a PDA before they use this system.

Additional Information:

Consumer Information on: Roche Diagnostics Accu-Check® Advantage® Module - K021513.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm083441.htm


FDA Clears Computer-Connected Glucose Meters

Here's another new diagnostic product, this one sold over the counter for people with diabetes. FDA recently cleared for marketing two glucose test meters for use in conjunction with hand-held computers. The computer technology allows diabetics to do a better job of tracking and managing their blood sugar levels. The devices are the FreeStyle Tracker Diabetes Management System, by TheraSense, Inc., of Alameda, California, and the Accu-Check Advantage Module, by Roche Diagnostics Corporation, of Indianapolis.

These products, for the first time, combine a glucose test meter with a hand-held computer, in this case a compatible personal digital assistant, or PDA. The new system not only measures and tracks glucose levels, it's also able to monitor and record other important data, such as insulin usage, food intake, exercise, and medications.

The patient uses the device by first inserting a glucose meter module into the hand-held computer. Then a test strip is inserted into the meter and a blood sample is collected and placed onto the test strip. The glucose levels are then read by the meter. The computer displays the results and saves them in a database which has the ability to store up to 2500 entries. The results can be uploaded to a PC and printed out, or viewed at a later time.

Of course, it's important that patients know how to operate a PDA before they use this system.

Additional Information:

Consumer Information on: TheraSense, Inc. FreeStyle Tracker™Diabetes Management System - K020866.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm083448.htm


FDA Clears Device for Reducing Tonsil Size

FDA recently gave marketing clearance for an electrosurgery device that shrinks the size of tonsils in adults and teenagers. For these patients, it offers a minimally invasive alternative to conventional tonsillectomy. The procedure takes about 30-45 minutes, and it's usually done on an outpatient basis, under local anesthesia.

The device is called the Somnoplasty Tissue Coagulating Electrode. It's made by the Gyrus Group of Bartlett, Tennessee. It was previously cleared by FDA for general use in coagulating and reducing tissue in the head and neck, in conditions such as obstructive sleep apnea.

The device works by emitting radio frequency energy through a special probe. This energy produces small lesions beneath the surface of the treated tissue. As those lesions heal, they shrink the tissue while leaving the surface intact.

Remember, this device is cleared for tonsil reduction only in patients 13 years of age and older.

Additional Information:

Gyrus ENT Somnoplasty Model 2420 Tissue Coagulating Electrodes - Premarket Notification Summary.
http://www.accessdata.fda.gov/cdrh_docs/pdf2/k020778.pdf


Certain Pulmonetic Systems Ventilators Recalled

If you or your patients use ventilators, you should know that Pulmonetic Systems of Colton, California has recalled some of its LTV series ventilators over the past several months. There have been several problems with these devices. One of them could result in a situation where no audible alarm would sound if the ventilator stopped working.

Not all LTV series ventilators are affected by these recalls. Pulmonetic Systems is contacting the purchasers of the affected ventilators. If you think ventilators in your facility could be covered by these recalls. We'll post more information as it becomes available.

Additional Information:

Medical Device Recalls - Class I Recall: Ventilator.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm064676.htm


Liquid Chemical Germicide Residue Causes Burns

FDA has received a number of reports of internal irritation and chemical burns in patients who were treated with devices processed with high level liquid disinfectants. Most health care facilities use these products to disinfect heat sensitive medical devices. They can be highly effective in killing microorganisms.

But they can also cause injuries to patients if you don't follow instructions and warnings. The problem occurs when the disinfectant isn't completely removed in the rinsing process.

One manufacturer, Advanced Sterilization Products, the maker of Cidex brand disinfectants, recently sent a letter to its customers, emphasizing the importance of proper rinsing for all of its high level disinfectants. If you use Cidex products, be sure to watch for the letter.

But the problem of residual disinfectant causing injuries isn't limited to just this one company's products. These sorts of injuries can occur with any high level disinfectant, if users don't follow proper rinsing procedures.

Regardless of the particular disinfectant being used, there are several steps that must be followed for effective rinsing after disinfection:

* Completely immerse the device in at least 2 gallons of water.
* Keep the device totally immersed for a minimum of 1 minute, unless otherwise indicated by the device manufacturer.
* Remove the device and discard the rinse water.
Repeat this procedure two additional times, for a total of three full rinses.
* Take special care when reprocessing devices with lumens or channels, like endoscopic instruments. Be sure to flush these channels with plenty of water during each rinse.
* Check the device labeling for additional rinsing instructions that are specific to that device.

There are two other precautions to keep in mind. First, it's important to clean devices properly before they're disinfected, because patient material or other debris may make it harder to rinse off the disinfectant. An enzymatic cleaner is typically recommended in the product labeling. Also, don't keep devices in the disinfectant too long, because this makes it harder to rinse off the disinfectant.

Additional Information:

Advanced Sterilization Products - Letter to Cidex Customers (see letter reproduced below).
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm212230.htm


List of Sterilants and Disinfectants for Reusable Equipment Now Available

Speaking about disinfectants, FDA now has a list of sterilants and high level disinfectants that we've cleared for processing reusable medical devices. The list identifies manufacturers, active ingredients and contact conditions for these products.

Additional Information:

FDA-Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices.
http://www.fda.gov/cdrh/ode/germlab.html


Hazards in Patient-Controlled Analgesia

Now for the part of the broadcast where we tell you about recent articles that pertain to patient safety. This time we want to talk about three recent articles by the Institute for Safe Medication Practices, warning of the potential danger of mis-using patient-controlled analgesia, or PCA.

The articles point out that when the patient is truly controlling the administration of the analgesic drug, there's a built-in safeguard, because when the drug dose exceeds the amount needed for analgesia, the patient becomes sedated, and then he or she can no longer push the button to administer more of the drug.

The problem occurs when other people push the button, bypassing this built-in safeguard. That can happen when well-meaning family members push the button, and sometimes even when staff members do so. As the ISMP puts it, “PCA means patient controlled analgesia. It does not mean family-controlled, visitor-controlled or clinician-controlled.”

One of the articles cites the case of a 72-year old woman who received morphine through PCA after surgery, and who died of an overdose. Despite the patient's inability to verbalize pain, and the fact that she remained obtunded after surgery, nurses pushed the PCA button and delivered frequent doses of morphine for 48 hours. The patient suffered a cardiorespiratory arrest and seizure, and died several months later without having regained consciousness.

ISMP points out that in this case, nurses did not recognize the signs of morphine toxicity, and they continued to administer the drug despite serious hypotension and very shallow respiration.

The ISMP articles don't say that nurses should never push the patient's PCA button. They say that nurse-controlled analgesia may be appropriate in critical care settings, but only with guidelines for selecting patients, along with tools to assess the level of pain and sedation.

Here are the ISMP recommendations:

* First, establish selection criteria for patient controlled analgesia. Note that some patients are not suitable for PCA because of their level of consciousness, their psychological state, or their intellectual capacity.
* Also, establish selection criteria for nurse-controlled analgesia. Decide in advance on risk factors that would call for increased monitoring, such as age and concomitant medications.
* Develop protocols and standardized order sets for infusion devices, drugs, dosing, and lockout periods.
* Carefully monitor patients. Opiates can suppress respiration, heart rate and blood pressure, so patients must be observed and monitored. Pay particular attention to the first 24 hours, since the effects of opiates on intellectual functioning can be unpredictable. Also be sure to monitor and observe the patient at night, since nocturnal hypoxia can be a serious side effect.
* Double check the patient's ID and the dose setting before starting to use PCA, and also before each pump refill. In other words, you should require two clinicians to perform this check independently.
* Educate patients and families about the proper use of PCA. Warn family members about the danger of pressing the button for the patient. Explain that this should only be done when the patient has clearly expressed a need for the medication and requires physical assistance to press the button.
* Finally, educate the staff about the proper use of PCA. Encourage them to think about the cumulative dose the patient could receive if the maximum dose were given, and ensure that they fully understand the hazards of using analgesics.

Additional Information:

ISMP Medication Safety Alert - More on avoiding opiate toxicity with PCA by proxy.
http://www.ismp.org/MSAarticles/PCA.htm


New Safety Guidelines for MRI Facilities

In a previous broadcast, we talked about the case of a six-year-old boy who was crushed to death in an MRI machine. It happened when a metal oxygen tank flew across the room, attracted by the powerful magnet in the machine.
This kind of problem, where metal objects near MRI machines injure patients, isn't going to go away. Dealing with it requires constant vigilance. But it also requires that MRI facilities set up detailed policies and procedures relating to safety. There's a new publication that does just that.

It's the report on Magnetic Resonance Safe Practice Guidelines, issued by the American College of Radiology. This is a comprehensive set of recommendations, covering all aspects of MRI safety, from the layout of the MRI suite to the training of personnel to emergency procedures.

If you work in or near an MRI facility, this document is a “must read” for you. Even if you're not directly involved with MRI, you'll probably find some of the questions addressed by the guidelines interesting.

For example, should metal detectors be used in the MRI facility? Is it necessary for patients to remove eye makeup before having an MRI? Why should patients not cross their legs during the procedure? How can you tell whether an unconscious patient has a metallic implant? How do you manage a patient who requires EKG monitoring during the MRI exam? What about patients with tattoos? What if the patient is a prisoner wearing metal handcuffs? What if there's a fire near the MRI unit and fire fighters arrive with metal tools?

You'll find the answers to these and other questions on MRI safety in the ACR guidelines.

Additional Information:

ACR - MRI Safe Practice Guidelines.
http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/dx/head-neck/mri_brain.aspx



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