How Fo You Know When an on-q Releif System Is Emptyq

Problem: In our May 21, 2009, newsletter we noted an clan betwixt the ON-Q PainBuster elastomeric pump and chondrolysis (destruction of cartilage), especially if the local anesthetic intended to reduce pain after surgery is infused directly into a joint rather than the tissue around it. Since then, we have received numerous reports of potential bug with using ON-Q pumps. Almost of these problems tin can be addressed by hospitals so the pumps can be used safely to provide surgical wound analgesia and/or peripheral nerve block.

The ON-Q PainBuster Post-Op Pain Relief Organization (run across Effigy 1) provides continuous infusion of a local anesthetic direct into the patient'due south surgical site for constructive, not-narcotic postoperative pain relief for up to 5 days. 4 pump models are available: 1 with a stock-still flow rate that cannot be changed; one that delivers a basal infusion and also allows delivery of on-demand boluses; 1 that allows the user to adjust the flow rate within a predetermined range; and 1 with an adjustable rate controller and a bolus device. Various sizes and types of catheters are available to deliver the medication. Co-ordinate to the company, about 700 hospitals are using ON-Q pumps after cardiovascular, cardiothoracic, urologic, gynecological, obstetrical, orthopedic, and general surgical procedures.

While the ON-Q pump may provide constructive pain relief, numerous hospitals and outpatient surgical centers have reported potentially harmful management bug associated with employ of the device. Recently, a hospital reported a serious event that may have been linked to premature emptying of the reservoir ball that holds the medication. A patient had been sent abode with an ON-Q pump filled with a local anesthetic. The surgeon asked the patient to come back in 5 days to refill the pump for another 5 days. Two days after the pump had been refilled, the patient was brought to the emergency department (ED) in cardiac abort.

The ED staff noticed that the medication reservoir ball of the ON-Q pump was empty. Initially, they did not know what medication had been delivered to the patient or how fast it had been delivered considering the device was unlabeled. (In its simplicity, the ON-Q pump does not record the infusion history, and so in that location was no tape of how fast the drug was delivered.) When the ED staff learned that the pump contained a local anesthetic, a drug level was drawn. Even so, this lab exam had to be performed by an external lab, then the results were not readily available to aid guide the treatment of the patient or determine the cause of his cardiac arrest. Later, a local anesthetic drug level was found to be elevated, but non alarming. Unfortunately, rescue efforts were unsuccessful and the patient died, although his expiry was probably not related to the incident. To date, hospital staff tin can only speculate regarding the cause of the premature emptying of the medication reservoir—mayhap patient tampering—and whether drug toxicity played whatsoever role in the patient'due south death.

Other potential process problems with ON-Q pump use accept been reported and are described below.

Used without staff teaching. Nosotros have received reports of patients appearing on postoperative units with an ON-Q pump where staff had never seen the pumps or been educated about their use.

Used without pharmacy interest. In many reported instances, the pumps were piloted in the operating room (OR), and/or used regularly without chemist's shop cognition. Pharmacy's commencement encounter with the device frequently occurred when nurses called the chemist's because the reservoir brawl was empty and they didn't know what to do, or when pharmacy staff was informed that a "hurting ball" trial would brainstorm the next day. One hospital reported that the but fashion pharmacy knew about ON-Q pump use was through unit-based pharmacists who happened to learn nearly them from nurses.

No chemist's profiling of orders. Fifty-fifty when pharmacy has knowledge regarding employ of the devices, orders for the medications are rarely profiled or screened. In many cases, the pumps are started in the OR, and the "social club" is office of the intra-operative documentation. Thus, an gild is not sent to the pharmacy for drugs being delivered by the pump. Some pharmacists told united states of america they now utilize a standard gild form for ON-Q pumps. 1 pharmacist told us she had to build special order templates for the pumps. Pharmacists also may have to remember to screen for drug interactions and allergies if such screening does not occur automatically.

Medication grooming exterior of chemist's shop. Many ON-Q pumps are non filled in the chemist's; they are filled in the OR where in that location is seldom a organisation of independent double-checks, and where labeling and hand-off communication may not be sufficient. We recently learned about an error in which the pumps for two patients were filled using a local anesthetic that contained EPINEPHrine, rather than the local anesthetic alone. (Vasoconstrictors such equally EPINEPHrine are not recommended for continuous infusion via ON-Q pumps.) Once, the nurse noticed the error and corrected information technology afterward the patient received merely 1 mL of the wrong drug. In the other case, the patient developed severe tissue damage and required follow- up care. Chemist's shop preparation of the medication has sometimes been met with resistance because surgeons claim they don't know until the end of the case whether they want to utilise the pump. The product may also exist marketed in a way that promotes physician autonomy and touts filling of the pumps by the surgeon or anesthesiologist in the OR as an reward (a marketing strategy we discourage). One hospital pharmacist reported that she idea the pharmacy was preparing all medications for the ON-Q pumps only to learn that surgeons were also preparing pumps in the OR.

Use with medications other than local anesthetics. The ON-Q pump is designed to deliver local anesthetics to surgical sites for not-narcotic hurting relief. The company's product information suggests using ropivacaine, bupivacaine, or lidocaine. Nonetheless, I-Flow, the company that markets ON-Q, as well provides data regarding stability when diverse local anesthetics are mixed with dexamethasone, ketorolac, morphine sulfate and ketorolac, cefTRIAXane, or ceFAZolin—implying that mixing the local anesthetics with other drugs is rubber and perhaps even effective. Withal, the company does not supply data to support this and does not brand any specific recommendations regarding employ of these products with ON-Q.

We take also received reports that surgeons have added vancomycin, and even fentaNYL, to the local anesthetic. With a simplistic pump that promises a delivery accurateness of ±15% of the labeled infusion charge per unit (± twenty% for models with adjustable menses rates), use with antibiotics and drugs such as ketorolac, morphine, and fentaNYL may non be appropriate.

Varying infusion rates. The accuracy of the pump's rate of delivering medication is dependent on filling the reservoir ball with an verbal amount of medication. The proper fill volume is variable based on the blazon of pump and duration of therapy. Over- or under-filling the ball results in variable rates of infusion. The menses restrictor part of the pump must also be in contact with the patient's skin and be kept away from any common cold therapy (e.1000., ice packs) or else the medication volition infuse more slowly than expected. Taping over the filter may affect the flow charge per unit. Flow rate is too unpredictable if the dial is not clicked into place at the proper numerical setting. Confusion has as well been reported when determining the right rate of infusion for pumps with dual catheters, with each port infusing half of the total volume of medication. If patients receive too much bupivacaine, ropivacaine, or lidocaine—the drugs most commonly used with ON-Q pumps—cardiotoxicity is possible.

Varying concentrations. We heard from a chemist who viewed a hospital protocol for ON-Q pumps with more than 17 concentrations available for bupivacaine, ropivacaine, and lidocaine because the staff changed the concentration when they needed to change the dose (similar to the rule of vi). The use of nonstandard concentrations has contributed to training and dosing errors.

Unlabeled medication. The drug reservoir ball (or ON-Q pump tubing) has been found unlabeled, specially when the ball has been filled in the OR. In cases where there is no "order" for the drug or pump, the medication being administered may be unknown by those providing care to the patient.

Drug administration documentation. If the chemist's shop profiles orders for ON-Q pumps, the drug therapy may appear on the nurses' computer-generated medication assistants record (MAR). But several hospital staff told us that the ON-Q pump does not appear on their MARs, and they exercise not monitor or document the blazon and amount of drug administered via this delivery method.

Extended duration of use. As in the outcome initially described in this commodity, some physicians are refilling the ON-Q pump after five days of use. However, the manufacturer states that the pump should not be refilled and is only intended for a single utilise (upward to v days), after which the pump should be removed and disposed. Longer use may present an infection command business concern.

Concomitant analgesics. As with other forms of analgesia delivery, unclear maximum doses of the local anesthetics delivered past the ON-Q pump and possible concomitant use of analgesics by other routes of administration are of business organisation. For example, many long-standing society sets already include intermittent and/or continuous hurting medications, which may still exist enacted despite use of the ON-Q pump. Since pharmacy may not be aware of the pump's apply or be profiling related orders, unnecessary and potentially dangerous indistinguishable therapy may non be identified. For example, one of our consultants was recently at a hospital where he reviewed a patient'due south nautical chart with concurrent orders for an ON-Q pump, patient-controlled analgesia, and ketorolac every 8 hours.

Safe Practice Recommendations

See Table 1 below for a listing of suggested strategies to meliorate safety when using ON-Q pumps. Delight also notation: While this commodity features problems associated with the management of ON-Q pumps, there are other elastomeric pumps manufactured past other companies that may take similar issues. Please take steps to reduce the hazard of errors and adverse events with these pumps and, thus, maximize the potential benefits of this form of pain control. In fact, a failure mode and effects assay (FMEA) should be considered in hospitals that are using these devices or are because their utilize.

Table one. Strategies for Safe Employ of ON-Q Pumps

Before Using the Pumps Grant privileges to surgeons through the credentialing process before they can insert the catheters and prescribe ON-Q pumps. Found protocols for use of ON-Q pumps which include: indications; models and tubing to be used for each indication; process steps for prescribing, preparing, and dispensing the device and associated medications; required testing of knowledge and skills; paw-off communication between providers; patient/family education; and patient monitoring. Have the Pharmacy and Therapeutics Committee corroborate the drugs that can be administered through the ON-Q pump, taking into consideration the accuracy of the infusion charge per unit (± 15-20% of desired rate) and conditions that could influence the rate (e.g., heat and common cold). Ensure clinical staff education before utilize—even "trial" use—of the pumps. (The manufacturer may provide orientation materials and some of the staff teaching if requested.) Include the signs of bupivacaine, ropivacaine, and lidocaine cardiotoxicity and the risks associated with pump use, as outlined in this article.
Prescribing the Pumps Plant standard order sets for prescribing the pumps and specific medications. Specify any concomitant analgesics that are acceptable or should be avoided. Require activation of the appropriate social club prepare before the patient is transferred from the OR. Use the device for a maximum of 5 days without refills, according to the manufacturer's recommendations.
Placing the Catheters and Setting Up the Pumps Ensure proper insertion of the catheter(due south) in the tissue and/or side by side nerves surrounding a wound. Do not insert the catheter directly into a articulation. Label the pump with the proper name of the drug, the concentration, infusion rate (in mL/60 minutes and dose/hour), and beginning engagement. Ensure that the adjustable rate controller (available on some models) is clicked into identify under the specified charge per unit of infusion. Utilize an occlusive dressing over the catheter insertion site. Tape the flow restrictor to the patient's skin. Do not record over the filter.
Dispensing the Pumps and Medication Constitute standard concentrations for the local anesthetics (and other drugs, if appropriate) used in the pumps. Too plant chemist's shop compounding procedures for preparing any mixtures of drugs. Establish order sets in the chemist's shop computer that will facilitate automatic screening of the drug(s) being used for appropriate dose, drug interactions, allergies, and duplicate therapy. Require pharmacy preparation of the medication reservoir balls following a protocol that specifies the exact corporeality of solution to instill based on the duration of therapy and expected charge per unit of infusion. Outsourced compounding can besides be utilized. Require an independent double-bank check in the chemist's of the drug, strength, and total volume added to the reservoir ball by comparison to the prescriber's club and the protocol.
Providing Nursing Care to Patients with Pumps Ensure that whatever medications administered via the pump are listed as an entry on the nursing medication administration tape. Ensure the occlusive dressing over the catheter site is intact. Regularly check that the flow restrictor is taped to patient's skin for accurate menses rates. Go along the pump at room temperature, and instruct the patient to proceed the pump in the carrying instance on the outside of wear. Go on the menstruation restrictor away from cold therapies (e.g. ice packs). Monitor the patient's level of pain and response to medication while using this device. Remove the charge per unit-changing key from the dial if the patient is discharged dwelling house with an ON-Q pump. Keep the rate-changing primal with the healthcare provider in example the patient's pump requires adjustment. Secure the plastic cover over the dial with a standard necktie wrap.
Educating Patients nearly Pumps Educate patients and caregivers virtually how the pump works and items to periodically cheque (east.k., flow restrictor is taped to the skin, medication ball appears to exist getting smaller each mean solar day, patient's pain is under control). Educate patients about the signs of cardiotoxicity, when to call the dr., and how to clench the tubing to forbid further drug administration, if necessary. Provide patients with the Patient Guidelines provided by the manufacturer of ON-Q pumps.

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Source: https://www.ismp.org/resources/process-handling-elastomeric-pain-relief-balls-q-painbuster-and-others-requires-safety

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