Frequently Asked Questions
Cleanroom FAQs
Closed System Drug Transfer Devices FAQs
HIPAA Compliance Statement
Latex-Free FAQs
MedBoard FAQs
National Patient Safety Agency Guidelines Q & A
Rapid Rate Infuser FAQs
Syringe Infusion FAQs
Total Parenteral Nutrition (TPN) FAQs
USP <797> FAQs
ValiMed FAQs
The USP General Chapter 797 on compounding sterile preparations makes some specific recommendations regarding cleanliness and cleanrooms. While it does not specifically require a cleanroom for sterile compounding, the guideline does require that sterile compounding take place in a separate area that meets a defined level of cleanliness. Many pharmacists have expressed concern about cleanrooms and their requirements in an attempt to clarify the requirements for USP 797 compliance. These Frequently Asked Questions are intended to provide a general understanding of what cleanrooms are and how they are monitored.
In a hospital pharmacy context, USP 797 requires the maintenance of ISO Class 5 air quality. Below are the particle count requirements for ISO Class 5*:
Walls may be standard drywall construction, primed and sealed. At a minimum a good quality washable enamel paint is recommended. Anti-microbial paints are available and may be a worthwhile expenditure. Acoustic ceilings require special cleanroom ceiling tiles. These tiles are vinyl coated to prevent debris generation and can be wiped down. Cleanrooms are sealed areas. Doors and windows must be gasketed to prevent leaks.
There are a number of suppliers for modular cleanrooms, hoods and cleanroom supplies. One source is www.TerraUniversal.com.
Alternately, banks of HEPA filters can be mounted in air-handling units outside of the cleanroom. Filtered air is pumped to the cleanroom and then returned and circulated through the filter banks. This method typically provides over-pressurization of the room.
References
BACK TO TOP
How does exposure occur when hazardous drugs are mixed in Biological Safety Cabinets (BSCs)? Using traditional syringe and needle technique, drug exposure can happen through open, wet connections; through the aerosolization and vaporization of the drug during reconstitution and transfer; or through poor technique or spillage.
BACK TO TOP
No Baxa Corporation software is involved with claims adjudication processing, so it is exempt from the requirements for standard coding and message sets.
Baxa Compounding System Software Products
Rapid-Fill™ and Kwik-Vial™ Label Programs contain no individual patient health data, and therefore do not fall under the act.
Abacus™ and TPN-PC Plus™ Software maintain some patient health data, and are covered by the act. The software provides the following security features:
Based on this information, it is Baxa Corporation's view that a covered entity using our software is capable of being HIPAA compliant.
BACK TO TOP
BACK TO TOP
The HL7 interface provides accurate and real-time order tracking because the information entry into MedBoard is immediate. The clock starts ticking once MedBoard acquires the information via the HL7 interface. Therefore, the time MedBoard reports from order entry to delivery is accurate. If the orders must be scanned into the application first, the time MedBoard reports from order entry to delivery doesn’t include the time from when the order label printed to the time it was scanned into the MedBoard Application. However, once the order is scanned into MedBoard, the application reports the accurate timing to process that medication order.
BACK TO TOP
N.B. There have also been recorded incidents of wrong route errors by parents/carers at home injecting oral medication including poorly dissolved crushed tablets. Enteral feeding at home has also increased substantially in recent years.
All tube fed patients where an IV syringe is currently used must only use an oral/enteral dispenser in the future.
As this is just advice, do the healthcare providers have to take notice? They could choose to ignore it, but as there have been incidents, it would be unwise not to take action.
Baxa Dispensers can be washed and reused if required, making them more cost-effective where multiple use of syringes is permitted. They have been tested through 30 washing cycles without significant loss of performance.
None of the Baxa Oral/Enteral Dispensers are marked single-use on the barrels or on the outer wrappers meaning they can be reused if Trust policy allows it. However, most competitor dispensers are single use and are marked as such. Reuse of a product marked as single use is officially discouraged.
When the reuse factor is taken into account, Baxa Oral/Enteral Dispensers are actually more cost-effective than single use IV syringes.
BACK TO TOP
BACK TO TOP
The JCAHO position is appropriate given the low risks posed by syringe infusers such as the MicroFuse Infusers. These units are intended to replace gravity-controlled minibags and IV push for small-volume IV therapies, and are not designed for the general use and critical care applications referenced in the guideline.
BACK TO TOP
Common indications for TPN administration include:
BACK TO TOP
What is
USP <797> is a chapter in a book, specifically chapter 797 in the United States Pharmacopoeia (USP). The title of the chapter is Pharmaceutical Compounding – Sterile Preparations. In the past, compliance with guidelines for sterile pharmaceutical compounding was voluntary. USP <797> set the first enforceable standards for sterile compounding. The primary objectives of the chapter are ensuring sterility and accuracy of compounded sterile preparations or CSPs.
Who is affected by
Anyone – in any practice setting – involved with sterile compounding is affected by chapter 797. Physicians, nurses, pharmacists, dentists, technicians – anyone who compounds sterile medications or pharmaceutical products – are subject to 797. Your state professional board has either reviewed, or is reviewing, chapter 797. Regulations may be passed affecting how your profession practices sterile compounding.
What is the scope and intent of
Chapter 797 deals with the pre-administration manipulations for sterile compounding in specific areas such as the whole arena of compounding, transportation and storage of sterile compounds. It is important to note that the IV drug administration itself is not covered by 797, other than some basic issues about handling the preparation once it leaves the pharmacy. However, that does not absolve the healthcare practitioner from putting appropriate beyond-use dating (BUD) on products due to the chemical or physical characteristics of the drug.
BACK TO TOP
Thirty to 60 seconds, depending on the medication.
The ValiMed Cuvettes require a 0.25 mL sample to perform the validation.
The unit is 21 inches wide by 9 inches high and 10 inches deep. The device is deployed with a keyboard and mouse but these are not required for day-to-day operation.
No. The drug sample will not be used for patient delivery so it does not need to remain sterile.
Yes, a record is stored for each test that is performed. This data can be retrieved through different forms of reporting.
This is the list of drug ‘signatures’ that have been created for users. As of March 2006, there are 90 signatures on file.
A signature is the comparative file that the ValiMed System uses to validate the medication sample. The signature represents a specific medication, concentration and diluent combination. For example, Vancomycin 10 mg/mL in D5W and 10 mg/mL in normal saline would be two separate signatures. Vancomycin 5 mg/mL D5W and Vancomycin 10 mg D5W would be two signatures.
A facility sends its medication samples to the ValiMed Lab. The lab team tests the sample with different UV light wavelengths to determine its unique signature.
About a week. Customers are asked to provide the drug sample necessary for creation of the signature.
No. Because the ValiMed Systems fluoresces the entire compounded sample, there are too many variables with an unlimited number of drug type, strength and diluent combinations to create TPN signatures.
There is no limit to the number of signatures that can be loaded. Currently, users have an average of 20 signatures loaded. University of Michigan is using 32 signatures and estimates they could use up to 70. Some users have found that work flow is optimized by dedicating individual ValiMed Units to specific functions (i.e., narcotic validation or high-impact drug testing) rather than loading all necessary signatures onto a single device.
The standard contract includes up to 30 signatures. Users may purchase additional signatures from Baxa if the need arises after implementation.
Yes, as long as the ingredients have consistent doses. In the lab we have validated up to four medications in a sample.
Elements do not fluoresce well in the ultraviolet range. We are working on a solution to validate potassium.
The ValiMed System does not currently validate TPN's; very dilute Sufentanil, Remifentanyl and Alfentanyl; Fentanyl less that 50 mcg/mL; potassium and phenylephrine. Additional work also needs to be done to validate some chemotherapy drugs. We are working on technology that will allow us to expand the medications that can be validated by the system.
In the Tucson lab, the ValiMed System has been able to validate both suspensions and oral liquids. As with any new drug, testing is necessary to confirm it can validate the medication.
The lab is continually reviewing medications and creating new signatures. The list of medications is determined by customers and qualified prospects.
We are currently working on a study to determine the specific variations for each tested medication.
We are currently averaging 90 days from contract signing to go-live for determining signatures and any necessary validation.
Our implementation specialist works with your facility team to review the work flow and medications to be verified. Medications samples are sent to the ValiMed Lab for creation of any new signatures. The requested signatures are then loaded onto the system and we set up the installation date and expectations.
Technical Support is available by phone during normal business hours. The ValiMed Units have limited warranty coverage for the duration of the lease period.
Not directly. Hospitals have the option of sending samples to a testing lab (for example HPLC testing averages $300 per test and three weeks for a response) or using a refractometer for validation.
Refractometers measure how much a specific substance bends light. Refractometers identify a sample’s refractive index; they do not identify the substance itself. Therefore, it is limited by the fact that multiple substances may have the same refractive index (for example, fentanyl and sterile water).
ValiMed uses a different technology (UV fluorescence) to confirm both a specific medication and its concentration, therefore providing a qualitative validation versus a referential identification.
Yes, for accuracy testing and no, for sterility testing.
No.
The ValiMed Technology has not been challenged in court. The ValiMed System should be used as a screening tool. When a sample comes back 'Not Validated,' it should be sent to a lab for third-party validation if it will be necessary to have legal backup.
ValiMed is used as a screening tool or to gather statistics. If a problem is suspected and validated, more documentation should be gathered to support the findings.
No, not at this time.
BACK TO TOP
Closed System Drug Transfer Devices FAQs
HIPAA Compliance Statement
Latex-Free FAQs
MedBoard FAQs
National Patient Safety Agency Guidelines Q & A
Rapid Rate Infuser FAQs
Syringe Infusion FAQs
Total Parenteral Nutrition (TPN) FAQs
USP <797> FAQs
ValiMed FAQs
Cleanroom FAQs
The USP General Chapter 797 on compounding sterile preparations makes some specific recommendations regarding cleanliness and cleanrooms. While it does not specifically require a cleanroom for sterile compounding, the guideline does require that sterile compounding take place in a separate area that meets a defined level of cleanliness. Many pharmacists have expressed concern about cleanrooms and their requirements in an attempt to clarify the requirements for USP 797 compliance. These Frequently Asked Questions are intended to provide a general understanding of what cleanrooms are and how they are monitored.
What is a cleanroom?
ISO 14644, the internationally recognized cleanroom standard defines it as, "A room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particulates inside the room, and in which other relevant parameters, e.g., temperature, humidity, pressure, are controlled as necessary." The key word in this definition is "controlled." Personnel and housekeeping access, air quality, pressure, temperature, humidity and microbial contamination are all likely candidates for control in a cleanroom setting. Control in this context means that a selected parameter is governed by procedure and practice, is routinely measured, and prescribed action taken if that parameter exceeds predetermined limits.What is a clean zone?
"A dedicated space in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the zone, and in which other relevant parameters, e.g., temperature, humidity, pressure, are controlled as necessary." See ISO 14644.How are cleanrooms and clean zones classified?
There are nine classes of cleanrooms specified in ISO 14644. These classifications are based upon particle counts within one cubic meter of room air. ISO Class 1 is the highest or cleanest rating. ISO Class 9 is the lowest possible rating.In a hospital pharmacy context, USP 797 requires the maintenance of ISO Class 5 air quality. Below are the particle count requirements for ISO Class 5*:
What sorts of materials are used in cleanroom construction?
Floors may be constructed of standard sheet vinyl or 12" square material. They must be smooth and easy to clean. Cove bases - where the floor meets the wall - are critical and non-standard material. Special 12" rubber material can be used here. Whatever the material, these corners must be gradually rounded so they do not harbor debris and organisms and are easily cleaned.Walls may be standard drywall construction, primed and sealed. At a minimum a good quality washable enamel paint is recommended. Anti-microbial paints are available and may be a worthwhile expenditure. Acoustic ceilings require special cleanroom ceiling tiles. These tiles are vinyl coated to prevent debris generation and can be wiped down. Cleanrooms are sealed areas. Doors and windows must be gasketed to prevent leaks.
There are a number of suppliers for modular cleanrooms, hoods and cleanroom supplies. One source is www.TerraUniversal.com.
How are particles counted?
Particle counts can be accomplished using air and surface test kits that are collected and sent for verification, or through automated particle counters. Firms that do the certification for laminar flow hoods and biological safety cabinets often have this capability as well. A number of firms provide environmental monitoring services. There are also a variety of equipment options. For background on particle counting, see http://www.particle.com/whitepapers_met/iaq.htm.What are air turns or air changes?
Based on a calculation that includes the room size and the air volume pumped into the room over a unit of time, the number of times that the entire air volume in the room is exchanged can be calculated. Typically, this is expressed as air changes per hour. For example, at Baxa, our ISO Class 8 cleanroom does about 40 air changes per hour.Why are particles a problem?
Airborne particles provide a ride for microorganisms, as well as food and surface area on which to reproduce. Outside of the microbial load, particulate that makes its way into IV solutions presents a challenge to the patient's organs and vascular system. Particulate undetectable by visual inspection can cause phlebitis or iatrogenic disease. People are the biggest contributors of particulate contamination.What sort of monitoring is usually done in cleanrooms?
Typically, airborne particles, airborne viables, surface viables, pressure, and temperature are all monitored. The risk level of the compounded sterile product (CSP), the nature of the room, its history, people load, and other variables need to be taken into account when establishing the monitoring frequency.What gives me the right to claim that my cleanroom meets ISO 14644 standards?
ISO 14644-4 specifies design construction and start-up. In order to classify a cleanroom, a qualification or validation must be done. There are three phases of qualification, which demonstrate that the cleanroom meets the requirements for the desired class. These three phases are: As Built, At Rest, and Operational. As Built is an empty room. At Rest is the room, plus tables and equipment etc. Operational is the room, the equipment and the people working at normal tasks. Note that USP 797 does not require a cleanroom that meets ISO Class 5 requirements. What it does require is that air quality to which CSPs are exposed be at least at the ISO Class 5 level.Do I need procedures for a cleanroom?
Yes, typically you would find the following procedures helpful in an effective cleanroom program:- Cleanroom definition or specification document. This describes the room, how it will be used and why it is adequate for the intended use.
- Cleanroom monitoring procedure. This indicates how and when you will perform environmental monitoring and includes a record of your monitoring activities.
- Cleanroom entry procedure. The "rules" for authorized entry, gowning, hair covering, hand washing, what materials are and are not allowed.
- Cleanroom housekeeping procedure. The guidelines for how you clean, approved cleaning agents, the frequency for cleaning, and a record of when it has been done.
- Cleanroom alert and action limits should be established, as well as what to do in the event of a power outage or other shutdown.
- An annual re-certification must be performed and documented.
What are HEPA Filters?
HEPA means High Efficiency Particulate Air. HEPA filters are disposable, extended-media, dry-type filters in a rigid frame, with a minimum particle-collection efficiency of 99.97% (that is, a maximum particle penetration of 0.03%) for 0.3 µm particles of thermally generated DOP or specified alternative aerosol.How is cleanroom air filtration accomplished?
There are two common filtration methods. Both employ HEPA filters. Fan Powered HEPA Filtration uses motorized ceiling-mounted units that filter the air. The units fit neatly into an existing acoustic ceiling grid. This method does not pressurize the room and is the more inexpensive approach.Alternately, banks of HEPA filters can be mounted in air-handling units outside of the cleanroom. Filtered air is pumped to the cleanroom and then returned and circulated through the filter banks. This method typically provides over-pressurization of the room.
References
- Control of Particulate Contamination in Healthcare Manufacturing, , Barber, Thomas A., Interpharm Press, ISBN 1-57491-072-8
- HEPA Corporation, www.hepa.com.
- ISO 14644 Cleanroom Standards (4 documents)
- Cleanroom Design, Whyte, W., ISBN 0471 942049.
BACK TO TOP
Closed-System Drug Transfer Devices FAQs
NOTE: Healthcare workers should follow NIOSH guidelines in any hazardous drug handling procedures.How does exposure occur when hazardous drugs are mixed in Biological Safety Cabinets (BSCs)? Using traditional syringe and needle technique, drug exposure can happen through open, wet connections; through the aerosolization and vaporization of the drug during reconstitution and transfer; or through poor technique or spillage.
What drugs are appropriate for closed-system drug transfer devices (CSDTDs)?
Closed-system drug transfer devices are designed for use with any drugs considered hazardous. This includes not only chemotherapy, but any drugs capable of causing toxicity to people who come in contact with them. Hazardous drugs include antineoplastic or cytotoxic agents, biologic agents, antivirals, and immunosuppressants. For a current list, reference the NIOSH Alert, “Preventing Occupational Exposures to Antineoplastic and other Hazardous Drugs in Health Care Settings” at www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165sum.pdf. In addition, OSHA recommends that all investigational agents be regarded as potentially hazardous until testing documents their safety.How long does it take a Pharmacist or Technician to learn how to use closed-system drug transfer devices and return to the rate of preparation they were at before they started?
Using closed systems will normally slow down the preparation time one or two weeks before the staff gets used to it and achieves the same rate of preparations again.What is the difference between closed-system drug transfer devices and chemo pins?
CSDTDs are closed systems that prevent drug contact with the atmosphere. Chemo pins and vent needles are open systems with wet connections designed to filter particles, not vapor.How do I dispose of the CSDTD components?
Closed-system drug transfer devices should be disposed without disconnecting the components according to your normal chemo waste procedures.Do I need to wipe CSDTDs with alcohol before connecting them?
Closed-system drug transfer devices are sterile in their original packages. Their connections can be wiped with alcohol swabs prior to use according to your facility’s policy guidelines.Do I still need to double glove if I am using CSDTDs?
OSHA recommends using double gloves when handling hazardous drugs.Do I still need to use a biological safety cabinet if I am using CSDTDs?
Although research has shown a dramatic reduction in environmental exposure with the use of closed-system transfer devices, OSHA recommends the use of a Biological Safety Cabinet when handling any hazardous drugs.BACK TO TOP
HIPAA COMPLIANCE STATEMENT
Baxa Corporation designs and sells software for pharmacy labeling, total parenteral nutrition calculation and solution order entry. We are not a covered entity under the Health Insurance Portability and Accountability Act (HIPAA), however we may act as a Business Associate in the provision of technical support related to our compounding system hardware and software. In order to assist our customers in assessing their risk related to the use of Baxa software, we offer the following compliance information.No Baxa Corporation software is involved with claims adjudication processing, so it is exempt from the requirements for standard coding and message sets.
Baxa Compounding System Software Products
Rapid-Fill™ and Kwik-Vial™ Label Programs contain no individual patient health data, and therefore do not fall under the act.
Abacus™ and TPN-PC Plus™ Software maintain some patient health data, and are covered by the act. The software provides the following security features:
- Database changes are audit trailed.
- Users are individually identified and authenticated using a unique user ID and password.
- Users are given permissions to restrict their access only to the areas they need.
- The applications automatically log users off after periods of no activity.
- Database changes are audit trailed.
- Users are individually identified and authenticated using a unique user ID and password.
- Users are given permissions to restrict their access only to the areas they need.
- The application automatically logs users off after periods of no activity.
- Users are individually identified and authenticated using a unique user ID and password.
- Users are given permissions to restrict their access only to the areas they need.
- Application automatically logs users off after periods of no activity.
Based on this information, it is Baxa Corporation's view that a covered entity using our software is capable of being HIPAA compliant.
BACK TO TOP
Latex Free FAQs
Latex Free Statement
Baxa Corporation is committed to providing customers with non-latex products wherever possible. Currently all of our medical products and equipment are latex free. We do, however, sell labels that contain synthetic latex in their adhesive. These labels are not for direct patient contact, but are used to identify drug container contents. The following label products may contain synthetic latex in their adhesive: Label-Ease Labels; Order Nos. 631, 633, 634, 635, 636, 637, 638, 639 TPN PC Plus Labels; Order No. 03-0505 TPN Labels; Order No. DPS-TPN-2-1BACK TO TOP
MedBoard FAQs
What is MedBoard?
MedBoard is a HIPAA-compliant, Web-based medication tracking system. Using handheld barcode scanners, with MedBoard hospital pharmacies are able to record order preparation and delivery activities quickly and efficiently. This information is transmitted wirelessly to a secure Web site that displays the real-time status of orders throughout an organization.How can the MedBoard Medication Tracking System help me?
MedBoard will help your facility:- Improve Productivity – Use the customization features to prioritize order preparation, pharmacist check and delivery dynamically.
- Reduce Waste – Easily identify time-sensitive orders that have not been checked or delivered within a specific time frame.
- Reduce Diversion – Quickly identify orders that have been prepared but not delivered, including identification of the last to handle the order.
- Enhance Communication – Reduce the time spent fielding calls from nursing and tracking down order status. Nurses can view the status for all deliveries to their unit simply by logging on to the secure Web site.
- Demonstrate Performance – Use the built-in reports to quantify delivery times by order type, nursing unit, employee and more.
Which orders are tracked in the MedBoard System?
Generally, all orders that are not tracked in the automated dispensing system are tracked using MedBoard, many of which are the more expensive medications. These doses include:- First fills
- Stat orders
- Compounded items
- Irregular size items
What is the typical workflow with the MedBoard System?
The chart below details a typical workflow:How does information get from the scanner to the Web site?
- The barcode scanner can transmit the data over the facility’s wireless network.
- The barcode scanner can be placed in a dock and transmit the data using the computer’s network connection.
- A wired/tethered scanner that is connected to a computer can transmit the data using the computer’s network connection.
How is the information displayed once the scanner transmits the data?
The main page of the application displays all orders that meet certain criteria. These criteria are user-defined. For example, the pharmacy may wish to view all in-process orders, whereas 3 South may only view orders for that unit. The following fields are displayed on the main page:- Category: Displays whether the order is Overdue, Approaching Overdue, In Progress, Delivered, Canceled, or Returned.
- Priority: This is a customizable field. Standard priorities are Stat, Now, and Routine.
- Nursing Unit: This is a customizable field, and is configured during setup.
- Drug: This is taken from the pharmacy system.
- Location: This is a customizable field, and is configured during setup. It displays the last known location for the order.
- Status: This is a customizable field. Standard priorities are:
- Awaiting preparation
- Prepared, awaiting pharmacist check
- Checked, awaiting delivery
- Delivery in progress
- Delivered
How can nurses use the MedBoard System?
If you decide to give the nursing staff access to MedBoard, they will see only orders for their floor. Note: Patient names can be removed from the nursing view, in order to ensure HIPAA compliance.What do I need to get started?
All you need is a Web browser (Internet Explorer 6.0+ is preferred) and handheld scanners with Windows CE Software, Version 5.0 or higher.What is the implementation process?
We recommend that MedBoard be implemented as an Internet application; however we also support intranet installations. In most cases, MedBoard may be implemented in just a few weeks. The typical implementation will follow these steps:- Definition: During this phase, a Technical Support representative will work with you to define the customizable elements of the MedBoard System, including:
- Users and permissions
- Order priorities and associated alarm features
- Nursing units
- Delivery locations
- Status fields
- Identifying changes to priorities
- High priority rules/alerts
- Build: During this phase, developers configure your handheld devices and customize the account to include your rules, lists, users, and more. We also provide you with laminated copies of barcodes for units, locations, etc.
- Integration: If you elect to integrate MedBoard with your employee directory, pharmacy system, or ADT system, we begin establishing the interface at this stage. We will work with your IT department to configure the VPN connection between your facility and our servers.
- Testing: At this stage, we work with your pharmacy and IT departments to ensure that the system and interfaces are working appropriately.
- Training: We provide in-depth Web training sessions for the administrators of the MedBoard System. Periodic Web training sessions are provided for all staff at all facilities.
- Rollout: We provide you with materials for internal promotion and getting started to support your rollout plans.
What do we need for an intranet installation?
A Windows server capable of running Ruby on Rails, Mongrel, and PostgreSQL, and the ability for Baxa to access the server via a VPN connection.How does MedBoard work with an HL7 interface?
After an order is entered, information about the order is automatically communicated to the MedBoard application via the HL7 interface. Without the HL7 interface, this same step requires the user scan the medication order into the MedBoard Application.The HL7 interface provides accurate and real-time order tracking because the information entry into MedBoard is immediate. The clock starts ticking once MedBoard acquires the information via the HL7 interface. Therefore, the time MedBoard reports from order entry to delivery is accurate. If the orders must be scanned into the application first, the time MedBoard reports from order entry to delivery doesn’t include the time from when the order label printed to the time it was scanned into the MedBoard Application. However, once the order is scanned into MedBoard, the application reports the accurate timing to process that medication order.
What are the benefits of using an HL7 interface with MedBoard?
Once the order is entered into the pharmacy information system, an HL7 interface allows the user to immediately and seamlessly track medication orders through the preparation process.- The HL7 interface does not depend on human interaction to get medication orders into the MedBoard application.
- Information is acquired immediately – allowing MedBoard to accurately report pharmacy service levels, such as preparation times and delivery times.
How do I know your Internet version is secure and HIPAA compliant?
All system access is through password-protected user accounts. Through technical, administrative and policy safeguards we are able to ensure the security of your data. Here are a few examples:- A VPN is established between the facility and the MedBoard servers to ensure private communication.
- Data transmission uses 128 bit SSL encryption
- Continuous monitoring
- Intrusion detection
- Virus alerts
- Custom patching
- Security audits
- Periodic backups
- Criminal and financial background checks
- Commitment to ISO 17799
BACK TO TOP
NPSA GUIDELINES
Background The NPSA guidelines released on 28th March 2007 are aimed at healthcare providers, and provide advice on making sure oral liquid medicines are delivered safely. The aim is to remove any confusion between IV syringes and oral/enteral syringes and avoid incidences of ‘wrong route’ error either from inadvertent injection of oral medication or confusing feeding lines and IV lines.Who are the guidelines specifically aimed at?
Healthcare providers on neonatal, paediatric or other wards where the possibilities for confusion between IV and oral/enteral administration are most likely.N.B. There have also been recorded incidents of wrong route errors by parents/carers at home injecting oral medication including poorly dissolved crushed tablets. Enteral feeding at home has also increased substantially in recent years.
Which patients does this affect?
Paediatric/neonatal patients who may have oral medication delivered directly into the mouth using a dosing device. They will now have to use an oral/enteral syringe.All tube fed patients where an IV syringe is currently used must only use an oral/enteral dispenser in the future.
As this is just advice, do the healthcare providers have to take notice? They could choose to ignore it, but as there have been incidents, it would be unwise not to take action.
Do the Baxa Exacta-Med® Oral/Enteral Dispensers comply with the guidelines?
Yes, the 17XX range of products have purple plungers and clear labelling to denote oral/enteral use only. All products are validated for single patient reuse, and are packaged sterile. There are three tips available:- Oral tip (to fit oral ports). Sizes 1mL – 50/60mL (#1701/1702/1705/1710/1720/1790)
- Catheter tip (to fit male luer lock ports). Size 50/60mL(#1750)
- Female luer-lock tip (to fit catheter ports). Size 50/60mL (#1760)
Are there any exceptions?
Yes, #1770 and #1780 50/60mL Dispensers with luer tips do not comply with the guidelines and these will be discontinued. The Baxa nasogastric adaptor, #13005 will also be discontinued as it converts an oral tip to a male luer tip.How does this affect the Baxa non-sterile Exacta-Med Dispensers?
Baxa non-sterile, white plunger products with either a clear barrel (#11XX range) or an amber barrel (#16XX range) also fall within these guidelines and will be appropriately labelled before the deadline for compliance by September 30th 2007 if not sooner.How do Baxa dispensers differ from others in the marketplace?
Some other dispensers have clear barrels but others are coloured and opaque which can make it difficult for nurses to see the fluid and draw up accurately. The opacity can also obscure particles and air bubbles. These difficulties has been recognised by a number of Trusts already and are not perceived positively.Baxa Dispensers can be washed and reused if required, making them more cost-effective where multiple use of syringes is permitted. They have been tested through 30 washing cycles without significant loss of performance.
None of the Baxa Oral/Enteral Dispensers are marked single-use on the barrels or on the outer wrappers meaning they can be reused if Trust policy allows it. However, most competitor dispensers are single use and are marked as such. Reuse of a product marked as single use is officially discouraged.
Are oral/enteral dispensers more expensive than intravenous syringes?
The NPSA alert makes a clear reference to pricing (see page 6) indicating that oral/enteral dispensers currently cost approximately 10 pence more than an equivalent IV syringe. The alert also mentions that they can be washed and reused which is a positive (albeit indirect) endorsement of the reuse of oral/enteral dispensers.When the reuse factor is taken into account, Baxa Oral/Enteral Dispensers are actually more cost-effective than single use IV syringes.
BACK TO TOP
MicroFuse® Rapid Rate Infuser FAQs
What is the most common application for the Rapid Rate Infuser (RRI)?
The MicroFuse RRI was designed to infuse adenosine (Adenoscan®) for cardiac stress imaging over periods of 4 to 6 minutes.How long does it take for the Rapid Rate Infuser (RRI) to infuse a full drug syringe?
The RRI pushes down the syringe plunger at one of two fixed rates. This means that each rate in mL/min is based on the syringe barrel diameter and height of the syringe as determined by the final volume. A ‘full syringe’ would be 45 mL in a B-D or Monoject 60 mL syringe, 30 mL in a B-D 30 mL syringe, or 51 mL in a Terumo 60 mL syringe. A full syringe infuses over 6 minutes on Rate 1. The same syringe filled 2/3 full will infuse over 4 minutes on Rate 1.Can the dose of adenosine be slowed with the RRI?
Yes, there are two fixed rates on the RRI. Frequently, the appropriate dose of concentrated adenosine is qs’d (added up to) with normal saline to a full syringe as defined above. An example of a typical desired infusion rate is 140 mcg/kg/min as the full dose infuses over 6 minutes at Rate 1. In this example, Rate 2 can be pressed at any time during the infusion to slow the infusion by 29%, which would be 100 mcg/kg/min.Can syringes smaller than 30 mL be used in the RRI?
No, the RRI’s occlusion pressure alarm system is designed for high speed infusion through large-diameter syringes. 20 mL and smaller size syringes are contraindicated in the RRI.Can the RRI be altered so that the infusion rates cannot be changed during the infusion?
Yes, there is a flow rate lockout switch inside the syringe infuser battery compartment. If the flow rate switch is turned to ‘lock’, the rate cannot be changed on the control panel on the side of the infuser.Can the RRI be used for dipyrimadole in cardiac stress testing?
Yes, doses of dipyrimadole can be further diluted in 30 and 60 mL syringes for infusion with the RRI. These doses can be infused over periods of 4 to 6 minutes depending on the syringe size and final solution volume.Can any infusion sets be used with the RRI for cardiac stress imaging?
No, the infusion sets must have an acceptable combination of length and internal diameter for appropriate administration. Sets that are too narrow or too long can cause the RRI to occlude, because the infusion is so rapid. Sets that contain too much volume waste drug, isotope and can delay therapy.Does Baxa sell specialty infusion sets for use with the RRI in cardiac stress imaging?
Yes, Baxa offers minibore administration sets with and without a Y-site for the isotope injection that address the infusion needs for this application.BACK TO TOP
Syringe Infusion FAQs
What are the most common drugs and doses delivered by syringe infusion?
Syringe infusion is a system for delivering small-volume parenteral drugs intermittently. Examples of syringe infusion drugs include cephalosporins, h1 antagonists, diuretics, penicillins, aminoglycosides, cardiac drugs, anti-emetics, steroids and other antibiotics. Most of these doses can be diluted in 1 to 40 mL volumes and infused over periods of one to 120 minutes in standard 5 to 60 mL disposable syringes.Why do facilities choose syringe infusion for delivering intermittent small-volume parenterals?
Syringe infusion provides a higher quality clinical outcome, using less nursing labor, for substantially lower material costs. Using syringes eliminates high proprietary drug and container costs, and allows pharmacies to buy economical bulk generic drug vials, reducing or eliminating minibag costs. Hundreds of millions of syringe infusion doses in the United States alone over the past 20 years continues to validate the clinical, operational and economic advantages of syringe infusion.What are the biggest barriers to implementing syringe infusion?
The labor required to make the syringes is probably at the top of the list. Syringe filling can be tedious and adding the label can be a time-consuming secondary step.Aren't the higher infuser occlusion pressures dangerous?
Occlusion pressure is not the same as infusion pressure. Syringe infusers deliver just enough pressure to overcome venous resistance and allow infusion. MicroFuse Infuser occlusion pressures are about the same (10 to 20 psi) as most large IV infusion pumps. The only way to generate high occlusion pressures is by attempting to infuse when the line is clamped. The clamped line will protect the patient from receiving a bolus of air or more serious problems. The infuser occlusion alarm stops the units from infusing.Why can't I just use my current IV pumps for syringe infusion?
Syringe infusers are designed for a single, simple purpose. They are not programmable, by design, and therefore are easy to use and require minimal inservicing. Syringe infusion is not intended to take the place of programmable pumps, but to provide an inexpensive, low-cost means for delivering intermittent, small-volume parenterals. Using syringe infusers for these drugs frees up the programmable pumps for other patients or therapies.Do the Baxa MicroFuse Infusers meet the JCAHO requirements for free-flow protection?
"Free flow" in this context refers to the unregulated flow of IV fluids to a patient. In a Special Report from JCAHO released in January 2003, Goal 5 - Improve the safety of infusion pumps, states"... this goal and its recommendations do not apply to syringe pumps or enteral pumps."The JCAHO position is appropriate given the low risks posed by syringe infusers such as the MicroFuse Infusers. These units are intended to replace gravity-controlled minibags and IV push for small-volume IV therapies, and are not designed for the general use and critical care applications referenced in the guideline.
How do I determine appropriate syringe dilutions and expirations for dose standardization to support syringe infusion?
The MicroFuse Reference Manual provides documentation on dilution and solution expiration. These reference guidelines are intended to supplement drug manufacturers' recommendations and are provided as a service to customers implementing a syringe infusion system. An extensive reference bibliography is provided in the manual as well, providing citations for further study for pharmacists requiring additional information.What other products support the effective implementation of a syringe infusion program?
Baxa offers a complete system to ensure that pharmacies are successful in implementing syringe infusion - from the MicroFuse® Syringe Infusers to comprehensive reference manuals, inservice training videos for nurses and outpatients and specialized IV admixture products. These include devices such as syringe tip caps, specialty needles and vents, the Rapid-Fill™ Automated Syringe Filler, the Repeater™ Pump for IV fluid transfer, collection bags and many more.BACK TO TOP
Total Parenteral Nutrition (TPN) FAQs
What is parenteral nutrition?
Parenteral nutrition is nutrition administered through an IV. Partial parenteral nutrition supplies only part of the patient's daily nutritional requirements, usually as a supplement to oral food intake. Many hospital patients receive dextrose or amino acid solutions by IV as part of their routine care.What is TPN?
TPN stands for total parenteral nutrition, also known as hyperalimentation. This is a complete form of nutrition, containing protein, sugar, fat and added vitamins and minerals as needed for each individual. TPN is also administered through IV infusion, usually through a central line.What are the applications for TPN?
TPN is given to patients unable to absorb adequate nutrition through their own intestines.Common indications for TPN administration include:
- Malnourishment prior to surgery
- Enterocutaneous fistula (hole in stomach)
- Renal and hepatic failure
- Sepsis
- Short bowel syndrome
- Radiation and chemotherapy
- Severe burns
- Neonates
- Conditions requiring bowel rest such as Crohn's disease, ulcerative colitis and pancreatitis
What's in a TPN solution?
2-in-1 solutions include dextrose and amino acid. 3-in-1s include dextrose, amino acid and fat. Following are common components:- Fluid: Water
- Energy source: Dextrose
- Protein source: Amino acids
- Electrolytes: Sodium, potassium, calcium, magnesium, phosphate
- Fats: Lipids
- Vitamins: A, B-complex, C, D, folic acid, multivitamin
- Elements: Copper, zinc, chromium, manganese
How are TPN solutions mixed?
Depending on the volume of solutions mixed each day at a given institution, TPN bags may be mixed manually, through an outsource partner or on automated compounding equipment.What automated compounders are used for TPN mixing?
The following equipment is in use for automated TPN solution compounding. The Abbott and B Braun compounders are out of date and no longer supported. Baxa is the only manufacturer that provides a system combining macro and micro ingredient delivery in a single compounder.- Abbott: Nutramix - 4 macro leads, Micro - 10 micro leads
- Baxa: Exacta-Mix™ 2400 - 24 macro or micro leads
- MicroMacro™ 23 - 23 macro or micro le ds
- MicroMacro™ 12 - 12 macro or micro leads
- Exacta-Mix™ 600 - 6 macro leads
- Baxter: Automix - 6 macro leads, Micromix - 10 micro leads
- Secure: Autocomp - 6 macro leads
What are possible complications of TPN therapy?
- Hyperglycemia
- Hypoglycemia
- Electrolyte imbalances
- Acidosis
- Hypertriglyceridemia
- Liver dysfunction
- Catheter-related sepsis
- Pneumothorax
- Hematoma
- Calcification of vena cava or right atrium
BACK TO TOP
USP <797> FAQs
What is 797?
USP <797> is a chapter in a book, specifically chapter 797 in the United States Pharmacopoeia (USP). The title of the chapter is Pharmaceutical Compounding – Sterile Preparations. In the past, compliance with guidelines for sterile pharmaceutical compounding was voluntary. USP <797> set the first enforceable standards for sterile compounding. The primary objectives of the chapter are ensuring sterility and accuracy of compounded sterile preparations or CSPs.Who has been responsible for development of 797 guidelines?
An expert committee of healthcare professionals from many practice settings was established by the USP to develop the guidelines for Chapter 797. A draft document was developed and comments have been collected regarding the Chapter. The process is designed to incorporate diverse views and opinions. The guidelines first became effective January 1, 2004, but this is a dynamic document that is still being reviewed and updated. Revised guidelines were published on the USP Web site on December 3, 2007 (www.usp.org/USPNF/pf/generalChapter797.html), and become official in June, 2008.Who is affected by 797?
Anyone – in any practice setting – involved with sterile compounding is affected by chapter 797. Physicians, nurses, pharmacists, dentists, technicians – anyone who compounds sterile medications or pharmaceutical products – are subject to 797. Your state professional board has either reviewed, or is reviewing, chapter 797. Regulations may be passed affecting how your profession practices sterile compounding.What is the scope and intent of 797?
Chapter 797 deals with the pre-administration manipulations for sterile compounding in specific areas such as the whole arena of compounding, transportation and storage of sterile compounds. It is important to note that the IV drug administration itself is not covered by 797, other than some basic issues about handling the preparation once it leaves the pharmacy. However, that does not absolve the healthcare practitioner from putting appropriate beyond-use dating (BUD) on products due to the chemical or physical characteristics of the drug.Does USP <797> require construction of a sophisticated cleanroom?
No. The short answer is that 797 requires sterile mixing in a properly maintained laminar airflow hood (ISO Class 5 – also known as Federal Standard Class 100, or a maximum of 100 particles per cubic foot) situated in a relatively clean room (ISO Class 7 – also known as Federal Standard Class 10,000). In other words, sterile compounding must take place in a controlled area that meets a defined level of cleanliness under dynamic conditions. For most pharmacies, this is neither a difficult, nor unreasonable expectation.What is required for sterile preparation areas?
The following basic production and process controls are required for all sterile preparation production areas:- ISO Class 5 air quality in the direct compounding area or DCA.
- Environmental controls and procedures on topics as diverse as air quality in the buffer areas, procedures for the area entry, materials movement and storage, gowning, hair covers, etc., hand washing, personnel behavior, area clearance between batches etc.
- Housekeeping procedures
- Visual controls
- Microbial and particulate monitoring
Can a pharmacy become USP <797> compliant simply by purchasing a compounding aseptic isolator(s) or CAI?
Isolators alone will not ensure compliance with USP 797. Using an isolator for sterile compounding addresses only part of the requirements for USP 797. Issues such as process validation, training, BUD determination, product quality maintenance after the CSP (compounded sterile product) leaves the pharmacy, caregiver training, patient monitoring, QA program, etc. remain the same as for products compounded in standard laminar flow hoods.Is environmental monitoring required for 797 compliance?
Yes, a comprehensive environmental monitoring program must be in place to identify trends, or points of failure, before they become critical. The intent is to address potential failures in the process when the issues are smaller and less significant. A properly constructed environmental monitoring program demonstrates that your engineering controls, cleaning procedures and overall employee training and work practices have resulted in an appropriate compounding environment that consistently maintains acceptably low microbial levels.What types of environmental monitoring programs are involved?
Air and surface sampling are two simple examples. There are numerous vendors that supply products to help fulfill this requirement.What are some examples of quality assurance programs required by 797?
- A QA plan formalized in writing. The best start is a written, procedurally accurate and current policy and procedure manual. The document should include personnel and position descriptions. Baxa Corporation provides a number of the written policy and procedures to support USP <797> compliance with its products.
- Descriptions of specific monitoring and evaluation activities, reporting and evaluation of results and identification of follow-up activities when thresholds are exceeded. It is important that individual responsibilities for each aspect of the program are delineated.
- Adequate employee training and validation of employee competency might be the most important variable in the entire 797 compliance process. Media fills to validate aseptic technique are a part of this step.
What are some examples of quality assurance practices required by 797?
- Routine disinfection and quality testing of the direct compounding environment
- Visual confirmation of personnel processes such as gowning, etc.
- Review of orders and packages of ingredients to assure correct identity and amounts of ingredients
- Visual inspection of the compounded sterile preparation
- A media-fill test procedure performed at least annually for each person
Is sterility testing required to establish BUD (beyond use dating, aka ‘expiration dates’) for compounded sterile preparations?
No. USP <797> has default maximum BUD times depending on the risk level and storage conditions of the compounded preparation. 797 only requires that there is ‘justification’ from ‘appropriate literature sources’ or direct testing for the BUD decisions that fall outside the maximum default times. Otherwise, BUDs can be assigned as described in the Chapter. Sterility and stability testing are required if the BUD exceeds the maximum default periods.What are the maximum default BUD times?
These vary by risk level and storage conditions and may be updated through the USP revision process:- Low Risk Level maximums, without sterility testing, are 48 hours at room temperature, 14 days refrigerated and 45 days frozen.
- Medium Risk Level maximums are 30 hours at room temperature, 9 days refrigerated and 45 days frozen. The refrigerated time is being changed to 9 days to help home care pharmacies ship a one week supply.
- High Risk Level maximums are 24 hours at room temperature, 3 days refrigerated and 45 days frozen.
Is there a category of ‘immediate use’ that is exempt from 797 compliance?
Yes, this category is revised from the original guidelines and there are significant restrictions in the definition of immediate use. In worse than ISO Class 5 air, simple aseptic transfer or no more than three commercially manufactured packages of sterile, non-hazardous products from the manufacturers’ original containers and not more than two entries into any one container or package of sterile infusion solution and administration begins within one hour. No hazardous drugs fall into this category.Does outsourcing IV preparation remove the institution from USP <797> compliance?
No, the healthcare facility is responsible for ultimate product quality. It is critical to verify that any outsourced IV products have been prepared under 797-compliant conditions. In addition, facilities need to comply with USP <797> for any preparations that cannot be supplied through outsourcing. Common examples include individualized doses, those subject to last-minutes changes, short-expiration drugs, some antineoplastics and other expensive and specialized drugs.What does USP <797> say about patient and caregiver training?
There must be a formalized program that includes:- Understanding of the therapy being provided
- Handling and storage of the compounded sterile product
- Appropriate administration techniques
- Use and maintenance of any infusion device involved
- A plan for appropriate follow-up for issues regarding the compounded products
Are there requirements for maintaining product quality and control once the compounded sterile preparation leaves the pharmacy?
Yes, written policies and procedures are required for:- Packaging, handling and transport of chemo toxic and hazardous preparations
- Use and storage of the ingredients and final products
- Compounded sterile preparation administration on topics such as hand washing, aseptic technique, site care etc
- Education and training of patients and caregivers
Where can I get additional expert training about USP <797> and specific help on how to become compliant?
There are numerous professional and commercial organizations with products and services to help. The ASHP Web site (www.ashp.org) has a compounding resource center offering written materials on compliance. Baxa Corporation has a unique opportunity through its STAR (Skills Training, Academics and Resources) Center located at its Denver-area headquarters. There, two and one-half day hands-on USP <797> classes are offered in a purpose-built pharmacy training facility. Industry experts teach small classes offering real-life solutions for USP 797 compliance. Please see www.baxa.com/starcenter for more information.BACK TO TOP
ValiMed™ Medication Validation System FAQs
How long has the ValiMed Technology been in use?
The first ValiMed System user, Dallas Children's Hospital, went live in October 2004.What technology does the ValiMed System use?
The ValiMed System uses UV fluorescence to validate medications.Do all medications fluoresce when exposed to UV light?
No. For new medications that are not in the ValiMed Library, drug samples need to be sent to the ValiMed laboratory to determine if they fluoresce. Our experience indicates that most medications do fluoresce. This lab testing determines the appropriate conditions under which to create an authentic signature.How long has UV fluorescence been used?
More than 30 years.How is the ValiMed Technology used in the pharmacy?
The validation is used as part of the QC process on drug preparations. The testing is always destructive, and no part of the ValiMed System comes in direct contact with the dose to be administered. The ValiMed Testing is one part of a comprehensive quality control process in the healthcare facility, and as such it should complement other methods of verification. ValiMed is also used to validate narcotic returns to reduce drug diversion.How can the ValiMed Technology be used in homecare?
Validating batches and individual doses for med error prevention.What does the ValiMed Technology validate?
The testing confirms a known drug sample and its concentration. The validation is a pass/fail process to confirm compounding accuracy.What are the key applications for the ValiMed System?
The ValiMed System provides medication safety for:- End product testing of high-impact medications (chemotherapy, insulin, antibiotics) and batch preparations
- Validation of narcotic returns
- Detection of counterfeit drugs
How long does it take the ValiMed to verify a medication?
Thirty to 60 seconds, depending on the medication.What is that sound that the ValiMed makes when it’s running?
The sound is the flash lamp shining UV light on the sample.Why does the verification time differ by medication?
The strength of the fluorescent signal determines the required test time (drugs with weaker signals require a longer test time, stronger signal requires a shorter test time).Can the device validate a drug directly in its container?
No, the ValiMed System requires that a sample of the test drug be removed from its container and placed in a disposable cuvette for validation. The test is destructive.
How much solution is required for a test?
The ValiMed Cuvettes require a 0.25 mL sample to perform the validation.
How big is the ValiMed System?
The unit is 21 inches wide by 9 inches high and 10 inches deep. The device is deployed with a keyboard and mouse but these are not required for day-to-day operation.
Do I need to operate the system in a hood?
No. The drug sample will not be used for patient delivery so it does not need to remain sterile.
Does the device store test results?
Yes, a record is stored for each test that is performed. This data can be retrieved through different forms of reporting.
What is the ValiMed System signature ‘library?’
This is the list of drug ‘signatures’ that have been created for users. As of March 2006, there are 90 signatures on file.
What is a signature?
A signature is the comparative file that the ValiMed System uses to validate the medication sample. The signature represents a specific medication, concentration and diluent combination. For example, Vancomycin 10 mg/mL in D5W and 10 mg/mL in normal saline would be two separate signatures. Vancomycin 5 mg/mL D5W and Vancomycin 10 mg D5W would be two signatures.
How is a new signature created?
A facility sends its medication samples to the ValiMed Lab. The lab team tests the sample with different UV light wavelengths to determine its unique signature.
How long does it take to create a new signature?
About a week. Customers are asked to provide the drug sample necessary for creation of the signature.
Do you have a signature for TPN's?
No. Because the ValiMed Systems fluoresces the entire compounded sample, there are too many variables with an unlimited number of drug type, strength and diluent combinations to create TPN signatures.
How many signatures can be on the device?
There is no limit to the number of signatures that can be loaded. Currently, users have an average of 20 signatures loaded. University of Michigan is using 32 signatures and estimates they could use up to 70. Some users have found that work flow is optimized by dedicating individual ValiMed Units to specific functions (i.e., narcotic validation or high-impact drug testing) rather than loading all necessary signatures onto a single device.
How many signatures are in the contract?
The standard contract includes up to 30 signatures. Users may purchase additional signatures from Baxa if the need arises after implementation.
Can you have more than one ingredient in a signature?
Yes, as long as the ingredients have consistent doses. In the lab we have validated up to four medications in a sample.
Can the ValiMed System recognize electrolytes (potassium chloride, sodium chloride, potassium acetate, potassium phosphate)?
Elements do not fluoresce well in the ultraviolet range. We are working on a solution to validate potassium.
What medications cannot be validated?
The ValiMed System does not currently validate TPN's; very dilute Sufentanil, Remifentanyl and Alfentanyl; Fentanyl less that 50 mcg/mL; potassium and phenylephrine. Additional work also needs to be done to validate some chemotherapy drugs. We are working on technology that will allow us to expand the medications that can be validated by the system.
Can ValiMed validate suspensions and oral liquids?
In the Tucson lab, the ValiMed System has been able to validate both suspensions and oral liquids. As with any new drug, testing is necessary to confirm it can validate the medication.
Is there a list of medications that is currently in review?
The lab is continually reviewing medications and creating new signatures. The list of medications is determined by customers and qualified prospects.
What are the accuracy tolerances associated with each medication formulation?
We are currently working on a study to determine the specific variations for each tested medication.
How long is the implementation?
We are currently averaging 90 days from contract signing to go-live for determining signatures and any necessary validation.
What is comprised in the installation?
Our implementation specialist works with your facility team to review the work flow and medications to be verified. Medications samples are sent to the ValiMed Lab for creation of any new signatures. The requested signatures are then loaded onto the system and we set up the installation date and expectations.
How is system support handled?
Technical Support is available by phone during normal business hours. The ValiMed Units have limited warranty coverage for the duration of the lease period.
Are there competitive products to ValiMed?
Not directly. Hospitals have the option of sending samples to a testing lab (for example HPLC testing averages $300 per test and three weeks for a response) or using a refractometer for validation.
What is a refractometer?
Refractometers measure how much a specific substance bends light. Refractometers identify a sample’s refractive index; they do not identify the substance itself. Therefore, it is limited by the fact that multiple substances may have the same refractive index (for example, fentanyl and sterile water).
How does the ValiMed System compare to a refractometer?
ValiMed uses a different technology (UV fluorescence) to confirm both a specific medication and its concentration, therefore providing a qualitative validation versus a referential identification.
Does ValiMed facilitate compliance to USP<797> Testing?
Yes, for accuracy testing and no, for sterility testing.
Can the ValiMed test for sterility?
No.
Will the ValiMed Technology hold up in court?
The ValiMed Technology has not been challenged in court. The ValiMed System should be used as a screening tool. When a sample comes back 'Not Validated,' it should be sent to a lab for third-party validation if it will be necessary to have legal backup.
Can an employee legally be fired if a narcotic return is not validated?
ValiMed is used as a screening tool or to gather statistics. If a problem is suspected and validated, more documentation should be gathered to support the findings.
Can I use the ValiMed System for testing the stability of drugs according to USP standards?
No, not at this time.BACK TO TOP
