Mallinckrodt Earns International Standard ISO 13485:2016 and Medical Device Single Audit Program (MDSAP) Certifications for INOmax® DSIR® Plus Nitric Oxide Delivery Systems
-- Achievements Indicate Mallinckrodt Meets Standards and Regulations Among the Most Comprehensive for Medical Device Quality Management Systems --
STAINES-UPON-THAMES, United Kingdom, Nov. 8, 2018 /PRNewswire/ -- Mallinckrodt Pharmaceuticals(NYSE: MNK), a leading global specialty pharmaceutical company, today announced it has received the International Organization for Standardization (ISO) 13485:2016 and Medical Device Single Audit Program (MDSAP) certifications following successful audits of INOmax® DSIR® Plus Nitric Oxide Delivery System sites, conducted by the British Standards Institute (BSI). These achievements indicate Mallinckrodt meets standards and regulations among the most comprehensive for medical device quality management systems.
INOmax DSIR Plus delivery systems are approved in the U.S., Europe and certain other countries for delivery of INOMAX® (nitric oxide) gas, for inhalation therapy into the patient-breathing circuit to provide a constant concentration of nitric oxide to the patient.1 The INOmax DSIR Plus MRI allows magnetic resonance imaging (MRI) scanner suite use with key adaptive features.2
"Mallinckrodt is committed to patient safety," said Dr. Frank Scholz, Executive Vice President and Chief Operations and Digital Innovation Officer. "We work to provide our customers quality products and services that meet or exceed the standards to fulfill the needs of the patients we serve, and we focus on continuous improvement and innovation companywide."
ISO 13485:2016 is the state-of-the-art quality management system standard for medical devices, under which an organization demonstrates its ability to provide medical devices and related services that consistently meet applicable regulatory requirements. ISO is an independent, non-governmental international organization that sets standards for compliance with industry best practices.
MDSAP regulatory certification was received for the company's two device manufacturing sites in Madison, Wis., and Port Allen, La., and the company's Specialty Brands office in Bedminster, N.J. MDSAP was established by a coalition of international medical device regulatory authorities, including the U.S. Food and Drug Administration, Australia's Therapeutic Goods Administration, Health Canada, Japan's Ministry of Health, Labour and Welfare, and Brazil's health regulatory agency ANVISA. This program enables a manufacturer to contract with an authorized third-party auditing organization to conduct a single audit to satisfy the relevant regulatory requirements of participating authorities.
In addition, ISO 13485:2016 specifically sets a new standard concerning design and development validation, indicating that if a medical device's intended use requires it to be connected to or interfaced with other medical devices(s), validation should include confirmation that all necessary requirements have been met when connected or interfaced.
Mallinckrodt continues to increase the number of third-party mechanical ventilation systems, both invasive and non-invasive, that are validated for use with the INOmax DSIR Plus. Currently, 75 U.S. validations and 86 global validations have been completed, and the company expects to achieve 6 to 8 additional validations by the end of 2018.
Extensive validations are part of INOMAX Total Care®, which also delivers a dependable supply of INOMAX gas, for inhalation therapy to hospitals; state-of-the-art bedside and transport delivery systems; services including emergency deliveries of INOMAX cylinders, delivery systems, and support components, most often within four to six hours; and around-the-clock clinical and technical support.
About INOmax DSIR Plus and INOmax DSIR Plus MRI
The INOmax DSIR uses a "dual-channel" design to provide delivery of INOMAX® nitric oxide (NO) gas. The first channel has the delivery central processing unit (CPU), the flow controller and the injector module to help ensure the accurate delivery of NO. The specially designed injector module enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and O2 cells) and the user interface including the display and a comprehensive alarm system. The dual-channel approach to delivery and monitoring permits INOMAX delivery independent of monitoring but also allows the monitoring system to shut down INOMAX delivery if the monitored NO concentration exceeds 100 ppm for 12 consecutive seconds. The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system. The INOmax DSIR Plus incorporates a battery that provides up to six hours of uninterrupted NO delivery in the absence of an external power source. The INOmax DSIR Plus includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO, which along with user supplied 10 L/min of oxygen, provides 20 ppm of NO to a patient breathing circuit. Retaining the same functionality of the INOmax DSIR Plus, the INOmax DSIR Plus MRI allows magnetic resonance imaging (MRI) scanner suite use with key adaptive features. For both delivery systems, the INOblender® can also be used for backup.
The INOmax DSIR Plus Delivery Systems deliver INOMAX (nitric oxide) gas, for inhalation. The INOmax DSIR Plus Delivery Systems must only be used in accordance with the indications, usage, contraindications, warnings and precautions described in the INOMAX package inserts and labeling. The approved patient population is limited to neonates. Refer to the INOMAX Full Prescribing Information prior to use.
- Abrupt discontinuation of INOMAX can lead to worsening oxygenation and increasing pulmonary artery pressure (rebound pulmonary hypertension syndrome). To avoid abrupt discontinuation, use the INOblender or backup mode immediately to reinstate INOMAX therapy and refer to the INOMAX package insert.
- If the high NO2 alarm activates, the delivery system should be assessed for proper setup while maintaining INOMAX delivery.
- Do not connect items that are not specified as part of the system.
- Monitor for PaO2, inspired NO2, and methemoglobin during INOMAX administration.
- If an alarm occurs, safeguard the patient first before troubleshooting or repair procedures.
- Use only INOMAX, pharmaceutical grade NO/N2.
Use in an MR Environment
- Only use a size "88" (1,963 liters) cylinder that is marked "MR Conditional. Keep cylinder at 100 gauss or less." with the DSIR Plus MRI while in the scanner room. Use of any other cylinder may create a projectile hazard.
- The INOmax DSIR Plus MRI is classified as MR Conditional with MR scanners of 1.5 or 3.0 Tesla strength ONLY in areas where the field strength is less than 100 gauss.
- This device contains ferromagnetic components and hence will experience strong attraction close to the magnet. It should be operated at a fringe field of less than 100 gauss.
- A strong magnetic field such as that from an MRI system can affect the ability of the INOmeter to detect if the cylinder valve is open. This can cause a "Cylinder Valve Closed" alarm to occur when the cylinder valve is actually open. If this alarm occurs, reposition/rotate the INOmax DSIR Plus MRI cart outside the 100 gauss area to reduce the magnetic interference in the area of the INOmeter until the cylinder handle graphic on the display turns green. This will resolve the "Cylinder Valve Closed" alarm. Typically the required INOmax DSIR Plus MRI cart location adjustment is less than 6 inches (15 cm)/90 degrees. Note that interruption of INOMAX therapy will occur one hour from the point when the "Cylinder Valve Closed" alarm is activated if the alarm is not resolved.
- Consult the Operation and Maintenance Manual, which may be found at www.inomax.com/inomax-deliverysystems/support-resources, for complete information. For technical assistance, call (877) 566-9466.
For additional information, technical assistance, or a complete list of warnings regarding use of validated ventilators, please refer to the INOmax DSIR Plus Operation Manual at inomax.com/dsirplusmanual.
About INOMAX (Nitric Oxide) Gas, For Inhalation
INOMAX is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.
Important Safety Information
- INOMAX is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood.
- Abrupt discontinuation of INOMAX may lead to increasing pulmonary artery pressure and worsening oxygenation.
- Methemoglobinemia and NO2 levels are dose dependent. Nitric oxide donor compounds may have an additive effect with INOMAX on the risk of developing methemoglobinemia. Nitrogen dioxide may cause airway inflammation and damage to lung tissues.
- In patients with pre-existing left ventricular dysfunction, INOMAX may increase pulmonary capillary wedge pressure leading to pulmonary edema.
- Monitor for PaO2, methemoglobin, and inspired NO2 during INOMAX administration.
- INOMAX must be administered using a calibrated INOmax DSIR® Nitric Oxide Delivery System operated by trained personnel. Only validated ventilator systems should be used in conjunction with INOMAX.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements concerning the INOmax DSIR Plus Delivery Systems, including expectations with regard to future validation activities and the potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
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© 2018 US-1800593 11/18
1 INOmax DSIR Plus Operation Manual. Hampton, NJ: INO Therapeutics LLC; 2014.
2 INOmax DSIR Plus MRI Operation Manual. Hampton, NJ: INO Therapeutics LLC; 2015.
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