Compliance Resources to Help you Stay Current

The Institute of Medicine has released a report that has found the FDA’s existing rules for the 510(k) clearance lacks the legal basis to be a reliable premarket screen of the safety and effectiveness.

The report has been criticized by the medical device industry while patient rights groups have welcomed its findings.

In this article, Dev Raheja, a renowned expert on Medical Devices, their software and regulatory requirements, discusses how to write effective software for medical devices, the risks, requirements and specifications.

South Korean medical device manufacturer Sometech Inc. has been sent a warning letter by the FDA on April 6, 2011, for inadequate, non-compliant CAPA, customer complaint handling and design documentation procedures, among other violations.

The European General Product Safety Directive (2001/95/EC) directive covers nearly all products sold in the European Union. It places responsibility on suppliers of consumer goods to make sure their products are safe for normal and foreseeable use. The directive also requires producers to supply consumers with relevant information that enables them to assess the risks inherent in that product.

Dr. W. Edward Deming, the architect of Japan’s world dominance in quality, used to say “working hard won’t help if you are working on the wrong things.” While this may not be quite appealing to many medical device developers, the opposite paradigm seems to make sense, which is, “working hard won’t help unless we are working on the right things.” This paradigm is a good value statement for medical devices. Therefore, we will discuss what some right things that are often overlooked are.

ISO 80369-1:2010 defines general requirements for small-bore connectors. These connectors carry liquids or gases in healthcare applications. They are used in medial devices or accessories planned for a patient’s use.

ISO 80369-1:2010 also specifies the healthcare fields in which these small-bore connectors are intended to be used.

These small-bore connectors are used in healthcare applications such as:

• Breathing systems and driving gases
• Enteral (feeding tube) and gastric applications
• Urethral and urinary tubing
• Limb cuff inflation or non-invasive blood pressure
• Neuraxial applications used in the delivery of medications to spinal fluid
• Intravascular or hypodermic applications

Small-bore connectors are non-interconnectable with:

• The cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006;
• The temperature sensor connector and mating ports specified in Annex DD of ISO 8185:2007; and
• The nipples of EN 13544-2:2002.

ISO 80369-1:2010 offers an approach to assess the non-interconnectable characteristics of small-bore connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications. It also provides an approach to reduce the risk of misconnections between medical devices with 6 % Luer connectors, and all other non-Luer (6 %) connectors that will be developed in future under this series of standards.

It does not specify requirements for the medical devices or accessories that use these small-bore connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.

Regulations

ISO 80369-1:2010 provides regulations for manufacturers on how to create a connector for their device and how to prepare for the remaining standards in the series. Sometimes multiple lines are connected to patients to deliver medicine and nutrients. The main problem is that numerous devices use the universal luer lock connector, which is a type of small-bore connector.

Through this connector, a healthcare worker could connect one device used for one application by mistake, such as a feeding tube to another device used for another application such as an intravenous fluid.

The goal of this series is to create connectors that can be used only among devices used for the same clinical application.

This standard offers manufacturers information on how to design a safe connector for just their medical devices within a specific clinical application.

Source

http://www.iso.org/iso/iso_catalogue/catalogue_ics/catalogue_detail_ics.htm?csnumber=45976&ics1=11&ics2=040&ics3=10

http://www.aami.org/publications/aaminews/Jan2011/80369.html

ISO 13485:2003 specifies requirements for a quality management system in which an organization should demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

All the requirements of this standard are specific to organizations providing medical devices, regardless of the type or size of the organization.

If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system.

If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system.

On Jan 5 and 6, U.S. Marshals seized all dental devices from Rite-Dent Manufacturing Corporation, Hialeah, Fla. They acted under a court order sought by the US Food & Drug Administration (FDA). The seizure took place as the FDA, during inspection, found serious deficiencies in the company’s manufacturing processes. The deficiencies could affect the safety and effectiveness of the products.

Seized Products

Alginate Impression Material, Ultra Impression Material, Enamel Bonding System, Pit and Fissure Chemical Curing Sealant, Tooth Shade Resin Material, Cavity Varnish, Polycarboxylate (PCA) Cement, and Zinc Phosphate Cement, all used in the practice of dentistry, are amongst the seized products.

Latest Inspection

During its Nov 2010 inspection, the FDA noticed that the company was not adhering to the current good manufacturing practice requirements. Strict adherence to good manufacturing practice requirements ensures the safety and effectiveness of medical devices. Also, the company had not obtained marketing approval from FDA for its Ultra Impression System. Incidentally, the FDA warned the company in 2005, March 2010 and May-June 2010 about these violations. It issued a Warning Letter to the company in 2005.

Regulations

The FDA is likely to revive a law that has been dormant since the 1980's, to send a strong signal to companies. The FDA gets its authority from the Park Doctrine, which allows it to seek criminal convictions for violations of the federal Food, Drug and Cosmetic Act against executives, even if they are unaware of specific manufacturing violations but are in a position of authority to prevent or correct the problems. Although the FDA is yet to bring any criminal charges against high-ranking executives, experts believe there are a lot of sleepless nights right now in the industry.

Sources:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm237894.htm

http://money.cnn.com/2010/08/23/news/companies/fda_recall_prosecutions/index.htm

The U.S Consumer Products Safety Commission (CPSC) unanimously voted the ban of the sale, resale, and manufacture of all drop-side cribs that have a side rail that moves up and down, allowing parents to easily lift their child from the crib. This follows years of deaths and injuries to the scale of around 32 infant deaths and several injuries in addition to the recall of more than 9 million cribs, all relating to the gap between the mattress and rail in such cribs. The gap poses potential danger to babies/toddlers who could get stuck, fall out, or suffocate. Users are required to replace defective cribs by the end of 2011. The new standard comes into effect in June, requiring cribs to have fixed sides.

Public accommodations such as hotels and childcare facilities are expected to comply to the ban within 12 months. The mandate of the ban is to stop drop-side cribs’ sale by June 2011.

The traditional crib that cradled millions of babies for generations has finally ended.

The new standard

The ban has received the approval of ASTM International, a globally recognized leader in the development and delivery of international voluntary consensus standards. ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence.

The Consumer Product Safety Improvement Act (CPSIA), signed into law in August of 2008, requires the agency to issue mandatory standards for infant durable products. The CPSIA requires mandatory standards and testing for durable infant and toddler products, product registration cards and a ban on the sale or lease of unsafe cribs. Cribs are among the first products for which mandatory standards were promulgated under this provision.

The mandate of the new standard expects compliance through tougher safety testing for cribs, using child mimicking in the crib. As the child gets older, more force can be applied to the crib through shaking it, running around it, or jumping up and down. The new tests’ goal is to ensure that cribs can withstand the different kinds of pressure.

Additional requirements include better labeling to reduce the instances of wrong assembly, a problem that a few have encountered.

Source

http://www.foxbusiness.com/markets/2010/12/16/cpsc-bans-drop-cribs/

http://www.msnbc.msn.com/id/40678788/ns/health-kids_and_parenting/

http://www.astm.org/ABOUT/aboutASTM.html

http://www.consumeraffairs.com/news04/2010/12/world-s-toughest-crib-standards-adopted.html

The Penumbra System Reperfusion Catheter 032 was marketed as a device used to re-establish blood supply to the brain, in patients experiencing stroke. However, the device maker Penumbra, after consultation with the FDA, issued a class I recall on their Reperfusion Catheters 032, belonging to lot F15020.

The FDA has issued a warning letter to Align Technology Inc., a company that makes a popular teeth straightener, the Invisalign system, on its failure to report information about patient side effects. The warning letter accused the company of failing to comply with FDA requirements to report serious side effects associated with medical devices. It cited some patient complaints about allergic reactions to the Invisalign trays such as swollen lips and mouth ulcers.

Reports about patients’ accidental exposure to excess radiation led to the U.S. Food and Drug Administration (FDA) investigate into computed tomography (CT) brain perfusion scans. The findings reported no malfunction when CT scanners were used correctly. The probable cause for overdose was determined as improper scanner use. Nonetheless, FDA came up with a set of steps designed to improve safety procedures. The chances of overexposure to radiation could be lessened with these steps, if the CT scanners were not used in the correct manner.

Assuring the safety and safe use of medical devices in the home is becoming an increasingly important public health issue. The U.S. Food and Drug Administration (FDA) recognizes the importance of safe, high-quality home healthcare and medical devices that are capable of meeting patients’ needs in the home.

This document announces the launch of FDA’s Medical Device Home Use Initiative. Through this initiative, FDA will take the following actions to support the safety and safe use of medical devices in the home:

1. Establish guidelines for manufacturers of home use devices;
2. Develop a home use device labeling repository;
3. Partner with home health accrediting bodies to support safe use;
4. Enhance postmarket oversight; and
5. Increase public awareness and education.

These steps will help address the challenges associated with the use of medical devices in the home and provide greater protections for patients receiving home healthcare.

FDA issued warning letter to Freeman Manufacturing Company Corporation for faulty labeling of medical devices. FDA has observed that the content in the labeling is varying from their declaration in Pre-Market Approval. They have been also charged for going ahead with commercial distribution pending PMA without notifying the agency.