Can You Use ISBT 128 for Non-Human Cells, Tissues, and Cellular Tissue-Base Product (HTC/P) Devices?

Generally speaking, you can’t use ISBT 128 for non-Human Cells, Tissues, and Cellular Tissue-Base Product (HTC/P) devices. There is one exception. You may use ISBT 128 for empty blood bags. We suggest people look at the Global Unique Device Identifier Database (GUDID) and Global Standards One (GS1) for anything that is not an HTC/P.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

Is it Acceptable to Push Back if You Disagree with a Notice of Violation or 483?

It certainly is acceptable to push back, but you need to be able to do that in a professional and politically correct manner. The best way to do that is to push back during the course of the audit or while the inspection is still in progress. If the investigator indicates that he or she has a particular concern, it is important to first understand their concerns, make sure they are not misinterpreting your quality system or your process or procedure, and make sure you have presented all your appropriate artifacts and objective evidence.

USDM does this during readiness assessments to make sure that if there are any observations, issues, or concerns being raised that the organization has had every opportunity to present proper documents or proper objective evidence. The burden is on you to make sure that you are presenting your case and defending your procedure.  FDA investigators don’t go out of the way to ask you to present all of the evidence in support of your rationale, scientific justification, or basis for your process or procedure. You can do that in a professional and politically correct manner in order to respectfully challenge them. If they’ve indicated they have an observation or a notice of violation, take that opportunity to make sure you have presented your case and presented all of your evidence.

Many issues can be resolved during the course of an investigation. If the inspection is concluded and you receive the report and there are observations there that you do not agree with or that you don’t find inaccurate, you can respond in your written response and you can indicate any additional information, artifacts, or rational. You can certainly provide additional information in the response to the Establishment Inspection Report (EIR) but in USDM’s experience, it’s better to resolve any issues while the inspection is still ongoing.  Many times you can resolve issues on the spot so they don’t show in the report as a comment or a 483.

USDM Life Sciences has a combination of over 100 years in regulatory compliance, Quality Assurance, Quality Systems and auditing. USDM’s auditors in the Global Audits Practice Team perform audits on Pharmaceutical, Biotech and Medical Device companies in the US and abroad.

With Each Submission of Data Using the Cloud System for Integration, Does Each System Need to Be Qualified? If So, How Does That Process Work?

Cloud systems must be qualified. Qualifying a cloud system is similar to the regular qualification and validation of hosting systems. This being the case, there are some nuances within the service that can be helped by selecting the vendor that best suits the needs of your business. The correct vendor can provide stable infrastructure that can be leveraged to qualify your system. Establishing a Service Level Agreement (SLA) with the vendor provides assurance that they will follow the protocol and take ownership of the system’s qualification. To ensure that nothing is adversely affected, vendors provide notice of changes. Changes made are followed by delivery notes as well as risk based testing. When qualifying a cloud system establish a SLA with a vendor that has a stable, reliable process.
The USDM Life Sciences Cloud Team is the one you can trust when looking to move applications and business processes to the Cloud. Our team of cloud experts understand compliance, validation, implementation, mobile, data security, data migration, and system integration, and we ensure that leading cloud vendors meet and maintain compliance regulations around the globe.

What is FDA Doing to Enforce the Regulation on Medical Device Manufacturers? What are the Consequences of Non-Compliance for the Provider?

Food and Drug Administration (FDA) is working very closely with all of the manufacturers so there should be few problems with compliance. Some of the manufacturers have requested extensions of 30, 60, or 90 days for various reasons but not for extended time frames. All class III packages should now be received with Unique Device Identification (UDI).

Devices within the supply chain before September 24, 2014 are not required to be re-labeled. There are also exemptions from UDI for kit and non-sterile devices, as well as individually requested exemptions by companies. An assessment of devices that should be in the Global Unique Device Identification Database (GUDID) versus how many are in GUDID will result in a percent compliance. When assessing the need to be compliant for the goods in commercial distribution with the exceptions, there is adequate explanation for why there are less than the expected amounts of devices on GUDID. After taking this into account, report any issues to the FDA so that the FDA is aware of which manufacturers they need to work with for compliance.

With regards to the provider, at this time the FDA does not have a plan to reach out to providers and investigate why the information was not provided. Jean Sargent, Vice President of Healthcare Strategy and Implementation at USDM Life Sciences, has reason to believe that this could change with time. As a case in point, 15 years ago an FDA regulation stated that hospitals could no longer make their own medical devices then sterilize them unless they registered as a manufacturer with the FDA. The FDA began  going into hospitals in order to make sure either all “manufacturing” was ceased or that the organization was approved by the FDA to manufacture products. In this case, FDA worked closely with The Joint Commission using Joint Commission’s surveyors to investigate the compliance. Jean assumes something like this could happen in relation to the current regulation.

USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.