FDA rolls out action plan to improve medical device safety

The FDA released The Medical Device Safety Action Plan April 17, which outlines agency strategies to better monitor and regulate the safety of medical devices.

The agency hopes the plan will spur more innovation for device safety, help identify safety risks earlier, and keep physicians and patients more informed.

“Our aim is to make sure that the new advances in technology that are enabling better capabilities and benefits are also harnessed to bring added assurances of safety, so that more patients can benefit from new devices and address unmet needs,” FDA Commissioner Scott Gottlieb, MD, said in a statement about the program.

Here are five goals the agency seeks to achieve through the plan.

  1. Establish a robust medical device patient safety net in the U.S.
  1. Explore regulatory options to streamline and modernize timely implementation of postmarket mitigations
  1. Spur innovation toward safer medical devices
  1. Advance medical device cybersecurity
  1. Integrate the FDA Center for Devices and Radiological Health’s premarket and postmarket offices and activities to advance the use of a total product life cycle approach to device safety

To learn more about the action plan, click here.

Source: https://www.beckershospitalreview.com/supply-chain/fda-rolls-out-plan-to-improve-medical-device-safety.html

Warehouse Mapping-Mesa Labs

The changing weather can greatly impact certain areas of your warehouse, and these temperatures changes may affect your product. Will temperature mapping your warehouse only once provide enough information to understand the storage conditions in the warehouse during the coldest time of the year (high use of heating) and warmest time of the year (high use of A/C) or should your warehouse be mapped multiple times so that your products are not potentially damaged?

Mesa’s Compliance and Validation Services experts will work with you and your team to review every potential variable that may impact the viability of your product. We will determine the risk factors by considering all HVAC activity and control, loading dock location and activity to develop criteria for and execution of a thermal mapping.

We will also establish acceptance criteria. The temperature and relative humidity acceptance criteria for each product is determined by testing conducted per the FDA Guidance Document – Stability Testing of New Drug Substances and Products, or similar guidance. The data logging system will be determined, a diagram will be developed, and the length of the study will be defined. Finally, Mesa experts will place the data loggers in the appropriate locations throughout your warehouse and collect the resulting data.

By performing regular mappings of your warehouse, you can greatly reduce the risk to your products by varying temperatures when the seasons change.


Fedegari Group was chosen as the preferred supplier of contamination control systems for a multinational pharmaceutical company with a new sterile antibiotic powder plant. The main challenges of the customer were to optimize the powder filling process and benefit from the cost-effectiveness of process integration with the best ergonomic design for the operators as well as ensuring a reliable and safe pharmaceutical process.


Cost-effective Solution for Filling Al-kegs with Sterile Antibiotics

Fedegari Engineering Team has worked with the customer for developing the most efficient and reliable solution that would allow to fill the containers (kegs) in the safest way for the product and for the operators. The outcome is a complete plant that combines in a modular way various subsystems which have been individually tested by Fedegari for different applications thus minimizing the risks typically associated with novelties. The solution also represents the most compact design for this type of operations.


Filling Al-kegs with Sterile Antibiotics

Fig. 1 – Removing the Al-kegs from the washer rack


Fedegari was choosen as the only manufacturer able to supply the process equipment (Washer-sterilizer) integrated with RABS and surface bio-decontamination with hydrogen peroxide MAL (Material Air-Lock).

The Project

A Washer-sterilizer integrated with RABS and bio-decontamination with hydrogen peroxide MAL applied to the system. The washer unloads on module 2 – RABS.

Module 1: Washing-sterilization

Module 2: Washed kegs unloading station

Module 3: Empty kegs buffer station

Module 4: Manual powder dosing, capping and bagging with automatic pneumatic lifting device. Packaging materials and tools are introduced through the hydrogen peroxide MAL connected to the module.

Module 5: Filled and packed kegs unloading station

Thema4 process controller delivered to the customer will be completely integrated with SCADA system.

Cost-effective Solution for Sterile Antibiotic Powder Filling of Al- kegs

Integrated Solution for Sterile Antibiotic Powder Filling of Al- kegs

Cost-effectiveness & Results

This solution helped the customer to achieve the desired ergonomic results on manual operations reducing the risks of contamination due to the integration of different machines connected by the RABS into one unique system managed by a single process controller.


ERGONOMIC DESIGN – Unloading system designed to work at the same level (height) throughout all the modules – from the washer to the RABS.


SIGNIFICANT TIME AND COST-SAVINGS by easily handling the kegs through sequential workflow inside the RABS.


CUSTOMIZATION – Modular & custom-made loading racks


COST-EFFECTIVENESS – Time and cost-savings on training and maintenance due to standardization of components, procedures and process controller.


Fresenius Kabi Specify Newman Vial Labeller For Reliability And Output

Newman Labelling Systems, a leading manufacturer of pharmaceutical labelling systems, has supplied a 6VAL labelling system to health care company Fresenius Kabi for use in their Port Elizabeth facility in South Africa.

The 6VAL labelling system is designed to apply both clear and paper self-adhesive labels to a range of rigid cylindrical containers. At Fresenius Kabi it is being used to label 2ml vials of PETOGEN 150mg/mL Injection. The well proven 6VAL container handling system is specifically designed for handling unstable containers such vials, in addition to ampoules, syringes and cartridges, at speeds of up to 275 containers per minute.

The 6VAL has been supplied by Newman with a PCE Pilot Optical Character Vision and Optical Character Recognition system and a Videojet Dataflex Thermal Transfer Coder with colour screen for printing batch and expiry dates.

Fresenius Kabi’s decision to purchase the 6VAL was based on a combination of machine quality and capability, plus the reputation of Newman Labelling Systems both within the company and the industry at large. Jeremiah Thorne, Project Engineer at Fresenius Kabi, explains: “We were impressed by the output capacity of the machine, the presence of a unit rejection station, 2D barcode scanning option and the fact that it is cGMP compliant. We also liked Newman’s ability to supply the machine with OCV and OCR options.

“The other consideration in our decision was the brand name and the manufacturer’s expertise when it comes to developing and manufacturing labelling equipment for vials and ampoules. Newman’s machines have proved to be reliable and Newman has always provided a professional, efficient and helpful service, which has led us to standardise on them in our factory. “

PDA Journal of Pharmaceutical Science and Technology

Mr. Andrea Simonetti (Senior Manager, Strategic Initiatives at Bonfiglioli Engineering) and Mr. Filippo Amari (Continuous Improvement Manager at Novartis Vaccines) authored an article on presenting an unprecedented case study conducted on Pre-filled Syringes. This work is an example of excellent collaboration between the two companies.
The following link takes you to the article published on the 2015 January/February issue of PDA Journal of Pharmaceutical Science and Technology: http://journal.pda.org/content/69/1/108. If you need more information on this, please contact us.

The case study presented in this publication, investigated the capability of four CCI testing methods to detect simulated defects of different sizes and types on glass syringes, prefilled both with drug product intended for parenteral administration and sterile water. The drug product was a flu vaccine (Agrippal, by Novartis Vaccines, Siena, Italy). Vacuum Decay, Pharmacopoeial Dye Ingress Test, Novartis Specific Dye Ingress Test and High Voltage Leak Detection were, in succession, the methods involved in the comparative studies. The case study execution was preceded by the preparation of two independent sets of reference pre-filled syringes (PFS), classified, respectively, as examples of conforming to closure integrity requirements (Negative Controls) and as defective (Positive Controls).

Positive Controls were, in turn, split in six groups, three of which with holes laser-drilled through the PFS glass barrel, while the other three with capillary tubes embedded in the PFS plunger. These reference populations were then investigated by means of validated equipments used for CCI testing of the PFS commercial production; data were collected and analyzed to determine the detection rate and the percentage of false results. Results showed that Vacuum Decay method had the highest performance in terms of detection sensitivity and also ensured the best reliability and repeatability of measurements. An innovative technical solution, preventing possible PFS plunger movement during CCI testing execution, was presented as well.


Source: http://www.bonfiglioliengineering.com/news-events/460/pda-journal-of-pharmaceutical-science-and-technology.html

FDA Warning Letter- Hospira Inc

One of the most common reasons for an FDA recall or a 483 warning notice are the inspection failures. There has been an increase in recalls due to visual defects lately. This is driven by recalls for particles, especially glass particles. Increased regulatory activity is pushing an upward spiral with companies taking increasingly conservative actions and recalling batches that would have been acceptable in the past. In the absence of good clinical studies on the risk posed to patients by small numbers of visible particles, we must base any risk assessment on anecdotal reports. It also has led to a wide range of differing practices within the industry, often based on a company’s recent regulatory experience. Among them the most common omissions are in the manual visual inspection of the final product. Beside visual inspection roles being the most responsible work positions, they are among the least liked work duties in a plant.

Manual visual inspection relies on the capability of the inspector, his level of attention and concentration, thus making this role the one that is most prone on mistakes and failures. Big portion of these types of mistakes lays in the size and detectability of the contamination and the level of structure anomalies of the container, because the level of anomalies is often undetectable by the naked eye.

Human manual inspectors, also suffer fatigue and require frequent breaks to maintain a high performance level. These limitations all lead to greater variation in manual inspection results, but this variation can be minimized through good training and operating procedures.

With visual inspection being a mandatory practice, Life Scientific, Inc. offers you a wide variety of visual inspection automation solutions that guarantee, quality, high level of productivity and patient safety.

Installing an automated visual inspection process in your facility over the manual visual inspection will most likely lower the odds of an unwanted 483 warning letters for visual inspection malfunctions or even FDA recalls.

Even the most experienced and the better trained inspectors are prone to mistakes and can fail. Recent FDA warnings and recalls are related to a Pfizer – McPherson affiliated pharmacy, even though the parent network is one of the three PDA licensed companies to provide visual inspection training and testing.

Limit the failures to minimum by upgrading to an automated or semi – automated visual inspection solution.  Have more questions? Leave a comment or send an email to info@Lsi1.com, or contact 800-829-5741.

Compliance and Validation Services Expert Spotlight From Mesa Labs

Mesa Labs’ Compliance and Validation Services Team has more than 14 years’ experience in:

  • IQ/OQ/PQ qualifications and temperature mapping of incubators, freezers, refrigerators, autoclaves, depyrogenation ovens, and lyophilizers.
  • Cleanroom qualifications, including viable and non-viable particulate monitoring for routine monitoring and ability to determine the placement of the non-viable particulate measuring equipment to meet ISO, FDA and EU requirements.
  • IQ/OQ/PQ qualifications of manufacturing equipment, e.g. reactors, mixing vessels, homogenizers, fluid beds, filter dryers, etc.

The experts are certified in Consumer Products & Quality Assurance Microbiology with the National Registry of Certified Microbiologists (NRCM).

Mesa Labs has teamed up with Life Scientific since the new agreement, to provide their expertise and services to Life Scientific customers.

All of Mesa’s final packages are completed to meet cGMP/GDP/GLP requirements and are well organized so that data and results are correctly referenced in the protocol and easily accessible. Mesa performs all temperature mappings using DataTrace data loggers, which have NIST-traceable calibrations that were performed in our ISO 17025 accredited laboratory.  The data loggers are serviced before every project to help ensure that there are no issues encountered due to defective data loggers or lost data. In addition to temperature mapping of equipment and terminal sterilization equipment, Mesa also provides qualification/validation services for clean rooms and qualification of manufacturing equipment. http://validation.mesalabs.com/2016/11/30/compliance-and-validation-services-expert-spotlight/

New Fedegari White Paper

Fedegari conducted an R&D study that has been presented at the 2016 PDAA Universe of Pre-filled Syringes and Injection Devices, in California. Developed in collaboration with IBSA Farmaceutici Italy and Amphenol (Kaye), the study has now been transformed in a white paper, “An Innovative Way To Sterilize Hyaluronic Acid PFS.”

Check it out in Fedegari’s Website: http://www.fedegari.com/en/an-innovative-way-to-thermally-sterilize-hyaluronic-acid-pre-filled-syringes/

Fedegari receives FDA inspectors for a training on chemical bio- decontamination

See More At: http://www.fedegari.com/news/events-exhibitions/fedegari-receives-fda-inspectors-for-training-chemical-bio–decontamination

Medical Devices Seek to Prevent Strokes, Still Pose Risks

The pursuit of a safe way to prevent blood clots that lead to deadly strokes has produced two medical devices, each taking two dramatically different routes to approval.

While Boston Scientific’s Watchman waded through a decade of safety testing before finally being approved by the U.S. Food and Drug Administration (FDA) last March, the SentreHEART’s LARIAT went through the FDA’s 510(k) process, which requires far less clinical testing and is now associated with six patient deaths, according to a July 13 FDA alert.

What is the LARIAT?

The LARIAT Suture Delivery Device is a surgical tool designed to deliver a pre-tied surgical stitch (suture) to help close the left atrial appendage (LAA) during surgery in patients with irregular heart rhythm, or atrial fibrillation, to prevent stroke. The left atrial appendage is a pouch-like region of the left atrium of the heart.

Some patients with atrial fibrillation have difficulty taking blood thinners because of the risk of uncontrollable bleeding and other side effects, and LAA closure has been performed as an alternative method to reduce the risk of stroke by preventing a blood clot that might form in the LAA.
The FDA conducted a search of the Manufacturer and User Facility Device Experience database and identified 45 adverse events associated with the use of the LARIAT Suture Delivery Device through June 30, 2015, prompting the alert. The patient deaths and other complications reported included:

Laceration and/or perforation of the heart
Complete LAA detachment from the heart
Low blood pressure
Fluid collection around the heart
Cardiac tamponade
Fluid collection around the lung
Of the 45 adverse events, approximately 75 percent resulted in the need for emergency heart surgery.

According to a recent report in the Minneapolis Star Tribune, the July 13 FDA advisory has dramatically cut down on the use of the Lariat, perhaps creating an opportunity for Boston Scientific, which has spent years testing and marketing Lariat’s competitor, the Watchman. Instead of suturing the LAA as the Lariat does, the Watchman acts as a sort of plug for the appendage that becomes permanent over time, as scar tissue forms over the device inside the heart.

See More At: http://chicago-land.legalexaminer.com/uncategorized/medical-devices-seek-to-prevent-strokes-still-pose-risks/