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Ten or more samples are usually required. Incubation time is 7 days. Medical device manufacturers use microbial environmental monitoring programs to evaluate the effectiveness of cleaning and disinfection procedures and to assess the overall microbial cleanliness of their manufacturing environment. An effective program to control microorganism levels in the manufacturing environment is essential to minimize the bioburden on the medical device being manufactured and reduce potential for bioburden spikes. Spikes in the bioburden of finished medical devices can cause a reduction in the sterility assurance level for the product.

Air and surface samples are taken during routine production operations to obtain a microbiological profile of the manufacturing environment. Observation of work practices are made during the survey. Test data and other information are evaluated to determine what actions can be taken to reduce or stabilize the bioburden of the medical device. Pacific BioLabs can provide the necessary supplies for microbiological sampling. Exposed materials are returned to Pacific BioLabs for enumeration and reporting.

If any major changes are made at the facility or in the manufacturing process, or if product bioburden levels increase significantly, a re-evaluation of environmental conditions should be conducted.

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Pacific BioLabs works with many of its clients to establish and maintain cost-effective programs to meet FDA requirements for monitoring the microbial cleanliness of their manufacturing environments and assessing the efficacy of production area disinfection procedures. Our microbiologists can train quality assurance and manufacturing personnel to collect microbial environmental samples.

Following is an overview of aspects of a microbial environmental monitoring program. It is used for taking samples of flat surfaces. The lid of the dish is removed. The agar surface is pressed lightly against the surface to be sampled. The lid is then immediately replaced on the dish. It is used for semi-quantitative air sampling. The dish is placed in the desired location, the lid is removed and the agar is exposed for a defined amount of time, usually for 30 minutes to 2 hours.

Organisms falling from the air settle on the surface of the agar.

Medical Device Development: From Specification through Validation

This combination is used to neutralize chlorine, glutaraldehyde, iodophor, phenolic and quat based disinfectants. This agar is used to culture many types of bacteria and some fungi. This combination is used to neutralize alcohol, phenolic and quaternary ammonium chloride based disinfectants. It is used to select for yeast and molds. The sterile swab is provided in a paper pouch. Swabs are used for taking samples of non-flat surfaces. The swab is moistened by dipping it in the sterile buffer solution. The surface to be sampled is swabbed. The tip of the swab is then cut or broken into the test tube of solution and the cap is replaced on the test tube.

Package integrity tests are used to detect packaging problems that could adversely affect the sterility of a medical device.

Analytical method validation

Sterile products are subjected to an environmental stress intended to simulate extreme conditions that a product might encounter in shipping or storage. The product packaging is then subjected to microbial challenge or dye penetration testing to determine if it has retained its properties as a microbial barrier. Thirteen samples are recommended for this test.

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A pyrogen is the product of the action of heat on an organic substance and, in medical terms, is frequently described as a fever producing substance. The most potent pyrogens originate from gram negative bacteria, which are common water-borne organisms. Although not entirely accurate, the terms pyrogen and endotoxin are often used interchangeably. Detection of bacterial endotoxin contamination is essential to insure the safety of certain medical devices. Any product that is labeled as nonpyrogenic must be tested to verify that claim.

Medical devices with bloodstream or cerebrospinal fluid contact must also be tested for the presence of bacterial endotoxins. W hether or not a device is considered pyrogenic is based on the amount of endotoxin the device contains in correlation to the accepted human tolerance of 5 endotoxin units EU per kilogram of body weight. Nonpyrogenic water is used to extract medical devices.

Historically, the USP rabbit pyrogen test was used to test the extract. This is equivalent to 40 mL tested against 0. The LAL test is usually performed on a composite of the extracts of 10 samples.

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The most endotoxin one device could contain, if all others in a 10 sample composite contained zero endotoxin, would be EU. In a composite test, 20 EU is the average endotoxin limit for most medical devices. However, the limit for the devices which contact cerebrospinal fluid is 2. The maximum allowable extraction volume is calculated to insure that the average endotoxin burden per device in the LAL test does not exceed these limits. FDA has published guidelines outlining validation procedures for endotoxin testing of finished products using the LAL test.

One test is performed on a composite of the test samples. The realisation of a new design can be very costly, especially with the shorter product life cycle. As technology advances, there is typically a level of quality, safety and reliability that increases exponentially with time. For example, initial models of the artificial cardiac pacemaker were external support devices that transmits pulses of electricity to the heart muscles via electrode leads on the chest.

The electrodes contact the heart directly through the chest, allowing stimulation pulses to pass through the body. Recipients of this typically suffered infection at the entrance of the electrodes, which led to the subsequent trial of the first internal pacemaker, with electrodes attached to the myocardium by thoracotomy. Future developments led to the isotope-power source that would last for the lifespan of the patient. With the rise of smartphone usage in the medical space, in , the FDA issued to regulate mobile medical applications and protect users from their unintended use, soon followed by European and other regulatory agencies.

This guidance distinguishes the apps subjected to regulation based on the marketing claims of the apps. On September 25, the FDA released a draft guidance document for regulation of mobile medical applications, to clarify what kind of mobile apps related to health would not be regulated, and which would be. Medical devices such as pacemakers , insulin pumps, operating room monitors, defibrillators , and surgical instruments , including deep-brain stimulators, can incorporate the ability to transmit vital health information from a patient's body to medical professionals. This has engendered concern about privacy and security issues, [64] human error , and technical glitches with this technology.


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While only a few studies have looked at the susceptibility of medical devices to hacking, there is a risk. Jay Radcliff, a security researcher interested in the security of medical devices, raised fears about the safety of these devices.

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He shared his concerns at the Black Hat security conference. Some medical device makers downplay the threat from such attacks and argue that the demonstrated attacks have been performed by skilled security researchers and are unlikely to occur in the real world. At the same time, other makers have asked software security experts to investigate the safety of their devices.

With the PIN of the device, the scientist could wirelessly control the dosage of the insulin. The downside is that additional security features would put an extra strain on the battery and size and drive up prices.

Medical Device Sterility Assurance Tests

William Maisel offered some thoughts on the motivation to engage in this activity. Motivation to do this hacking might include acquisition of private information for financial gain or competitive advantage; damage to a device manufacturer's reputation; sabotage; intent to inflict financial or personal injury or just satisfaction for the attacker. One would be to use rolling codes. Another solution is to use a technology called "body-coupled communication" that uses the human skin as a wave guide for wireless communication.

On 28 December the US Food and Drug Administration released its recommendations that are not legally enforceable for how medical device manufacturers should maintain the security of Internet-connected devices. Similar to hazards, cybersecurity threats and vulnerabilities cannot be eliminated entirely but must be managed and reduced to a reasonable level. The medical device design approach employed should be consistent with the NIST Cybersecurity Framework for managing cybersecurity-related risks. In August , the FDA released over 20 regulations aiming to improve the security of data in medical devices, [76] in response to the growing risks of limited cybersecurity.

Medical equipment also known as armamentarium [77] is designed to aid in the diagnosis , monitoring or treatment of medical conditions. A biomedical equipment technician BMET is a vital component of the healthcare delivery system. Employed primarily by hospitals, BMETs are the people responsible for maintaining a facility's medical equipment. BMET mainly act as an interface between doctor and equipment. From Wikipedia, the free encyclopedia. Main article: Medical device manufacturing.

This section duplicates the scope of other articles , specifically, Medical device manufacturing. March Main article: Safety standards. Main article: Medical software. Further information: Medical device hijack. Equipment designed to aid in the diagnosis, monitoring or treatment of medical conditions.