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Industry News: ASP to Pay $1.2 M to FDA for Unsupported Shelflife of Biological Indicators

The FDA issued a News Release on 12/4/13 saying that it had reached a$1.25 million settlement with Advanced Sterilization Products and company executives for distributing adulterated and misbranded devices.

 ... The settlement requires ASP to pay $1.2 million, company President Bernard J. Zovighian to pay $30,000, and company Vice President of Quality and Regulatory Compliance Richard J. Alberti to pay $20,000.

This action was taken after the FDA learned that the company knew that it did not have sufficient data to support the shelf life stated on the label of its Sterrad Cyclesure 24 Biological Indicators, but continued to ship the product to customers with inaccurate expiration dates. Sterrad Cyclesure 24 Biological Indicators are used to monitor and confirm the effectiveness of the sterilization process in ASP’s Sterrad sterilizers.

“Accurate expiration dates are critical to ensuring product integrity,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “ASP’s actions violated the law and put patients at unnecessary risk for infection. ...”

During an inspection in June 2012, FDA learned that ASP had study data indicating that the effectiveness of the biological indicators had not been established for the entire 15-month shelf life indicated in the product labeling. ASP issued voluntary recalls of affected product in July 2012. ...

ASP has addressed the shelf-life issues relating to the recalled product by reducing the labeled shelf-life. ... 

OSHA Publishes Regulatory Agenda for Fall 2013

The Office of Information and Regulatory Affairs has published a unified regulatory agenda for federal government departments and agencies. The Department of Labor's regulatory agenda is on a linked page, including OSHA. There are two items of interest to readers of this blog.:

The first is the Review/Lookback of OSHA Chemical Standards (Pre-rule stage), 1218-AC74. This blog has frequently commented on the need to update the OSHA PELs and OSHA itself is well aware of the problem, and writes:

The majority of OSHA's Permissible Exposure Limits (PELs) were adopted in 1971, ... and only a few have been successfully updated since that time. There is widespread agreement among industry, labor, and professional occupational safety and health organizations that occupational safety and health organizations that OSHA's PELs are outdated and need revising in order to take into account newer scientific data that indicates that significant occupational health risks exist at levels below OSHA's current PELs. ... Recently, OSHA sought input through a stakeholder meeting and web forum to discuss various approaches that might be used to address its outdated PELs. As part of the Department's Regulatory Review and Lookback Efforts, OSHA is developing a Request for Information (RFI) seeking input from the public to help the Agency identify effective ways to address occupational exposure to chemicals.

It is still early days in the process and the wheels of government turn slowly, especially in a small agency like OSHA with limited resources and a large workplace to protect. Essentially the same proposal was made in  in the Fall of 2011 and again in the spring of 2013 with little progress so far; but we remain hopeful that OSHA will be able to issue modern standards in the not too distant future.

The second item is the Occupational Injury and Illness Recording and Reporting Requirements--NAICS Update and Reporting Revisions (Final rule stage). 1218-AC50 which has already been discussed in this blog.

NIOSH Solicits Comments on New Classification of Carcinogens

NIOSH has published a draft document titled Current Intelligence Bulletin: Update of NIOSH Carcinogen Classification and Target Risk Level Policy for Chemical Hazards in the Workplace and and has published a notice in the Federal Register. soliciting comments.

There have been several criticisms of NIOSH's current system for classifying carcinogens. The current method is described in 29 CFR 1999 "Identification, Classification and Regulations of Potential Occupational Carcinogens."

One of the objections is the term "Potential Occupational Carcinogen" which makes it sound as if the dangers of carcinogens such as benzene, ethylene oxide etc. are only 'Potential Carcinogens' and not the more definitive 'Known Carcinogens'.

Another criticism is that unlike other organizations such as the National Toxicology Program (NTP), the International Agency for Research on Cancer (IARC) and the Environmental Protection Agency (EPA) the current NIOSH carcinogen policy does not classify compounds based on the weight of the scientific evidence. The new proposals would bring NIOSH into line with these other organizations and avoid duplication of effort.

NIOSH will also continue to provide quantitative assessment of cancer risk but will modify the way it estimates its recommended exposure limits (RELs). The RELs will continue to be health-based but unlike before, NIOSH will no longer 'specifically consider technical 10 achievability (i.e., ability to control exposures) in establishing RELs.' Instead, the RELs include a note saying whether existing controls are available or effective, and suggest alternative methods to reduce worker exposure.

Comments must be submitted to NIOSH by February 13, 2014.

Blame Health and Safety!

Everyone knows that Health and Safety of important in the workplace and this blog often discusses serious issues related to health and safety. The Health and Safety Executive (HSE) is the UK's occupational safety agency, similar to the US OSHA.The HSE has collected a number of cases where individuals have cited Health and Safety regulations in situations that may not strictly apply. A few of the more humorous  2013 cases are copied below.

• The Chef at a carvery restaurant refused to serve the customer some skin off the turkey on the grounds of health and safety. The Chef said it was a 'choking hazard'.
•  A member of staff in a café refused to put sauce on the enquirers' ice cream due to health and safety reasons.
• The enquirer visited a racecourse as a spectator. While she was there, a steward confiscated her parasol because it posed a health and safety risk. She was told that someone could use it as a weapon.
• The enquirer and a friend went to a restaurant in a Department store and decided to share a baguette between them. When they asked for the baguette to be cut in half to share the assistant told them they were no longer able to do that because the store had taken away all the knives on health and safety grounds.
• During children's swimming lessons, the local swimming pool has banned spectating parents from reading e-readers, for child protection and health and safety reasons
• The school had planned to run a sports day for 3-4 year old pupils in the morning – followed by activities for older pupils in the afternoon. The morning event was postponed due to dew on the grass.
• The enquirer visited a department store restaurant with friends for breakfast and were told they couldn't have fried eggs because of 'health and safety issues'. Puzzled at this remark they enquired further. They were told it was because someone in another store had left a pan on the heat whilst frying eggs causing a fire, therefore the decision was made to stop supplying fried eggs in all store restaurants.
• The enquirer wanted to purchase filleted trout in her local supermarket. None was available pre-packed so they asked the assistant on the fresh fish counter if he could fillet some from a whole fish. He agreed but then his supervisor intervened saying that this wasn't possible on the grounds of health and safety because the fish are too slippery. The enquirer noted that on the supermarket website, it states "just ask if you'd like your fish skinned or filleted".
• A custard pie fight at a local event has been cancelled because the event organisers could not get insurance on the basis that the activity is too dangerous.
  
  

Some of these cases may be the result of people blaming health and safety laws in order to get their own way; others may be an over reaction to past accident and some may be the result of poor education, i.e. people learning about the regulations third or fourth hand; by which time they have become greatly embellished.

Therefore, if one does not want to end up on a list like the one above, is always important to ensure that both the employer and the employees have an accurate understanding of the health and safety laws and to apply common sense.

There are many more cases on the HSE website, including the HSE's commentary on each one.

OSHA uses General Duty Clause to Work Around Obsolete PELs

OSHA shifts tack with obsolete PELs and fines a company under the General Duty Clause for exposing workers to high levels of styrene vapor, resulting in lung injuries, despite the measured styrene concentration being below the outdated OSHA PEL. To do so, OSHA uses third party occupational exposure standards as the accepted standard of care instead of the PEL.

OSHA inspected a fiber glass factory and issued a fine in September for $49,500, in part for exposing workers to high levels of styrene—even though OSHA determined that styrene exposure at the factory was below OSHA's Permissible exposure limit (PEL) for styrene (currently 100 ppm 8 hr TWA, 200 ppm ceiling)

The OSHA (PELs) are widely acknowledged to be out of date, most being over 40 years old. OSHA recognizes that some of the PELs do not adequately protect worker health and in some cases are far above other exposure standards such as the the ACGIH TLVs (TLV for styrene = 20 ppm 8 Hr TWA, 40 ppm STEL (ACGIH 2008)) and NIOSH recommended exposure limits. (REL for styrene = TWA 50 ppm (215 mg/m3) ST 100 ppm (425 mg/m3))

OSHA tried to update the PELs in the 1980s, but the revised PELs were struck down by the 11th Circuit Court of Appeals in 1992 on the grounds that OSHA did not sufficiently demonstrate that the new PELs were necessary or that they were feasible.OSHA's PEL for styrene that was struck down was 8 hr TWA 50 ppm (215 mg/m3), STEL 100 ppm (425 mg/m3), or half the current limits, but still two and half times the ACGIH's TLV.

For OSHA to prosecute an employer for exposing employees to a chemical vapor below the PEL, OSHA must use the General Duty clause in the 1970 Occupational Safety and Health Act, Sec. (5), Duties.

(a) Each employer --
(1) shall furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees;...

To successfully prosecute under the general duty clause, OSHA must prove that the employer failed to provide a safe work environment and consequently that the styrene exposures were greater than safe levels, i.e. above the safe occupational exposure level (perhaps the ACGIH TLV).

It places OSHA in the ironic position of having to use another organization's occupational exposure limit, rather than the PEL and is a sad reflection on the inability of the agency to update its standards such that it must use this approach. However, OSHA appears to have decided that it needed a work-around for its obsolete PELs involving recommended third party occupational exposure limits and use of the General Duty clause.

As this blog recently reported, OSHA posted on its website an annotated table of exposure limits that includes occupational exposure limits from third-party organizations such as ACGIH and NIOSH that, for many chemicals, are much lower than the OSHA PELs. The fiber glass factory, (Fiberdome Inc) has already said that it intends to appeal. If the court accepts OSHA's approach, we can expect to see OSHA applying the same tactic against many other employers that use chemicals whose PELs are obsolete.

For employers it means that the compliance with OSHA PELs is no longer a bright line safe harbor and if workers are experiencing symptoms of chemical exposure, employers must take appropriate measures to protect their people and look to other applicable standards such as ACGIH. Appropriate measures include engineering controls (air turn overs, exhausts), continuous gas monitors, PPE and of course training on how to use the chemicals safely.

Peracetic Acid Spills in Hospitals - an Administrators nightmare

Every hospital administrator's nightmare is to see hazmat crews dressed in white overalls breathing through respirators running into their facility in front of the TV cameras while staff are evacuating patients in response to a chemical spill. High level disinfectant (HLD) chemicals such as peracetic acid are an essential part of modern healthcare, being used to disinfect those items that cannot be heat treated. These HLDs are used safely everyday across the world; but if something goes wrong, these chemicals pose a risk to anyone exposed to them and the administrators start having those dreams again.

Recently a few adminstrators had to face this very problem.On November 8th, over 100 staff and outpatients were evacuated from Harrogate Hospital, in the UK after a spill from a drum of peracetic acid in the endoscopy department. Closer to home, on November 15th a hazmat crew responded to report of a leaking peracetic acid container at a dialysis unit of Cape Coral Hospital in Florida.

In February last year Llandudno Hospital, Wales evacuated their outpatient department due to a peracetic acid spill and in June a peracetic acid spill at the Northbay Surgical Regional Center in Novato, CA resulted in one employee being treated for throat discomfort from the acid fumes. and evacuation of the first-floor patients who were able to walk, while three surgery patients who were semi-sedated were sheltered in a sealed room with their attendants. In 2010 another spill had Addenbrook's hospital near Cambridge, UK in 2010 evacuate staff and patients.

Peracetic acid is widely used as a high level disinfectant because of its superior antimicrobial properties but like all high level disinfectants, it poses a risk to anyone exposed to it. These hazards are well recognized and the ACGIH has proposed a TLV of 0.4 ppm 15 minute STEL.

Peracetic acid spills and leaks can occur form many reasons including container failure, equipment malfunction, wear and tear and of course human error. Leaks may be as vapor or liquid, though with the latter, there will always be vapor associated with liquid. Therefore when using peracetic acid it is important to employ good engineering controls, continuous gas monitoring, person protective equipment and good training etc.

Some problems appear suddenly and if the problem results in the release of peracetic acid vapors a continuous gas monitor will sound an alarm if the concentration approaches hazardous levels. However, many, perhaps most problems develop gradually over time. For these problems, a continuous gas monitor may provide an alert of the problem before it becomes a major issue. For more information about continuous gas monitors for peracetic acid or other gases and vapors contact ChemDAQ by e-mail at info@chemdaq.com or by telephone at 412-787-0202.

Government News: OSHA proposes new rules to increase reporting of workplace injuries

OSHA has announced proposed rules to increase reporting of workplace injuries and illnesses. Employers are currently required to keep records of workplace injuries and illnesses but under the new rules instead of just recording injury data, OSHA would require companies with more than 250 employees and some smaller high-risk organizations to report quarterly on-line. The proposed rules are available on-line in the Federal Register and the public has until Feb. 6, 2014 to submit written comments.

For comparison, the current reporting/recording regulations are summarized below.

Reporting
If an employee is killed in a work place related accident or three or more employees are hospitalized then Under the current regulations (29 CFR 1904) the employer must orally report the death to OSHA within eight (8) hours.

Recording
Employers are also required to keep records of serious occupational injuries and illnesses, using the OSHA 300 Log (with certain exceptions for very small and/or very safe workplaces)

OSHA Lists the recordable events as follows:

• Covered employers must record all work-related fatalities.
• Covered employers must record all work-related injuries and illnesses that result in days away from work, restricted work or transfer to another job, loss of consciousness or medical treatment beyond first aid.
• In addition, employers must record significant work-related injuries or illnesses diagnoses by a physician or other licensed health care professional, even if it does not result in death, days away from work, restricted work or job transfer, medical treatment beyond first aid, or loss of consciousness.
• Injuries include cases such as, but not limited to, a cut, fracture, sprain, or amputation.
• Illnesses include both acute and chronic illnesses, such as, but not limited to, a skin disease (i.e. contact dermatitis), respiratory disorder (i.e. occupational asthma, pneumoconiosis), or poisoning (i.e. lead poisoning, solvent intoxication).
• OSHA's definition of work-related injuries, illnesses and fatalities are those in which an event or exposure in the work environment either caused or contributed to the condition. In addition, if an event or exposure in the work environment significantly aggravated a pre-existing injury or illness, this is also considered work-related.

Annually, the summary of all incidents must be posted in a public area where employees can see it.

Further information about the current requirements is available at https://www.osha.gov/recordkeeping/.

The New AAMI Chemical Sterilization and High Level Disinfection Standard

As mentioned earlier in this blog, AAMI recently released a revised version of ST58, "Chemical sterilization and high-level disinfection in health care facilities" and copies are available from the AAMI website. Most people in healthcare know of AAMI and the AAMI standards which provide best practices for a range of healthcare operations. AAMI has several standards associated with sterilization and high level disinfection/disinfectant (HLD) and these standards have become the go-to documents for current best practices. Sterilization and HLD is a subject currently undergoing rapid developments with new equipment, new chemicals and new practices introduced in recent years and this topic is likely to continue to rapidly evolve.

The completely revised ST58 standard covers both gas sterilization (hydrogen peroxide and ozone) as well as HLDs (glutaraldehyde, o-phthalaldehdye (OPA), peracetic acid (PAA) and sodium hypochlorite (NaOCl)) and provides practical advice to enable users to employ the best practices. Ethylene oxide (EtO) is not included in ST58 since it has its own standard ST41
Ethylene oxide sterilization in health care facilities: Safety and effectiveness.

Compared to the prior version, this new version has greater emphasis on workplace safety, a subject about which ChemDAQ cares passionately about, well beyond gas detection. ChemDAQ's own David Hilliker and Richard Warburton served on the AAMI Chemical Sterilants Hospital Practice Working Group that revised the standard.

About half of the standard is comprised of annexes and each of the FDA approved chemical sterilants and HLDs has its own annex that provides succinct information including the following topics:

• Sterilant/ HLD chemical's properties and how it is used
• Health effects (short and long term)
• Exposure limits
• Suitable personal protective equipment for eyes, skin, respiratory system
• Guidance on how to use the chemical safety (ventilation, transportation, storing, use, rinsing (for HLDs))
• What to do in the event of a leaks or spill
• Disposal and 
• Vapor monitoring. 

Hydrogen peroxide is listed twice, once in Annex C as an HLD and again in Annex H as a sterilant gas (Steris' VHP & ASP's plasma sterilizers) since the applications are very different.

The vapor monitoring section in each annex has been updated to indicate the need for continuous gas monitoring and whether they are commercially available. For example, in light of the hazards of inhaling hydrogen peroxide vapor, the vapor monitoring section of annex H now reads:

H.7 Vapor monitoring
Vapor monitoring is recommended if there is the potential for the hydrogen peroxide vapor concentration to exceed the OSHA recommended permissible exposure limits. Emissions from properly operated and maintained chemical vapor sterilizers should be well below the OSHA PEL (see H.4.1.3), but sterilizers and exhaust systems, as with any other complex equipment, can and sometimes do fail. If monitoring is deemed necessary, continuous personal and area monitors for hydrogen peroxide are commercially available.

Gas and vapor emissions can occur from even the best made equipment and odor is an unreliable indicator of the presence and concentration of hydrogen peroxide gas below hazardous concentrations. Continuous gas monitoring systems are available to help employers satisfy the requirement to provide a safe work environment by providing alerts in case of potentially hazardous concentrations, informing workers when it is safe to return after a release and provide record keeping. Review the SDS and consult the suppliers of the hydrogen peroxide solutions and the manufacturers of the sterilizer and the gas monitoring equipment for more information.

In addition to the chemical annexes, there is also a new section (Annex N) that provides users some background on gas monitoring, the pros and cons of the technologies available and the difference between personal monitoring and area monitoring and the advantages of each. This annex should prove very valuable to anyone who uses chemical sterilization and who knows they need gas monitoring but is not sure where to start. 

Of course, readers of this blog know that the best place to start for any gas/vapor monitoring question is www.chemdaq.com. ChemDAQ offers continuous gas monitors for ethylene oxide, hydrogen peroxide, peracetic acid and ozone among others.


While the annexes are chemical specific, there is a lot of valuable general information in the body of the annexes, especially regarding:

• The safe use of chemical sterilants and HLDs 
• Location of a sterilizer or automatic reprocessor
• Storage of chemicals
• Qualifications and training of personnel
• Personal protective equipment
• Selection of appropriate sterilization technologies including health and safety considerations, 
• Decontamination
• Device storage
• Quality control and Quality improvement.

 The new ST58 standard should prove to be a valuable resource to those healthcare facilities that use chemical sterilization and high level disinfection.

Comparision of Healthcare Injury Rates in the US and UK

This blog has commented several times about the very high injury rate in healthcare compared to other industries and has repeated the statements made in the Executive Summary of the 2009 NORA report “State of the Sector Healthcare and Social Assistance.

The HCSA [Healthcare and Social Assistance] sector is burdened by the historical and entrenched belief that patient care issues supersede the personal safety and health of workers and that it is acceptable for HCSA workers to have less than optimal protections against the risks of hazardous exposures or injuries. Because patients and providers share the healthcare environment, efforts to protect patients and providers can be complimentary, even synergistic, when pursued through a comprehensive , integrated approach.

An OSHA press release, discussing statistics from the BLS for nonfatal occupational injuries and illnesses requiring days away from work in 2010 in healthcare stated that  
... the incidence rate for health care support workers increased 6 percent to 283 cases per 10,000 full-time workers, almost 2 1/2 times the rate for all private and public sector workers at 118 cases per 10,000 full-time workers. The rate among nursing aides, orderlies and attendants rose 7 percent, to 489 per 10,000 workers. Additionally, the rate of musculoskeletal disorder cases with days away from work for nursing aides, orderlies and attendants increased 10 percent to a rate of 249 cases per 10,000 workers.  

Assistant Secretary for the department's Occupational Safety and Health Administration Dr. David Michaels issued the following statement in response:

"It is unacceptable that the workers who have dedicated their lives to caring for our loved ones when they are sick are the very same workers who face the highest risk of work-related injury and illness. These injuries can end up destroying a family's emotional and financial security. While workplace injuries, illnesses and fatalities take an enormous toll on this nation's economy – the toll on injured workers and their families is intolerable...."

It is interesting to compare the situation in the US with the UK to determine if this lack of regard for employee safety is an industry or US problem or a more global issue. Both the US and UK are modern industrialized countries with comparable levels of healthcare technology and life expectancy (79 and; 80 yrs for the US and UK respectively), though the former is largely private institutions and the latter is a mix of National Healthcare Service (NHS) and private hospitals.

In the US occupational injury statistics are collected and reported by the Bureau of Labor Statistics (BLS) and in the UK by the Health and Safety Executive (HSE). The HSE has a webpage dedicated to the healthcare sector and has issued a report Health and safety in human health and social care in Great Britain, 2013 from which most of the UK data is drawn from.

 In the UK the rate of non-fatal injuries in healthcare (SIC 2007 divisions 86, 87, 88) has been slowly decreasing over time. The chart below shows the estimated averaged numbers of all self-reported workplace injury and of non-fatal injury with over three day absence, for people working  in health and social care in the last 12 months.




If we compare the UK and US numbers for 2010, the injury rate requiring time off was 2,830 per 100,000 workers for the US compared to the UK all non-fatal injuries 2,500 and 1,000 for injuries requiring more than 3 days off work. 

The two numbers though are not directly comparable since the US numbers are based on taking time off, whereas the UK numbers are based on both any reported non-fatal injury and non-fatal injuries taking three or more days off. It is reasonable to assume that the UK any non-fatal injury requiring time off would be between these lines. This data suggests that the non-fatal injury rate for UK healthcare personnel is significantly less than their US based colleagues, but because of the different data formats we are unable to say by how much less.

One of the more striking aspects of the US summary was the high rate of injury in healthcare compared to general industry. The same trend is seen in the UK.  The tables below based on the labor force survey (LFS) clearly shows that people in the caring personal services sector of healthcare are much more likely to suffer an injury and take time off work because of that injury than the general workforce. 

Non-fatal injuries vary with occupation





 The injury rate rate for caring personal services was (0.28/0.17=) 1.65 times greater than general industry compared to almost 2 1/2 times in the US indicating that this industry is more injury prone on both sides of the Atlantic.

We should be cautious about drawing too many conclusions from these numbers since the data may have been collected in different ways, with different assumptions made and the analysis above is only a cursory review of published summaries and so as Mark Twain credited Disraeli with saying "There are three kinds of lies: lies, damned lies and statistics."

However, overall it appears that the UK has a lower injury rate in healthcare compared to the US. In part this difference may be because OSHA's enforcement arm is needlessly cash limited, as discussed previously in this blog, and OSHA is limited to the size of the fine it can issue. Consider for example where an employee is fatally injured. Section 17 of the Occupational Safety and Health Act of 1970 sets the fine.

Any employer who willfully violates any standard, rule, or order promulgated pursuant to section 6 of this Act, or of any regulations prescribed pursuant to this Act, and that violation caused death to any employee, shall, upon conviction, be punished by a fine of not more than $10,000 or by imprisonment for not more than six months, or by both; except that if the conviction is for a violation committed after a first conviction of such person, punishment shall be by a fine of not more than $20,000 or by imprisonment for not more than one year, or by both.

OSHA's fines and the associated publicity are more embarrassing to organizations than having any real financial impact. In comparison, the HSE fined a cleaning company £175,000 ($281,000 at today's exchange rate) after a hospital porter was killed by an industrial waste compactor. 

The problem with small OSHA fines has been recognized by OSHA others and the Protecting America's Workers Act was introduced to Congress in January 2011 and would have increased OSHA fines, but it was not passed and the chance of it passing in the new future appears to be small.

A recent RAND report  suggests that the UK may have a stronger culture of workplace safety than the US, finding that in 2010, the fatality rate in the UK was about 1/3 the rate in the US. In construction the rate was about ¼ the US rate, a difference that had grown substantially since the 1990s. ..., lower rates were associated with high-level management attention to safety issues and to in-house preparation of “risk assessments.”  The authors concluded "Although work fatality rates have declined in the US, fatality rates are much lower and have declined faster in recent years in the UK. Efforts to find out the reasons for the much better UK outcomes could be productive."